Trial Outcomes & Findings for Efficacy of Polyethylene Glycol-Interferon Alfa-2B (PEG-Intron, SCH 54031) Compared to Interferon Alfa-2B in Participants With Chronic Hepatitis C (MK-4031-016) (NCT NCT03537274)

NCT ID: NCT03537274

Last Updated: 2019-04-09

Results Overview

The number of participants achieving responder status at 24 weeks of treatment was assessed. A participant was classified as a responder if, at 24 weeks of treatment, they met both of the following criteria: 1) HCV-Ribonucleic Acid (RNA) negative (defined as \<100 copies/mL serum by quantitative polymerase chain reaction \[qPCR\] assay); and 2) alanine transaminase (ALT) level normal.

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 1224 participants
• Primary outcome timeframe: Up to 24 weeks
• Results posted on: 2019-04-09

Participant Flow

In total, 1224 participants with chronic Hepatitis C virus (HCV) infection were randomized, with 1219 receiving study treatment.

Participant milestones

Measure	PEG-Intron, 0.5 mg/kg PEG-Intron administered once weekly (QW) for 48 weeks at 0.5 mg/kg by subcutaneous (SC) injection.	PEG-Intron, 1.0 mg/kg PEG-Intron administered QW for 48 weeks at 1.0 mg/kg by SC injection.	PEG-Intron, 1.5 mg/kg PEG-Intron administered QW for 48 weeks at 1.5 mg/kg by SC injection.	Interferon Alfa-2b Interferon Alfa-2b administered three times per week (TIW) for 48 weeks at 3 million international units (MIU) by SC injection.
Overall Study STARTED	315	298	304	307
Overall Study Treated	315	297	304	303
Overall Study COMPLETED	255	229	228	231
Overall Study NOT COMPLETED	60	69	76	76

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy of Polyethylene Glycol-Interferon Alfa-2B (PEG-Intron, SCH 54031) Compared to Interferon Alfa-2B in Participants With Chronic Hepatitis C (MK-4031-016)

Baseline characteristics by cohort

Measure	PEG-Intron, 0.5 mg/kg n=315 Participants PEG-Intron administered QW for 48 weeks at 0.5 mg/kg by SC injection.	PEG-Intron, 1.0 mg/kg n=297 Participants PEG-Intron administered QW for 48 weeks at 1.0 mg/kg by SC injection.	PEG-Intron, 1.5 mg/kg n=304 Participants PEG-Intron administered QW for 48 weeks at 1.5 mg/kg by SC injection.	Interferon Alfa-2b n=303 Participants Interferon Alfa-2b administered TIW for 48 weeks at 3 MIU by SC injection.	Total n=1219 Participants Total of all reporting groups
Age, Continuous	43.1 Years STANDARD_DEVIATION 9.4 • n=5 Participants	43.7 Years STANDARD_DEVIATION 9.5 • n=7 Participants	42.9 Years STANDARD_DEVIATION 8.7 • n=5 Participants	42.6 Years STANDARD_DEVIATION 9.2 • n=4 Participants	43.1 Years STANDARD_DEVIATION 9.2 • n=21 Participants
Sex: Female, Male Female	130 Participants n=5 Participants	109 Participants n=7 Participants	114 Participants n=5 Participants	96 Participants n=4 Participants	449 Participants n=21 Participants
Sex: Female, Male Male	185 Participants n=5 Participants	188 Participants n=7 Participants	190 Participants n=5 Participants	207 Participants n=4 Participants	770 Participants n=21 Participants

PRIMARY outcome

Timeframe: Up to 24 weeks

Population: Includes all randomized participants receiving ≥1 dose of study treatment.

The number of participants achieving responder status at 24 weeks of treatment was assessed. A participant was classified as a responder if, at 24 weeks of treatment, they met both of the following criteria: 1) HCV-Ribonucleic Acid (RNA) negative (defined as <100 copies/mL serum by quantitative polymerase chain reaction [qPCR] assay); and 2) alanine transaminase (ALT) level normal.

