Trial Outcomes & Findings for A Study of Niraparib Combination Therapies for the Treatment of Metastatic Castration-Resistant Prostate Cancer (NCT NCT03431350)

Last Updated: 2025-11-12

Results Overview

Number of participants with specified toxicity during Cycle 1 was reported. Only toxicities that occurred during safety evaluation period(defined as first 28 days of treatment-Cycle 1 of Part 1) was used for analysis of specified toxicities and for dose reduction decisions. Toxicities were graded for severity as per NCI-CTCAE, version 4.03. Safety evaluation criteria were: Any Grade(G) \>=3 non-hematological toxicity without anorexia, or constipation, fatigue improved to G\<=2 in \<7 days, vomiting and diarrhea resolved in \<=3 days, laboratory abnormalities with hospitalization, tumor flare improved to G\<=2 in \<=7 days, elevation in AST/ALT for \<=7 days and G3 hypertension controlled by medical therapy; any treatment-related(TR)G4 or G\>=3 thrombocytopenia required platelet transfusion; Any TR G4 neutropenia \>=7 days or G3 or 4 neutropenia with infection/fever \>38.5 degrees Celsius; Any TR SAE or intolerable toxicity.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

136 participants

Primary outcome timeframe

Cycle 1 (28 days)

Results posted on

2025-11-12

Participant Flow

In Combination 2, one participant who was homologous recombination repair (HRR) negative was erroneously enrolled to Cohort 2C (BRCA monoallelic loss) and thus was not included in the Intent-to-Treat (ITT) Population for the efficacy analysis. but was included in the safety analysis. This participant data were presented in participant flow, baseline characteristics and adverse events section. Data reported based on primary completion date, i.e., August 31, 2021.

Participant milestones

Participant milestones
Measure	Combination 1: Part 1 (Dose Seletion): Niraparib 200 mg + Cetrelimab 240 mg Participants with metastatic castration-resistant prostate cancer (mCRPC) who were either biomarker positive (BM+) or BM negative (BM-) for deoxyribonucleic acid (DNA)-repair gene defects (DRD) or BM+ for cyclin-dependent kinase 12 (CDK12) pathogenic alterations received niraparib 200 milligrams (mg) orally once daily in combination with cetrelimab 240 mg intravenous (IV) once every 4 weeks (i.e., on Day 1 of each cycle) in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.	Combination 1: Part 1 (Dose Selection): Niraparib 200 mg + Cetrelimab 480 mg Participants with mCRPC who were either BM+ or BM- for DRD or BM+ for CDK12 pathogenic alterations received niraparib 200 mg orally once daily in combination with cetrelimab 480 mg IV infusion once every 4 weeks (i.e., on Day 1 of each cycle) in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.	Combination 1: Part 2 (Dose Expansion): Cohort 1A: BM+: Niraparib 200 mg + Cetrelimab 480 mg Participants with mCRPC and were BM+ received established recommended Phase 2 dose (RP2D) of niraparib 200 mg once daily in combination with cetrelimab 480 mg IV infusion every 4 weeks i.e., on Day 1 of each cycle) in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.	Combination 1: Part 2 (Dose Expansion): Cohort 1B: BM-: Niraparib 200 mg + Cetrelimab 480 mg Participants with mCRPC and were BM- received established RP2D of niraparib 200 mg once daily in combination with cetrelimab 480 mg IV infusion every 4 weeks i.e., on Day 1 of each cycle) in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.	Combination 2: Cohort 2A: Niraparib+Abiraterone Acetate+Prednisone Participants with mCRPC and HRR gene alterations (breast cancer gene \[BRCA\] biallelic loss \[2A\]) received niraparib 200 mg orally once daily in combination with abiraterone acetate 1000 mg orally once daily plus prednisone (P) 10 mg (2\*5 mg) orally twice daily in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.	Combination 2: Cohort 2C: Niraparib+Abiraterone Acetate+Prednisone Participants with mCRPC and HRR gene alterations (BRCA monoallelic loss \[2C\]) received niraparib 200 mg orally once daily in combination with abiraterone acetate 1000 mg orally once daily plus prednisone 10 mg (2\*5 mg) orally twice daily in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.	Combination 2: Cohort 2D: Niraparib+Abiraterone Acetate+Prednisone Participants with mCRPC and HRR gene alterations (other DRD monoallelic loss \[2D\]) received niraparib 200 mg orally once daily in combination with abiraterone acetate 1000 mg orally once daily plus prednisone 10 mg (2\*5 mg) orally twice daily in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.	Combination 2: Cohort 2C: HRR Negative: Niraparib + Abiraterone Acetate + Prednisone Participants with mCRPC and HRR gene alteration negative received niraparib 200 mg orally once daily in combination with abiraterone acetate 1000 mg orally once daily plus prednisone 10 mg (2\*5 mg) orally twice daily in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.	Combination 3: Cohort 1A: Niraparib + Abiraterone Acetate, SA Participants with mCRPC (regardless of HRR BM status) received a single dose of niraparib 200 mg in combination with single oral dose of abiraterone acetate 1000 mg as single agent (SA) orally from Cycle 1 Day 1 to Day 8. After completion of Cycle 1 Day 8 (Pharmacokinetic \[PK\] Assessment Phase), Participants had the option to enter the Long-term Extension Phase of the study and received protocol defined treatment until study discontinuation.	Combination 3: Cohort 1B: Niraparib + Abiraterone Acetate, FDC1-RS (G010) Participants with mCRPC received a single dose of niraparib 200 mg in combination with single oral dose of abiraterone acetate 1000 as fixed-dose combination 1 (FDC1) regular-strength (RS) tablets orally from Cycle 2 1 Day 1 to Day 8. After completion of Cycle 1 Day 8 (PK Assessment Phase), participants had an option to enter the Long-term Extension Phase of the study and received protocol defined treatment until study discontinuation.	Combination 3: Cohort 2: Niraparib + Abiraterone Acetate, FDC2-RS (G012) Participants with mCRPC received a single dose of niraparib 200 mg in combination with single oral dose of abiraterone acetate 1000 mg as FDC2 RS tablets orally from Cycle 2 1 Day 1 to Day 8. After completion of Cycle 1 Day 8 (PK Assessment Phase), participants had an option to enter the Long-term Extension Phase of the study and received protocol defined treatment until study discontinuation.	Combination 3: Cohort 3: Niraparib + Abiraterone Acetate, FDC1-LS Participants with mCRPC received a single oral dose of niraparib 100 mg in combination with single oral dose of abiraterone acetate 1000 mg as FDC1 low strength (LS) tablets orally from Cycle 2 1 Day 1 to Day 8. After completion of Cycle 1 Day 8 (PK Assessment Phase), participants had an option to enter the Long-term Extension Phase of the study and received protocol defined treatment until study discontinuation.
Overall Study STARTED	6	6	21	11	8	9	6	1	17	17	17	17
Overall Study COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0
Overall Study NOT COMPLETED	6	6	21	11	8	9	6	1	17	17	17	17

Reasons for withdrawal

Reasons for withdrawal
Measure	Combination 1: Part 1 (Dose Seletion): Niraparib 200 mg + Cetrelimab 240 mg Participants with metastatic castration-resistant prostate cancer (mCRPC) who were either biomarker positive (BM+) or BM negative (BM-) for deoxyribonucleic acid (DNA)-repair gene defects (DRD) or BM+ for cyclin-dependent kinase 12 (CDK12) pathogenic alterations received niraparib 200 milligrams (mg) orally once daily in combination with cetrelimab 240 mg intravenous (IV) once every 4 weeks (i.e., on Day 1 of each cycle) in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.	Combination 1: Part 1 (Dose Selection): Niraparib 200 mg + Cetrelimab 480 mg Participants with mCRPC who were either BM+ or BM- for DRD or BM+ for CDK12 pathogenic alterations received niraparib 200 mg orally once daily in combination with cetrelimab 480 mg IV infusion once every 4 weeks (i.e., on Day 1 of each cycle) in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.	Combination 1: Part 2 (Dose Expansion): Cohort 1A: BM+: Niraparib 200 mg + Cetrelimab 480 mg Participants with mCRPC and were BM+ received established recommended Phase 2 dose (RP2D) of niraparib 200 mg once daily in combination with cetrelimab 480 mg IV infusion every 4 weeks i.e., on Day 1 of each cycle) in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.	Combination 1: Part 2 (Dose Expansion): Cohort 1B: BM-: Niraparib 200 mg + Cetrelimab 480 mg Participants with mCRPC and were BM- received established RP2D of niraparib 200 mg once daily in combination with cetrelimab 480 mg IV infusion every 4 weeks i.e., on Day 1 of each cycle) in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.	Combination 2: Cohort 2A: Niraparib+Abiraterone Acetate+Prednisone Participants with mCRPC and HRR gene alterations (breast cancer gene \[BRCA\] biallelic loss \[2A\]) received niraparib 200 mg orally once daily in combination with abiraterone acetate 1000 mg orally once daily plus prednisone (P) 10 mg (2\*5 mg) orally twice daily in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.	Combination 2: Cohort 2C: Niraparib+Abiraterone Acetate+Prednisone Participants with mCRPC and HRR gene alterations (BRCA monoallelic loss \[2C\]) received niraparib 200 mg orally once daily in combination with abiraterone acetate 1000 mg orally once daily plus prednisone 10 mg (2\*5 mg) orally twice daily in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.	Combination 2: Cohort 2D: Niraparib+Abiraterone Acetate+Prednisone Participants with mCRPC and HRR gene alterations (other DRD monoallelic loss \[2D\]) received niraparib 200 mg orally once daily in combination with abiraterone acetate 1000 mg orally once daily plus prednisone 10 mg (2\*5 mg) orally twice daily in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.	Combination 2: Cohort 2C: HRR Negative: Niraparib + Abiraterone Acetate + Prednisone Participants with mCRPC and HRR gene alteration negative received niraparib 200 mg orally once daily in combination with abiraterone acetate 1000 mg orally once daily plus prednisone 10 mg (2\*5 mg) orally twice daily in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.	Combination 3: Cohort 1A: Niraparib + Abiraterone Acetate, SA Participants with mCRPC (regardless of HRR BM status) received a single dose of niraparib 200 mg in combination with single oral dose of abiraterone acetate 1000 mg as single agent (SA) orally from Cycle 1 Day 1 to Day 8. After completion of Cycle 1 Day 8 (Pharmacokinetic \[PK\] Assessment Phase), Participants had the option to enter the Long-term Extension Phase of the study and received protocol defined treatment until study discontinuation.	Combination 3: Cohort 1B: Niraparib + Abiraterone Acetate, FDC1-RS (G010) Participants with mCRPC received a single dose of niraparib 200 mg in combination with single oral dose of abiraterone acetate 1000 as fixed-dose combination 1 (FDC1) regular-strength (RS) tablets orally from Cycle 2 1 Day 1 to Day 8. After completion of Cycle 1 Day 8 (PK Assessment Phase), participants had an option to enter the Long-term Extension Phase of the study and received protocol defined treatment until study discontinuation.	Combination 3: Cohort 2: Niraparib + Abiraterone Acetate, FDC2-RS (G012) Participants with mCRPC received a single dose of niraparib 200 mg in combination with single oral dose of abiraterone acetate 1000 mg as FDC2 RS tablets orally from Cycle 2 1 Day 1 to Day 8. After completion of Cycle 1 Day 8 (PK Assessment Phase), participants had an option to enter the Long-term Extension Phase of the study and received protocol defined treatment until study discontinuation.	Combination 3: Cohort 3: Niraparib + Abiraterone Acetate, FDC1-LS Participants with mCRPC received a single oral dose of niraparib 100 mg in combination with single oral dose of abiraterone acetate 1000 mg as FDC1 low strength (LS) tablets orally from Cycle 2 1 Day 1 to Day 8. After completion of Cycle 1 Day 8 (PK Assessment Phase), participants had an option to enter the Long-term Extension Phase of the study and received protocol defined treatment until study discontinuation.
Overall Study ONGOING	0	0	2	0	1	3	0	1	3	4	2	1
Overall Study Death	6	5	18	7	4	3	2	0	0	0	4	0
Overall Study Lost to Follow-up	0	1	0	0	0	0	0	0	0	0	0	0
Overall Study Withdrawal by Subject	0	0	0	1	1	1	0	0	0	2	0	1
Overall Study Other	0	0	1	3	2	2	4	0	14	11	11	15

