Trial Outcomes & Findings for The Effect of Boceprevir in Russian Participants Diagnosed With Chronic Hepatitis C Genotype 1 (P08160) (NCT NCT01425203)

Last Updated: 2021-02-08

Results Overview

SVR24 was defined as an undetectable plasma Hepatitis C Virus-ribonucleic acid (HCV-RNA) level at Follow-up Week 24 (FW24). If a participant was missing FW24 data and had undetectable HCV-RNA at FW12, the participant was considered a sustained virologic responder.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

238 participants

Primary outcome timeframe

Follow-up Week 24 (up to 72 weeks)

Results posted on

2021-02-08

Participant Flow

A total of 18 Russian sites recruited participants for this boceprevir (BOC) trial.

Of 238 randomized participants, 237 received at least 1 dose of peginterferon alpha-2b (PEG) + ribavirin (RBV) \[PR\] and comprised the Full Analysis Set (FAS). 4 discontinued (DC) treatment during the PR lead-in phase and did not receive BOC or Placebo (PBO). 27 from PBO Arm failed the futility time point and were rolled over into Crossover Phase.

Participant milestones

Participant milestones
Measure	RGT BOC + PR Participants received PR for 4 weeks before addition of BOC. Participants then received response guided therapy (RGT) with BOC + PR for up to 32 weeks followed by PBO + PR for up to 20 weeks.	PBO + PR (Control) Participants received PR for 4 weeks before addition of BOC-matched PBO. Participants then received BOC + PR for up to 44 weeks.	Crossover Arm Participants randomized to the PBO + PR Control arm who failed the futility rule at treatment week (TW) 12 or 24 were rolled over to the Crossover arm and received BOC + PR for 32 weeks and PR for up to 44 weeks depending on HCV-RNA level assessment at Crossover Weeks 4 and 8.
Treatment Phase STARTED	159	79	0
Treatment Phase Treated (FAS)	159	78	0
Treatment Phase COMPLETED	132	42	0
Treatment Phase NOT COMPLETED	27	37	0
Crossover Phase STARTED	0	0	27
Crossover Phase COMPLETED	0	0	21
Crossover Phase NOT COMPLETED	0	0	6
Follow-up Phase STARTED	153	49	27
Follow-up Phase COMPLETED	153	49	27
Follow-up Phase NOT COMPLETED	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	RGT BOC + PR Participants received PR for 4 weeks before addition of BOC. Participants then received response guided therapy (RGT) with BOC + PR for up to 32 weeks followed by PBO + PR for up to 20 weeks.	PBO + PR (Control) Participants received PR for 4 weeks before addition of BOC-matched PBO. Participants then received BOC + PR for up to 44 weeks.	Crossover Arm Participants randomized to the PBO + PR Control arm who failed the futility rule at treatment week (TW) 12 or 24 were rolled over to the Crossover arm and received BOC + PR for 32 weeks and PR for up to 44 weeks depending on HCV-RNA level assessment at Crossover Weeks 4 and 8.
Treatment Phase DC during PR Lead-in Phase	3	1	0
Treatment Phase Failure at futility timepoint	8	27	0
Treatment Phase Other virologic failure criteria	5	3	0
Treatment Phase Unidentified reasons	11	5	0
Treatment Phase Did not receive treatment	0	1	0
Crossover Phase Failure at futility timepoint	0	0	3
Crossover Phase Other virologic failure criteria	0	0	3

Baseline Characteristics

The Effect of Boceprevir in Russian Participants Diagnosed With Chronic Hepatitis C Genotype 1 (P08160)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	RGT BOC + PR n=159 Participants Participants received PR for 4 weeks before addition of BOC. Participants then received response guided therapy (RGT) with BOC + PR for up to 32 weeks followed by PBO + PR for up to 20 weeks.	PBO + PR (Control) n=78 Participants Participants received PR for 4 weeks before addition of BOC-matched PBO. Participants then received BOC + PR for up to 44 weeks.	Total n=237 Participants Total of all reporting groups
Age, Continuous	38.6 years STANDARD_DEVIATION 9.8 • n=93 Participants	38.1 years STANDARD_DEVIATION 10.0 • n=4 Participants	38.4 years STANDARD_DEVIATION 9.8 • n=27 Participants
Sex: Female, Male Female	65 Participants n=93 Participants	33 Participants n=4 Participants	98 Participants n=27 Participants
Sex: Female, Male Male	94 Participants n=93 Participants	45 Participants n=4 Participants	139 Participants n=27 Participants