Outcome measures

Measure	PEG-Intron, 0.5 mg/kg n=315 Participants PEG-Intron administered QW for 48 weeks at 0.5 mg/kg by SC injection.	PEG-Intron, 1.0 mg/kg n=297 Participants PEG-Intron administered QW for 48 weeks at 1.0 mg/kg by SC injection.	PEG-Intron, 1.5 mg/kg n=304 Participants PEG-Intron administered QW for 48 weeks at 1.5 mg/kg by SC injection.	Interferon Alfa-2b n=303 Participants Interferon Alfa-2b administered TIW for 48 weeks at 3 MIU by SC injection.
Number of Participants Achieving Responder Status at 24 Weeks of Treatment	80 Participants	87 Participants	90 Participants	59 Participants

PRIMARY outcome

Timeframe: Up to 72 weeks (up to 48 weeks treatment and 24 weeks follow-up)

Population: Includes all randomized participants receiving ≥1 dose of study treatment.

The number of participants achieving sustained responder status at 24 weeks of follow-up was assessed. A participant was classified as a sustained responder if, at 24 weeks of follow-up, they met both of the following criteria: 1) HCV-RNA negative (defined as <100 copies/mL serum by qPCR assay); and 2) ALT level normal.

Outcome measures

Measure	PEG-Intron, 0.5 mg/kg n=315 Participants PEG-Intron administered QW for 48 weeks at 0.5 mg/kg by SC injection.	PEG-Intron, 1.0 mg/kg n=297 Participants PEG-Intron administered QW for 48 weeks at 1.0 mg/kg by SC injection.	PEG-Intron, 1.5 mg/kg n=304 Participants PEG-Intron administered QW for 48 weeks at 1.5 mg/kg by SC injection.	Interferon Alfa-2b n=303 Participants Interferon Alfa-2b administered TIW for 48 weeks at 3 MIU by SC injection.
Number of Participants Achieving Sustained Responder Status at 24 Weeks of Follow-up	52 Participants	70 Participants	69 Participants	37 Participants

