Trial Outcomes & Findings for Boceprevir (SCH 503034) Plus Peg-Intron, With and Without Added Ribavirin, in Patients With Chronic Hepatitis C, Genotype 1, Who Did Not Respond to Previous Treatment With Peginterferon Alfa Plus Ribavirin (Study P03659AM2)(COMPLETED) (NCT NCT00160251)
NCT ID: NCT00160251
Last Updated: 2015-10-14
Results Overview
Sustained Viral Response (SVR) was defined as the percentage of participants with HCV-RNA undetectable at the follow-up Week 24. All percentages were based on the total number of participants originally randomized/enrolled to that particular arm. For Arm 1B, the denominator for the percentages was the number who received at least 1 dose of BOC. Arm 1A was not analyzed.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
357 participants
Primary outcome timeframe
Baseline up to Week 49
Results posted on
2015-10-14
Participant Flow
Participant milestones
| Measure |
Arm 1A: PEG + RBV
A single dose of PEG was given first, followed 1 week A single dose of PEG was given first, followed 1 week later by PEG + RBV + BOC 400. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
Arm 1B: PEG + RBV + BOC
A single dose of PEG was given first, followed 1 week later by PEG + RBV for 12 weeks. If HCV-RNA was detectable, BOC 400 was added for another 36 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
Arm 2: PEG + BOC 100 (48 Weeks)
A single dose of PEG was given first, followed 1 week later by PEG + BOC 100 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
Arm 3: PEG + BOC 200 (48 Weeks)
A single dose of PEG was given first, followed 1 week later by PEG + BOC 200 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
Arm 5: PEG + RBV + BOC 400
A single dose of PEG was given first, followed 1 week A single dose of PEG was given first, followed 1 week later by PEG + RBV + BOC 400. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
ARM 4+6: PEG + BOC 400 (24 + 48 Weeks)
A single dose of PEG was given first, followed 1 week A single dose of PEG was given first, followed 1 week later by PEG + RBV + BOC 400. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
Arm 7: PEG + BOC 800
A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
Arm 8: PEG + RBV + BOC 800
By protocol amendment 2, participants from all arms except Arm 1A were rolled over into PEG + RBV + BOC 800 for the remainder of the treatment period.
|
|---|---|---|---|---|---|---|---|---|
|
Prior to Amendment 2
STARTED
|
15
|
34
|
48
|
49
|
49
|
97
|
65
|
0
|
|
Prior to Amendment 2
COMPLETED
|
6
|
28
|
4
|
9
|
21
|
14
|
61
|
0
|
|
Prior to Amendment 2
NOT COMPLETED
|
9
|
6
|
44
|
40
|
28
|
83
|
4
|
0
|
|
Post-amendment 2
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
143
|
|
Post-amendment 2
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
88
|
|
Post-amendment 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
55
|
Reasons for withdrawal
| Measure |
Arm 1A: PEG + RBV
A single dose of PEG was given first, followed 1 week A single dose of PEG was given first, followed 1 week later by PEG + RBV + BOC 400. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
Arm 1B: PEG + RBV + BOC
A single dose of PEG was given first, followed 1 week later by PEG + RBV for 12 weeks. If HCV-RNA was detectable, BOC 400 was added for another 36 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
Arm 2: PEG + BOC 100 (48 Weeks)
A single dose of PEG was given first, followed 1 week later by PEG + BOC 100 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
Arm 3: PEG + BOC 200 (48 Weeks)
A single dose of PEG was given first, followed 1 week later by PEG + BOC 200 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
Arm 5: PEG + RBV + BOC 400
A single dose of PEG was given first, followed 1 week A single dose of PEG was given first, followed 1 week later by PEG + RBV + BOC 400. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
ARM 4+6: PEG + BOC 400 (24 + 48 Weeks)
A single dose of PEG was given first, followed 1 week A single dose of PEG was given first, followed 1 week later by PEG + RBV + BOC 400. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
Arm 7: PEG + BOC 800
A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
Arm 8: PEG + RBV + BOC 800
By protocol amendment 2, participants from all arms except Arm 1A were rolled over into PEG + RBV + BOC 800 for the remainder of the treatment period.
|
|---|---|---|---|---|---|---|---|---|
|
Prior to Amendment 2
Adverse Event
|
2
|
1
|
3
|
1
|
1
|
1
|
1
|
0
|
|
Prior to Amendment 2
Lack of Efficacy
|
0
|
4
|
37
|
35
|
24
|
55
|
0
|
0
|
|
Prior to Amendment 2
Lost to Follow-up
|
0
|
0
|
1
|
0
|
1
|
1
|
0
|
0
|
|
Prior to Amendment 2
Withdrawal by Subject
|
3
|
1
|
3
|
4
|
2
|
3
|
3
|
0
|
|
Prior to Amendment 2
Noncompliance with protocol
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Prior to Amendment 2
Completed Treatment Phase
|
3
|
0
|
0
|
0
|
0
|
23
|
0
|
0
|
|
Post-amendment 2
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
20
|
|
Post-amendment 2
Lack of Efficacy
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
24
|
|
Post-amendment 2
Lost to follow-up/withdrawal by subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
11
|
Baseline Characteristics
Boceprevir (SCH 503034) Plus Peg-Intron, With and Without Added Ribavirin, in Patients With Chronic Hepatitis C, Genotype 1, Who Did Not Respond to Previous Treatment With Peginterferon Alfa Plus Ribavirin (Study P03659AM2)(COMPLETED)
Baseline characteristics by cohort
| Measure |
Arm 1A: PEG + RBV OR Arm 1B: PEG + RBV + BOC 400
n=49 Participants
Arm 1A: A single dose of PEG was given first, followed 1 week later by PEG + RBV for 12 weeks. If participant was HCV-RNA negative, PEG + RBV was continued for another 36 weeks.