PRIMARY outcome

Timeframe: Follow-up Week 24 (up to 72 weeks)

Population: Full Analysis Set (FAS); all randomized participants who received at least 1 dose of any trial medication (PEG, RBV, or BOC) in the Treatment Phase. Participants in the PBO Control Arm who switched to the Crossover Arm were considered failures for SVR24 in this analysis and are not reported here.

Outcome measures

Outcome measures
Measure	RGT BOC + PR n=159 Participants Participants received PR for 4 weeks before addition of BOC. Participants then received response guided therapy (RGT) with BOC + PR for up to 32 weeks followed by PBO + PR for up to 20 weeks.	PBO + PR (Control) n=78 Participants Participants received PR for 4 weeks before addition of BOC-matched PBO. Participants then received BOC + PR for up to 44 weeks.	Crossover Arm Participants randomized to the PBO + PR Control arm who failed the futility rule at treatment week (TW) 12 or 24 were rolled over to the Crossover arm and received BOC + PR for 32 weeks and PR for up to 44 weeks depending on HCV-RNA level assessment at Crossover Weeks 4 and 8.
Percentage of Participants Achieving Sustained Virologic Response At Follow-up Week 24 (SVR24) Among Participants Who Received At Least One Dose of Any Trial Medication (Full Analysis Set Population)	74.8 percentage of participants	46.2 percentage of participants	—

SECONDARY outcome

Timeframe: Follow-up Week 24 (up to 72 weeks)

Population: mITT population included all randomized participants who received ≥1 dose of experimental trial drug: BOC (for Experimental RGT BOC + PR arm) or Placebo (for PBO + PR Control arm). Participants in the PBO Control Arm who switched to the Crossover Arm were considered failures for SVR24 in this analysis and are not reported here.

SVR24 was defined as an undetectable plasma HCV-RNA level at FW24. If a participant was missing FW24 data and had undetectable HCV-RNA at FW12, the participant was considered a sustained virologic responder.

Outcome measures

Outcome measures
Measure	RGT BOC + PR n=156 Participants Participants received PR for 4 weeks before addition of BOC. Participants then received response guided therapy (RGT) with BOC + PR for up to 32 weeks followed by PBO + PR for up to 20 weeks.	PBO + PR (Control) n=77 Participants Participants received PR for 4 weeks before addition of BOC-matched PBO. Participants then received BOC + PR for up to 44 weeks.	Crossover Arm Participants randomized to the PBO + PR Control arm who failed the futility rule at treatment week (TW) 12 or 24 were rolled over to the Crossover arm and received BOC + PR for 32 weeks and PR for up to 44 weeks depending on HCV-RNA level assessment at Crossover Weeks 4 and 8.
Percentage of Participants Achieving SVR24 Among Participants Who Received At Least One Dose of Experimental Trial Drug (Modified Intent-To-Treat [mITT] Population)	76.3 percentage of participants	46.8 percentage of participants	—

SECONDARY outcome

Timeframe: Treatment Week 8

Population: Full Analysis Set (FAS); all randomized participants who received at least 1 dose of any trial medication (PEG, RBV, or BOC) in the Treatment Phase. The Crossover arm had zero participants at TW8 since the first opportunity for participants in the PBO + PR Control arm to roll over to the Crossover arm was at TW12.

EVR was defined as an undetectable HCV-RNA level at TW 8. This analysis was conducted when all participants had completed 8 weeks of the study or had discontinued prior to TW 8.