Adverse Events

PEG-Intron, 0.5 mg/kg

Serious events: 37 serious events

Other events: 306 other events

Deaths: 1 deaths

PEG-Intron, 1.0 mg/kg

Serious events: 32 serious events

Other events: 291 other events

Deaths: 0 deaths

PEG-Intron, 1.5 mg/kg

Serious events: 31 serious events

Other events: 296 other events

Deaths: 0 deaths

Interferon Alfa-2b

Serious events: 29 serious events

Other events: 293 other events

Deaths: 2 deaths

Serious adverse events

Measure	PEG-Intron, 0.5 mg/kg n=315 participants at risk PEG-Intron administered QW for 48 weeks at 0.5 mg/kg SC injection.	PEG-Intron, 1.0 mg/kg n=297 participants at risk PEG-Intron administered QW for 48 weeks at 1.0 mg/kg by SC injection.	PEG-Intron, 1.5 mg/kg n=304 participants at risk PEG-Intron administered QW for 48 weeks at 1.5 mg/kg by SC injection.	Interferon Alfa-2b n=303 participants at risk Interferon Alfa-2b administered TIW for 48 weeks at 3 MIU by SC injection.
Blood and lymphatic system disorders Neutropenia	0.00% 0/315 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.33% 1/304 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/303 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/315 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.67% 2/297 • Number of events 2 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/304 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/303 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Cardiac disorders Atrial fibrillation	0.00% 0/315 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/297 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/304 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.33% 1/303 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Cardiac disorders Atrial flutter	0.00% 0/315 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/297 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.33% 1/304 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/303 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Cardiac disorders Cardiomyopathy	0.00% 0/315 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/304 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/303 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Cardiac disorders Cardiopulmonary failure	0.00% 0/315 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/297 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/304 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.33% 1/303 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Cardiac disorders Myocardial infarction	0.00% 0/315 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/297 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.33% 1/304 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/303 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Cardiac disorders Pericarditis	0.00% 0/315 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/297 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.33% 1/304 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/303 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Ear and labyrinth disorders Hypoacusis	0.00% 0/315 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/297 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.33% 1/304 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/303 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Ear and labyrinth disorders Sudden hearing loss	0.32% 1/315 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/297 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.33% 1/304 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/303 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Ear and labyrinth disorders Vertigo	0.00% 0/315 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/297 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.66% 2/304 • Number of events 2 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/303 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Endocrine disorders Hyperthyroidism	0.00% 0/315 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/297 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.33% 1/304 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/303 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Eye disorders Ophthalmic vein thrombosis	0.00% 0/315 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/297 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/304 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.33% 1/303 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Eye disorders Retinal exudates	0.00% 0/315 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/297 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/304 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.33% 1/303 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Eye disorders Retinal tear	0.00% 0/315 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/297 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/304 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.33% 1/303 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Gastrointestinal disorders Abdominal hernia	0.32% 1/315 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/297 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/304 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/303 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Gastrointestinal disorders Abdominal pain	0.63% 2/315 • Number of events 2 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/304 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.33% 1/303 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/315 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/304 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/303 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Gastrointestinal disorders Appendix disorder	0.32% 1/315 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/297 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/304 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/303 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Gastrointestinal disorders Haemorrhoids	0.00% 0/315 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/304 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/303 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Gastrointestinal disorders Inguinal hernia	0.32% 1/315 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/297 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.33% 1/304 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/303 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/315 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/304 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/303 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Gastrointestinal disorders Vomiting	0.00% 0/315 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/304 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/303 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
General disorders Asthenia	0.00% 0/315 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/297 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.33% 1/304 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/303 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
General disorders Chest pain	0.63% 2/315 • Number of events 2 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/304 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/303 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
General disorders Granuloma	0.32% 1/315 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/297 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/304 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/303 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
General disorders Malaise	0.00% 0/315 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/304 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/303 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Hepatobiliary disorders Cholelithiasis	0.32% 1/315 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/297 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/304 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/303 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Hepatobiliary disorders Gallbladder disorder	0.00% 0/315 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/297 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.33% 1/304 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/303 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Immune system disorders Anaphylactic reaction	0.00% 0/315 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/304 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/303 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Immune system disorders Sarcoidosis	0.00% 0/315 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/304 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/303 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Infections and infestations Abscess	0.32% 1/315 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/297 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/304 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/303 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Infections and infestations Abscess limb	0.32% 1/315 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/297 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/304 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/303 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Infections and infestations Abscess oral	0.00% 0/315 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/297 