Arm 1B: A single dose of PEG was given first, followed 1 week later by PEG + RBV for 12 weeks. If HCV-RNA was detectable, BOC 400 was added for another 36 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
Arm 2: PEG + BOC 100 (48 Weeks)
n=48 Participants
A single dose of PEG was given first, followed 1 week later by PEG + BOC 100 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
Arm 3: PEG + BOC 200 (48 Weeks)
n=49 Participants
A single dose of PEG was given first, followed 1 week later by PEG + BOC 200 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
Arm 5: PEG + RBV + BOC 400
n=49 Participants
A single dose of PEG was given first, followed 1 week later by PEG + RBV + BOC 400. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks)
n=97 Participants
A single dose of PEG was given first, followed 1 week later by PEG + BOC (24 or 48 weeks). By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
Arm 7: PEG + BOC 800
n=65 Participants
A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
Total
n=357 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
48.9 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
51.6 years
STANDARD_DEVIATION 7.0 • n=7 Participants
|
48.6 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
48.2 years
STANDARD_DEVIATION 8.9 • n=4 Participants
|
49.2 years
STANDARD_DEVIATION 8.7 • n=21 Participants
|
50.4 years
STANDARD_DEVIATION 7.3 • n=8 Participants
|
49.5 years
STANDARD_DEVIATION 8.6 • n=8 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
37 Participants
n=21 Participants
|
24 Participants
n=8 Participants
|
134 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
60 Participants
n=21 Participants
|
41 Participants
n=8 Participants
|
223 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Week 49Population: For PEG + RBV + BOC number of participants was number who received at least one dose of BOC. For all others, it was number of randomized participants. The PEG + BOC 800 arm was not randomized.
Sustained Viral Response (SVR) was defined as the percentage of participants with HCV-RNA undetectable at the follow-up Week 24. All percentages were based on the total number of participants originally randomized/enrolled to that particular arm. For Arm 1B, the denominator for the percentages was the number who received at least 1 dose of BOC. Arm 1A was not analyzed.
Outcome measures
| Measure |
Arm 1B: PEG + RBV + BOC 400
n=40 Participants
A single dose of PEG was given first, followed 1 week later by PEG + RBV for 12 weeks. If HCV-RNA was detectable, BOC 400 was added for another 36 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
Arm 2: PEG + BOC 100 (48 Weeks)
n=48 Participants
A single dose of PEG was given first, followed 1 week later by PEG + BOC 100 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
Arm 3: PEG + BOC 200 (48 Weeks)
n=49 Participants
A single dose of PEG was given first, followed 1 week later by PEG + BOC 200 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks)
n=97 Participants
A single dose of PEG was given first, followed 1 week later by PEG + BOC (24 or 48 weeks). By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
Arm 5: PEG + RBV + BOC 400
n=49 Participants
A single dose of PEG was given first, followed 1 week A single dose of PEG was given first, followed 1 week later by PEG + RBV + BOC 400. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
Arm 7: PEG + BOC 800
n=65 Participants
A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
Arm 7: PEG + BOC 800
A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
Arm 8: PEG + RBV + BOC 800
By protocol amendment 2, participants from all arms except Arm 1A were rolled over into PEG + RBV + BOC 800 for the remainder of the treatment period.
|
|---|---|---|---|---|---|---|---|---|
|
Percent of Participants Who Were Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Negative at the End of Treatment (EoT)
|
35.0 Percent of participants
|
6.3 Percent of participants
|
16.3 Percent of participants
|
13.4 Percent of participants
|
20.4 Percent of participants
|
21.5 Percent of participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline up to Week 73 [24 weeks after end of treatment (EoT)]Population: For PEG + RBV + BOC number of participants was number who received at least one dose of BOC. For all others, it was number of randomized participants. The PEG + BOC 800 arm was not randomized.
SVR was defined as the percentage of participants with Hepatitis C Virus Ribonucleic Acid (HCV-RNA) undetectable at the follow-up Week 24. All percentages were based on the total number of participants originally randomized/enrolled to that particular arm. For Arm 1B, the denominator for the percentages was the number who received at least 1 dose of BOC. Arm 1A was not analyzed.
Outcome measures
| Measure |
Arm 1B: PEG + RBV + BOC 400
n=40 Participants
A single dose of PEG was given first, followed 1 week later by PEG + RBV for 12 weeks. If HCV-RNA was detectable, BOC 400 was added for another 36 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
Arm 2: PEG + BOC 100 (48 Weeks)
n=48 Participants
A single dose of PEG was given first, followed 1 week later by PEG + BOC 100 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
Arm 3: PEG + BOC 200 (48 Weeks)
n=49 Participants
A single dose of PEG was given first, followed 1 week later by PEG + BOC 200 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks)
n=97 Participants
A single dose of PEG was given first, followed 1 week later by PEG + BOC (24 or 48 weeks). By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
Arm 5: PEG + RBV + BOC 400
n=49 Participants
A single dose of PEG was given first, followed 1 week A single dose of PEG was given first, followed 1 week later by PEG + RBV + BOC 400. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
Arm 7: PEG + BOC 800
n=65 Participants
A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
Arm 7: PEG + BOC 800
A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
Arm 8: PEG + RBV + BOC 800
By protocol amendment 2, participants from all arms except Arm 1A were rolled over into PEG + RBV + BOC 800 for the remainder of the treatment period.
|
|---|---|---|---|---|---|---|---|---|
|
Percent of Participants Who Achieved Sustained Virologic Response (SVR)
|
7.5 Percent of participants
|
2.1 Percent of participants
|
12.2 Percent of participants
|
5.2 Percent of participants
|
14.3 Percent of participants
|
4.6 Percent of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Week 73 [24 weeks after EoT]Population: Number of participants across all treatment arms who achieved negative HCV-RNA
Percentage of participants who became HCV-RNA undetectable within the first 13 weeks and subsequently became HCV-RNA positive were not considered negative for this analysis.