Baseline Characteristics

A Study of Niraparib Combination Therapies for the Treatment of Metastatic Castration-Resistant Prostate Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Combination 1: Part 1 (Dose Seletion): Niraparib 200 mg + Cetrelimab 240 mg n=6 Participants Participants with metastatic castration-resistant prostate cancer (mCRPC) who were either biomarker positive (BM+) or BM negative (BM-) for deoxyribonucleic acid (DNA)-repair gene defects (DRD) or BM+ for cyclin-dependent kinase 12 (CDK12) pathogenic alterations received niraparib 200 milligrams (mg) orally once daily in combination with cetrelimab 240 mg intravenous (IV) once every 4 weeks (i.e., on Day 1 of each cycle) in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.	Combination 1: Part 1 (Dose Selection): Niraparib 200 mg + Cetrelimab 480 mg n=6 Participants Participants with mCRPC who were either BM+ or BM- for DRD or BM+ for CDK12 pathogenic alterations received niraparib 200 mg orally once daily in combination with cetrelimab 480 mg IV infusion once every 4 weeks (i.e., on Day 1 of each cycle) in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.	Combination 1: Part 2 (Dose Expansion): Cohort 1A: BM+: Niraparib 200 mg + Cetrelimab 480 mg n=21 Participants Participants with mCRPC and were BM+ received established recommended Phase 2 dose (RP2D) of niraparib 200 mg once daily in combination with cetrelimab 480 mg IV infusion every 4 weeks i.e., on Day 1 of each cycle) in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.	Combination 1: Part 2 (Dose Expansion): Cohort 1B: BM-: Niraparib 200 mg + Cetrelimab 480 mg n=11 Participants Participants with mCRPC and were BM- received established RP2D of niraparib 200 mg once daily in combination with cetrelimab 480 mg IV infusion every 4 weeks i.e., on Day 1 of each cycle) in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.	Combination 2: Cohort 2A: Niraparib+Abiraterone Acetate+Prednisone n=8 Participants Participants with mCRPC and HRR gene alterations (breast cancer gene \[BRCA\] biallelic loss \[2A\]) received niraparib 200 mg orally once daily in combination with abiraterone acetate 1000 mg orally once daily plus prednisone (P) 10 mg (2\*5 mg) orally twice daily in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.	Combination 2: Cohort 2C: Niraparib+Abiraterone Acetate+Prednisone n=9 Participants Participants with mCRPC and HRR gene alterations (BRCA monoallelic loss \[2C\]) received niraparib 200 mg orally once daily in combination with abiraterone acetate 1000 mg orally once daily plus prednisone 10 mg (2\*5 mg) orally twice daily in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.	Combination 2: Cohort 2D: Niraparib+Abiraterone Acetate+Prednisone n=6 Participants Participants with mCRPC and HRR gene alterations (other DRD monoallelic loss \[2D\]) received niraparib 200 mg orally once daily in combination with abiraterone acetate 1000 mg orally once daily plus prednisone 10 mg (2\*5 mg) orally twice daily in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.	Combination 2: Cohort 2C: HRR Negative: Niraparib + Abiraterone Acetate + Prednisone n=1 Participants Participants with mCRPC and HRR gene alteration negative received niraparib 200 mg orally once daily in combination with abiraterone acetate 1000 mg orally once daily plus prednisone 10 mg (2\*5 mg) orally twice daily in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.	Combination 3: Cohort 1A: Niraparib + Abiraterone Acetate, SA n=17 Participants Participants with mCRPC (regardless of HRR BM status) received a single dose of niraparib 200 mg in combination with single oral dose of abiraterone acetate 1000 mg as single agent (SA) orally from Cycle 1 Day 1 to Day 8. After completion of Cycle 1 Day 8 (Pharmacokinetic \[PK\] Assessment Phase), Participants had the option to enter the Long-term Extension Phase of the study and received protocol defined treatment until study discontinuation.	Combination 3: Cohort 1B: Niraparib + Abiraterone Acetate, FDC1-RS (G010) n=17 Participants Participants with mCRPC received a single dose of niraparib 200 mg in combination with single oral dose of abiraterone acetate 1000 as fixed-dose combination 1 (FDC1) regular-strength (RS) tablets orally from Cycle 2 1 Day 1 to Day 8. After completion of Cycle 1 Day 8 (PK Assessment Phase), participants had an option to enter the Long-term Extension Phase of the study and received protocol defined treatment until study discontinuation.	Combination 3: Cohort 2: Niraparib + Abiraterone Acetate, FDC2-RS (G012) n=17 Participants Participants with mCRPC received a single dose of niraparib 200 mg in combination with single oral dose of abiraterone acetate 1000 mg as FDC2 RS tablets orally from Cycle 2 1 Day 1 to Day 8. After completion of Cycle 1 Day 8 (PK Assessment Phase), participants had an option to enter the Long-term Extension Phase of the study and received protocol defined treatment until study discontinuation.	Combination 3: Cohort 3: Niraparib + Abiraterone Acetate, FDC1-LS n=17 Participants Participants with mCRPC received a single oral dose of niraparib 100 mg in combination with single oral dose of abiraterone acetate 1000 mg as FDC1 low strength (LS) tablets orally from Cycle 2 1 Day 1 to Day 8. After completion of Cycle 1 Day 8 (PK Assessment Phase), participants had an option to enter the Long-term Extension Phase of the study and received protocol defined treatment until study discontinuation.	Total n=136 Participants Total of all reporting groups
Age, Continuous	65.3 years STANDARD_DEVIATION 7.15 • n=10 Participants	66.7 years STANDARD_DEVIATION 12.56 • n=10 Participants	68.1 years STANDARD_DEVIATION 6.6 • n=20 Participants	66.6 years STANDARD_DEVIATION 3.91 • n=45 Participants	71.4 years STANDARD_DEVIATION 8.23 • n=44 Participants	71.3 years STANDARD_DEVIATION 5.89 • n=8 Participants	72.8 years STANDARD_DEVIATION 9.75 • n=48 Participants	80 years n=18 Participants	72.3 years STANDARD_DEVIATION 7.19 • n=15 Participants	71.1 years STANDARD_DEVIATION 7.96 • n=91 Participants	71.2 years STANDARD_DEVIATION 7.85 • n=101 Participants	72.9 years STANDARD_DEVIATION 7.36 • n=101 Participants	70.4 years STANDARD_DEVIATION 7.61 • n=105 Participants
Sex: Female, Male Female	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants	0 Participants n=45 Participants	0 Participants n=44 Participants	0 Participants n=8 Participants	0 Participants n=48 Participants	0 Participants n=18 Participants	0 Participants n=15 Participants	0 Participants n=91 Participants	0 Participants n=101 Participants	0 Participants n=101 Participants	0 Participants n=105 Participants
Sex: Female, Male Male	6 Participants n=10 Participants	6 Participants n=10 Participants	21 Participants n=20 Participants	11 Participants n=45 Participants	8 Participants n=44 Participants	9 Participants n=8 Participants	6 Participants n=48 Participants	1 Participants n=18 Participants	17 Participants n=15 Participants	17 Participants n=91 Participants	17 Participants n=101 Participants	17 Participants n=101 Participants	136 Participants n=105 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants	0 Participants n=45 Participants	0 Participants n=44 Participants	0 Participants n=8 Participants	0 Participants n=48 Participants	0 Participants n=18 Participants	0 Participants n=15 Participants	0 Participants n=91 Participants	0 Participants n=101 Participants	0 Participants n=101 Participants	0 Participants n=105 Participants
Race/Ethnicity, Customized Asian	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants	1 Participants n=45 Participants	0 Participants n=44 Participants	0 Participants n=8 Participants	0 Participants n=48 Participants	0 Participants n=18 Participants	1 Participants n=15 Participants	0 Participants n=91 Participants	0 Participants n=101 Participants	0 Participants n=101 Participants	2 Participants n=105 Participants
Race/Ethnicity, Customized Black or African American	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants	2 Participants n=45 Participants	1 Participants n=44 Participants	0 Participants n=8 Participants	1 Participants n=48 Participants	1 Participants n=18 Participants	0 Participants n=15 Participants	0 Participants n=91 Participants	0 Participants n=101 Participants	0 Participants n=101 Participants	5 Participants n=105 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants	0 Participants n=45 Participants	0 Participants n=44 Participants	0 Participants n=8 Participants	0 Participants n=48 Participants	0 Participants n=18 Participants	0 Participants n=15 Participants	1 Participants n=91 Participants	0 Participants n=101 Participants	0 Participants n=101 Participants	1 Participants n=105 Participants
Race/Ethnicity, Customized White	5 Participants n=10 Participants	6 Participants n=10 Participants	21 Participants n=20 Participants	8 Participants n=45 Participants	7 Participants n=44 Participants	9 Participants n=8 Participants	5 Participants n=48 Participants	0 Participants n=18 Participants	14 Participants n=15 Participants	14 Participants n=91 Participants	16 Participants n=101 Participants	16 Participants n=101 Participants	121 Participants n=105 Participants
Race/Ethnicity, Customized More than one race	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants	0 Participants n=45 Participants	0 Participants n=44 Participants	0 Participants n=8 Participants	0 Participants n=48 Participants	0 Participants n=18 Participants	0 Participants n=15 Participants	0 Participants n=91 Participants	0 Participants n=101 Participants	0 Participants n=101 Participants	0 Participants n=105 Participants
Race/Ethnicity, Customized Unknown or Not Reported	1 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants	0 Participants n=45 Participants	0 Participants n=44 Participants	0 Participants n=8 Participants	0 Participants n=48 Participants	0 Participants n=18 Participants	2 Participants n=15 Participants	2 Participants n=91 Participants	1 Participants n=101 Participants	1 Participants n=101 Participants	7 Participants n=105 Participants
Region of Enrollment BELGIUM	0 Participants n=10 Participants	0 Participants n=10 Participants	1 Participants n=20 Participants	0 Participants n=45 Participants	1 Participants n=44 Participants	0 Participants n=8 Participants	1 Participants n=48 Participants	0 Participants n=18 Participants	4 Participants n=15 Participants	2 Participants n=91 Participants	4 Participants n=101 Participants	3 Participants n=101 Participants	16 Participants n=105 Participants
Region of Enrollment CANADA	0 Participants n=10 Participants	0 Participants n=10 Participants	3 Participants n=20 Participants	0 Participants n=45 Participants	1 Participants n=44 Participants	4 Participants n=8 Participants	2 Participants n=48 Participants	0 Participants n=18 Participants	2 Participants n=15 Participants	2 Participants n=91 Participants	2 Participants n=101 Participants	0 Participants n=101 Participants	16 Participants n=105 Participants
Region of Enrollment ISRAEL	0 Participants n=10 Participants	0 Participants n=10 Participants	3 Participants n=20 Participants	2 Participants n=45 Participants	0 Participants n=44 Participants	0 Participants n=8 Participants	0 Participants n=48 Participants	0 Participants n=18 Participants	7 Participants n=15 Participants	5 Participants n=91 Participants	2 Participants n=101 Participants	8 Participants n=101 Participants	27 Participants n=105 Participants
Region of Enrollment ITALY	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants	0 Participants n=45 Participants	2 Participants n=44 Participants	1 Participants n=8 Participants	0 Participants n=48 Participants	0 Participants n=18 Participants	0 Participants n=15 Participants	0 Participants n=91 Participants	0 Participants n=101 Participants	0 Participants n=101 Participants	3 Participants n=105 Participants
Region of Enrollment SPAIN	2 Participants n=10 Participants	4 Participants n=10 Participants	2 Participants n=20 Participants	1 Participants n=45 Participants	0 Participants n=44 Participants	0 Participants n=8 Participants	0 Participants n=48 Participants	0 Participants n=18 Participants	0 Participants n=15 Participants	0 Participants n=91 Participants	4 Participants n=101 Participants	0 Participants n=101 Participants	13 Participants n=105 Participants
Region of Enrollment UNITED KINGDOM	3 Participants n=10 Participants	0 Participants n=10 Participants	4 Participants n=20 Participants	0 Participants n=45 Participants	0 Participants n=44 Participants	0 Participants n=8 Participants	0 Participants n=48 Participants	0 Participants n=18 Participants	0 Participants n=15 Participants	0 Participants n=91 Participants	1 Participants n=101 Participants	0 Participants n=101 Participants	8 Participants n=105 Participants
Region of Enrollment UNITED STATES	1 Participants n=10 Participants	2 Participants n=10 Participants	8 Participants n=20 Participants	8 Participants n=45 Participants	4 Participants n=44 Participants	4 Participants n=8 Participants	3 Participants n=48 Participants	1 Participants n=18 Participants	4 Participants n=15 Participants	8 Participants n=91 Participants	4 Participants n=101 Participants	6 Participants n=101 Participants	53 Participants n=105 Participants