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.33% 1/304 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/303 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Infections and infestations Appendicitis	0.00% 0/315 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/297 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/304 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.33% 1/303 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Infections and infestations Bronchitis	0.00% 0/315 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/304 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.33% 1/303 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Infections and infestations Diverticulitis	0.00% 0/315 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/297 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.33% 1/304 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/303 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Infections and infestations Douglas' abscess	0.00% 0/315 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/297 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.33% 1/304 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/303 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Infections and infestations Erysipelas	0.00% 0/315 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/297 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/304 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.33% 1/303 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Infections and infestations Gastroenteritis	0.32% 1/315 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/297 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/304 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.33% 1/303 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Infections and infestations Herpes zoster	0.00% 0/315 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/297 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.33% 1/304 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/303 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Infections and infestations Malaria	0.00% 0/315 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/297 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/304 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.33% 1/303 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Infections and infestations Pneumonia	0.00% 0/315 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.66% 2/304 • Number of events 2 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/303 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Infections and infestations Salmonellosis	0.32% 1/315 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/297 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/304 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/303 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Infections and infestations Tonsillitis	0.00% 0/315 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/297 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/304 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.33% 1/303 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Injury, poisoning and procedural complications Femur fracture	0.32% 1/315 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/297 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/304 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/303 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Injury, poisoning and procedural complications Gun shot wound	0.00% 0/315 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/304 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/303 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Injury, poisoning and procedural complications Hand fracture	0.32% 1/315 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/297 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/304 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/303 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/315 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/297 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.33% 1/304 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.33% 1/303 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.32% 1/315 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/297 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/304 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/303 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal squamous cell carcinoma	0.00% 0/315 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/297 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.33% 1/304 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/303 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.00% 0/315 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/297 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/304 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.33% 1/303 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm	0.00% 0/315 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/304 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/303 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Nervous system neoplasm	0.00% 0/315 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/297 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/304 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.33% 1/303 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/315 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/304 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/303 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin cancer	0.00% 0/315 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/304 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/303 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Nervous system disorders Facial paralysis	0.32% 1/315 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	1.0% 3/297 • Number of events 3 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/304 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/303 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Nervous system disorders IIIrd nerve paralysis	0.00% 0/315 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/297 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/304 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.33% 1/303 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Nervous system disorders Loss of consciousness	0.32% 1/315 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/297 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/304 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.33% 1/303 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Nervous system disorders Migraine	0.00% 0/315 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/297 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/304 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.33% 1/303 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Nervous system disorders Presyncope	0.00% 0/315 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/304 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/303 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Nervous system disorders Sciatica	0.00% 0/315 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/297 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.33% 1/304 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/303 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Nervous system disorders Seizure	0.00% 0/315 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/304 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/303 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Nervous system disorders Somnolence	0.00% 0/315 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/297 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/304 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.33% 1/303 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Nervous system disorders Syncope	0.00% 0/315 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/297 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/304 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.33% 1/303 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Nervous system disorders Transient ischaemic attack	0.00% 0/315 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/297 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.33% 1/304 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/303 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Pregnancy, puerperium and perinatal conditions Foetal death	0.32% 1/315 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/297 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/304 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/303 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Psychiatric disorders Alcohol abuse	0.00% 0/315 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/297 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/304 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.33% 1/303 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Psychiatric disorders Anxiety	0.32% 1/315 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/297 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/304 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/303 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Psychiatric disorders Completed suicide	0.32% 1/315 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/297 