Outcome measures
| Measure |
Arm 1B: PEG + RBV + BOC 400
n=33 Participants
A single dose of PEG was given first, followed 1 week later by PEG + RBV for 12 weeks. If HCV-RNA was detectable, BOC 400 was added for another 36 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
Arm 2: PEG + BOC 100 (48 Weeks)
n=12 Participants
A single dose of PEG was given first, followed 1 week later by PEG + BOC 100 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
Arm 3: PEG + BOC 200 (48 Weeks)
n=6 Participants
A single dose of PEG was given first, followed 1 week later by PEG + BOC 200 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks)
n=11 Participants
A single dose of PEG was given first, followed 1 week later by PEG + BOC (24 or 48 weeks). By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
Arm 5: PEG + RBV + BOC 400
A single dose of PEG was given first, followed 1 week A single dose of PEG was given first, followed 1 week later by PEG + RBV + BOC 400. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
Arm 7: PEG + BOC 800
A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
Arm 7: PEG + BOC 800
A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
Arm 8: PEG + RBV + BOC 800
By protocol amendment 2, participants from all arms except Arm 1A were rolled over into PEG + RBV + BOC 800 for the remainder of the treatment period.
|
|---|---|---|---|---|---|---|---|---|
|
Percent of Participants Who Achieved Sustained Viral Response (SVR) by Time to First Negative HCV-RNA
|
58 Percent of participants
|
33 Percent of participants
|
33 Percent of participants
|
0 Percent of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 1 and Week 49Population: N=Number of Participants Analyzed, n=number of participants in each log category group. The PEG + BOC 100, 200, or 400 arm combined the following treatment arms: Arm 2 PEG + BOC 100 (48 weeks), Arm 3 PEG + BOC 200 (48 weeks), Arm 4 PEG + BOC 400 (48 weeks), Arm 6 PEG + BOC 400 (24 weeks).
For each log drop category (\<0, 0 to 0.5, 0.5 to \<1, 1 to \<1.5, ≥1.5, and Missing), the percentage of participants receiving combination therapy who were HCV-RNA negative at EoT (Week 49) was calculated as follows: Number of participants in a log category who were HCV-RNA negative divided by the total number of participants in that log drop category (n). Percentages were NOT derived using treatment arm N values. The sum of the n values for all 6 log drop categories within a treatment arm equals the overall N for that treatment group.
Outcome measures
| Measure |
Arm 1B: PEG + RBV + BOC 400
n=194 Participants
A single dose of PEG was given first, followed 1 week later by PEG + RBV for 12 weeks. If HCV-RNA was detectable, BOC 400 was added for another 36 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
Arm 2: PEG + BOC 100 (48 Weeks)
n=49 Participants
A single dose of PEG was given first, followed 1 week later by PEG + BOC 100 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
Arm 3: PEG + BOC 200 (48 Weeks)
n=65 Participants
A single dose of PEG was given first, followed 1 week later by PEG + BOC 200 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks)
A single dose of PEG was given first, followed 1 week later by PEG + BOC (24 or 48 weeks). By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
Arm 5: PEG + RBV + BOC 400
A single dose of PEG was given first, followed 1 week A single dose of PEG was given first, followed 1 week later by PEG + RBV + BOC 400. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
Arm 7: PEG + BOC 800
A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
Arm 7: PEG + BOC 800
A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
Arm 8: PEG + RBV + BOC 800
By protocol amendment 2, participants from all arms except Arm 1A were rolled over into PEG + RBV + BOC 800 for the remainder of the treatment period.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Were HCV-RNA Negative at EoT After Receiving 1 Week of Treatment With PegIntron (PEG) by Log Drop
Log drop <0 (Arm2-4,6 n=21/Arm5 n=6/Arm7 n=3)
|
9.5 Percent of participants
|
16.7 Percent of participants
|
1 Percent of participants
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Were HCV-RNA Negative at EoT After Receiving 1 Week of Treatment With PegIntron (PEG) by Log Drop
Log drop 0-0.5 (Arm2-4,6 n=55/Arm5 n=17/Arm7 n=16)
|
1.8 Percent of participants
|
17.6 Percent of participants
|
18.8 Percent of participants
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Were HCV-RNA Negative at EoT After Receiving 1 Week of Treatment With PegIntron (PEG) by Log Drop
Log drop 0.5to<1(Arm2-4,6 n=73/Arm5 n=11/Arm7 n=9)
|
12.3 Percent of participants
|
9.1 Percent of participants
|
0 Percent of participants
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Were HCV-RNA Negative at EoT After Receiving 1 Week of Treatment With PegIntron (PEG) by Log Drop
Log drop 1to<1.5(Arm2-4,6 n=31/Arm5 n=9/Arm7 n=18)
|
25.8 Percent of participants
|
33.3 Percent of participants
|
16.7 Percent of participants
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Were HCV-RNA Negative at EoT After Receiving 1 Week of Treatment With PegIntron (PEG) by Log Drop
Log drop ≥1.5 (Arm2-4,6 n=12/Arm5 n=4/Arm7 n=18)
|
33.3 Percent of participants
|
50.0 Percent of participants
|
44.4 Percent of participants
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Who Were HCV-RNA Negative at EoT After Receiving 1 Week of Treatment With PegIntron (PEG) by Log Drop
Missing (Arm2-4,6 n=2/Arm5 n=2/Arm7 n=1)
|
0 Percent of participants
|
0 Percent of participants
|
0 Percent of participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 3, Week 5, Week 13Virologic response was defined as the percentage of participants with Hepatitis C Virus Ribonucleic Acid (HCV-RNA) ≤10,000 IU/mL.
