Trial Outcomes & Findings for Safety and Efficacy of Boceprevir in Previously Untreated Subjects With Chronic Hepatitis C Genotype 1 (Study P05216AM2) (COMPLETED) (NCT NCT00705432)
NCT ID: NCT00705432
Last Updated: 2017-04-07
Results Overview
Previously untreated adults with CHC genotype 1 were treated with the assigned study medication. Participants who had undetectable plasma HCV-RNA at FW 24 had achieved SVR. SVR rate is the percent of participants achieving SVR. HCV-RNA was detected by a nucleic acid amplification test and the limit of detection for this assay is 9.3 IU/mL. If a participant was missing data at FW 24 after having had undetectable HCV-RNA at FW 12, the participant was to be considered to have SVR.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1472 participants
Primary outcome timeframe
At Follow-up Week (FW) 24
Results posted on
2017-04-07
Participant Flow
1472 participants were enrolled in this study.
373 participants were screened but not randomized. 1099 participants were randomized. Only 1097 received at least one dose of PegIntron (PEG) + Ribavirin (RBV) (lead-in treatment).
Participant milestones
| Measure |
Cohort I - 1. Placebo + PEG + RBV
Cohort I (White participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing \[WBD\]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
|
Cohort I - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)
Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.
* At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.
* At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up.
|
Cohort I - 3. Boceprevir + PEG + RBV - 44 Weeks
Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
|
Cohort II - 1. Placebo + PEG + RBV
Cohort II (Black participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing \[WBD\]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
|
Cohort II - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)
Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.
* At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.
* At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up.
|
Cohort II - 3. Boceprevir + PEG + RBV - 44 Weeks
Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
|
|---|---|---|---|---|---|---|
|
Treatment Period
STARTED
|
311
|
316
|
311
|
52
|
52
|
55
|
|
Treatment Period
STARTED BOCEPREVIR/PLACEBO
|
297
|
303
|
299
|
47
|
47
|
55
|
|
Treatment Period
COMPLETED
|
148
|
205
|
190
|
11
|
24
|
25
|
|
Treatment Period
NOT COMPLETED
|
163
|
111
|
121
|
41
|
28
|
30
|
|
Follow-up Period (Upto Week 72)
STARTED
|
278
|
295
|
291
|
42
|
44
|
53
|
|
Follow-up Period (Upto Week 72)
COMPLETED
|
207
|
252
|
266
|
28
|
38
|
46
|
|
Follow-up Period (Upto Week 72)
NOT COMPLETED
|
71
|
43
|
25
|
14
|
6
|
7
|
Reasons for withdrawal
| Measure |
Cohort I - 1. Placebo + PEG + RBV
Cohort I (White participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing \[WBD\]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
|
Cohort I - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)
Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.
* At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.
* At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up.
|
Cohort I - 3. Boceprevir + PEG + RBV - 44 Weeks
Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
|
Cohort II - 1. Placebo + PEG + RBV
Cohort II (Black participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing \[WBD\]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
|
Cohort II - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)
Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.
* At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.
* At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up.
|
Cohort II - 3. Boceprevir + PEG + RBV - 44 Weeks
Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
|
|---|---|---|---|---|---|---|
|
Treatment Period
Adverse Event
|
45
|
37
|
51
|
12
|
8
|
9
|
|
Treatment Period
Treatment failure
|
92
|
42
|
33
|
25
|
13
|
14
|
|
Treatment Period
Non medical reason
|
26
|
32
|
37
|
4
|
7
|
7
|
|
Follow-up Period (Upto Week 72)
Adverse Event
|
2
|
1
|
1
|
0
|
0
|
0
|
|
Follow-up Period (Upto Week 72)
Non medical reason
|
69
|
42
|
24
|
14
|
6
|
7
|
Baseline Characteristics
Safety and Efficacy of Boceprevir in Previously Untreated Subjects With Chronic Hepatitis C Genotype 1 (Study P05216AM2) (COMPLETED)
Baseline characteristics by cohort
| Measure |
Cohort I - 1. Placebo + PEG + RBV
n=311 Participants
Cohort I (White participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing \[WBD\]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
|
Cohort I - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)
n=316 Participants
Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.
* At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.
* At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up.
|
Cohort I - 3. Boceprevir + PEG + RBV - 44 Weeks
n=311 Participants
Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
|
Cohort II - 1. Placebo + PEG + RBV
n=52 Participants
Cohort II (Black participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing \[WBD\]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
|
Cohort II - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)
n=52 Participants
Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.
* At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.
* At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up.
|
Cohort II - 3. Boceprevir + PEG + RBV - 44 Weeks
n=55 Participants
Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
|
Total
n=1097 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Customized
<40 years
|
51 participants
n=93 Participants
|
45 participants
n=4 Participants
|
49 participants
n=27 Participants
|
6 participants
n=483 Participants
|
3 participants
n=36 Participants
|
4 participants
n=10 Participants
|
158 participants
n=115 Participants
|
|
Age, Customized
>= 40 and <65 years
|
246 participants
n=93 Participants
|
261 participants
n=4 Participants
|
255 participants
n=27 Participants
|
45 participants
n=483 Participants
|
47 participants
n=36 Participants
|
51 participants
n=10 Participants
|
905 participants
n=115 Participants
|
|
Age, Customized
>=65 years
|
14 participants
n=93 Participants
|
10 participants
n=4 Participants
|
7 participants
n=27 Participants
|
1 participants
n=483 Participants
|
2 participants
n=36 Participants
|
0 participants
n=10 Participants
|
34 participants
n=115 Participants
|
|
Sex: Female, Male
Female
|
140 Participants
n=93 Participants
|
116 Participants
n=4 Participants
|
123 Participants
n=27 Participants
|
17 Participants
n=483 Participants
|
23 Participants
n=36 Participants
|
22 Participants
n=10 Participants
|
441 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
171 Participants
n=93 Participants
|
200 Participants
n=4 Participants
|
188 Participants
n=27 Participants
|
35 Participants
n=483 Participants
|
29 Participants
n=36 Participants
|
33 Participants
n=10 Participants
|
656 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: At Follow-up Week (FW) 24Population: Full analysis set (FAS). All randomized participants who received at least one dose of any study medication (PEG, RBV or boceprevir).