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/304 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.33% 1/303 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Psychiatric disorders Dependence	0.00% 0/315 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/297 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/304 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.33% 1/303 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Psychiatric disorders Depression	0.63% 2/315 • Number of events 2 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.33% 1/304 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/303 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Psychiatric disorders Depressive symptom	0.00% 0/315 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/297 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.33% 1/304 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.33% 1/303 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Psychiatric disorders Suicidal ideation	0.95% 3/315 • Number of events 3 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.67% 2/297 • Number of events 2 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.66% 2/304 • Number of events 2 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.33% 1/303 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Psychiatric disorders Suicide attempt	0.00% 0/315 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/297 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.66% 2/304 • Number of events 2 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/303 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Renal and urinary disorders Tubulointerstitial nephritis	0.32% 1/315 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/297 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/304 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/303 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Reproductive system and breast disorders Breast discharge	0.32% 1/315 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/297 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/304 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/303 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Reproductive system and breast disorders Uterine disorder	0.00% 0/315 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/304 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.33% 1/303 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/315 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/304 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/303 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Skin and subcutaneous tissue disorders Dermatosis	0.00% 0/315 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/297 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.33% 1/304 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/303 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Skin and subcutaneous tissue disorders Eczema	0.32% 1/315 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/297 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/304 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/303 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Skin and subcutaneous tissue disorders Psoriasis	0.32% 1/315 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/297 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/304 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/303 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Skin and subcutaneous tissue disorders Rash erythematous	0.00% 0/315 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/304 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/303 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/315 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/304 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/303 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Surgical and medical procedures Cholecystectomy	0.32% 1/315 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/297 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/304 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/303 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Vascular disorders Hypertension	0.00% 0/315 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/297 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.66% 2/304 • Number of events 2 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/303 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Vascular disorders Varicose vein	0.00% 0/315 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/304 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/303 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Injury, poisoning and procedural complications Ligament sprain	0.32% 1/315 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/297 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/304 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.33% 1/303 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Injury, poisoning and procedural complications Limb injury	0.32% 1/315 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/297 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/304 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/303 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Injury, poisoning and procedural complications Overdose	0.32% 1/315 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/297 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/304 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/303 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Injury, poisoning and procedural complications Pelvic fracture	0.32% 1/315 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/297 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/304 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/303 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.00% 0/315 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/297 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.33% 1/304 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/303 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Injury, poisoning and procedural complications Procedural pain	0.32% 1/315 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/297 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/304 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.33% 1/303 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Injury, poisoning and procedural complications Subarachnoid haemorrhage	0.32% 1/315 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/297 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/304 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/303 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Injury, poisoning and procedural complications Toxicity to various agents	0.32% 1/315 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/297 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/304 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/303 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Injury, poisoning and procedural complications Wrist fracture	0.32% 1/315 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/297 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/304 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/303 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Metabolism and nutrition disorders Body fat disorder	0.32% 1/315 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/297 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/304 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/303 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/315 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/297 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/304 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.33% 1/303 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/315 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/304 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/303 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Musculoskeletal and connective tissue disorders Arthropathy	0.32% 1/315 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/297 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/304 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/303 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/315 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/297 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.33% 1/304 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.33% 1/303 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/315 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.67% 2/297 • Number of events 2 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/304 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/303 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Musculoskeletal and connective tissue disorders Musculoskeletal disorder	0.00% 0/315 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/297 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/304 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.66% 2/303 • Number of events 2 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Musculoskeletal and connective tissue disorders Spinal disorder	0.00% 0/315 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.34% 1/297 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.66% 2/304 • Number of events 2 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.00% 0/303 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.