PRIMARY outcome

Timeframe: Cycle 1 (28 days)

Population: The safety analysis set included all randomized participants who received at least 1 dose of study drug. Here, 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. This outcome measure was analyzed for specified arms only as pre-planned in the protocol.

Outcome measures

Outcome measures
Measure	Combination 1: Part 1 (Dose Seletion): Niraparib 200 mg + Cetrelimab 240 mg n=5 Participants Participants with metastatic castration-resistant prostate cancer (mCRPC) who were either biomarker positive (BM+) or BM negative (BM-) for deoxyribonucleic acid (DNA)-repair gene defects (DRD) or BM+ for cyclin-dependent kinase 12 (CDK12) pathogenic alterations received niraparib 200 milligrams (mg) orally once daily in combination with cetrelimab 240 mg intravenous (IV) once every 4 weeks (i.e., on Day 1 of each cycle) in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.	Combination 1: Part 1 (Dose Selection): Niraparib 200 mg + Cetrelimab 480 mg n=6 Participants Participants with mCRPC who were either BM+ or BM- for DRD or BM+ for CDK12 pathogenic alterations received niraparib 200 mg orally once daily in combination with cetrelimab 480 mg IV infusion once every 4 weeks (i.e., on Day 1 of each cycle) in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.	Combination 2: Cohort 2D: Niraparib+Abiraterone Acetate+Prednisone Participants with mCRPC and HRR gene alterations (other DRD monoallelic loss \[2D\]) received niraparib 200 mg orally once daily in combination with abiraterone acetate 1000 mg orally once daily plus prednisone 10 mg (2\*5 mg) orally twice daily in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.	Combination 2: Cohort 2C: HRR Negative: Niraparib + Abiraterone Acetate + Prednisone Participants with mCRPC and HRR gene alteration negative received niraparib 200 mg orally once daily in combination with abiraterone acetate 1000 mg orally once daily plus prednisone 10 mg (2\*5 mg) orally twice daily in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.
Combination 1: Part 1: Number of Participants With Specified Toxicity	0 Participants	0 Participants	—	—

PRIMARY outcome

Timeframe: Up to 37 months

Population: Intent-to-Treat (ITT) analysis set included all participants who had at least 1 dose of both study drugs at the selected RP2D in Combination 1: Part 2 of study. This outcome measure was analyzed for specified arms only as pre-planned in the protocol.

ORR of soft tissue (visceral or nodal disease) was defined as percentage of participants with measurable disease who achieved a best response of either complete response (CR) or partial response (PR) as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 with no evidence of bone progression according to prostate cancer working group 3 (PCWG3) criteria.

Outcome measures

Outcome measures
Measure	Combination 1: Part 1 (Dose Seletion): Niraparib 200 mg + Cetrelimab 240 mg n=21 Participants Participants with metastatic castration-resistant prostate cancer (mCRPC) who were either biomarker positive (BM+) or BM negative (BM-) for deoxyribonucleic acid (DNA)-repair gene defects (DRD) or BM+ for cyclin-dependent kinase 12 (CDK12) pathogenic alterations received niraparib 200 milligrams (mg) orally once daily in combination with cetrelimab 240 mg intravenous (IV) once every 4 weeks (i.e., on Day 1 of each cycle) in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.	Combination 1: Part 1 (Dose Selection): Niraparib 200 mg + Cetrelimab 480 mg n=11 Participants Participants with mCRPC who were either BM+ or BM- for DRD or BM+ for CDK12 pathogenic alterations received niraparib 200 mg orally once daily in combination with cetrelimab 480 mg IV infusion once every 4 weeks (i.e., on Day 1 of each cycle) in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.	Combination 2: Cohort 2D: Niraparib+Abiraterone Acetate+Prednisone Participants with mCRPC and HRR gene alterations (other DRD monoallelic loss \[2D\]) received niraparib 200 mg orally once daily in combination with abiraterone acetate 1000 mg orally once daily plus prednisone 10 mg (2\*5 mg) orally twice daily in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.	Combination 2: Cohort 2C: HRR Negative: Niraparib + Abiraterone Acetate + Prednisone Participants with mCRPC and HRR gene alteration negative received niraparib 200 mg orally once daily in combination with abiraterone acetate 1000 mg orally once daily plus prednisone 10 mg (2\*5 mg) orally twice daily in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.
Combination 1: Part 2: Objective Response Rate (ORR)	23.8 Percentage of participants Interval 9.9 to 43.7	9.1 Percentage of participants Interval 0.5 to 36.4	—	—

PRIMARY outcome

Timeframe: Up to 31 months

Population: ITT analysis set included all participants who had at least 1 dose of both study drugs at the selected RP2D in Part 2 of study. In Combination 2, one participant who was HRR negative was erroneously enrolled to Cohort 2C (BRCA monoallelic loss) and was presented under arm named "Combination 2: Cohort 2C: HRR negative: Niraparib + Abiraterone Acetate + Prednisone". Due to erroneous enrollment, this participant was not included in the ITT population for the efficacy analysis of this endpoint.

Composite response rate was defined as the percentage of participants who had a composite response which is defined as one of the following PCWG3 criteria: Objective response (percentage of participants with measurable disease who achieved a best response of either CR or PR as assessed by RECIST 1.1 with no evidence of bone progression according to PCWG3 criteria) (confirmed per RECIST 1.1), or; circulating tumor cells (CTC) response: defined as CTC=0 per 7.5 milliliters (mL) of blood at 8 weeks for participants who had CTC greater than or equal to (\>=) 1 at baseline or CTC less than (\<) 5 per 7.5 mL with CTC \>=5 at baseline, confirmed by a second consecutive value obtained 4 or more weeks later, or prostate-specific antigen (PSA) declined of \>=50 percentage (%), measured twice 3 to 4 weeks apart. This outcome measure was analyzed for specified arms only as pre-planned in the protocol.

Outcome measures

Outcome measures
Measure	Combination 1: Part 1 (Dose Seletion): Niraparib 200 mg + Cetrelimab 240 mg n=8 Participants Participants with metastatic castration-resistant prostate cancer (mCRPC) who were either biomarker positive (BM+) or BM negative (BM-) for deoxyribonucleic acid (DNA)-repair gene defects (DRD) or BM+ for cyclin-dependent kinase 12 (CDK12) pathogenic alterations received niraparib 200 milligrams (mg) orally once daily in combination with cetrelimab 240 mg intravenous (IV) once every 4 weeks (i.e., on Day 1 of each cycle) in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.	Combination 1: Part 1 (Dose Selection): Niraparib 200 mg + Cetrelimab 480 mg n=9 Participants Participants with mCRPC who were either BM+ or BM- for DRD or BM+ for CDK12 pathogenic alterations received niraparib 200 mg orally once daily in combination with cetrelimab 480 mg IV infusion once every 4 weeks (i.e., on Day 1 of each cycle) in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.	Combination 2: Cohort 2D: Niraparib+Abiraterone Acetate+Prednisone n=6 Participants Participants with mCRPC and HRR gene alterations (other DRD monoallelic loss \[2D\]) received niraparib 200 mg orally once daily in combination with abiraterone acetate 1000 mg orally once daily plus prednisone 10 mg (2\*5 mg) orally twice daily in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.	Combination 2: Cohort 2C: HRR Negative: Niraparib + Abiraterone Acetate + Prednisone Participants with mCRPC and HRR gene alteration negative received niraparib 200 mg orally once daily in combination with abiraterone acetate 1000 mg orally once daily plus prednisone 10 mg (2\*5 mg) orally twice daily in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.
Combination 2: Composite Response Rate (RR)	75.0 Percentage of participants Interval 40.0 to 95.4	55.6 Percentage of participants Interval 25.1 to 83.1	33.3 Percentage of participants Interval 6.3 to 72.9	—

PRIMARY outcome

Timeframe: Up to 37 months

Population: The safety analysis set included all randomized participants who received at least 1 dose of study drug. This outcome measure was analyzed for specified arms only as pre-planned in the protocol.