Previously untreated adults with CHC genotype 1 were treated with the assigned study medication. Participants who had undetectable plasma HCV-RNA at FW 24 had achieved SVR. SVR rate is the percent of participants achieving SVR. HCV-RNA was detected by a nucleic acid amplification test and the limit of detection for this assay is 9.3 IU/mL. If a participant was missing data at FW 24 after having had undetectable HCV-RNA at FW 12, the participant was to be considered to have SVR.
Outcome measures
| Measure |
Cohort I - 1. Placebo + PEG + RBV
n=311 Participants
Cohort I (White participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing \[WBD\]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
|
Cohort I - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)
n=316 Participants
Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.
* At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.
* At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up.
|
Cohort I - 3. Boceprevir + PEG + RBV - 44 Weeks
n=311 Participants
Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
|
Cohort II - 1. Placebo + PEG + RBV
n=52 Participants
Cohort II (Black participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing \[WBD\]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
|
Cohort II - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)
n=52 Participants
Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.
* At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.
* At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up.
|
Cohort II - 3. Boceprevir + PEG + RBV - 44 Weeks
n=55 Participants
Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
|
|---|---|---|---|---|---|---|
|
Sustained Virologic Response (SVR) Rate
|
40.2 Percentage of participants
|
66.8 Percentage of participants
|
68.5 Percentage of participants
|
23.1 Percentage of participants
|
42.3 Percentage of participants
|
52.7 Percentage of participants
|
SECONDARY outcome
Timeframe: At FW 24Population: Modified intent-to-treat set (mITT). All randomized participants who received at least one dose of boceprevir or placebo.
Previously untreated adults with CHC genotype 1 were treated with the assigned study medication. Participants who had undetectable plasma HCV-RNA at FW 24 had achieved SVR. SVR rate was the percentage of participants treated with at least one dose of boceprevir or placebo who had achieved SVR. HCV-RNA in participant's plasma samples was detected by a nucleic acid amplification assay with a limit of detection of 9.3 IU/mL. If a participant was missing data at FW 24 after having had undetectable HCV-RNA at FW 12, the participant was to be considered to have a SVR.
Outcome measures
| Measure |
Cohort I - 1. Placebo + PEG + RBV
n=297 Participants
Cohort I (White participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing \[WBD\]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
|
Cohort I - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)
n=303 Participants
Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.
* At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.
* At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up.
|
Cohort I - 3. Boceprevir + PEG + RBV - 44 Weeks
n=299 Participants
Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
|
Cohort II - 1. Placebo + PEG + RBV
n=47 Participants
Cohort II (Black participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing \[WBD\]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
|
Cohort II - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)
n=47 Participants
Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.
* At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.
* At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up.
|
Cohort II - 3. Boceprevir + PEG + RBV - 44 Weeks
n=55 Participants
Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
|
|---|---|---|---|---|---|---|
|
Sustained Virologic Response (SVR) Rate in Participants Treated With Study Drug (Boceprevir or Placebo)
|
42.1 Percentage of participants
|
69.6 Percentage of participants
|
71.2 Percentage of participants
|
25.5 Percentage of participants
|
46.8 Percentage of participants
|
52.7 Percentage of participants
|
SECONDARY outcome
Timeframe: At FW 12 and at 72 weeks after randomizationPopulation: Full analysis set (FAS). All randomized participants who received at least one dose of any study medication (PEG, RBV or boceprevir).
Previously untreated adults with CHC genotype 1 were treated with the assigned study medication. The number of participants who had undetectable plasma HCV-RNA at FW 12, and 72 weeks after randomization are reported. HCV-RNA was detected by a nucleic acid amplification test and the limit of detection for this assay is 9.3 IU/mL.
Outcome measures
| Measure |
Cohort I - 1. Placebo + PEG + RBV
n=311 Participants
Cohort I (White participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing \[WBD\]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
|
Cohort I - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)
n=316 Participants
Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.
* At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.
* At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up.
|
Cohort I - 3. Boceprevir + PEG + RBV - 44 Weeks
n=311 Participants
Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
|
Cohort II - 1. Placebo + PEG + RBV
n=52 Participants
Cohort II (Black participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing \[WBD\]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
|
Cohort II - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)
n=52 Participants
Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.
* At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.
* At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up.
|
Cohort II - 3. Boceprevir + PEG + RBV - 44 Weeks
n=55 Participants
Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Undetectable HCV-RNA at Follow-up Week 12 and at 72 Weeks After Randomization.
At follow-up week 12
|
127 Participants
|
209 Participants
|
209 Participants
|
11 Participants
|
21 Participants
|
29 Participants
|
|
Number of Participants With Undetectable HCV-RNA at Follow-up Week 12 and at 72 Weeks After Randomization.
72 weeks after randomization
|
120 Participants
|
194 Participants
|
205 Participants
|
11 Participants
|
20 Participants
|
27 Participants
|
SECONDARY outcome
Timeframe: At Treatment Week 2, 4, 8, 12, 16, or 20Population: Full analysis set (FAS). All randomized participants who received at least one dose of any study medication (PEG, RBV or boceprevir).
Early virologic response was defined as undetectable HCV-RNA at in participants by treatment week 2, 4, 8, 12, 16, or 20. HCV-RNA in participant's plasma samples was detected by a nucleic acid amplification assay with a limit of detection of 9.3 IU/mL.
Outcome measures
| Measure |
Cohort I - 1. Placebo + PEG + RBV
n=311 Participants
Cohort I (White participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing \[WBD\]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
|
Cohort I - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)
n=316 Participants
Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.
* At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.
* At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up.
|
Cohort I - 3. Boceprevir + PEG + RBV - 44 Weeks
n=311 Participants
Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
|
Cohort II - 1. Placebo + PEG + RBV
n=52 Participants
Cohort II (Black participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing \[WBD\]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
|
Cohort II - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)
n=52 Participants
Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.
* At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.