Outcome measures

Outcome measures
Measure	RGT BOC + PR n=159 Participants Participants received PR for 4 weeks before addition of BOC. Participants then received response guided therapy (RGT) with BOC + PR for up to 32 weeks followed by PBO + PR for up to 20 weeks.	PBO + PR (Control) n=78 Participants Participants received PR for 4 weeks before addition of BOC-matched PBO. Participants then received BOC + PR for up to 44 weeks.	Crossover Arm Participants randomized to the PBO + PR Control arm who failed the futility rule at treatment week (TW) 12 or 24 were rolled over to the Crossover arm and received BOC + PR for 32 weeks and PR for up to 44 weeks depending on HCV-RNA level assessment at Crossover Weeks 4 and 8.
Percentage of Participants Achieving Early Virologic Response (EVR) At Treatment Week (TW) 8	87.4 percentage of participants	42.3 percentage of participants	—

Adverse Events

RGT BOC + PR

Serious events: 17 serious events

Other events: 153 other events

Deaths: 0 deaths

PBO + PR (Control)

Serious events: 9 serious events

Other events: 71 other events

Deaths: 0 deaths

Crossover Arm

Serious events: 1 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	RGT BOC + PR n=159 participants at risk Participants received PR for 4 weeks before addition of BOC. Participants then received response guided therapy (RGT) with BOC + PR for up to 32 weeks followed by PBO + PR for up to 20 weeks.	PBO + PR (Control) n=78 participants at risk Participants received PR for 4 weeks before addition of BOC-matched PBO. Participants then received BOC + PR for up to 44 weeks.	Crossover Arm n=27 participants at risk Participants randomized to the PBO + PR Control arm who failed the futility rule at treatment week (TW) 12 or 24 were rolled over to the Crossover arm and received BOC + PR for 32 weeks and PR for up to 44 weeks depending on HCV-RNA level assessment at Crossover Weeks 4 and 8.
Blood and lymphatic system disorders Neutropenia	6.9% 11/159 • Number of events 14 • RGT BOC+PR Arm and PBO+PR Arm (not entering Crossover): 1st dose to up to 52 weeks; PBO+PR Arm (entering Crossover): 1st dose to up to 48 weeks; Crossover Arm: 1st crossover dose to up to 48 weeks. Adverse events (AE) were reported for 237 randomized participants treated during the Treatment Period. AEs were not reported for 1 randomized participant that did not receive treatment in the Treatment Period. AEs for the 27 participants who started at Baseline in the Control Arm and switched to the Crossover Arm were also reported separately.	5.1% 4/78 • Number of events 4 • RGT BOC+PR Arm and PBO+PR Arm (not entering Crossover): 1st dose to up to 52 weeks; PBO+PR Arm (entering Crossover): 1st dose to up to 48 weeks; Crossover Arm: 1st crossover dose to up to 48 weeks. Adverse events (AE) were reported for 237 randomized participants treated during the Treatment Period. AEs were not reported for 1 randomized participant that did not receive treatment in the Treatment Period. AEs for the 27 participants who started at Baseline in the Control Arm and switched to the Crossover Arm were also reported separately.	3.7% 1/27 • Number of events 1 • RGT BOC+PR Arm and PBO+PR Arm (not entering Crossover): 1st dose to up to 52 weeks; PBO+PR Arm (entering Crossover): 1st dose to up to 48 weeks; Crossover Arm: 1st crossover dose to up to 48 weeks. Adverse events (AE) were reported for 237 randomized participants treated during the Treatment Period. AEs were not reported for 1 randomized participant that did not receive treatment in the Treatment Period. AEs for the 27 participants who started at Baseline in the Control Arm and switched to the Crossover Arm were also reported separately.