Outcome measures

Outcome measures
Measure	Combination 1: Part 1 (Dose Seletion): Niraparib 200 mg + Cetrelimab 240 mg n=21 Participants Participants with metastatic castration-resistant prostate cancer (mCRPC) who were either biomarker positive (BM+) or BM negative (BM-) for deoxyribonucleic acid (DNA)-repair gene defects (DRD) or BM+ for cyclin-dependent kinase 12 (CDK12) pathogenic alterations received niraparib 200 milligrams (mg) orally once daily in combination with cetrelimab 240 mg intravenous (IV) once every 4 weeks (i.e., on Day 1 of each cycle) in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.	Combination 1: Part 1 (Dose Selection): Niraparib 200 mg + Cetrelimab 480 mg n=11 Participants Participants with mCRPC who were either BM+ or BM- for DRD or BM+ for CDK12 pathogenic alterations received niraparib 200 mg orally once daily in combination with cetrelimab 480 mg IV infusion once every 4 weeks (i.e., on Day 1 of each cycle) in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.	Combination 2: Cohort 2D: Niraparib+Abiraterone Acetate+Prednisone Participants with mCRPC and HRR gene alterations (other DRD monoallelic loss \[2D\]) received niraparib 200 mg orally once daily in combination with abiraterone acetate 1000 mg orally once daily plus prednisone 10 mg (2\*5 mg) orally twice daily in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.	Combination 2: Cohort 2C: HRR Negative: Niraparib + Abiraterone Acetate + Prednisone Participants with mCRPC and HRR gene alteration negative received niraparib 200 mg orally once daily in combination with abiraterone acetate 1000 mg orally once daily plus prednisone 10 mg (2\*5 mg) orally twice daily in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.
Combination 1: Part 2: Number of Participants With Adverse Events (AEs)	21 Participants	11 Participants	—	—

PRIMARY outcome

Timeframe: Up to 31 months

Outcome measures

Outcome measures
Measure	Combination 1: Part 1 (Dose Seletion): Niraparib 200 mg + Cetrelimab 240 mg n=8 Participants Participants with metastatic castration-resistant prostate cancer (mCRPC) who were either biomarker positive (BM+) or BM negative (BM-) for deoxyribonucleic acid (DNA)-repair gene defects (DRD) or BM+ for cyclin-dependent kinase 12 (CDK12) pathogenic alterations received niraparib 200 milligrams (mg) orally once daily in combination with cetrelimab 240 mg intravenous (IV) once every 4 weeks (i.e., on Day 1 of each cycle) in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.	Combination 1: Part 1 (Dose Selection): Niraparib 200 mg + Cetrelimab 480 mg n=9 Participants Participants with mCRPC who were either BM+ or BM- for DRD or BM+ for CDK12 pathogenic alterations received niraparib 200 mg orally once daily in combination with cetrelimab 480 mg IV infusion once every 4 weeks (i.e., on Day 1 of each cycle) in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.	Combination 2: Cohort 2D: Niraparib+Abiraterone Acetate+Prednisone n=6 Participants Participants with mCRPC and HRR gene alterations (other DRD monoallelic loss \[2D\]) received niraparib 200 mg orally once daily in combination with abiraterone acetate 1000 mg orally once daily plus prednisone 10 mg (2\*5 mg) orally twice daily in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.	Combination 2: Cohort 2C: HRR Negative: Niraparib + Abiraterone Acetate + Prednisone n=1 Participants Participants with mCRPC and HRR gene alteration negative received niraparib 200 mg orally once daily in combination with abiraterone acetate 1000 mg orally once daily plus prednisone 10 mg (2\*5 mg) orally twice daily in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.
Combination 2: Number of Participants With Adverse Events (AEs)	8 Participants	9 Participants	5 Participants	1 Participants

PRIMARY outcome

Timeframe: Up to 37 months

AE was defined as an any untoward medical occurrence in a clinical study subject administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. An assessment of severity grade was made using the National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) as Grade 1 (mild): awareness of symptoms that are easily tolerated, causing minimal discomfort and not interfering with everyday activities; Grade 2 (moderate): sufficient discomfort is present to cause interference with normal activity; Grade 3 (severe): extreme distress, causing significant impairment of functioning or incapacitation, prevents normal everyday activities; Grade 4 (Life-threatening): urgent intervention indicated; and Grade 5 (death).

Outcome measures

Outcome measures
Measure	Combination 1: Part 1 (Dose Seletion): Niraparib 200 mg + Cetrelimab 240 mg n=21 Participants Participants with metastatic castration-resistant prostate cancer (mCRPC) who were either biomarker positive (BM+) or BM negative (BM-) for deoxyribonucleic acid (DNA)-repair gene defects (DRD) or BM+ for cyclin-dependent kinase 12 (CDK12) pathogenic alterations received niraparib 200 milligrams (mg) orally once daily in combination with cetrelimab 240 mg intravenous (IV) once every 4 weeks (i.e., on Day 1 of each cycle) in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.	Combination 1: Part 1 (Dose Selection): Niraparib 200 mg + Cetrelimab 480 mg n=11 Participants Participants with mCRPC who were either BM+ or BM- for DRD or BM+ for CDK12 pathogenic alterations received niraparib 200 mg orally once daily in combination with cetrelimab 480 mg IV infusion once every 4 weeks (i.e., on Day 1 of each cycle) in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.	Combination 2: Cohort 2D: Niraparib+Abiraterone Acetate+Prednisone Participants with mCRPC and HRR gene alterations (other DRD monoallelic loss \[2D\]) received niraparib 200 mg orally once daily in combination with abiraterone acetate 1000 mg orally once daily plus prednisone 10 mg (2\*5 mg) orally twice daily in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.	Combination 2: Cohort 2C: HRR Negative: Niraparib + Abiraterone Acetate + Prednisone Participants with mCRPC and HRR gene alteration negative received niraparib 200 mg orally once daily in combination with abiraterone acetate 1000 mg orally once daily plus prednisone 10 mg (2\*5 mg) orally twice daily in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.
Combination 1: Part 2: Number of Participants With Adverse Events (AEs) of Grade >=3 Severity	14 Participants	8 Participants	—	—

PRIMARY outcome

Timeframe: Up to 31 months

AE was defined as an any untoward medical occurrence in a clinical study subject administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. An assessment of severity grade was made using the NCI-CTCAE as Grade 1 (mild): awareness of symptoms that are easily tolerated, causing minimal discomfort and not interfering with everyday activities; Grade 2 (moderate): sufficient discomfort is present to cause interference with normal activity; Grade 3 (severe): extreme distress, causing significant impairment of functioning or incapacitation, prevents normal everyday activities; Grade 4 (Life-threatening): urgent intervention indicated; and Grade 5 (death).

Outcome measures

Outcome measures
Measure	Combination 1: Part 1 (Dose Seletion): Niraparib 200 mg + Cetrelimab 240 mg n=8 Participants Participants with metastatic castration-resistant prostate cancer (mCRPC) who were either biomarker positive (BM+) or BM negative (BM-) for deoxyribonucleic acid (DNA)-repair gene defects (DRD) or BM+ for cyclin-dependent kinase 12 (CDK12) pathogenic alterations received niraparib 200 milligrams (mg) orally once daily in combination with cetrelimab 240 mg intravenous (IV) once every 4 weeks (i.e., on Day 1 of each cycle) in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.	Combination 1: Part 1 (Dose Selection): Niraparib 200 mg + Cetrelimab 480 mg n=9 Participants Participants with mCRPC who were either BM+ or BM- for DRD or BM+ for CDK12 pathogenic alterations received niraparib 200 mg orally once daily in combination with cetrelimab 480 mg IV infusion once every 4 weeks (i.e., on Day 1 of each cycle) in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.	Combination 2: Cohort 2D: Niraparib+Abiraterone Acetate+Prednisone n=6 Participants Participants with mCRPC and HRR gene alterations (other DRD monoallelic loss \[2D\]) received niraparib 200 mg orally once daily in combination with abiraterone acetate 1000 mg orally once daily plus prednisone 10 mg (2\*5 mg) orally twice daily in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.	Combination 2: Cohort 2C: HRR Negative: Niraparib + Abiraterone Acetate + Prednisone n=1 Participants Participants with mCRPC and HRR gene alteration negative received niraparib 200 mg orally once daily in combination with abiraterone acetate 1000 mg orally once daily plus prednisone 10 mg (2\*5 mg) orally twice daily in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.
Combination 2: Number of Participants With Adverse Events (AEs) of Grade >=3 Severity	6 Participants	7 Participants	4 Participants	1 Participants

PRIMARY outcome

Timeframe: Pre-dose, 30 min, 1 hour (hr), 1.5 hr, 2hr, 3 hr, 4 hr, 6 hr, 8 hr, 10 hr, 24 hr, 48 hr, 72 hr, and 168 hr post dose on Day 1

Population: Pharmacokinetic (PK) analysis set included all participants who received at least 1 dose of both study agents (either as a fixed dose combination \[FDC\] or single agent combination \[SAC\]) and had at least 1 concentration value. Here, 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. This outcome measure was analyzed for specified arms only as pre-planned in the protocol.

Cmax is defined as maximum observed plasma concentration of niraparib and abiraterone acetate (AA) after a single dose.