* At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up.
|
Cohort II - 3. Boceprevir + PEG + RBV - 44 Weeks
n=55 Participants
Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Early Virologic Response (Undetectable HCV-RNA at Treatment Week 2, 4, 8, 12, 16, or 20)
Treatment week 2
|
8 Participants
|
11 Participants
|
8 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Early Virologic Response (Undetectable HCV-RNA at Treatment Week 2, 4, 8, 12, 16, or 20)
Treatment week 4
|
28 Participants
|
18 Participants
|
20 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Early Virologic Response (Undetectable HCV-RNA at Treatment Week 2, 4, 8, 12, 16, or 20)
Treatment week 8
|
56 Participants
|
190 Participants
|
182 Participants
|
4 Participants
|
18 Participants
|
22 Participants
|
|
Number of Participants With Early Virologic Response (Undetectable HCV-RNA at Treatment Week 2, 4, 8, 12, 16, or 20)
Treatment week 12
|
108 Participants
|
237 Participants
|
231 Participants
|
10 Participants
|
25 Participants
|
33 Participants
|
|
Number of Participants With Early Virologic Response (Undetectable HCV-RNA at Treatment Week 2, 4, 8, 12, 16, or 20)
Treatment week 16
|
138 Participants
|
231 Participants
|
237 Participants
|
15 Participants
|
26 Participants
|
36 Participants
|
|
Number of Participants With Early Virologic Response (Undetectable HCV-RNA at Treatment Week 2, 4, 8, 12, 16, or 20)
Treatment week 20
|
157 Participants
|
231 Participants
|
231 Participants
|
15 Participants
|
27 Participants
|
32 Participants
|
SECONDARY outcome
Timeframe: At Treatment Week 4, 8, 12, 16, 20Population: Participants that had undetectable HCV RNA for the treatment weeks 4, 8, 12, 16, and 20.
Participants with early virologic response were those who had undetectable HCV-RNA by treatment week 4, 8, 12, 16, or 20. Participants who had undetectable plasma HCV-RNA at FW 24 had SVR. The number of participants with early virologic response that also achieved SVR is reported. HCV-RNA in participant's plasma samples was detected by a nucleic acid amplification assay with a limit of detection of 9.3 IU/mL.
Outcome measures
| Measure |
Cohort I - 1. Placebo + PEG + RBV
n=311 Participants
Cohort I (White participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing \[WBD\]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
|
Cohort I - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)
n=316 Participants
Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.
* At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.
* At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up.
|
Cohort I - 3. Boceprevir + PEG + RBV - 44 Weeks
n=311 Participants
Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
|
Cohort II - 1. Placebo + PEG + RBV
n=52 Participants
Cohort II (Black participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing \[WBD\]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
|
Cohort II - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)
n=52 Participants
Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.
* At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.
* At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up.
|
Cohort II - 3. Boceprevir + PEG + RBV - 44 Weeks
n=55 Participants
Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Early Virologic Response (Undetectable HCV-RNA at Treatment Week 4, 8, 12, 16, or 20) Who Achieved SVR
Treatment week 4 (n=28, 18, 20, 2, 1, 0)
|
27 Participants
|
16 Participants
|
18 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Early Virologic Response (Undetectable HCV-RNA at Treatment Week 4, 8, 12, 16, or 20) Who Achieved SVR
Treatment week 8 (n=56, 190, 182, 4, 18, 22)
|
48 Participants
|
170 Participants
|
166 Participants
|
3 Participants
|
14 Participants
|
18 Participants
|
|
Number of Participants With Early Virologic Response (Undetectable HCV-RNA at Treatment Week 4, 8, 12, 16, or 20) Who Achieved SVR
Treatment week 12 (n=108, 237, 231, 10, 25, 33)
|
90 Participants
|
205 Participants
|
204 Participants
|
7 Participants
|
19 Participants
|
26 Participants
|
|
Number of Participants With Early Virologic Response (Undetectable HCV-RNA at Treatment Week 4, 8, 12, 16, or 20) Who Achieved SVR
Treatment week 16 (n=138, 231, 237, 15, 26, 36)
|
106 Participants
|
205 Participants
|
210 Participants
|
12 Participants
|
20 Participants
|
26 Participants
|
|
Number of Participants With Early Virologic Response (Undetectable HCV-RNA at Treatment Week 4, 8, 12, 16, or 20) Who Achieved SVR
Treatment week 20 (n=157, 231, 231, 15, 27, 32)
|
118 Participants
|
201 Participants
|
208 Participants
|
12 Participants
|
21 Participants
|
26 Participants
|
Adverse Events
PEG + RBV
Serious events: 31 serious events
Other events: 353 other events
Deaths: 0 deaths
BOCEPREVIR + PEG + RBV - 24 WEEKS
Serious events: 42 serious events
Other events: 365 other events
Deaths: 0 deaths
BOCEPRIVIR + PEG + RBV - 44 WEEKS
Serious events: 45 serious events
Other events: 363 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PEG + RBV
n=363 participants at risk
Cohort I (White participants) and Cohort II (Black participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing \[WBD\]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
|
BOCEPREVIR + PEG + RBV - 24 WEEKS
n=368 participants at risk
Cohort I (White participants) and Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.
* At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.
* At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up.