Other adverse events

Measure	PEG-Intron, 0.5 mg/kg n=315 participants at risk PEG-Intron administered QW for 48 weeks at 0.5 mg/kg SC injection.	PEG-Intron, 1.0 mg/kg n=297 participants at risk PEG-Intron administered QW for 48 weeks at 1.0 mg/kg by SC injection.	PEG-Intron, 1.5 mg/kg n=304 participants at risk PEG-Intron administered QW for 48 weeks at 1.5 mg/kg by SC injection.	Interferon Alfa-2b n=303 participants at risk Interferon Alfa-2b administered TIW for 48 weeks at 3 MIU by SC injection.
Blood and lymphatic system disorders Neutropenia	4.1% 13/315 • Number of events 26 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	6.1% 18/297 • Number of events 37 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	8.2% 25/304 • Number of events 36 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	2.3% 7/303 • Number of events 15 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Blood and lymphatic system disorders Thrombocytopenia	2.2% 7/315 • Number of events 13 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	6.4% 19/297 • Number of events 37 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	4.9% 15/304 • Number of events 17 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.33% 1/303 • Number of events 1 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Endocrine disorders Hypothyroidism	3.2% 10/315 • Number of events 12 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	6.1% 18/297 • Number of events 22 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	4.9% 15/304 • Number of events 19 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	3.6% 11/303 • Number of events 13 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Gastrointestinal disorders Abdominal discomfort	3.8% 12/315 • Number of events 16 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	5.7% 17/297 • Number of events 20 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	4.9% 15/304 • Number of events 18 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	5.0% 15/303 • Number of events 18 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Gastrointestinal disorders Abdominal pain	8.9% 28/315 • Number of events 37 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	8.1% 24/297 • Number of events 31 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	6.2% 19/304 • Number of events 20 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	4.6% 14/303 • Number of events 16 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Gastrointestinal disorders Abdominal pain upper	15.2% 48/315 • Number of events 75 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	12.8% 38/297 • Number of events 51 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	12.2% 37/304 • Number of events 54 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	10.9% 33/303 • Number of events 39 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Gastrointestinal disorders Diarrhoea	16.8% 53/315 • Number of events 75 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	19.5% 58/297 • Number of events 90 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	22.7% 69/304 • Number of events 103 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	16.5% 50/303 • Number of events 70 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Gastrointestinal disorders Dry mouth	3.5% 11/315 • Number of events 12 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	4.0% 12/297 • Number of events 13 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	8.2% 25/304 • Number of events 28 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	4.0% 12/303 • Number of events 13 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Gastrointestinal disorders Dyspepsia	5.1% 16/315 • Number of events 20 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	3.7% 11/297 • Number of events 13 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	3.9% 12/304 • Number of events 20 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	5.0% 15/303 • Number of events 17 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Gastrointestinal disorders Nausea	23.2% 73/315 • Number of events 114 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	27.9% 83/297 • Number of events 128 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	27.3% 83/304 • Number of events 130 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	21.1% 64/303 • Number of events 95 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Gastrointestinal disorders Vomiting	7.0% 22/315 • Number of events 29 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	7.7% 23/297 • Number of events 36 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	7.6% 23/304 • Number of events 33 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	6.6% 20/303 • Number of events 22 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
General disorders Asthenia	13.3% 42/315 • Number of events 89 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	13.5% 40/297 • Number of events 89 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	16.4% 50/304 • Number of events 120 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	13.5% 41/303 • Number of events 63 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
General disorders Chest pain	3.8% 12/315 • Number of events 14 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	5.7% 17/297 • Number of events 20 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	2.3% 7/304 • Number of events 10 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	2.6% 8/303 • Number of events 8 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
General disorders Chills	33.7% 106/315 • Number of events 140 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	40.4% 120/297 • Number of events 162 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	43.8% 133/304 • Number of events 184 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	32.7% 99/303 • Number of events 125 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
General disorders Fatigue	50.8% 160/315 • Number of events 279 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	55.2% 164/297 • Number of events 283 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	52.3% 159/304 • Number of events 287 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	56.1% 170/303 • Number of events 295 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
General disorders Influenza like illness	18.1% 57/315 • Number of events 74 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	22.2% 66/297 • Number of events 95 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	25.0% 76/304 • Number of events 113 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	19.5% 59/303 • Number of events 78 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
General disorders Injection site erythema	42.9% 135/315 • Number of events 189 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	40.4% 120/297 • Number of events 166 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	40.1% 122/304 • Number of events 164 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	15.5% 47/303 • Number of events 49 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
General disorders Malaise	6.3% 20/315 • Number of events 41 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	9.1% 27/297 • Number of events 43 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	7.9% 24/304 • Number of events 86 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	6.9% 21/303 • Number of events 28 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