Outcome measures

Outcome measures
Measure	Combination 1: Part 1 (Dose Seletion): Niraparib 200 mg + Cetrelimab 240 mg n=16 Participants Participants with metastatic castration-resistant prostate cancer (mCRPC) who were either biomarker positive (BM+) or BM negative (BM-) for deoxyribonucleic acid (DNA)-repair gene defects (DRD) or BM+ for cyclin-dependent kinase 12 (CDK12) pathogenic alterations received niraparib 200 milligrams (mg) orally once daily in combination with cetrelimab 240 mg intravenous (IV) once every 4 weeks (i.e., on Day 1 of each cycle) in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.	Combination 1: Part 1 (Dose Selection): Niraparib 200 mg + Cetrelimab 480 mg n=16 Participants Participants with mCRPC who were either BM+ or BM- for DRD or BM+ for CDK12 pathogenic alterations received niraparib 200 mg orally once daily in combination with cetrelimab 480 mg IV infusion once every 4 weeks (i.e., on Day 1 of each cycle) in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.	Combination 2: Cohort 2D: Niraparib+Abiraterone Acetate+Prednisone n=17 Participants Participants with mCRPC and HRR gene alterations (other DRD monoallelic loss \[2D\]) received niraparib 200 mg orally once daily in combination with abiraterone acetate 1000 mg orally once daily plus prednisone 10 mg (2\*5 mg) orally twice daily in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.	Combination 2: Cohort 2C: HRR Negative: Niraparib + Abiraterone Acetate + Prednisone Participants with mCRPC and HRR gene alteration negative received niraparib 200 mg orally once daily in combination with abiraterone acetate 1000 mg orally once daily plus prednisone 10 mg (2\*5 mg) orally twice daily in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.
Combination 3: Maximum Observed Plasma Concentration (Cmax) of Niraparib and Abiraterone Acetate After a Single Dose	428 Nanograms per milliliter (ng/mL) Standard Deviation 189	398 Nanograms per milliliter (ng/mL) Standard Deviation 160	417 Nanograms per milliliter (ng/mL) Standard Deviation 176	—

PRIMARY outcome

Timeframe: Pre-dose, 30 min, 1 hour (hr), 1.5 hr, 2hr, 3 hr, 4 hr, 6 hr, 8 hr, 10 hr, 24 hr, 48 hr, 72 hr, and 168 hr post dose on Day 1

Population: PK analysis set included all participants who received at least 1 dose of both study agents (either as a FDC or SAC) and had at least 1 concentration value. Here, 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. This outcome measure was analyzed for specified arms only as pre-planned in the protocol.

Cmax/dose of niraparib was defined as maximum observed plasma concentration of niraparib Cmax normalized by the dose of niraparib administered with AA after a single dose.

Outcome measures

Outcome measures
Measure	Combination 1: Part 1 (Dose Seletion): Niraparib 200 mg + Cetrelimab 240 mg n=16 Participants Participants with metastatic castration-resistant prostate cancer (mCRPC) who were either biomarker positive (BM+) or BM negative (BM-) for deoxyribonucleic acid (DNA)-repair gene defects (DRD) or BM+ for cyclin-dependent kinase 12 (CDK12) pathogenic alterations received niraparib 200 milligrams (mg) orally once daily in combination with cetrelimab 240 mg intravenous (IV) once every 4 weeks (i.e., on Day 1 of each cycle) in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.	Combination 1: Part 1 (Dose Selection): Niraparib 200 mg + Cetrelimab 480 mg n=16 Participants Participants with mCRPC who were either BM+ or BM- for DRD or BM+ for CDK12 pathogenic alterations received niraparib 200 mg orally once daily in combination with cetrelimab 480 mg IV infusion once every 4 weeks (i.e., on Day 1 of each cycle) in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.	Combination 2: Cohort 2D: Niraparib+Abiraterone Acetate+Prednisone n=17 Participants Participants with mCRPC and HRR gene alterations (other DRD monoallelic loss \[2D\]) received niraparib 200 mg orally once daily in combination with abiraterone acetate 1000 mg orally once daily plus prednisone 10 mg (2\*5 mg) orally twice daily in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.	Combination 2: Cohort 2C: HRR Negative: Niraparib + Abiraterone Acetate + Prednisone Participants with mCRPC and HRR gene alteration negative received niraparib 200 mg orally once daily in combination with abiraterone acetate 1000 mg orally once daily plus prednisone 10 mg (2\*5 mg) orally twice daily in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.
Combination 3: Maximum Observed Plasma Concentration (Cmax) of Niraparib Normalized by the Dose(Niraparib) (Cmax/Dose) of Niraparib Administered With AA After a Single Dose	2.14 nanograms per milliliter per milligram Standard Deviation 0.95	1.99 nanograms per milliliter per milligram Standard Deviation 0.80	2.09 nanograms per milliliter per milligram Standard Deviation 0.88	—

PRIMARY outcome

Timeframe: Pre-dose, 30 min, 1 hour (hr), 1.5 hr, 2hr, 3 hr, 4 hr, 6 hr, 8 hr, 10 hr, 24 hr, 48 hr, 72 hr, and 168 hr post dose on Day 1

AUC(0-168 hours) was defined as area under the plasma concentration-time curve from time zero to 168 hours of Niraparib administered with AA After a single dose.

Outcome measures

Outcome measures
Measure	Combination 1: Part 1 (Dose Seletion): Niraparib 200 mg + Cetrelimab 240 mg n=16 Participants Participants with metastatic castration-resistant prostate cancer (mCRPC) who were either biomarker positive (BM+) or BM negative (BM-) for deoxyribonucleic acid (DNA)-repair gene defects (DRD) or BM+ for cyclin-dependent kinase 12 (CDK12) pathogenic alterations received niraparib 200 milligrams (mg) orally once daily in combination with cetrelimab 240 mg intravenous (IV) once every 4 weeks (i.e., on Day 1 of each cycle) in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.	Combination 1: Part 1 (Dose Selection): Niraparib 200 mg + Cetrelimab 480 mg n=15 Participants Participants with mCRPC who were either BM+ or BM- for DRD or BM+ for CDK12 pathogenic alterations received niraparib 200 mg orally once daily in combination with cetrelimab 480 mg IV infusion once every 4 weeks (i.e., on Day 1 of each cycle) in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.	Combination 2: Cohort 2D: Niraparib+Abiraterone Acetate+Prednisone n=17 Participants Participants with mCRPC and HRR gene alterations (other DRD monoallelic loss \[2D\]) received niraparib 200 mg orally once daily in combination with abiraterone acetate 1000 mg orally once daily plus prednisone 10 mg (2\*5 mg) orally twice daily in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.	Combination 2: Cohort 2C: HRR Negative: Niraparib + Abiraterone Acetate + Prednisone Participants with mCRPC and HRR gene alteration negative received niraparib 200 mg orally once daily in combination with abiraterone acetate 1000 mg orally once daily plus prednisone 10 mg (2\*5 mg) orally twice daily in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.
Combination 3: Area Under the Plasma Concentration-Time Curve From Time Zero to 168 Hours (AUC [0-168hr]) of Niraparib Administered With AA After a Single Dose	14672 Nanogramshour per milliliter (ngh/mL) Standard Deviation 7346	11862 Nanogramshour per milliliter (ngh/mL) Standard Deviation 4973	13321 Nanogramshour per milliliter (ngh/mL) Standard Deviation 5843	—

PRIMARY outcome

Timeframe: Pre-dose, 30 min, 1 hour (hr), 1.5 hr, 2hr, 3 hr, 4 hr, 6 hr, 8 hr, 10 hr, 24 hr, 48 hr, 72 hr, and 168 hr post dose on Day 1

AUC0(168 hours)/dose was defined as area under the plasma concentration-time curve for niraparib from time 0 to 168 hours of niraparib administered with AA after a single dose.

Outcome measures

Outcome measures
Measure	Combination 1: Part 1 (Dose Seletion): Niraparib 200 mg + Cetrelimab 240 mg n=16 Participants Participants with metastatic castration-resistant prostate cancer (mCRPC) who were either biomarker positive (BM+) or BM negative (BM-) for deoxyribonucleic acid (DNA)-repair gene defects (DRD) or BM+ for cyclin-dependent kinase 12 (CDK12) pathogenic alterations received niraparib 200 milligrams (mg) orally once daily in combination with cetrelimab 240 mg intravenous (IV) once every 4 weeks (i.e., on Day 1 of each cycle) in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.	Combination 1: Part 1 (Dose Selection): Niraparib 200 mg + Cetrelimab 480 mg n=16 Participants Participants with mCRPC who were either BM+ or BM- for DRD or BM+ for CDK12 pathogenic alterations received niraparib 200 mg orally once daily in combination with cetrelimab 480 mg IV infusion once every 4 weeks (i.e., on Day 1 of each cycle) in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.	Combination 2: Cohort 2D: Niraparib+Abiraterone Acetate+Prednisone n=17 Participants Participants with mCRPC and HRR gene alterations (other DRD monoallelic loss \[2D\]) received niraparib 200 mg orally once daily in combination with abiraterone acetate 1000 mg orally once daily plus prednisone 10 mg (2\*5 mg) orally twice daily in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.	Combination 2: Cohort 2C: HRR Negative: Niraparib + Abiraterone Acetate + Prednisone Participants with mCRPC and HRR gene alteration negative received niraparib 200 mg orally once daily in combination with abiraterone acetate 1000 mg orally once daily plus prednisone 10 mg (2\*5 mg) orally twice daily in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.
Combination 3: Area Under the Plasma Concentration-Time Curve for Niraparib From Time Zero to 168 Hours (AUC [0-168 Hours]/Dose) of Niraparib Administered With AA After a Single Dose	73.36 nanogram*hour/milliliter/milligram Standard Deviation 36.73	59.31 nanogram*hour/milliliter/milligram Standard Deviation 24.87	66.61 nanogram*hour/milliliter/milligram Standard Deviation 29.22	—

Serious events: 2 serious events

Other events: 6 other events

Deaths: 6 deaths

Combination 1: Part 1 (Dose Selection): Niraparib 200 mg + Cetrelimab 480 mg

Serious events: 3 serious events

Other events: 6 other events

Deaths: 5 deaths

Combination 1: Part 2 (Dose Expansion): Cohort 1A: BM+: Niraparib 200 mg + Cetrelimab 480 mg

Serious events: 12 serious events

Other events: 21 other events

Deaths: 18 deaths

Combination 1: Part 2 (Dose Expansion): Cohort 1B: BM-: Niraparib 200 mg + Cetrelimab 480 mg

Serious events: 6 serious events

Other events: 11 other events

Deaths: 7 deaths

Combination 2: Cohort 2A: Niraparib+Abiraterone Acetate+Prednisone

Serious events: 4 serious events

Other events: 8 other events

Deaths: 5 deaths

Combination 2: Cohort 2C: Niraparib+Abiraterone Acetate+Prednisone

Serious events: 5 serious events

Other events: 9 other events

Deaths: 4 deaths

Combination 2: Cohort 2D: Niraparib+Abiraterone Acetate+Prednisone

Serious events: 1 serious events

Other events: 5 other events

Deaths: 2 deaths

Combination 2: Cohort 2C: HRR Negative: Niraparib + Abiraterone Acetate + Prednisone

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Combination 3: Cohort 1A: Niraparib + Abiraterone Acetate, SA

Serious events: 4 serious events

Other events: 10 other events

Deaths: 3 deaths

Combination 3: Cohort 1B: Niraparib + Abiraterone Acetate, FDC1-RS (G010)

Serious events: 4 serious events

Other events: 10 other events

Deaths: 1 deaths

Combination 3: Cohort 2: Niraparib + Abiraterone Acetate, FDC2-RS (G012)