|
BOCEPRIVIR + PEG + RBV - 44 WEEKS
n=366 participants at risk
Cohort I (White participants) and Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.28%
1/363 • Number of events 1
|
0.82%
3/368 • Number of events 5
|
1.1%
4/366 • Number of events 7
|
|
Blood and lymphatic system disorders
APLASIA PURE RED CELL
|
0.00%
0/363
|
0.00%
0/368
|
0.27%
1/366 • Number of events 1
|
|
Blood and lymphatic system disorders
LEUKOCYTOSIS
|
0.28%
1/363 • Number of events 1
|
0.00%
0/368
|
0.00%
0/366
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
0.00%
0/363
|
0.00%
0/368
|
0.55%
2/366 • Number of events 2
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
0.00%
0/363
|
0.27%
1/368 • Number of events 1
|
0.55%
2/366 • Number of events 3
|
|
Blood and lymphatic system disorders
PANCYTOPENIA
|
0.00%
0/363
|
0.00%
0/368
|
0.27%
1/366 • Number of events 1
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
0.00%
0/363
|
0.00%
0/368
|
0.82%
3/366 • Number of events 3
|
|
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION
|
0.00%
0/363
|
0.27%
1/368 • Number of events 1
|
0.00%
0/366
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.00%
0/363
|
0.27%
1/368 • Number of events 1
|
0.00%
0/366
|
|
Cardiac disorders
ATRIAL FLUTTER
|
0.00%
0/363
|
0.27%
1/368 • Number of events 1
|
0.00%
0/366
|
|
Cardiac disorders
CARDIAC ARREST
|
0.28%
1/363 • Number of events 1
|
0.00%
0/368
|
0.27%
1/366 • Number of events 1
|
|
Cardiac disorders
CARDIO-RESPIRATORY ARREST
|
0.28%
1/363 • Number of events 1
|
0.00%
0/368
|
0.00%
0/366
|
|
Cardiac disorders
CORONARY ARTERY DISEASE
|
0.00%
0/363
|
0.27%
1/368 • Number of events 1
|
0.00%
0/366
|
|
Cardiac disorders
CORONARY ARTERY OCCLUSION
|
0.00%
0/363
|
0.27%
1/368 • Number of events 1
|
0.00%
0/366
|
|
Cardiac disorders
HYPERTROPHIC CARDIOMYOPATHY
|
0.00%
0/363
|
0.27%
1/368 • Number of events 1
|
0.00%
0/366
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
0.28%
1/363 • Number of events 1
|
0.00%
0/368
|
0.00%
0/366
|
|
Cardiac disorders
TACHYCARDIA
|
0.00%
0/363
|
0.00%
0/368
|
0.27%
1/366 • Number of events 1
|
|
Ear and labyrinth disorders
DEAFNESS
|
0.00%
0/363
|
0.00%
0/368
|
0.27%
1/366 • Number of events 1
|
|
Endocrine disorders
HYPOTHYROIDISM
|
0.28%
1/363 • Number of events 1
|
0.00%
0/368
|
0.00%
0/366
|
|
Eye disorders
CONJUNCTIVITIS
|
0.00%
0/363
|
0.00%
0/368
|
0.27%
1/366 • Number of events 1
|
|
Eye disorders
OPTIC NEUROPATHY
|
0.00%
0/363
|
0.00%
0/368
|
0.27%
1/366 • Number of events 1
|
|
Eye disorders
PAPILLOEDEMA
|
0.00%
0/363
|
0.27%
1/368 • Number of events 1
|
0.00%
0/366
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.28%
1/363 • Number of events 1
|
0.27%
1/368 • Number of events 1
|
0.27%
1/366 • Number of events 1
|
|
Gastrointestinal disorders
ABDOMINAL PAIN LOWER
|
0.00%
0/363
|
0.00%
0/368
|
0.27%
1/366 • Number of events 1
|
|
Gastrointestinal disorders
COLITIS
|
0.28%
1/363 • Number of events 1
|
0.00%
0/368
|
0.00%
0/366
|
|
Gastrointestinal disorders
COLONIC POLYP
|
0.00%
0/363
|
0.00%
0/368
|
0.27%
1/366 • Number of events 1
|
|
Gastrointestinal disorders
GASTRITIS
|
0.00%
0/363
|
0.00%
0/368
|
0.27%
1/366 • Number of events 1
|
|
Gastrointestinal disorders
GASTROINTESTINAL HAEMORRHAGE
|
0.00%
0/363
|
0.27%
1/368 • Number of events 1
|
0.00%
0/366
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
0.00%
0/363
|
0.27%
1/368 • Number of events 1
|
0.00%
0/366
|
|
Gastrointestinal disorders
HAEMATEMESIS
|
0.00%
0/363
|
0.27%
1/368 • Number of events 1
|
0.00%
0/366
|
|
Gastrointestinal disorders
HAEMORRHOIDAL HAEMORRHAGE
|
0.00%
0/363
|
0.00%
0/368
|
0.27%
1/366 • Number of events 1
|
|
Gastrointestinal disorders
HAEMORRHOIDS
|
0.00%
0/363
|
0.00%
0/368
|
0.27%
1/366 • Number of events 1
|
|
Gastrointestinal disorders
MALLORY-WEISS SYNDROME
|
0.00%
0/363
|
0.27%
1/368 • Number of events 1
|
0.00%
0/366
|
|
Gastrointestinal disorders
NAUSEA
|
0.28%
1/363 • Number of events 1
|
0.00%
0/368
|
0.27%
1/366 • Number of events 1
|
|
Gastrointestinal disorders
PANCREATITIS
|
0.55%
2/363 • Number of events 2
|
0.00%
0/368
|
0.00%
0/366
|
|
Gastrointestinal disorders
PANCREATITIS ACUTE
|
0.00%
0/363
|
0.00%
0/368
|
0.27%
1/366 • Number of events 1
|
|
Gastrointestinal disorders
UMBILICAL HERNIA
|
0.00%
0/363
|
0.27%
1/368 • Number of events 1
|
0.00%
0/366
|
|
Gastrointestinal disorders
VOMITING
|
0.28%
1/363 • Number of events 1
|
0.00%
0/368
|
0.55%
2/366 • Number of events 2
|
|
General disorders
CHEST DISCOMFORT
|
0.00%
0/363
|
0.00%
0/368
|
0.55%
2/366 • Number of events 2
|
|
General disorders
CHEST PAIN
|
0.00%
0/363
|
0.27%
1/368 • Number of events 1
|
1.1%
4/366 • Number of events 4
|
|
General disorders
DEATH
|
0.55%
2/363 • Number of events 2
|
0.00%
0/368
|
0.00%
0/366
|
|
General disorders
FATIGUE
|
0.00%
0/363
|
0.00%
0/368
|
0.27%
1/366 • Number of events 1
|
|
General disorders
GENERAL PHYSICAL HEALTH DETERIORATION
|
0.00%
0/363
|
0.00%
0/368
|
0.27%
1/366 • Number of events 1
|
|
General disorders
MALAISE
|
0.00%
0/363
|