Gastrointestinal disorders Intestinal obstruction	0.63% 1/159 • Number of events 1 • RGT BOC+PR Arm and PBO+PR Arm (not entering Crossover): 1st dose to up to 52 weeks; PBO+PR Arm (entering Crossover): 1st dose to up to 48 weeks; Crossover Arm: 1st crossover dose to up to 48 weeks. Adverse events (AE) were reported for 237 randomized participants treated during the Treatment Period. AEs were not reported for 1 randomized participant that did not receive treatment in the Treatment Period. AEs for the 27 participants who started at Baseline in the Control Arm and switched to the Crossover Arm were also reported separately.	0.00% 0/78 • RGT BOC+PR Arm and PBO+PR Arm (not entering Crossover): 1st dose to up to 52 weeks; PBO+PR Arm (entering Crossover): 1st dose to up to 48 weeks; Crossover Arm: 1st crossover dose to up to 48 weeks. Adverse events (AE) were reported for 237 randomized participants treated during the Treatment Period. AEs were not reported for 1 randomized participant that did not receive treatment in the Treatment Period. AEs for the 27 participants who started at Baseline in the Control Arm and switched to the Crossover Arm were also reported separately.	0.00% 0/27 • RGT BOC+PR Arm and PBO+PR Arm (not entering Crossover): 1st dose to up to 52 weeks; PBO+PR Arm (entering Crossover): 1st dose to up to 48 weeks; Crossover Arm: 1st crossover dose to up to 48 weeks. Adverse events (AE) were reported for 237 randomized participants treated during the Treatment Period. AEs were not reported for 1 randomized participant that did not receive treatment in the Treatment Period. AEs for the 27 participants who started at Baseline in the Control Arm and switched to the Crossover Arm were also reported separately.
General disorders Adverse event	0.00% 0/159 • RGT BOC+PR Arm and PBO+PR Arm (not entering Crossover): 1st dose to up to 52 weeks; PBO+PR Arm (entering Crossover): 1st dose to up to 48 weeks; Crossover Arm: 1st crossover dose to up to 48 weeks. Adverse events (AE) were reported for 237 randomized participants treated during the Treatment Period. AEs were not reported for 1 randomized participant that did not receive treatment in the Treatment Period. AEs for the 27 participants who started at Baseline in the Control Arm and switched to the Crossover Arm were also reported separately.	1.3% 1/78 • Number of events 1 • RGT BOC+PR Arm and PBO+PR Arm (not entering Crossover): 1st dose to up to 52 weeks; PBO+PR Arm (entering Crossover): 1st dose to up to 48 weeks; Crossover Arm: 1st crossover dose to up to 48 weeks. Adverse events (AE) were reported for 237 randomized participants treated during the Treatment Period. AEs were not reported for 1 randomized participant that did not receive treatment in the Treatment Period. AEs for the 27 participants who started at Baseline in the Control Arm and switched to the Crossover Arm were also reported separately.	0.00% 0/27 • RGT BOC+PR Arm and PBO+PR Arm (not entering Crossover): 1st dose to up to 52 weeks; PBO+PR Arm (entering Crossover): 1st dose to up to 48 weeks; Crossover Arm: 1st crossover dose to up to 48 weeks. Adverse events (AE) were reported for 237 randomized participants treated during the Treatment Period. AEs were not reported for 1 randomized participant that did not receive treatment in the Treatment Period. AEs for the 27 participants who started at Baseline in the Control Arm and switched to the Crossover Arm were also reported separately.
Infections and infestations Osteomyelitis chronic	0.63% 1/159 • Number of events 1 • RGT BOC+PR Arm and PBO+PR Arm (not entering Crossover): 1st dose to up to 52 weeks; PBO+PR Arm (entering Crossover): 1st dose to up to 48 weeks; Crossover Arm: 1st crossover dose to up to 48 weeks. Adverse events (AE) were reported for 237 randomized participants treated during the Treatment Period. AEs were not reported for 1 randomized participant that did not receive treatment in the Treatment Period. AEs for the 27 participants who started at Baseline in the Control Arm and switched to the Crossover Arm were also reported separately.	0.00% 0/78 • RGT BOC+PR Arm and PBO+PR Arm (not entering Crossover): 1st dose to up to 52 weeks; PBO+PR Arm (entering Crossover): 1st dose to up to 48 weeks; Crossover Arm: 1st crossover dose to up to 48 weeks. Adverse events (AE) were reported for 237 randomized participants treated during the Treatment Period. AEs were not reported for 1 randomized participant that did not receive treatment in the Treatment Period. AEs for the 27 participants who started at Baseline in the Control Arm and switched to the Crossover Arm were also reported separately.	0.00% 0/27 • RGT BOC+PR Arm and PBO+PR Arm (not entering Crossover): 1st dose to up to 52 weeks; PBO+PR Arm (entering Crossover): 1st dose to up to 48 weeks; Crossover Arm: 1st crossover dose to up to 48 weeks. Adverse events (AE) were reported for 237 randomized participants treated during the Treatment Period. AEs were not reported for 1 randomized participant that did not receive treatment in the Treatment Period. AEs for the 27 participants who started at Baseline in the Control Arm and switched to the Crossover Arm were also reported separately.