Outcome measures
| Measure |
Arm 1B: PEG + RBV + BOC 400
n=49 Participants
A single dose of PEG was given first, followed 1 week later by PEG + RBV for 12 weeks. If HCV-RNA was detectable, BOC 400 was added for another 36 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
Arm 2: PEG + BOC 100 (48 Weeks)
n=48 Participants
A single dose of PEG was given first, followed 1 week later by PEG + BOC 100 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
Arm 3: PEG + BOC 200 (48 Weeks)
n=49 Participants
A single dose of PEG was given first, followed 1 week later by PEG + BOC 200 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks)
n=49 Participants
A single dose of PEG was given first, followed 1 week later by PEG + BOC (24 or 48 weeks). By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
Arm 5: PEG + RBV + BOC 400
n=97 Participants
A single dose of PEG was given first, followed 1 week A single dose of PEG was given first, followed 1 week later by PEG + RBV + BOC 400. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
Arm 7: PEG + BOC 800
n=65 Participants
A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
Arm 7: PEG + BOC 800
A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
Arm 8: PEG + RBV + BOC 800
By protocol amendment 2, participants from all arms except Arm 1A were rolled over into PEG + RBV + BOC 800 for the remainder of the treatment period.
|
|---|---|---|---|---|---|---|---|---|
|
Percent of Participants With Virologic Response Prior to Amendment 2
Week 3
|
4.1 Percent of participants
|
0.0 Percent of participants
|
0.0 Percent of participants
|
0 Percent of participants
|
5.2 Percent of participants
|
4.6 Percent of participants
|
—
|
—
|
|
Percent of Participants With Virologic Response Prior to Amendment 2
Week 5
|
4.1 Percent of participants
|
0.0 Percent of participants
|
8.2 Percent of participants
|
12.2 Percent of participants
|
9.3 Percent of participants
|
15.4 Percent of participants
|
—
|
—
|
|
Percent of Participants With Virologic Response Prior to Amendment 2
Week 13
|
6.1 Percent of participants
|
2.1 Percent of participants
|
14.3 Percent of participants
|
30.6 Percent of participants
|
13.4 Percent of participants
|
0 Percent of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: All visits during treatment (baseline to Week 49) except Day 1 of Week 1Population: Participants were only included in the analysis if the recorded previous dose of boceprevir was taken \< 8.5 hours prior to sample collection. Participants also must have started BOC treatment or amendment 2 dosing more than 1 week prior to sample collection.
All plasma samples were assayed using a validated liquid chromatography with tandem mass spectrometric detection (LCMS/MS) method.
Outcome measures
| Measure |
Arm 1B: PEG + RBV + BOC 400
n=29 Participants
A single dose of PEG was given first, followed 1 week later by PEG + RBV for 12 weeks. If HCV-RNA was detectable, BOC 400 was added for another 36 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
Arm 2: PEG + BOC 100 (48 Weeks)
n=24 Participants
A single dose of PEG was given first, followed 1 week later by PEG + BOC 100 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
Arm 3: PEG + BOC 200 (48 Weeks)
n=62 Participants
A single dose of PEG was given first, followed 1 week later by PEG + BOC 200 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks)
n=64 Participants
A single dose of PEG was given first, followed 1 week later by PEG + BOC (24 or 48 weeks). By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
Arm 5: PEG + RBV + BOC 400
A single dose of PEG was given first, followed 1 week A single dose of PEG was given first, followed 1 week later by PEG + RBV + BOC 400. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
Arm 7: PEG + BOC 800
A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
Arm 7: PEG + BOC 800
A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
Arm 8: PEG + RBV + BOC 800
By protocol amendment 2, participants from all arms except Arm 1A were rolled over into PEG + RBV + BOC 800 for the remainder of the treatment period.
|
|---|---|---|---|---|---|---|---|---|
|
Peak Plasma Concentration of Boceprevir (BOC)
|
203 ng/mL
Standard Error 5
|
427 ng/mL
Standard Error 18
|
704 ng/mL
Standard Error 16
|
1312 ng/mL
Standard Error 45
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: All visits during treatment (baseline to Week 49) except Day 1 of Week 1Population: Participants were only included in the analysis if the recorded previous dose of boceprevir was taken \< 8.5 hours prior to sample collection. Participants also must have started BOC treatment or amendment 2 dosing more than 1 week prior to sample collection.
All plasma samples were assayed using a validated liquid chromatography with tandem mass spectrometric detection (LCMS/MS) method. The dosing interval of 8 hours is represented as the hr in the unit of measure.