Serious events: 7 serious events

Other events: 6 other events

Deaths: 4 deaths

Combination 3: Cohort 3: Niraparib + Abiraterone Acetate, FDC1-LS

Serious events: 3 serious events

Other events: 5 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Combination 1: Part 1 (Dose Seletion): Niraparib 200 mg + Cetrelimab 240 mg n=6 participants at risk Participants with metastatic castration-resistant prostate cancer (mCRPC) who were either biomarker positive (BM+) or BM negative (BM-) for deoxyribonucleic acid (DNA)-repair gene defects (DRD) or BM+ for cyclin-dependent kinase 12 (CDK12) pathogenic alterations received niraparib 200 milligrams (mg) orally once daily in combination with cetrelimab 240 mg intravenous (IV) once every 4 weeks (i.e., on Day 1 of each cycle) in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.	Combination 1: Part 1 (Dose Selection): Niraparib 200 mg + Cetrelimab 480 mg n=6 participants at risk Participants with mCRPC who were either BM+ or BM- for DRD or BM+ for CDK12 pathogenic alterations received niraparib 200 mg orally once daily in combination with cetrelimab 480 mg IV infusion once every 4 weeks (i.e., on Day 1 of each cycle) in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.	Combination 1: Part 2 (Dose Expansion): Cohort 1A: BM+: Niraparib 200 mg + Cetrelimab 480 mg n=21 participants at risk Participants with mCRPC and were BM+ received established recommended Phase 2 dose (RP2D) of niraparib 200 mg once daily in combination with cetrelimab 480 mg IV infusion every 4 weeks i.e., on Day 1 of each cycle) in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.	Combination 1: Part 2 (Dose Expansion): Cohort 1B: BM-: Niraparib 200 mg + Cetrelimab 480 mg n=11 participants at risk Participants with mCRPC and were BM- received established RP2D of niraparib 200 mg once daily in combination with cetrelimab 480 mg IV infusion every 4 weeks i.e., on Day 1 of each cycle) in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.	Combination 2: Cohort 2A: Niraparib+Abiraterone Acetate+Prednisone n=8 participants at risk Participants with mCRPC and HRR gene alterations (breast cancer gene \[BRCA\] biallelic loss \[2A\]) received niraparib 200 mg orally once daily in combination with abiraterone acetate 1000 mg orally once daily plus prednisone (P) 10 mg (2\*5 mg) orally twice daily in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.	Combination 2: Cohort 2C: Niraparib+Abiraterone Acetate+Prednisone n=9 participants at risk Participants with mCRPC and HRR gene alterations (BRCA monoallelic loss \[2C\]) received niraparib 200 mg orally once daily in combination with abiraterone acetate 1000 mg orally once daily plus prednisone 10 mg (2\*5 mg) orally twice daily in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.	Combination 2: Cohort 2D: Niraparib+Abiraterone Acetate+Prednisone n=6 participants at risk Participants with mCRPC and HRR gene alterations (other DRD monoallelic loss \[2D\]) received niraparib 200 mg orally once daily in combination with abiraterone acetate 1000 mg orally once daily plus prednisone 10 mg (2\*5 mg) orally twice daily in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.	Combination 2: Cohort 2C: HRR Negative: Niraparib + Abiraterone Acetate + Prednisone n=1 participants at risk Participants with mCRPC and HRR gene alteration negative received niraparib 200 mg orally once daily in combination with abiraterone acetate 1000 mg orally once daily plus prednisone 10 mg (2\*5 mg) orally twice daily in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.	Combination 3: Cohort 1A: Niraparib + Abiraterone Acetate, SA n=17 participants at risk Participants with mCRPC (regardless of HRR BM status) received a single dose of niraparib 200 mg in combination with single oral dose of abiraterone acetate 1000 mg as single agent (SA) orally from Cycle 1 Day 1 to Day 8. After completion of Cycle 1 Day 8 (Pharmacokinetic \[PK\] Assessment Phase), Participants had the option to enter the Long-term Extension Phase of the study and received protocol defined treatment until study discontinuation.	Combination 3: Cohort 1B: Niraparib + Abiraterone Acetate, FDC1-RS (G010) n=17 participants at risk Participants with mCRPC received a single dose of niraparib 200 mg in combination with single oral dose of abiraterone acetate 1000 as fixed-dose combination 1 (FDC1) regular-strength (RS) tablets orally from Cycle 2 1 Day 1 to Day 8. After completion of Cycle 1 Day 8 (PK Assessment Phase), participants had an option to enter the Long-term Extension Phase of the study and received protocol defined treatment until study discontinuation.	Combination 3: Cohort 2: Niraparib + Abiraterone Acetate, FDC2-RS (G012) n=17 participants at risk Participants with mCRPC received a single dose of niraparib 200 mg in combination with single oral dose of abiraterone acetate 1000 mg as FDC2 RS tablets orally from Cycle 2 1 Day 1 to Day 8. After completion of Cycle 1 Day 8 (PK Assessment Phase), participants had an option to enter the Long-term Extension Phase of the study and received protocol defined treatment until study discontinuation.	Combination 3: Cohort 3: Niraparib + Abiraterone Acetate, FDC1-LS n=17 participants at risk Participants with mCRPC received a single oral dose of niraparib 100 mg in combination with single oral dose of abiraterone acetate 1000 mg as FDC1 low strength (LS) tablets orally from Cycle 2 1 Day 1 to Day 8. After completion of Cycle 1 Day 8 (PK Assessment Phase), participants had an option to enter the Long-term Extension Phase of the study and received protocol defined treatment until study discontinuation.
Blood and lymphatic system disorders Anaemia	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	4.8% 1/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	9.1% 1/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	22.2% 2/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	11.8% 2/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	11.8% 2/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	11.8% 2/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Blood and lymphatic system disorders Neutropenia	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	5.9% 1/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	9.5% 2/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	18.2% 2/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	5.9% 1/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Cardiac disorders Atrial Fibrillation	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	11.1% 1/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	5.9% 1/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Endocrine disorders Hypothyroidism	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	4.8% 1/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Abdominal Distension	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	5.9% 1/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Abdominal Pain	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	11.1% 1/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	5.9% 1/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Anal Fistula	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	16.7% 1/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Constipation	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	9.5% 2/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	9.1% 1/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	5.9% 1/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Diarrhoea	16.7% 1/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	16.7% 1/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Lower Gastrointestinal Haemorrhage	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	11.1% 1/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Oesophagitis	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	16.7% 1/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Pancreatitis	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	9.1% 1/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Stomatitis	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	4.8% 1/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
General disorders Asthenia	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	11.1% 1/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
General disorders General Physical Health Deterioration	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	4.8% 1/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	5.9% 1/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
General disorders Localised Oedema	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	4.8% 1/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
General disorders Non-Cardiac Chest Pain	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	11.1% 1/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
General disorders Peripheral Swelling	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	4.8% 1/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
General disorders Pyrexia	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	5.9% 1/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Infections and infestations Arthritis Bacterial	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	5.9% 1/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Infections and infestations Bacteraemia	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	4.8% 1/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Infections and infestations Corona Virus Infection	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	5.9% 1/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	5.9% 1/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Infections and infestations Enterocolitis Infectious	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	5.9% 1/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Infections and infestations Herpes Simplex Encephalitis	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	5.9% 1/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Infections and infestations Pneumonia	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	9.5% 2/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	9.1% 1/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	11.1% 1/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	5.9% 1/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	5.9% 1/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Infections and infestations Pyelonephritis	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	4.8% 1/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	5.9% 1/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Infections and infestations Pyonephrosis	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	4.8% 1/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Infections and infestations Upper Respiratory Tract Infection	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	9.1% 1/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Infections and infestations Urinary Tract Infection	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	4.8% 1/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	11.8% 2/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Infections and infestations Urosepsis	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	16.7% 1/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	5.9% 1/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Infections and infestations Viral Upper Respiratory Tract Infection	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	11.1% 1/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Femur Fracture	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	12.5% 1/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Humerus Fracture	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	5.9% 1/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Lower Limb Fracture	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	5.9% 1/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Spinal Compression Fracture	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	12.5% 1/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Investigations Blood Creatinine Increased	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	5.9% 1/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Cachexia	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	33.3% 2/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Diabetic Ketoacidosis	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	4.8% 1/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	12.5% 1/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	5.9% 1/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	12.5% 1/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	11.1% 1/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	9.1% 1/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	9.1% 1/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	12.5% 1/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Back Pain	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	11.1% 1/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Muscular Weakness	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	5.9% 1/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Myositis	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	16.7% 1/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Osteoporosis	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	12.5% 1/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour Compression	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	5.9% 1/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour Pain	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	5.9% 1/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Nervous system disorders Cerebral Ischaemia	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	12.5% 1/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Nervous system disorders Cerebrovascular Accident	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	9.1% 1/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	5.9% 1/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Nervous system disorders Presyncope	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	11.1% 1/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Nervous system disorders Spinal Cord Compression	16.7% 1/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	4.8% 1/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	11.8% 2/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Nervous system disorders Syncope	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	4.8% 1/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	9.1% 1/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	5.9% 1/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Product Issues Device Dislocation	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	4.8% 1/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Product Issues Device Occlusion	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	4.8% 1/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Renal and urinary disorders Acute Kidney Injury	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	9.5% 2/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Renal and urinary disorders Haematuria	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	5.9% 1/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	5.9% 1/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Renal and urinary disorders Hydronephrosis	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	4.8% 1/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	5.9% 1/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Renal and urinary disorders Nephrolithiasis	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	4.8% 1/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Reproductive system and breast disorders Pelvic Pain	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	5.9% 1/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Reproductive system and breast disorders Prostatitis	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	16.7% 1/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea	16.7% 1/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	12.5% 1/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	5.9% 1/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	4.8% 1/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Pharyngeal Haemorrhage	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	4.8% 1/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	5.9% 1/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	4.8% 1/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	100.0% 1/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	5.9% 1/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Vascular disorders Embolism	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	4.8% 1/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Vascular disorders Pelvic Venous Thrombosis	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	4.8% 1/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.