0.27%
1/368 • Number of events 1
|
0.00%
0/366
|
|
General disorders
PYREXIA
|
0.55%
2/363 • Number of events 2
|
0.27%
1/368 • Number of events 1
|
0.82%
3/366 • Number of events 3
|
|
Hepatobiliary disorders
CHOLECYSTITIS
|
0.28%
1/363 • Number of events 1
|
0.00%
0/368
|
0.27%
1/366 • Number of events 1
|
|
Hepatobiliary disorders
CHOLECYSTITIS ACUTE
|
0.28%
1/363 • Number of events 1
|
0.00%
0/368
|
0.00%
0/366
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
0.55%
2/363 • Number of events 2
|
0.00%
0/368
|
0.00%
0/366
|
|
Hepatobiliary disorders
CHOLELITHIASIS OBSTRUCTIVE
|
0.28%
1/363 • Number of events 1
|
0.00%
0/368
|
0.00%
0/366
|
|
Immune system disorders
SARCOIDOSIS
|
0.00%
0/363
|
0.00%
0/368
|
0.27%
1/366 • Number of events 2
|
|
Infections and infestations
ABSCESS
|
0.00%
0/363
|
0.27%
1/368 • Number of events 1
|
0.00%
0/366
|
|
Infections and infestations
ABSCESS LIMB
|
0.00%
0/363
|
0.00%
0/368
|
0.27%
1/366 • Number of events 1
|
|
Infections and infestations
APPENDICITIS
|
0.28%
1/363 • Number of events 1
|
0.00%
0/368
|
0.00%
0/366
|
|
Infections and infestations
ATYPICAL MYCOBACTERIAL INFECTION
|
0.28%
1/363 • Number of events 1
|
0.00%
0/368
|
0.00%
0/366
|
|
Infections and infestations
BACTERAEMIA
|
0.00%
0/363
|
0.00%
0/368
|
0.27%
1/366 • Number of events 1
|
|
Infections and infestations
BRONCHITIS
|
0.00%
0/363
|
0.54%
2/368 • Number of events 2
|
0.00%
0/366
|
|
Infections and infestations
CELLULITIS
|
0.28%
1/363 • Number of events 1
|
0.27%
1/368 • Number of events 1
|
0.55%
2/366 • Number of events 2
|
|
Infections and infestations
DIVERTICULITIS
|
0.28%
1/363 • Number of events 1
|
0.00%
0/368
|
0.00%
0/366
|
|
Infections and infestations
ENTEROCOLITIS INFECTIOUS
|
0.28%
1/363 • Number of events 1
|
0.00%
0/368
|
0.00%
0/366
|
|
Infections and infestations
EPIGLOTTITIS
|
0.00%
0/363
|
0.27%
1/368 • Number of events 1
|
0.00%
0/366
|
|
Infections and infestations
GASTROENTERITIS
|
0.00%
0/363
|
0.54%
2/368 • Number of events 2
|
0.55%
2/366 • Number of events 2
|
|
Infections and infestations
INFECTED BITES
|
0.00%
0/363
|
0.27%
1/368 • Number of events 1
|
0.00%
0/366
|
|
Infections and infestations
INJECTION SITE INFECTION
|
0.00%
0/363
|
0.00%
0/368
|
0.27%
1/366 • Number of events 1
|
|
Infections and infestations
PERIRECTAL ABSCESS
|
0.00%
0/363
|
0.27%
1/368 • Number of events 1
|
0.00%
0/366
|
|
Infections and infestations
PNEUMONIA
|
0.28%
1/363 • Number of events 1
|
0.82%
3/368 • Number of events 4
|
0.27%
1/366 • Number of events 1
|
|
Infections and infestations
PNEUMONIA PNEUMOCOCCAL
|
0.00%
0/363
|
0.00%
0/368
|
0.27%
1/366 • Number of events 1
|
|
Infections and infestations
SCROTAL ABSCESS
|
0.00%
0/363
|
0.00%
0/368
|
0.27%
1/366 • Number of events 1
|
|
Infections and infestations
SINUSITIS
|
0.28%
1/363 • Number of events 1
|
0.00%
0/368
|
0.00%
0/366
|
|
Infections and infestations
STAPHYLOCOCCAL INFECTION
|
0.00%
0/363
|
0.00%
0/368
|
0.27%
1/366 • Number of events 1
|
|
Infections and infestations
TRACHEOBRONCHITIS
|
0.00%
0/363
|
0.00%
0/368
|
0.27%
1/366 • Number of events 1
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
0.28%
1/363 • Number of events 1
|
0.00%
0/368
|
0.00%
0/366
|
|
Injury, poisoning and procedural complications
ACCIDENTAL OVERDOSE
|
0.28%
1/363 • Number of events 1
|
0.00%
0/368
|
0.00%
0/366
|
|
Injury, poisoning and procedural complications
ALCOHOL POISONING
|
0.28%
1/363 • Number of events 1
|
0.00%
0/368
|
0.00%
0/366
|
|
Injury, poisoning and procedural complications
OVERDOSE
|
0.00%
0/363
|
0.00%
0/368
|
0.27%
1/366 • Number of events 2
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL COMPLICATION
|
0.00%
0/363
|
0.27%
1/368 • Number of events 1
|
0.00%
0/366
|
|
Injury, poisoning and procedural complications
ROAD TRAFFIC ACCIDENT
|
0.00%
0/363
|
0.00%
0/368
|
0.27%
1/366 • Number of events 1
|
|
Injury, poisoning and procedural complications
SPINAL FRACTURE
|
0.28%
1/363 • Number of events 1
|
0.00%
0/368
|
0.00%
0/366
|
|
Injury, poisoning and procedural complications
TRANSFUSION REACTION
|
0.00%
0/363
|
0.00%
0/368
|
0.27%
1/366 • Number of events 1
|
|
Injury, poisoning and procedural complications
VASCULAR PSEUDOANEURYSM
|
0.00%
0/363
|
0.27%
1/368 • Number of events 1
|
0.00%
0/366
|
|
Injury, poisoning and procedural complications
WOUND DEHISCENCE
|
0.00%
0/363
|
0.00%
0/368
|
0.27%
1/366 • Number of events 1
|
|
Investigations
WHITE BLOOD CELL COUNT DECREASED
|
0.28%
1/363 • Number of events 1
|
0.00%
0/368
|
0.00%
0/366
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.00%
0/363
|
0.00%
0/368
|
0.27%
1/366 • Number of events 1
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
0.00%
0/363
|
0.54%
2/368 • Number of events 2
|
0.00%
0/366
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
0.00%
0/363
|
0.27%
1/368 • Number of events 1
|
0.00%
0/366
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.00%
0/363
|
0.00%
0/368
|
0.27%
1/366 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