Infections and infestations Pneumonia	0.63% 1/159 • Number of events 1 • RGT BOC+PR Arm and PBO+PR Arm (not entering Crossover): 1st dose to up to 52 weeks; PBO+PR Arm (entering Crossover): 1st dose to up to 48 weeks; Crossover Arm: 1st crossover dose to up to 48 weeks. Adverse events (AE) were reported for 237 randomized participants treated during the Treatment Period. AEs were not reported for 1 randomized participant that did not receive treatment in the Treatment Period. AEs for the 27 participants who started at Baseline in the Control Arm and switched to the Crossover Arm were also reported separately.	0.00% 0/78 • RGT BOC+PR Arm and PBO+PR Arm (not entering Crossover): 1st dose to up to 52 weeks; PBO+PR Arm (entering Crossover): 1st dose to up to 48 weeks; Crossover Arm: 1st crossover dose to up to 48 weeks. Adverse events (AE) were reported for 237 randomized participants treated during the Treatment Period. AEs were not reported for 1 randomized participant that did not receive treatment in the Treatment Period. AEs for the 27 participants who started at Baseline in the Control Arm and switched to the Crossover Arm were also reported separately.	0.00% 0/27 • RGT BOC+PR Arm and PBO+PR Arm (not entering Crossover): 1st dose to up to 52 weeks; PBO+PR Arm (entering Crossover): 1st dose to up to 48 weeks; Crossover Arm: 1st crossover dose to up to 48 weeks. Adverse events (AE) were reported for 237 randomized participants treated during the Treatment Period. AEs were not reported for 1 randomized participant that did not receive treatment in the Treatment Period. AEs for the 27 participants who started at Baseline in the Control Arm and switched to the Crossover Arm were also reported separately.
Injury, poisoning and procedural complications Accidental overdose	0.00% 0/159 • RGT BOC+PR Arm and PBO+PR Arm (not entering Crossover): 1st dose to up to 52 weeks; PBO+PR Arm (entering Crossover): 1st dose to up to 48 weeks; Crossover Arm: 1st crossover dose to up to 48 weeks. Adverse events (AE) were reported for 237 randomized participants treated during the Treatment Period. AEs were not reported for 1 randomized participant that did not receive treatment in the Treatment Period. AEs for the 27 participants who started at Baseline in the Control Arm and switched to the Crossover Arm were also reported separately.	1.3% 1/78 • Number of events 1 • RGT BOC+PR Arm and PBO+PR Arm (not entering Crossover): 1st dose to up to 52 weeks; PBO+PR Arm (entering Crossover): 1st dose to up to 48 weeks; Crossover Arm: 1st crossover dose to up to 48 weeks. Adverse events (AE) were reported for 237 randomized participants treated during the Treatment Period. AEs were not reported for 1 randomized participant that did not receive treatment in the Treatment Period. AEs for the 27 participants who started at Baseline in the Control Arm and switched to the Crossover Arm were also reported separately.	0.00% 0/27 • RGT BOC+PR Arm and PBO+PR Arm (not entering Crossover): 1st dose to up to 52 weeks; PBO+PR Arm (entering Crossover): 1st dose to up to 48 weeks; Crossover Arm: 1st crossover dose to up to 48 weeks. Adverse events (AE) were reported for 237 randomized participants treated during the Treatment Period. AEs were not reported for 1 randomized participant that did not receive treatment in the Treatment Period. AEs for the 27 participants who started at Baseline in the Control Arm and switched to the Crossover Arm were also reported separately.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.63% 1/159 • Number of events 1 • RGT BOC+PR Arm and PBO+PR Arm (not entering Crossover): 1st dose to up to 52 weeks; PBO+PR Arm (entering Crossover): 1st dose to up to 48 weeks; Crossover Arm: 1st crossover dose to up to 48 weeks. Adverse events (AE) were reported for 237 randomized participants treated during the Treatment Period. AEs were not reported for 1 randomized participant that did not receive treatment in the Treatment Period. AEs for the 27 participants who started at Baseline in the Control Arm and switched to the Crossover Arm were also reported separately.	