Other adverse events

Other adverse events
Measure	Combination 1: Part 1 (Dose Seletion): Niraparib 200 mg + Cetrelimab 240 mg n=6 participants at risk Participants with metastatic castration-resistant prostate cancer (mCRPC) who were either biomarker positive (BM+) or BM negative (BM-) for deoxyribonucleic acid (DNA)-repair gene defects (DRD) or BM+ for cyclin-dependent kinase 12 (CDK12) pathogenic alterations received niraparib 200 milligrams (mg) orally once daily in combination with cetrelimab 240 mg intravenous (IV) once every 4 weeks (i.e., on Day 1 of each cycle) in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.	Combination 1: Part 1 (Dose Selection): Niraparib 200 mg + Cetrelimab 480 mg n=6 participants at risk Participants with mCRPC who were either BM+ or BM- for DRD or BM+ for CDK12 pathogenic alterations received niraparib 200 mg orally once daily in combination with cetrelimab 480 mg IV infusion once every 4 weeks (i.e., on Day 1 of each cycle) in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.	Combination 1: Part 2 (Dose Expansion): Cohort 1A: BM+: Niraparib 200 mg + Cetrelimab 480 mg n=21 participants at risk Participants with mCRPC and were BM+ received established recommended Phase 2 dose (RP2D) of niraparib 200 mg once daily in combination with cetrelimab 480 mg IV infusion every 4 weeks i.e., on Day 1 of each cycle) in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.	Combination 1: Part 2 (Dose Expansion): Cohort 1B: BM-: Niraparib 200 mg + Cetrelimab 480 mg n=11 participants at risk Participants with mCRPC and were BM- received established RP2D of niraparib 200 mg once daily in combination with cetrelimab 480 mg IV infusion every 4 weeks i.e., on Day 1 of each cycle) in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.	Combination 2: Cohort 2A: Niraparib+Abiraterone Acetate+Prednisone n=8 participants at risk Participants with mCRPC and HRR gene alterations (breast cancer gene \[BRCA\] biallelic loss \[2A\]) received niraparib 200 mg orally once daily in combination with abiraterone acetate 1000 mg orally once daily plus prednisone (P) 10 mg (2\*5 mg) orally twice daily in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.	Combination 2: Cohort 2C: Niraparib+Abiraterone Acetate+Prednisone n=9 participants at risk Participants with mCRPC and HRR gene alterations (BRCA monoallelic loss \[2C\]) received niraparib 200 mg orally once daily in combination with abiraterone acetate 1000 mg orally once daily plus prednisone 10 mg (2\*5 mg) orally twice daily in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.	Combination 2: Cohort 2D: Niraparib+Abiraterone Acetate+Prednisone n=6 participants at risk Participants with mCRPC and HRR gene alterations (other DRD monoallelic loss \[2D\]) received niraparib 200 mg orally once daily in combination with abiraterone acetate 1000 mg orally once daily plus prednisone 10 mg (2\*5 mg) orally twice daily in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.	Combination 2: Cohort 2C: HRR Negative: Niraparib + Abiraterone Acetate + Prednisone n=1 participants at risk Participants with mCRPC and HRR gene alteration negative received niraparib 200 mg orally once daily in combination with abiraterone acetate 1000 mg orally once daily plus prednisone 10 mg (2\*5 mg) orally twice daily in each 28-day treatment cycle until disease progression, unacceptable toxicity, death, or the sponsor terminated the study.	Combination 3: Cohort 1A: Niraparib + Abiraterone Acetate, SA n=17 participants at risk Participants with mCRPC (regardless of HRR BM status) received a single dose of niraparib 200 mg in combination with single oral dose of abiraterone acetate 1000 mg as single agent (SA) orally from Cycle 1 Day 1 to Day 8. After completion of Cycle 1 Day 8 (Pharmacokinetic \[PK\] Assessment Phase), Participants had the option to enter the Long-term Extension Phase of the study and received protocol defined treatment until study discontinuation.	Combination 3: Cohort 1B: Niraparib + Abiraterone Acetate, FDC1-RS (G010) n=17 participants at risk Participants with mCRPC received a single dose of niraparib 200 mg in combination with single oral dose of abiraterone acetate 1000 as fixed-dose combination 1 (FDC1) regular-strength (RS) tablets orally from Cycle 2 1 Day 1 to Day 8. After completion of Cycle 1 Day 8 (PK Assessment Phase), participants had an option to enter the Long-term Extension Phase of the study and received protocol defined treatment until study discontinuation.	Combination 3: Cohort 2: Niraparib + Abiraterone Acetate, FDC2-RS (G012) n=17 participants at risk Participants with mCRPC received a single dose of niraparib 200 mg in combination with single oral dose of abiraterone acetate 1000 mg as FDC2 RS tablets orally from Cycle 2 1 Day 1 to Day 8. After completion of Cycle 1 Day 8 (PK Assessment Phase), participants had an option to enter the Long-term Extension Phase of the study and received protocol defined treatment until study discontinuation.	Combination 3: Cohort 3: Niraparib + Abiraterone Acetate, FDC1-LS n=17 participants at risk Participants with mCRPC received a single oral dose of niraparib 100 mg in combination with single oral dose of abiraterone acetate 1000 mg as FDC1 low strength (LS) tablets orally from Cycle 2 1 Day 1 to Day 8. After completion of Cycle 1 Day 8 (PK Assessment Phase), participants had an option to enter the Long-term Extension Phase of the study and received protocol defined treatment until study discontinuation.
Blood and lymphatic system disorders Anaemia	50.0% 3/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	50.0% 3/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	33.3% 7/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	36.4% 4/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	50.0% 4/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	66.7% 6/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	33.3% 2/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	100.0% 1/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	5.9% 1/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Blood and lymphatic system disorders Leukopenia	16.7% 1/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	23.8% 5/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	18.2% 2/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	25.0% 2/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	23.8% 5/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	36.4% 4/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	12.5% 1/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	100.0% 1/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Blood and lymphatic system disorders Neutropenia	16.7% 1/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	23.8% 5/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	9.1% 1/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	25.0% 2/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	33.3% 3/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Blood and lymphatic system disorders Thrombocytopenia	16.7% 1/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	33.3% 2/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	28.6% 6/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	27.3% 3/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	62.5% 5/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	66.7% 6/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	5.9% 1/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Cardiac disorders Angina Pectoris	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	9.1% 1/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Cardiac disorders Atrial Fibrillation	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	4.8% 1/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	9.1% 1/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Cardiac disorders Palpitations	16.7% 1/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	4.8% 1/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	12.5% 1/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Cardiac disorders Sinus Tachycardia	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	9.5% 2/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Cardiac disorders Tachycardia	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	4.8% 1/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	12.5% 1/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	11.1% 1/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Ear and labyrinth disorders Ear Pain	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	9.1% 1/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Ear and labyrinth disorders Tinnitus	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	9.1% 1/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Ear and labyrinth disorders Vertigo	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	9.1% 1/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Endocrine disorders Adrenal Insufficiency	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	16.7% 1/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	4.8% 1/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	9.1% 1/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Endocrine disorders Hyperthyroidism	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	4.8% 1/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	18.2% 2/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Endocrine disorders Hypothyroidism	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	16.7% 1/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Eye disorders Eye Pain	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	9.1% 1/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Eye disorders Eye Swelling	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	16.7% 1/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Eye disorders Ocular Hyperaemia	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	9.1% 1/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Abdominal Distension	16.7% 1/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	18.2% 2/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	16.7% 1/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Abdominal Pain	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	9.1% 1/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	11.1% 1/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	5.9% 1/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	5.9% 1/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Constipation	33.3% 2/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	33.3% 2/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	61.9% 13/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	27.3% 3/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	37.5% 3/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	66.7% 6/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	50.0% 3/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	100.0% 1/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	11.8% 2/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	5.9% 1/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	5.9% 1/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	11.8% 2/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Diarrhoea	50.0% 3/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	4.8% 1/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	9.1% 1/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	25.0% 2/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	22.2% 2/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	5.9% 1/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	5.9% 1/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	5.9% 1/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Diverticulum	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	11.1% 1/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Dry Mouth	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	33.3% 2/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	9.5% 2/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	9.1% 1/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	11.1% 1/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	16.7% 1/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Dyspepsia	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	16.7% 1/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	9.1% 1/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	11.1% 1/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Dysphagia	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	9.5% 2/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	9.1% 1/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Gastritis	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	22.2% 2/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Gastrointestinal Angiodysplasia	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	11.1% 1/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Gastrooesophageal Reflux Disease	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	16.7% 1/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	5.9% 1/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Gingival Pain	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	9.1% 1/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Haematochezia	16.7% 1/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	11.1% 1/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Haemorrhoids	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	16.7% 1/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	11.1% 1/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Hiatus Hernia	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	16.7% 1/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	11.1% 1/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Lip Dry	16.7% 1/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Mouth Ulceration	16.7% 1/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Nausea	33.3% 2/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	33.3% 2/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	42.9% 9/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	9.1% 1/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	37.5% 3/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	44.4% 4/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	33.3% 2/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	11.8% 2/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	11.8% 2/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	5.9% 1/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Oral Pain	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	4.8% 1/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	18.2% 2/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Retching	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	11.1% 1/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Stomatitis	16.7% 1/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	4.8% 1/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	9.1% 1/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	25.0% 2/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	11.1% 1/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Tongue Coated	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	11.1% 1/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Toothache	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	12.5% 1/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Gastrointestinal disorders Vomiting	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	16.7% 1/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	38.1% 8/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	18.2% 2/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	50.0% 4/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	33.3% 3/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	100.0% 1/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	11.8% 2/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
General disorders Asthenia	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	9.5% 2/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	9.1% 1/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	12.5% 1/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	33.3% 3/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	5.9% 1/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	5.9% 1/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
General disorders Chest Discomfort	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	4.8% 1/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	16.7% 1/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
General disorders Chills	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	33.3% 2/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	9.5% 2/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	12.5% 1/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
General disorders Discomfort	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	16.7% 1/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
General disorders Fatigue	33.3% 2/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	50.0% 3/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	47.6% 10/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	72.7% 8/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	37.5% 3/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	55.6% 5/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	66.7% 4/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	100.0% 1/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	11.8% 2/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	17.6% 3/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
General disorders Influenza Like Illness	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	16.7% 1/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
General disorders Injection Site Swelling	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	11.1% 1/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
General disorders Malaise	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	11.1% 1/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	16.7% 1/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
General disorders Non-Cardiac Chest Pain	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	9.1% 1/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
General disorders Oedema Peripheral	16.7% 1/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	19.0% 4/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	22.2% 2/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
General disorders Pain	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	11.1% 1/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
General disorders Peripheral Swelling	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	4.8% 1/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	9.1% 1/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
General disorders Pyrexia	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	9.5% 2/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	18.2% 2/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	12.5% 1/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	11.1% 1/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	5.9% 1/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
General disorders Temperature Intolerance	16.7% 1/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	4.8% 1/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	11.1% 1/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Infections and infestations Candida Infection	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	11.1% 1/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Infections and infestations Eye Infection	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	9.1% 1/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Infections and infestations Herpes Zoster	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	12.5% 1/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Infections and infestations Influenza	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	11.1% 1/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Infections and infestations Nasopharyngitis	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	4.8% 1/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	9.1% 1/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Infections and infestations Oral Candidiasis	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	9.1% 1/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	11.1% 1/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Infections and infestations Oral Infection	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	16.7% 1/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Infections and infestations Pneumonia	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	4.8% 1/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	9.1% 1/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Infections and infestations Respiratory Tract Infection	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	11.1% 1/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	5.9% 1/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Infections and infestations Tooth Infection	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	16.7% 1/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	16.7% 1/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	5.9% 1/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Infections and infestations Urinary Tract Infection	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	16.7% 1/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	9.5% 2/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	9.1% 1/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	22.2% 2/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	16.7% 1/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Infections and infestations Urosepsis	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	16.7% 1/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Infections and infestations Viral Infection	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	9.1% 1/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Infections and infestations Viral Upper Respiratory Tract Infection	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	22.2% 2/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Contusion	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	16.7% 1/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	12.5% 1/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	11.1% 1/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	16.7% 1/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Fall	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	33.3% 3/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Muscle Strain	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	9.1% 1/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Procedural Pain	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	12.5% 1/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Radiation Proctitis	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	11.1% 1/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Skin Abrasion	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	11.1% 1/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Skin Laceration	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	4.8% 1/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	22.2% 2/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Investigations Alanine Aminotransferase Increased	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	16.7% 1/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	9.5% 2/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	36.4% 4/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Investigations Alpha 1 Globulin Increased	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	9.1% 1/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Investigations Alpha 2 Globulin Increased	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	9.1% 1/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Investigations Aspartate Aminotransferase Increased	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	16.7% 1/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	14.3% 3/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	36.4% 4/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	12.5% 1/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	5.9% 1/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Investigations Blood Alkaline Phosphatase Increased	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	16.7% 1/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	28.6% 6/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	27.3% 3/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	12.5% 1/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	16.7% 1/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Investigations Blood Chloride Decreased	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	9.5% 2/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	18.2% 2/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Investigations