FLANK PAIN
|
0.00%
0/363
|
0.27%
1/368 • Number of events 1
|
0.00%
0/366
|
|
Musculoskeletal and connective tissue disorders
GROIN PAIN
|
0.00%
0/363
|
0.00%
0/368
|
0.27%
1/366 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC PROTRUSION
|
0.00%
0/363
|
0.27%
1/368 • Number of events 1
|
0.00%
0/366
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
|
0.00%
0/363
|
0.00%
0/368
|
0.27%
1/366 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BLADDER CANCER
|
0.00%
0/363
|
0.00%
0/368
|
0.27%
1/366 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST CANCER
|
0.28%
1/363 • Number of events 1
|
0.00%
0/368
|
0.27%
1/366 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
COLON CANCER
|
0.00%
0/363
|
0.27%
1/368 • Number of events 1
|
0.00%
0/366
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
HEPATIC NEOPLASM MALIGNANT
|
0.28%
1/363 • Number of events 1
|
0.00%
0/368
|
0.00%
0/366
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LUNG ADENOCARCINOMA
|
0.28%
1/363 • Number of events 1
|
0.00%
0/368
|
0.00%
0/366
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PANCREATIC CARCINOMA
|
0.00%
0/363
|
0.27%
1/368 • Number of events 1
|
0.00%
0/366
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PROSTATE CANCER
|
0.28%
1/363 • Number of events 1
|
0.27%
1/368 • Number of events 1
|
0.00%
0/366
|
|
Nervous system disorders
CAROTID ARTERY STENOSIS
|
0.00%
0/363
|
0.27%
1/368 • Number of events 1
|
0.00%
0/366
|
|
Nervous system disorders
CEREBRAL ISCHAEMIA
|
0.00%
0/363
|
0.27%
1/368 • Number of events 1
|
0.00%
0/366
|
|
Nervous system disorders
DIZZINESS
|
0.28%
1/363 • Number of events 1
|
0.00%
0/368
|
0.27%
1/366 • Number of events 2
|
|
Nervous system disorders
HYPOAESTHESIA
|
0.28%
1/363 • Number of events 1
|
0.00%
0/368
|
0.00%
0/366
|
|
Nervous system disorders
LOSS OF CONSCIOUSNESS
|
0.28%
1/363 • Number of events 1
|
0.00%
0/368
|
0.00%
0/366
|
|
Nervous system disorders
MOTOR NEURONE DISEASE
|
0.00%
0/363
|
0.27%
1/368 • Number of events 1
|
0.00%
0/366
|
|
Nervous system disorders
MUSCLE SPASTICITY
|
0.00%
0/363
|
0.27%
1/368 • Number of events 1
|
0.00%
0/366
|
|
Nervous system disorders
SYNCOPE
|
0.00%
0/363
|
0.27%
1/368 • Number of events 1
|
1.1%
4/366 • Number of events 4
|
|
Psychiatric disorders
AFFECTIVE DISORDER
|
0.28%
1/363 • Number of events 1
|
0.00%
0/368
|
0.27%
1/366 • Number of events 1
|
|
Psychiatric disorders
ALCOHOL ABUSE
|
0.00%
0/363
|
0.27%
1/368 • Number of events 1
|
0.00%
0/366
|
|
Psychiatric disorders
ANXIETY
|
0.00%
0/363
|
0.27%
1/368 • Number of events 1
|
0.00%
0/366
|
|
Psychiatric disorders
BIPOLAR I DISORDER
|
0.28%
1/363 • Number of events 1
|
0.00%
0/368
|
0.00%
0/366
|
|
Psychiatric disorders
COMPLETED SUICIDE
|
0.28%
1/363 • Number of events 1
|
0.27%
1/368 • Number of events 1
|
0.00%
0/366
|
|
Psychiatric disorders
DEPRESSION
|
0.28%
1/363 • Number of events 1
|
0.27%
1/368 • Number of events 1
|
0.27%
1/366 • Number of events 1
|
|
Psychiatric disorders
DRUG ABUSE
|
0.00%
0/363
|
0.00%
0/368
|
0.27%
1/366 • Number of events 1
|
|
Psychiatric disorders
DRUG DEPENDENCE
|
0.28%
1/363 • Number of events 1
|
0.00%
0/368
|
0.00%
0/366
|
|
Psychiatric disorders
INTENTIONAL SELF-INJURY
|
0.28%
1/363 • Number of events 1
|
0.00%
0/368
|
0.00%
0/366
|
|
Psychiatric disorders
PERSONALITY DISORDER
|
0.28%
1/363 • Number of events 1
|
0.00%
0/368
|
0.00%
0/366
|
|
Psychiatric disorders
PSYCHIATRIC DECOMPENSATION
|
0.00%
0/363
|
0.00%
0/368
|
0.27%
1/366 • Number of events 1
|
|
Psychiatric disorders
SUICIDAL IDEATION
|
0.28%
1/363 • Number of events 1
|
0.00%
0/368
|
1.1%
4/366 • Number of events 4
|
|
Psychiatric disorders
SUICIDE ATTEMPT
|
0.28%
1/363 • Number of events 1
|
0.00%
0/368
|
0.27%
1/366 • Number of events 1
|
|
Renal and urinary disorders
GLOMERULONEPHRITIS MINIMAL LESION
|
0.28%
1/363 • Number of events 1
|
0.00%
0/368
|
0.00%
0/366
|
|
Renal and urinary disorders
RENAL TUBULAR NECROSIS
|
0.28%
1/363 • Number of events 1
|
0.00%
0/368
|
0.00%
0/366
|
|
Reproductive system and breast disorders
SCROTAL PAIN
|
0.00%
0/363
|
0.00%
0/368
|
0.27%
1/366 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.00%
0/363
|
0.00%
0/368
|
0.55%
2/366 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.00%
0/363
|
0.00%
0/368
|
0.27%
1/366 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
HAEMOPTYSIS
|
0.00%
0/363
|
0.27%
1/368 • Number of events 1
|
0.00%
0/366
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL FIBROSIS
|
0.00%
0/363
|
0.27%
1/368 • Number of events 1
|
0.00%
0/366
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMOTHORAX
|
0.28%
1/363 • Number of events 1
|
0.00%
0/368
|
0.00%
0/366
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.00%
0/363
|
0.54%
2/368 • Number of events 2
|
0.00%
0/366
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
0.00%
0/363
|
0.00%
0/368
|
0.27%
1/366 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
RASH ERYTHEMATOUS
|
0.00%
0/363
|
0.00%
0/368
|
0.27%
1/366 • Number of events 1