Outcome measures
| Measure |
Arm 1B: PEG + RBV + BOC 400
n=29 Participants
A single dose of PEG was given first, followed 1 week later by PEG + RBV for 12 weeks. If HCV-RNA was detectable, BOC 400 was added for another 36 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
Arm 2: PEG + BOC 100 (48 Weeks)
n=24 Participants
A single dose of PEG was given first, followed 1 week later by PEG + BOC 100 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
Arm 3: PEG + BOC 200 (48 Weeks)
n=62 Participants
A single dose of PEG was given first, followed 1 week later by PEG + BOC 200 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks)
n=64 Participants
A single dose of PEG was given first, followed 1 week later by PEG + BOC (24 or 48 weeks). By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
Arm 5: PEG + RBV + BOC 400
A single dose of PEG was given first, followed 1 week A single dose of PEG was given first, followed 1 week later by PEG + RBV + BOC 400. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
Arm 7: PEG + BOC 800
A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
Arm 7: PEG + BOC 800
A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
Arm 8: PEG + RBV + BOC 800
By protocol amendment 2, participants from all arms except Arm 1A were rolled over into PEG + RBV + BOC 800 for the remainder of the treatment period.
|
|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve of Boceprevir Plasma Concentration for an 8-hour Dosing Period
|
1042 ng*hr/mL
Standard Error 25
|
2184 ng*hr/mL
Standard Error 181
|
3633 ng*hr/mL
Standard Error 88
|
6276 ng*hr/mL
Standard Error 337
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: All visits during treatment (baseline to Week 49) except Day 1 of Week 1Population: Participants were only included in the analysis if the recorded previous dose of boceprevir was taken \< 8.5 hours prior to sample collection. Participants also must have started BOC treatment or amendment 2 dosing more than 1 week prior to sample collection.
All plasma samples were assayed using a validated liquid chromatography with tandem mass spectrometric detection (LCMS/MS) method.
Outcome measures
| Measure |
Arm 1B: PEG + RBV + BOC 400
n=29 Participants
A single dose of PEG was given first, followed 1 week later by PEG + RBV for 12 weeks. If HCV-RNA was detectable, BOC 400 was added for another 36 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
Arm 2: PEG + BOC 100 (48 Weeks)
n=24 Participants
A single dose of PEG was given first, followed 1 week later by PEG + BOC 100 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
Arm 3: PEG + BOC 200 (48 Weeks)
n=62 Participants
A single dose of PEG was given first, followed 1 week later by PEG + BOC 200 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks)
n=64 Participants
A single dose of PEG was given first, followed 1 week later by PEG + BOC (24 or 48 weeks). By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
Arm 5: PEG + RBV + BOC 400
A single dose of PEG was given first, followed 1 week A single dose of PEG was given first, followed 1 week later by PEG + RBV + BOC 400. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
Arm 7: PEG + BOC 800
A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
Arm 7: PEG + BOC 800
A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
Arm 8: PEG + RBV + BOC 800
By protocol amendment 2, participants from all arms except Arm 1A were rolled over into PEG + RBV + BOC 800 for the remainder of the treatment period.
|
|---|---|---|---|---|---|---|---|---|
|
Trough Plasma Concentration Level
|
56.7 ng/mL
Standard Error 3
|
133.0 ng/mL
Standard Error 27
|
214.0 ng/mL
Standard Error 10
|
355 ng/mL
Standard Error 42
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline up to dosing change (> 25 weeks)Population: Only participants with at least one value for the laboratory test were included.
Change in ALT levels during initial treatment regimen and after rolling into amendment 2 as compared to baseline.
Outcome measures
| Measure |
Arm 1B: PEG + RBV + BOC 400
n=15 Participants
A single dose of PEG was given first, followed 1 week later by PEG + RBV for 12 weeks. If HCV-RNA was detectable, BOC 400 was added for another 36 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
Arm 2: PEG + BOC 100 (48 Weeks)
n=34 Participants
A single dose of PEG was given first, followed 1 week later by PEG + BOC 100 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
Arm 3: PEG + BOC 200 (48 Weeks)
n=48 Participants
A single dose of PEG was given first, followed 1 week later by PEG + BOC 200 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks)
n=47 Participants
A single dose of PEG was given first, followed 1 week later by PEG + BOC (24 or 48 weeks). By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
Arm 5: PEG + RBV + BOC 400
n=48 Participants
A single dose of PEG was given first, followed 1 week A single dose of PEG was given first, followed 1 week later by PEG + RBV + BOC 400. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
Arm 7: PEG + BOC 800
n=97 Participants
A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
Arm 7: PEG + BOC 800
n=64 Participants
A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
Arm 8: PEG + RBV + BOC 800
n=143 Participants
By protocol amendment 2, participants from all arms except Arm 1A were rolled over into PEG + RBV + BOC 800 for the remainder of the treatment period.
|
|---|---|---|---|---|---|---|---|---|
|
Change in Alanine Aminotransferase (ALT) Levels
5.10-10.0 x baseline ALT value
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Change in Alanine Aminotransferase (ALT) Levels
<2.00 x baseline ALT value
|
14 Participants
|
33 Participants
|
45 Participants
|
43 Participants
|
47 Participants
|
84 Participants
|
61 Participants
|
119 Participants
|
|
Change in Alanine Aminotransferase (ALT) Levels
2.00-2.09 x baseline ALT value
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
4 Participants
|
|
Change in Alanine Aminotransferase (ALT) Levels
2.10-5.09 x baseline ALT value
|
0 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
9 Participants
|
3 Participants
|
18 Participants
|
|
Change in Alanine Aminotransferase (ALT) Levels
>10.0 x baseline ALT value
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From dosing change to end of follow-up (Week 73)(up to 48 weeks)Population: All participants, per the second amendment to P03659, with significant HCV-RNA decrease (HCV\_RNA ≤ 10,000 IU) switched to continuing triple therapy.
Log drop at baseline of dosing change = difference of log viral loads between baseline (closest to the treatment begin date) and dosing change baseline (virology value closest to the dosing change begin date).