Blood Corticotrophin Decreased	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	9.1% 1/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Investigations Blood Corticotrophin Increased	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	4.8% 1/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	9.1% 1/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Investigations Blood Creatinine Increased	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	16.7% 1/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	19.0% 4/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	27.3% 3/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	12.5% 1/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	11.1% 1/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	16.7% 1/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Investigations Blood Lactate Dehydrogenase Increased	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	16.7% 1/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Investigations Blood Pressure Increased	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	16.7% 1/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	4.8% 1/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	9.1% 1/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Investigations Blood Thyroid Stimulating Hormone Decreased	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	9.1% 1/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Investigations Blood Thyroid Stimulating Hormone Increased	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	14.3% 3/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	12.5% 1/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Investigations Blood Urea Increased	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	4.8% 1/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	9.1% 1/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Investigations Cortisol Decreased	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	4.8% 1/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	18.2% 2/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Investigations Fibrin D Dimer Increased	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	9.1% 1/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Investigations Gamma-Glutamyltransferase Increased	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	5.9% 1/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Investigations Lipase Increased	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	16.7% 1/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	4.8% 1/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Investigations Thyroxine Decreased	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	16.7% 1/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Investigations Thyroxine Increased	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	9.1% 1/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Investigations Tri-Iodothyronine Decreased	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	16.7% 1/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	9.5% 2/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	18.2% 2/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Investigations Troponin T Increased	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	9.1% 1/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Investigations Vitamin D Decreased	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	16.7% 1/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Investigations Weight Decreased	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	47.6% 10/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	9.1% 1/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	37.5% 3/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	11.1% 1/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	16.7% 1/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Abnormal Loss of Weight	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	11.1% 1/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Decreased Appetite	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	66.7% 4/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	61.9% 13/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	63.6% 7/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	12.5% 1/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	44.4% 4/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	33.3% 2/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	100.0% 1/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	5.9% 1/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	5.9% 1/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Dehydration	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	4.8% 1/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	11.1% 1/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Hyperamylasaemia	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	9.1% 1/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Hyperglycaemia	16.7% 1/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	33.3% 2/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	19.0% 4/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	27.3% 3/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	14.3% 3/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	11.1% 1/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	4.8% 1/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	12.5% 1/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	4.8% 1/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	9.1% 1/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Hypokalaemia	16.7% 1/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	9.5% 2/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	9.1% 1/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	22.2% 2/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	9.5% 2/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	14.3% 3/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	18.2% 2/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	12.5% 1/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Polydipsia	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	12.5% 1/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Arthralgia	16.7% 1/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	16.7% 1/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	19.0% 4/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	18.2% 2/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	12.5% 1/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	11.1% 1/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Back Pain	33.3% 2/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	16.7% 1/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	28.6% 6/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	27.3% 3/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	12.5% 1/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	22.2% 2/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	33.3% 2/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	5.9% 1/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Bone Pain	16.7% 1/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	4.8% 1/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	12.5% 1/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	5.9% 1/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	9.1% 1/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Flank Pain	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	11.1% 1/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	16.7% 1/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Foot Deformity	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	100.0% 1/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Joint Swelling	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	9.5% 2/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Muscle Spasms	16.7% 1/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	4.8% 1/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	9.1% 1/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	25.0% 2/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	11.1% 1/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	5.9% 1/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Muscular Weakness	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	4.8% 1/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	27.3% 3/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	11.1% 1/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	5.9% 1/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	5.9% 1/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	5.9% 1/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Musculoskeletal Chest Pain	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	12.5% 1/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	11.1% 1/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	16.7% 1/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	5.9% 1/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Musculoskeletal Pain	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	14.3% 3/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	12.5% 1/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	22.2% 2/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	5.9% 1/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	11.8% 2/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Musculoskeletal Stiffness	16.7% 1/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	16.7% 1/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	18.2% 2/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	11.1% 1/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Neck Pain	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	11.1% 1/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Osteoporosis	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	4.8% 1/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	12.5% 1/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Pain in Extremity	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	19.0% 4/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	27.3% 3/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	11.1% 1/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	16.7% 1/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	100.0% 1/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Melanocytic Naevus	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	11.1% 1/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to Bone	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	12.5% 1/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour Pain	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	16.7% 1/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	4.8% 1/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	9.1% 1/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Nervous system disorders Amnesia	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	9.1% 1/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Nervous system disorders Dizziness	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	33.3% 2/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	9.5% 2/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	45.5% 5/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	12.5% 1/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	33.3% 3/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	5.9% 1/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	5.9% 1/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Nervous system disorders Dysaesthesia	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	9.1% 1/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Nervous system disorders Dysgeusia	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	16.7% 1/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	4.8% 1/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	9.1% 1/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	11.1% 1/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	5.9% 1/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Nervous system disorders Facial Neuralgia	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	11.1% 1/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Nervous system disorders Headache	16.7% 1/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	16.7% 1/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	14.3% 3/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	12.5% 1/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	33.3% 3/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	5.9% 1/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Nervous system disorders Hypoaesthesia	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	12.5% 1/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Nervous system disorders Mental Impairment	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	5.9% 1/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Nervous system disorders Migraine	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	5.9% 1/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Nervous system disorders Paraesthesia	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	11.1% 1/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Nervous system disorders Peripheral Motor Neuropathy	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	16.7% 1/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Nervous system disorders Peripheral Sensory Neuropathy	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	16.7% 1/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	4.8% 1/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	12.5% 1/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	22.2% 2/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Nervous system disorders Spinal Cord Compression	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	12.5% 1/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Nervous system disorders Syncope	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	12.5% 1/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	11.1% 1/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Nervous system disorders Taste Disorder	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	9.5% 2/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	11.1% 1/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Nervous system disorders Tremor	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	4.8% 1/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	9.1% 1/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Psychiatric disorders Anxiety	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	9.5% 2/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Psychiatric disorders Insomnia	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	23.8% 5/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	12.5% 1/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	11.1% 1/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Psychiatric disorders Mood Altered	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	9.1% 1/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Renal and urinary disorders Chromaturia	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	4.8% 1/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	16.7% 1/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Renal and urinary disorders Chronic Kidney Disease	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	4.8% 1/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	11.1% 1/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Renal and urinary disorders Dysuria	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	9.1% 1/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	22.2% 2/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	5.9% 1/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Renal and urinary disorders Haematuria	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	16.7% 1/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	9.5% 2/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	11.1% 1/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Renal and urinary disorders Micturition Urgency	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	9.1% 1/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Renal and urinary disorders Nephrolithiasis	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	11.1% 1/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Renal and urinary disorders Pollakiuria	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	16.7% 1/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	12.5% 1/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Renal and urinary disorders Polyuria	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	9.1% 1/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Renal and urinary disorders Renal Impairment	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	19.0% 4/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	11.1% 1/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Renal and urinary disorders Urinary Incontinence	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	5.9% 1/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Renal and urinary disorders Urinary Retention	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	16.7% 1/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	11.1% 1/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Renal and urinary disorders Urinary Tract Obstruction	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	9.1% 1/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	11.1% 1/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Renal and urinary disorders Urine Flow Decreased	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	9.1% 1/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Reproductive system and breast disorders Gynaecomastia	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	11.1% 1/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Reproductive system and breast disorders Pelvic Discomfort	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	16.7% 1/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Reproductive system and breast disorders Pelvic Pain	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	4.8% 1/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	11.1% 1/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Reproductive system and breast disorders Testicular Pain	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	16.7% 1/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	28.6% 6/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	18.2% 2/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	11.1% 1/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	16.7% 1/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	100.0% 1/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	9.1% 1/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	14.3% 3/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	36.4% 4/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	12.5% 1/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	22.2% 2/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea Exertional	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	19.0% 4/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	11.1% 1/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	33.3% 2/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	16.7% 1/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	9.5% 2/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	9.1% 1/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	25.0% 2/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	9.1% 1/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	5.9% 1/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Nasal Congestion	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	9.5% 2/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	11.1% 1/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	11.1% 1/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	4.8% 1/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	9.1% 1/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Productive Cough	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	4.8% 1/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	9.1% 1/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	16.7% 1/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	9.5% 2/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Rhinitis Allergic	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	14.3% 3/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	16.7% 1/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Sinus Pain	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	16.7% 1/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Sneezing	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	16.7% 1/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	9.1% 1/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Upper-Airway Cough Syndrome	16.7% 1/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	12.5% 1/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	16.7% 1/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	5.9% 1/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Petechiae	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	11.1% 1/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Photosensitivity Reaction	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	11.1% 1/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	16.7% 1/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Purpura	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	4.8% 1/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	100.0% 1/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Rash	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	14.3% 3/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	9.1% 1/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	16.7% 1/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	100.0% 1/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	5.9% 1/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Rash Maculo-Papular	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	16.7% 1/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	9.5% 2/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	9.1% 1/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Skin Burning Sensation	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	12.5% 1/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Skin Exfoliation	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	16.7% 1/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Skin Hyperpigmentation	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	100.0% 1/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Skin Lesion	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	16.7% 1/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	9.1% 1/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Vascular disorders Deep Vein Thrombosis	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	12.5% 1/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Vascular disorders Embolism	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	12.5% 1/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Vascular disorders Hot Flush	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	4.8% 1/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	12.5% 1/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	11.1% 1/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Vascular disorders Hypertension	16.7% 1/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	16.7% 1/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	19.0% 4/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	27.3% 3/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	33.3% 2/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	100.0% 1/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Vascular disorders Hypotension	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	4.8% 1/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	9.1% 1/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Vascular disorders Lymphoedema	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	9.1% 1/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.
Vascular disorders Orthostatic Hypotension	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/21 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/11 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/8 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	11.1% 1/9 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/6 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/1 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.	0.00% 0/17 • Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months The safety analysis set included all randomized participants who received at least 1 dose of study drug.

Additional Information

Executive Medical Director Oncology

Janssen Research & Development, LLC

Phone: 844-434-4210

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
Publication restrictions are in place

Restriction type: OTHER