|
|
Social circumstances
ALCOHOL USE
|
0.00%
0/363
|
0.00%
0/368
|
0.27%
1/366 • Number of events 1
|
|
Social circumstances
PHYSICAL ASSAULT
|
0.28%
1/363 • Number of events 1
|
0.00%
0/368
|
0.00%
0/366
|
|
Surgical and medical procedures
CHOLECYSTECTOMY
|
0.28%
1/363 • Number of events 1
|
0.00%
0/368
|
0.00%
0/366
|
|
Surgical and medical procedures
LARYNGEAL OPERATION
|
0.00%
0/363
|
0.00%
0/368
|
0.27%
1/366 • Number of events 1
|
|
Surgical and medical procedures
SKIN NEOPLASM EXCISION
|
0.28%
1/363 • Number of events 1
|
0.00%
0/368
|
0.00%
0/366
|
|
Vascular disorders
ACCELERATED HYPERTENSION
|
0.00%
0/363
|
0.00%
0/368
|
0.27%
1/366 • Number of events 1
|
|
Vascular disorders
ARTERIAL THROMBOSIS LIMB
|
0.00%
0/363
|
0.00%
0/368
|
0.27%
1/366 • Number of events 1
|
|
Vascular disorders
HYPERTENSIVE CRISIS
|
0.00%
0/363
|
0.00%
0/368
|
0.27%
1/366 • Number of events 1
|
|
Vascular disorders
HYPOTENSION
|
0.00%
0/363
|
0.27%
1/368 • Number of events 1
|
0.27%
1/366 • Number of events 1
|
Other adverse events
| Measure |
PEG + RBV
n=363 participants at risk
Cohort I (White participants) and Cohort II (Black participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing \[WBD\]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
|
BOCEPREVIR + PEG + RBV - 24 WEEKS
n=368 participants at risk
Cohort I (White participants) and Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.
* At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.
* At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up.
|
BOCEPRIVIR + PEG + RBV - 44 WEEKS
n=366 participants at risk
Cohort I (White participants) and Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
29.5%
107/363 • Number of events 188
|
49.5%
182/368 • Number of events 292
|
48.9%
179/366 • Number of events 352
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
9.1%
33/363 • Number of events 81
|
8.4%
31/368 • Number of events 83
|
12.3%
45/366 • Number of events 126
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
21.2%
77/363 • Number of events 208
|
24.7%
91/368 • Number of events 216
|
25.4%
93/366 • Number of events 257
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
1.9%
7/363 • Number of events 16
|
4.3%
16/368 • Number of events 50
|
5.2%
19/366 • Number of events 38
|
|
Eye disorders
DRY EYE
|
4.4%
16/363 • Number of events 16
|
3.5%
13/368 • Number of events 13
|
6.0%
22/366 • Number of events 24
|
|
Eye disorders
VISION BLURRED
|
3.9%
14/363 • Number of events 15
|
6.2%
23/368 • Number of events 25
|
6.0%
22/366 • Number of events 25
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
5.5%
20/363 • Number of events 30
|
6.8%
25/368 • Number of events 28
|
6.3%
23/366 • Number of events 28
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
8.8%
32/363 • Number of events 40
|
8.2%
30/368 • Number of events 41
|
12.0%
44/366 • Number of events 54
|
|
Gastrointestinal disorders
CONSTIPATION
|
8.8%
32/363 • Number of events 34
|
6.0%
22/368 • Number of events 24
|
8.7%
32/366 • Number of events 34
|
|
Gastrointestinal disorders
DIARRHOEA
|
21.8%
79/363 • Number of events 103
|
21.7%
80/368 • Number of events 104
|
27.3%
100/366 • Number of events 125
|
|
Gastrointestinal disorders
DRY MOUTH
|
11.0%
40/363 • Number of events 45
|
10.6%
39/368 • Number of events 42
|
11.7%
43/366 • Number of events 51
|
|
Gastrointestinal disorders
DYSPEPSIA
|
8.8%
32/363 • Number of events 39
|
7.9%
29/368 • Number of events 35
|
9.0%
33/366 • Number of events 40
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
2.2%
8/363 • Number of events 9
|
5.2%
19/368 • Number of events 22
|
5.5%
20/366 • Number of events 22
|
|
Gastrointestinal disorders
NAUSEA
|
42.1%
153/363 • Number of events 199
|
47.6%
175/368 • Number of events 231
|
43.4%
159/366 • Number of events 212
|
|
Gastrointestinal disorders
VOMITING
|
15.7%
57/363 • Number of events 70
|
20.4%
75/368 • Number of events 99
|
19.1%
70/366 • Number of events 90
|
|
General disorders
ASTHENIA
|
19.3%
70/363 • Number of events 129
|
14.9%
55/368 • Number of events 86
|
19.1%
70/366 • Number of events 132
|
|
General disorders
CHILLS
|
28.1%
102/363 • Number of events 114
|
36.4%
134/368 • Number of events 156
|
33.1%
121/366 • Number of events 139
|
|
General disorders
FATIGUE
|
59.8%
217/363 • Number of events 279
|
53.3%
196/368 • Number of events 250
|
57.1%
209/366 • Number of events 290
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
25.6%
93/363 • Number of events 160
|
24.7%
91/368 • Number of events 113
|
22.7%
83/366 • Number of events 102
|
|
General disorders
INJECTION SITE ERYTHEMA
|
12.9%
47/363 • Number of events 55
|
12.5%
46/368 • Number of events 48
|
10.1%
37/366 • Number of events 38
|
|
General disorders
INJECTION SITE REACTION
|
12.1%
44/363 • Number of events 46
|
12.2%
45/368 • Number of events 46
|
10.7%
39/366 • Number of events 39
|
|
General disorders
IRRITABILITY
|
23.7%
86/363 • Number of events 106
|
22.0%
81/368 • Number of events 104
|
22.7%