Outcome measures
| Measure |
Arm 1B: PEG + RBV + BOC 400
n=4 Participants
A single dose of PEG was given first, followed 1 week later by PEG + RBV for 12 weeks. If HCV-RNA was detectable, BOC 400 was added for another 36 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
Arm 2: PEG + BOC 100 (48 Weeks)
n=2 Participants
A single dose of PEG was given first, followed 1 week later by PEG + BOC 100 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
Arm 3: PEG + BOC 200 (48 Weeks)
n=2 Participants
A single dose of PEG was given first, followed 1 week later by PEG + BOC 200 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks)
n=4 Participants
A single dose of PEG was given first, followed 1 week later by PEG + BOC (24 or 48 weeks). By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
Arm 5: PEG + RBV + BOC 400
n=12 Participants
A single dose of PEG was given first, followed 1 week A single dose of PEG was given first, followed 1 week later by PEG + RBV + BOC 400. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
Arm 7: PEG + BOC 800
n=3 Participants
A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
Arm 7: PEG + BOC 800
A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
Arm 8: PEG + RBV + BOC 800
By protocol amendment 2, participants from all arms except Arm 1A were rolled over into PEG + RBV + BOC 800 for the remainder of the treatment period.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on Arms 2 (PEG+BOC 100), 3 (PEG+BOC 200), 4 (PEG+BOC 400 [48 Weeks]), 6 (PEG+BOC 400 [24 Weeks])
Week 3 after dosing change
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
11 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on Arms 2 (PEG+BOC 100), 3 (PEG+BOC 200), 4 (PEG+BOC 400 [48 Weeks]), 6 (PEG+BOC 400 [24 Weeks])
Week 6 after dosing change
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
11 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on Arms 2 (PEG+BOC 100), 3 (PEG+BOC 200), 4 (PEG+BOC 400 [48 Weeks]), 6 (PEG+BOC 400 [24 Weeks])
Week 9 after dosing change
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
9 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on Arms 2 (PEG+BOC 100), 3 (PEG+BOC 200), 4 (PEG+BOC 400 [48 Weeks]), 6 (PEG+BOC 400 [24 Weeks])
Week 12 after dosing change
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
9 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on Arms 2 (PEG+BOC 100), 3 (PEG+BOC 200), 4 (PEG+BOC 400 [48 Weeks]), 6 (PEG+BOC 400 [24 Weeks])
Week 18 after dosing change
|
1 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
11 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on Arms 2 (PEG+BOC 100), 3 (PEG+BOC 200), 4 (PEG+BOC 400 [48 Weeks]), 6 (PEG+BOC 400 [24 Weeks])
Week 24 after dosing change
|
1 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
12 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on Arms 2 (PEG+BOC 100), 3 (PEG+BOC 200), 4 (PEG+BOC 400 [48 Weeks]), 6 (PEG+BOC 400 [24 Weeks])
End of treatment
|
1 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
11 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on Arms 2 (PEG+BOC 100), 3 (PEG+BOC 200), 4 (PEG+BOC 400 [48 Weeks]), 6 (PEG+BOC 400 [24 Weeks])
Follow-up Week 4 after dosing change
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
8 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on Arms 2 (PEG+BOC 100), 3 (PEG+BOC 200), 4 (PEG+BOC 400 [48 Weeks]), 6 (PEG+BOC 400 [24 Weeks])
Follow-up Week 8 after dosing change
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
6 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on Arms 2 (PEG+BOC 100), 3 (PEG+BOC 200), 4 (PEG+BOC 400 [48 Weeks]), 6 (PEG+BOC 400 [24 Weeks])
Follow-up Week 12 after dosing change
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
6 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on Arms 2 (PEG+BOC 100), 3 (PEG+BOC 200), 4 (PEG+BOC 400 [48 Weeks]), 6 (PEG+BOC 400 [24 Weeks])
Follow-up Week 24 after dosing change
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
7 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on Arms 2 (PEG+BOC 100), 3 (PEG+BOC 200), 4 (PEG+BOC 400 [48 Weeks]), 6 (PEG+BOC 400 [24 Weeks])
End of follow-up after dosing change
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
7 Participants
|
1 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From dosing change to end of follow-up (Week 73)(up to 48 weeks)Population: All participants, per the second amendment to P03659, with significant HCV-RNA decrease (HCV\_RNA ≤ 10,000 IU) switched to continuing triple therapy.
Log drop at baseline of dosing change = difference of log viral loads between baseline (closest to the treatment begin date) and dosing change baseline (virology value closest to the dosing change begin date).