0.00% 0/78 • RGT BOC+PR Arm and PBO+PR Arm (not entering Crossover): 1st dose to up to 52 weeks; PBO+PR Arm (entering Crossover): 1st dose to up to 48 weeks; Crossover Arm: 1st crossover dose to up to 48 weeks. Adverse events (AE) were reported for 237 randomized participants treated during the Treatment Period. AEs were not reported for 1 randomized participant that did not receive treatment in the Treatment Period. AEs for the 27 participants who started at Baseline in the Control Arm and switched to the Crossover Arm were also reported separately.	0.00% 0/27 • RGT BOC+PR Arm and PBO+PR Arm (not entering Crossover): 1st dose to up to 52 weeks; PBO+PR Arm (entering Crossover): 1st dose to up to 48 weeks; Crossover Arm: 1st crossover dose to up to 48 weeks. Adverse events (AE) were reported for 237 randomized participants treated during the Treatment Period. AEs were not reported for 1 randomized participant that did not receive treatment in the Treatment Period. AEs for the 27 participants who started at Baseline in the Control Arm and switched to the Crossover Arm were also reported separately.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.63% 1/159 • Number of events 1 • RGT BOC+PR Arm and PBO+PR Arm (not entering Crossover): 1st dose to up to 52 weeks; PBO+PR Arm (entering Crossover): 1st dose to up to 48 weeks; Crossover Arm: 1st crossover dose to up to 48 weeks. Adverse events (AE) were reported for 237 randomized participants treated during the Treatment Period. AEs were not reported for 1 randomized participant that did not receive treatment in the Treatment Period. AEs for the 27 participants who started at Baseline in the Control Arm and switched to the Crossover Arm were also reported separately.	0.00% 0/78 • RGT BOC+PR Arm and PBO+PR Arm (not entering Crossover): 1st dose to up to 52 weeks; PBO+PR Arm (entering Crossover): 1st dose to up to 48 weeks; Crossover Arm: 1st crossover dose to up to 48 weeks. Adverse events (AE) were reported for 237 randomized participants treated during the Treatment Period. AEs were not reported for 1 randomized participant that did not receive treatment in the Treatment Period. AEs for the 27 participants who started at Baseline in the Control Arm and switched to the Crossover Arm were also reported separately.	0.00% 0/27 • RGT BOC+PR Arm and PBO+PR Arm (not entering Crossover): 1st dose to up to 52 weeks; PBO+PR Arm (entering Crossover): 1st dose to up to 48 weeks; Crossover Arm: 1st crossover dose to up to 48 weeks. Adverse events (AE) were reported for 237 randomized participants treated during the Treatment Period. AEs were not reported for 1 randomized participant that did not receive treatment in the Treatment Period. AEs for the 27 participants who started at Baseline in the Control Arm and switched to the Crossover Arm were also reported separately.
Nervous system disorders Transient ischaemic attack	0.63% 1/159 • Number of events 1 • RGT BOC+PR Arm and PBO+PR Arm (not entering Crossover): 1st dose to up to 52 weeks; PBO+PR Arm (entering Crossover): 1st dose to up to 48 weeks; Crossover Arm: 1st crossover dose to up to 48 weeks. Adverse events (AE) were reported for 237 randomized participants treated during the Treatment Period. AEs were not reported for 1 randomized participant that did not receive treatment in the Treatment Period. AEs for the 27 participants who started at Baseline in the Control Arm and switched to the Crossover Arm were also reported separately.	0.00% 0/78 • RGT BOC+PR Arm and PBO+PR Arm (not entering Crossover): 1st dose to up to 52 weeks; PBO+PR Arm (entering Crossover): 1st dose to up to 48 weeks; Crossover Arm: 1st crossover dose to up to 48 weeks. Adverse events (AE) were reported for 237 randomized participants treated during the Treatment Period. AEs were not reported for 1 randomized participant that did not receive treatment in the Treatment Period. AEs for the 27 participants who started at Baseline in the Control Arm and switched to the Crossover Arm were also reported separately.	0.00% 0/27 • RGT BOC+PR Arm and PBO+PR Arm (not entering Crossover): 1st dose to up to 52 weeks; PBO+PR Arm (entering Crossover): 1st dose to up to 48 weeks; Crossover Arm: 1st crossover dose to up to 48 weeks. Adverse events (AE) were reported for 237 randomized participants treated during the Treatment Period. AEs were not reported for 1 randomized participant that did not receive treatment in the Treatment Period. AEs for the 27 participants who started at Baseline in the Control Arm and switched to the Crossover Arm were also reported separately.