83/366 • Number of events 111
|
|
General disorders
PAIN
|
9.4%
34/363 • Number of events 36
|
11.1%
41/368 • Number of events 43
|
10.1%
37/366 • Number of events 41
|
|
General disorders
PYREXIA
|
33.1%
120/363 • Number of events 196
|
33.4%
123/368 • Number of events 180
|
32.0%
117/366 • Number of events 218
|
|
Infections and infestations
SINUSITIS
|
4.1%
15/363 • Number of events 18
|
4.3%
16/368 • Number of events 20
|
5.2%
19/366 • Number of events 22
|
|
Investigations
WEIGHT DECREASED
|
12.7%
46/363 • Number of events 54
|
11.7%
43/368 • Number of events 50
|
14.2%
52/366 • Number of events 64
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
24.8%
90/363 • Number of events 101
|
26.4%
97/368 • Number of events 107
|
24.3%
89/366 • Number of events 98
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
18.2%
66/363 • Number of events 84
|
18.8%
69/368 • Number of events 87
|
19.7%
72/366 • Number of events 103
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
11.0%
40/363 • Number of events 45
|
8.2%
30/368 • Number of events 33
|
10.9%
40/366 • Number of events 45
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
6.3%
23/363 • Number of events 25
|
4.1%
15/368 • Number of events 20
|
4.9%
18/366 • Number of events 20
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
25.9%
94/363 • Number of events 125
|
21.2%
78/368 • Number of events 98
|
25.1%
92/366 • Number of events 120
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
5.2%
19/363 • Number of events 21
|
3.0%
11/368 • Number of events 12
|
5.7%
21/366 • Number of events 24
|
|
Nervous system disorders
DISTURBANCE IN ATTENTION
|
7.4%
27/363 • Number of events 30
|
6.0%
22/368 • Number of events 23
|
4.9%
18/366 • Number of events 18
|
|
Nervous system disorders
DIZZINESS
|
16.3%
59/363 • Number of events 74
|
21.7%
80/368 • Number of events 97
|
18.0%
66/366 • Number of events 70
|
|
Nervous system disorders
DYSGEUSIA
|
17.6%
64/363 • Number of events 68
|
37.2%
137/368 • Number of events 143
|
42.6%
156/366 • Number of events 164
|
|
Nervous system disorders
HEADACHE
|
42.1%
153/363 • Number of events 264
|
45.7%
168/368 • Number of events 233
|
45.6%
167/366 • Number of events 311
|
|
Nervous system disorders
MEMORY IMPAIRMENT
|
5.8%
21/363 • Number of events 21
|
2.4%
9/368 • Number of events 9
|
6.6%
24/366 • Number of events 28
|
|
Nervous system disorders
PARAESTHESIA
|
3.6%
13/363 • Number of events 32
|
2.7%
10/368 • Number of events 11
|
5.2%
19/366 • Number of events 23
|
|
Psychiatric disorders
ANXIETY
|
11.6%
42/363 • Number of events 49
|
13.6%
50/368 • Number of events 57
|
13.1%
48/366 • Number of events 65
|
|
Psychiatric disorders
DEPRESSION
|
21.5%
78/363 • Number of events 86
|
22.3%
82/368 • Number of events 103
|
18.9%
69/366 • Number of events 85
|
|
Psychiatric disorders
INSOMNIA
|
32.5%
118/363 • Number of events 137
|
31.8%
117/368 • Number of events 145
|
33.3%
122/366 • Number of events 141
|
|
Psychiatric disorders
MOOD SWINGS
|
1.7%
6/363 • Number of events 7
|
3.5%
13/368 • Number of events 17
|
5.2%
19/366 • Number of events 21
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
20.9%
76/363 • Number of events 87
|
15.2%
56/368 • Number of events 69
|
20.2%
74/366 • Number of events 100
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
16.3%
59/363 • Number of events 66
|
18.5%
68/368 • Number of events 87
|
23.0%
84/366 • Number of events 94
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA EXERTIONAL
|
8.3%
30/363 • Number of events 33
|
11.4%
42/368 • Number of events 44
|
8.5%
31/366 • Number of events 39
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
3.6%
13/363 • Number of events 15
|
5.2%
19/368 • Number of events 23
|
5.7%
21/366 • Number of events 21
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
6.1%
22/363 • Number of events 24
|
3.8%
14/368 • Number of events 18
|
9.0%
33/366 • Number of events 34
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
27.3%
99/363 • Number of events 105
|
20.4%
75/368 • Number of events 82
|
28.4%
104/366 • Number of events 109
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
18.2%
66/363 • Number of events 77
|
18.2%
67/368 • Number of events 72
|
23.5%
86/366 • Number of events 98
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
27.0%
98/363 • Number of events 130
|
23.6%
87/368 • Number of events 101
|
25.7%
94/366 • Number of events 138
|
|
Skin and subcutaneous tissue disorders
RASH
|
22.9%
83/363 • Number of events 124
|
25.3%
93/368 • Number of events 111
|
24.0%
88/366 • Number of events 119
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee In this multicenter trial, initially, the investigator may only publish study results together with the other sites, unless specific written permission is obtained in advance from the sponsor. The disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a 45 day period from the time submitted to the sponsor for review.
- Publication restrictions are in place
Restriction type: OTHER