Outcome measures
| Measure |
Arm 1B: PEG + RBV + BOC 400
n=1 Participants
A single dose of PEG was given first, followed 1 week later by PEG + RBV for 12 weeks. If HCV-RNA was detectable, BOC 400 was added for another 36 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
Arm 2: PEG + BOC 100 (48 Weeks)
n=1 Participants
A single dose of PEG was given first, followed 1 week later by PEG + BOC 100 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
Arm 3: PEG + BOC 200 (48 Weeks)
n=4 Participants
A single dose of PEG was given first, followed 1 week later by PEG + BOC 200 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks)
n=14 Participants
A single dose of PEG was given first, followed 1 week later by PEG + BOC (24 or 48 weeks). By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
Arm 5: PEG + RBV + BOC 400
n=1 Participants
A single dose of PEG was given first, followed 1 week A single dose of PEG was given first, followed 1 week later by PEG + RBV + BOC 400. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
Arm 7: PEG + BOC 800
A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
Arm 7: PEG + BOC 800
A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
Arm 8: PEG + RBV + BOC 800
By protocol amendment 2, participants from all arms except Arm 1A were rolled over into PEG + RBV + BOC 800 for the remainder of the treatment period.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Rebetol (RVB) + Boceprevir (BOC) 400 (Arm 5)
Week 18 after dosing change
|
0 Participants
|
0 Participants
|
2 Participants
|
6 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Rebetol (RVB) + Boceprevir (BOC) 400 (Arm 5)
Week 24 after dosing change
|
0 Participants
|
0 Participants
|
3 Participants
|
5 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Rebetol (RVB) + Boceprevir (BOC) 400 (Arm 5)
End of treatment
|
0 Participants
|
0 Participants
|
3 Participants
|
7 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Rebetol (RVB) + Boceprevir (BOC) 400 (Arm 5)
Follow-up Week 4 after dosing change
|
0 Participants
|
0 Participants
|
3 Participants
|
6 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Rebetol (RVB) + Boceprevir (BOC) 400 (Arm 5)
Week 3 after dosing change
|
0 Participants
|
0 Participants
|
3 Participants
|
12 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Rebetol (RVB) + Boceprevir (BOC) 400 (Arm 5)
Week 6 after dosing change
|
0 Participants
|
0 Participants
|
3 Participants
|
10 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Rebetol (RVB) + Boceprevir (BOC) 400 (Arm 5)
Week 9 after dosing change
|
0 Participants
|
0 Participants
|
3 Participants
|
10 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Rebetol (RVB) + Boceprevir (BOC) 400 (Arm 5)
Week 12 after dosing change
|
0 Participants
|
0 Participants
|
3 Participants
|
9 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Rebetol (RVB) + Boceprevir (BOC) 400 (Arm 5)
Follow-up Week 8 after dosing change
|
0 Participants
|
0 Participants
|
3 Participants
|
4 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Rebetol (RVB) + Boceprevir (BOC) 400 (Arm 5)
Follow-up Week 12 after dosing change
|
0 Participants
|
0 Participants
|
2 Participants
|
5 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Rebetol (RVB) + Boceprevir (BOC) 400 (Arm 5)
Follow-up Week 24 after dosing change
|
0 Participants
|
0 Participants
|
3 Participants
|
4 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Rebetol (RVB) + Boceprevir (BOC) 400 (Arm 5)
End of follow-up after dosing change
|
0 Participants
|
0 Participants
|
3 Participants
|
4 Participants
|
0 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From dosing change to end of follow-up (Week 73) (up to 48 weeks)Population: All participants, per the second amendment to P03659, with significant HCV-RNA decrease (HCV\_RNA ≤ 10,000 IU) switched to continuing triple therapy.
Log drop at baseline of dosing change = difference of log viral loads between baseline (closest to the treatment begin date) and dosing change baseline (virology value closest to the dosing change begin date).
Outcome measures
| Measure |
Arm 1B: PEG + RBV + BOC 400
n=2 Participants
A single dose of PEG was given first, followed 1 week later by PEG + RBV for 12 weeks. If HCV-RNA was detectable, BOC 400 was added for another 36 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
Arm 2: PEG + BOC 100 (48 Weeks)
n=12 Participants
A single dose of PEG was given first, followed 1 week later by PEG + BOC 100 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
Arm 3: PEG + BOC 200 (48 Weeks)
n=12 Participants
A single dose of PEG was given first, followed 1 week later by PEG + BOC 200 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks)
n=5 Participants
A single dose of PEG was given first, followed 1 week later by PEG + BOC (24 or 48 weeks). By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
Arm 5: PEG + RBV + BOC 400
n=10 Participants
A single dose of PEG was given first, followed 1 week A single dose of PEG was given first, followed 1 week later by PEG + RBV + BOC 400. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
Arm 7: PEG + BOC 800
n=9 Participants
A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
Arm 7: PEG + BOC 800
n=6 Participants
A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
Arm 8: PEG + RBV + BOC 800
n=5 Participants
By protocol amendment 2, participants from all arms except Arm 1A were rolled over into PEG + RBV + BOC 800 for the remainder of the treatment period.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)
Week 24 after dosing change
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
3 Participants
|
4 Participants
|
1 Participants
|
|
Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)
End of treatment
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
3 Participants
|
4 Participants
|
1 Participants
|
|
Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)
Week 3 after dosing change
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
7 Participants
|
4 Participants
|
3 Participants
|
|
Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)
Week 6 after dosing change
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
5 Participants
|
4 Participants
|
1 Participants
|
|
Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)
Week 9 after dosing change
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
7 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)
Week 12 after dosing change
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
5 Participants
|
4 Participants
|
2 Participants
|
|
Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)
Week 18 after dosing change
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
5 Participants
|
3 Participants
|
4 Participants
|
2 Participants
|
|
Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)
Follow-up Week 4 after dosing change
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)
Follow-up Week 8 after dosing change
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)
Follow-up Week 12 after dosing change
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)
Follow-up Week 24 after dosing change
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)
End of follow-up after dosing change
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
Adverse Events
PEG + RBV
Serious events: 2 serious events
Other events: 14 other events
Deaths: 0 deaths
PEG + RBV + BOC 400 (24 Weeks)
Serious events: 1 serious events
Other events: 33 other events
Deaths: 0 deaths
PEG + BOC 100 (48 Weeks)
Serious events: 2 serious events
Other events: 48 other events
Deaths: 0 deaths
PEG + BOC 200 (48 Weeks)
Serious events: 4 serious events
Other events: 48 other events
Deaths: 0 deaths
PEG + RBV + BOC 400 (48 Weeks)
Serious events: 2 serious events
Other events: 47 other events
Deaths: 0 deaths
PEG + BOC 400 (24 + 48 Weeks)
Serious events: 4 serious events
Other events: 96 other events
Deaths: 0 deaths
PEG + BOC 800 (24 Weeks)
Serious events: 3 serious events
Other events: 64 other events
Deaths: 0 deaths
PEG + RBV + BOC 800
Serious events: 12 serious events
Other events: 136 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PEG + RBV
n=15 participants at risk
Arm 1A: A single dose of PEG was given first, followed 1 week later by PEG + RBV for 12 weeks. If participant was HCV-RNA negative, PEG + RBV was continued for another 36 weeks.