Reproductive system and breast disorders Prostatitis	0.00% 0/159 • RGT BOC+PR Arm and PBO+PR Arm (not entering Crossover): 1st dose to up to 52 weeks; PBO+PR Arm (entering Crossover): 1st dose to up to 48 weeks; Crossover Arm: 1st crossover dose to up to 48 weeks. Adverse events (AE) were reported for 237 randomized participants treated during the Treatment Period. AEs were not reported for 1 randomized participant that did not receive treatment in the Treatment Period. AEs for the 27 participants who started at Baseline in the Control Arm and switched to the Crossover Arm were also reported separately.	1.3% 1/78 • Number of events 1 • RGT BOC+PR Arm and PBO+PR Arm (not entering Crossover): 1st dose to up to 52 weeks; PBO+PR Arm (entering Crossover): 1st dose to up to 48 weeks; Crossover Arm: 1st crossover dose to up to 48 weeks. Adverse events (AE) were reported for 237 randomized participants treated during the Treatment Period. AEs were not reported for 1 randomized participant that did not receive treatment in the Treatment Period. AEs for the 27 participants who started at Baseline in the Control Arm and switched to the Crossover Arm were also reported separately.	0.00% 0/27 • RGT BOC+PR Arm and PBO+PR Arm (not entering Crossover): 1st dose to up to 52 weeks; PBO+PR Arm (entering Crossover): 1st dose to up to 48 weeks; Crossover Arm: 1st crossover dose to up to 48 weeks. Adverse events (AE) were reported for 237 randomized participants treated during the Treatment Period. AEs were not reported for 1 randomized participant that did not receive treatment in the Treatment Period. AEs for the 27 participants who started at Baseline in the Control Arm and switched to the Crossover Arm were also reported separately.
Vascular disorders Hypertension	0.00% 0/159 • RGT BOC+PR Arm and PBO+PR Arm (not entering Crossover): 1st dose to up to 52 weeks; PBO+PR Arm (entering Crossover): 1st dose to up to 48 weeks; Crossover Arm: 1st crossover dose to up to 48 weeks. Adverse events (AE) were reported for 237 randomized participants treated during the Treatment Period. AEs were not reported for 1 randomized participant that did not receive treatment in the Treatment Period. AEs for the 27 participants who started at Baseline in the Control Arm and switched to the Crossover Arm were also reported separately.	2.6% 2/78 • Number of events 2 • RGT BOC+PR Arm and PBO+PR Arm (not entering Crossover): 1st dose to up to 52 weeks; PBO+PR Arm (entering Crossover): 1st dose to up to 48 weeks; Crossover Arm: 1st crossover dose to up to 48 weeks. Adverse events (AE) were reported for 237 randomized participants treated during the Treatment Period. AEs were not reported for 1 randomized participant that did not receive treatment in the Treatment Period. AEs for the 27 participants who started at Baseline in the Control Arm and switched to the Crossover Arm were also reported separately.	0.00% 0/27 • RGT BOC+PR Arm and PBO+PR Arm (not entering Crossover): 1st dose to up to 52 weeks; PBO+PR Arm (entering Crossover): 1st dose to up to 48 weeks; Crossover Arm: 1st crossover dose to up to 48 weeks. Adverse events (AE) were reported for 237 randomized participants treated during the Treatment Period. AEs were not reported for 1 randomized participant that did not receive treatment in the Treatment Period. AEs for the 27 participants who started at Baseline in the Control Arm and switched to the Crossover Arm were also reported separately.

Other adverse events

Additional Information

Vice President, Late Stage Development Group Leader

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Investigator agrees not to publish or publicly present any interim results of trial without prior written consent of Sponsor. Investigator further agrees to provide to Sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication that report any results of the trial. Sponsor has right to review and comment with respect to publications, abstracts, slides, data analysis and presentation
Publication restrictions are in place

Restriction type: OTHER