General disorders Pain	17.5% 55/315 • Number of events 89 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	20.5% 61/297 • Number of events 87 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	19.7% 60/304 • Number of events 90 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	16.5% 50/303 • Number of events 64 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
General disorders Pyrexia	30.5% 96/315 • Number of events 141 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	41.8% 124/297 • Number of events 191 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	41.8% 127/304 • Number of events 206 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	28.4% 86/303 • Number of events 106 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Hepatobiliary disorders Hepatomegaly	6.3% 20/315 • Number of events 22 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	5.4% 16/297 • Number of events 17 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	5.3% 16/304 • Number of events 18 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	3.3% 10/303 • Number of events 12 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Hepatobiliary disorders Liver tenderness	3.8% 12/315 • Number of events 12 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	3.4% 10/297 • Number of events 12 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	5.3% 16/304 • Number of events 17 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	3.0% 9/303 • Number of events 10 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Infections and infestations Bronchitis	4.8% 15/315 • Number of events 24 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	6.1% 18/297 • Number of events 19 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	4.3% 13/304 • Number of events 19 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	3.3% 10/303 • Number of events 12 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Infections and infestations Influenza	5.4% 17/315 • Number of events 21 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	6.4% 19/297 • Number of events 22 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	6.6% 20/304 • Number of events 23 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	7.3% 22/303 • Number of events 29 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Infections and infestations Nasopharyngitis	11.4% 36/315 • Number of events 45 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	7.1% 21/297 • Number of events 31 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	8.9% 27/304 • Number of events 33 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	7.9% 24/303 • Number of events 30 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Infections and infestations Sinusitis	8.3% 26/315 • Number of events 33 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	7.1% 21/297 • Number of events 22 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	8.9% 27/304 • Number of events 37 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	6.3% 19/303 • Number of events 29 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Infections and infestations Upper respiratory tract infection	6.3% 20/315 • Number of events 23 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	4.0% 12/297 • Number of events 14 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	3.0% 9/304 • Number of events 10 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	4.6% 14/303 • Number of events 22 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Investigations Weight decreased	10.8% 34/315 • Number of events 45 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	12.1% 36/297 • Number of events 45 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	24.3% 74/304 • Number of events 91 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	13.9% 42/303 • Number of events 46 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Metabolism and nutrition disorders Decreased appetite	10.5% 33/315 • Number of events 39 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	19.9% 59/297 • Number of events 72 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	25.0% 76/304 • Number of events 86 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	16.2% 49/303 • Number of events 60 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Musculoskeletal and connective tissue disorders Arthralgia	24.8% 78/315 • Number of events 145 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	23.9% 71/297 • Number of events 116 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	28.3% 86/304 • Number of events 159 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	24.1% 73/303 • Number of events 124 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Musculoskeletal and connective tissue disorders Back pain	14.6% 46/315 • Number of events 58 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	19.2% 57/297 • Number of events 81 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	15.8% 48/304 • Number of events 78 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	18.5% 56/303 • Number of events 89 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Musculoskeletal and connective tissue disorders Muscle spasms	7.9% 25/315 • Number of events 34 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	5.1% 15/297 • Number of events 21 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	3.6% 11/304 • Number of events 15 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	4.0% 12/303 • Number of events 21 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	3.2% 10/315 • Number of events 14 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	5.7% 17/297 • Number of events 24 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	2.6% 8/304 • Number of events 10 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	4.0% 12/303 • Number of events 13 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Musculoskeletal and connective tissue disorders Myalgia	35.2% 111/315 • Number of events 212 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	36.0% 107/297 • Number of events 178 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	44.4% 135/304 • Number of events 249 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	37.6% 114/303 • Number of events 187 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Musculoskeletal and connective tissue disorders Pain in extremity	6.3% 20/315 • Number of events 31 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	10.4% 31/297 • Number of events 45 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	7.2% 22/304 • Number of events 34 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	6.6% 20/303 • Number of events 22 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Nervous system disorders Disturbance in attention	6.3% 20/315 • Number of events 27 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	7.4% 22/297 • Number of events 29 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	6.9% 21/304 • Number of events 23 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	5.3% 16/303 • Number of events 19 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Nervous system disorders Dizziness	9.2% 29/315 • Number of events 34 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	12.8% 38/297 • Number of events 43 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	14.8% 45/304 • Number of events 58 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	11.2% 34/303 • Number of events 51 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Nervous system disorders Headache	61.0% 192/315 • Number of events 445 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	67.3% 200/297 • Number of events 481 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	64.1% 195/304 • Number of events 492 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	58.4% 177/303 • Number of events 351 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Psychiatric disorders Anxiety	10.2% 32/315 • Number of events 59 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	10.1% 30/297 • Number of events 51 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	8.2% 25/304 • Number of events 34 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	10.9% 33/303 • Number of events 53 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Psychiatric disorders Depression	23.2% 73/315 • Number of events 135 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	24.2% 72/297 • Number of events 114 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	24.3% 74/304 • Number of events 116 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	21.8% 66/303 • Number of events 112 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Psychiatric disorders Insomnia	16.2% 51/315 • Number of events 73 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	24.9% 74/297 • Number of events 101 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	19.1% 58/304 • Number of events 82 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	21.1% 64/303 • Number of events 105 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Psychiatric disorders Irritability	20.6% 65/315 • Number of events 92 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	17.8% 53/297 • Number of events 76 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	18.8% 57/304 • Number of events 84 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	24.4% 74/303 • Number of events 106 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Psychiatric disorders Libido decreased	2.9% 9/315 • Number of events 9 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	2.0% 6/297 • Number of events 7 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	3.3% 10/304 • Number of events 13 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	5.6% 17/303 • Number of events 19 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Psychiatric disorders Nervousness	4.4% 14/315 • Number of events 20 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	5.1% 15/297 • Number of events 22 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	3.3% 10/304 • Number of events 15 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	2.0% 6/303 • Number of events 7 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders Cough	7.3% 23/315 • Number of events 28 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	8.4% 25/297 • Number of events 27 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	9.9% 30/304 • Number of events 36 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	5.3% 16/303 • Number of events 18 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders Dyspnoea	5.7% 18/315 • Number of events 25 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	4.0% 12/297 • Number of events 14 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	4.9% 15/304 • Number of events 15 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	0.99% 3/303 • Number of events 3 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	5.4% 17/315 • Number of events 19 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	5.7% 17/297 • Number of events 20 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	5.3% 16/304 • Number of events 18 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	5.3% 16/303 • Number of events 22 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Skin and subcutaneous tissue disorders Alopecia	20.3% 64/315 • Number of events 75 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	22.9% 68/297 • Number of events 82 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	34.2% 104/304 • Number of events 113 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	22.1% 67/303 • Number of events 78 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Skin and subcutaneous tissue disorders Dry skin	5.7% 18/315 • Number of events 23 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	11.1% 33/297 • Number of events 38 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	9.5% 29/304 • Number of events 33 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	8.9% 27/303 • Number of events 30 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Skin and subcutaneous tissue disorders Hyperhidrosis	5.1% 16/315 • Number of events 21 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	4.4% 13/297 • Number of events 14 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	5.6% 17/304 • Number of events 23 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	4.3% 13/303 • Number of events 16 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Skin and subcutaneous tissue disorders Pruritus	9.5% 30/315 • Number of events 38 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	12.5% 37/297 • Number of events 45 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	9.2% 28/304 • Number of events 30 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	7.3% 22/303 • Number of events 28 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Skin and subcutaneous tissue disorders Rash	7.0% 22/315 • Number of events 27 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	7.1% 21/297 • Number of events 24 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	7.9% 24/304 • Number of events 27 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	5.9% 18/303 • Number of events 19 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.
Vascular disorders Hot flush	2.5% 8/315 • Number of events 9 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	5.4% 16/297 • Number of events 17 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	2.3% 7/304 • Number of events 8 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.	2.0% 6/303 • Number of events 7 • Up to 72 weeks (up to 48 weeks treatment and 24 weeks of follow-up) Analysis population includes all randomized participants receiving ≥1 dose of study treatment.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: ClinicalTrialsDisclosure@merck.com

Results disclosure agreements

• Principal investigator is a sponsor employee The investigator agrees to provide the Sponsor thirty (30) days prior to submission for publication or presentation, copies of abstracts or manuscripts for publication which report project results. The Sponsor shall have editorial rights with respect to Publications, abstracts, slides, and manuscripts and the right to review and comment on the data analysis and presentation with regard to (a) proprietary information and, (b) the accuracy of the information contained in the Publication.
• Publication restrictions are in place

Restriction type: OTHER