|
PEG + RBV + BOC 400 (24 Weeks)
n=34 participants at risk
Arm 1B: A single dose of PEG was given first, followed 1 week later by PEG + RBV for 12 weeks. If HCV-RNA was detectable, BOC 400 was added for another 36 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
PEG + BOC 100 (48 Weeks)
n=48 participants at risk
Arm 2: A single dose of PEG was given first, followed 1 week later by PEG + BOC 100 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
PEG + BOC 200 (48 Weeks)
n=49 participants at risk
Arm 3: A single dose of PEG was given first, followed 1 week later by PEG + BOC 200 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
PEG + RBV + BOC 400 (48 Weeks)
n=49 participants at risk
Arm 5: A single dose of PEG was given first, followed 1 week later by PEG + RBV + BOC 400. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
PEG + BOC 400 (24 + 48 Weeks)
n=97 participants at risk
Arms 4 + 6: A single dose of PEG was given first, followed 1 week later by PEG + BOC (24 or 48 weeks). By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
PEG + BOC 800 (24 Weeks)
n=65 participants at risk
Arm 7: A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
PEG + RBV + BOC 800
n=143 participants at risk
Arm 8: By protocol amendment 2, participants from all arms except Arm 1A were rolled over into PEG + RBV + BOC 800 for the remainder of the treatment period.
|
|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.00%
0/15
|
2.9%
1/34 • Number of events 1
|
0.00%
0/48
|
0.00%
0/49
|
0.00%
0/49
|
0.00%
0/97
|
0.00%
0/65
|
0.00%
0/143
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
0.00%
0/15
|
0.00%
0/34
|
0.00%
0/48
|
0.00%
0/49
|
0.00%
0/49
|
0.00%
0/97
|
0.00%
0/65
|
0.70%
1/143 • Number of events 1
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.00%
0/15
|
0.00%
0/34
|
2.1%
1/48 • Number of events 1
|
0.00%
0/49
|
0.00%
0/49
|
0.00%
0/97
|
0.00%
0/65
|
0.00%
0/143
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.00%
0/15
|
0.00%
0/34
|
0.00%
0/48
|
2.0%
1/49 • Number of events 1
|
0.00%
0/49
|
0.00%
0/97
|
0.00%
0/65
|
0.00%
0/143
|
|
Gastrointestinal disorders
ALCOHOLIC PANCREATITIS
|
0.00%
0/15
|
0.00%
0/34
|
0.00%
0/48
|
0.00%
0/49
|
0.00%
0/49
|
1.0%
1/97 • Number of events 1
|
0.00%
0/65
|
0.00%
0/143
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.00%
0/15
|
0.00%
0/34
|
0.00%
0/48
|
0.00%
0/49
|
0.00%
0/49
|
0.00%
0/97
|
3.1%
2/65 • Number of events 2
|
0.00%
0/143
|
|
Gastrointestinal disorders
NAUSEA
|
0.00%
0/15
|
0.00%
0/34
|
0.00%
0/48
|
0.00%
0/49
|
0.00%
0/49
|
0.00%
0/97
|
1.5%
1/65 • Number of events 1
|
0.00%
0/143
|
|
Gastrointestinal disorders
VOMITING
|
0.00%
0/15
|
0.00%
0/34
|
0.00%
0/48
|
0.00%
0/49
|
0.00%
0/49
|
0.00%
0/97
|
1.5%
1/65 • Number of events 1
|
0.70%
1/143 • Number of events 1
|
|
General disorders
CHEST PAIN
|
0.00%
0/15
|
0.00%
0/34
|
0.00%
0/48
|
2.0%
1/49 • Number of events 1
|
0.00%
0/49
|
0.00%
0/97
|
0.00%
0/65
|
2.1%
3/143 • Number of events 3
|
|
Hepatobiliary disorders
CHOLECYSTITIS ACUTE
|
0.00%
0/15
|
0.00%
0/34
|
0.00%
0/48
|
0.00%
0/49
|
0.00%
0/49
|
0.00%
0/97
|
0.00%
0/65
|
0.70%
1/143 • Number of events 1
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
0.00%
0/15
|
0.00%
0/34
|
0.00%
0/48
|
0.00%
0/49
|
0.00%
0/49
|
0.00%
0/97
|
0.00%
0/65
|
0.70%
1/143 • Number of events 1
|
|
Hepatobiliary disorders
CHRONIC HEPATIC FAILURE
|
0.00%
0/15
|
0.00%
0/34
|
0.00%
0/48
|
0.00%
0/49
|
0.00%
0/49
|
0.00%
0/97
|
0.00%
0/65
|
0.70%
1/143 • Number of events 1
|
|
Infections and infestations
APPENDICITIS
|
0.00%
0/15
|
0.00%
0/34
|
0.00%
0/48
|
2.0%
1/49 • Number of events 1
|
0.00%
0/49
|
0.00%
0/97
|
0.00%
0/65
|
0.00%
0/143
|
|
Infections and infestations
GASTROENTERITIS
|
0.00%
0/15
|
0.00%
0/34
|
2.1%
1/48 • Number of events 1
|
0.00%
0/49
|
0.00%
0/49
|
0.00%
0/97
|
0.00%
0/65
|
0.00%
0/143
|
|
Infections and infestations
MASTOIDITIS
|
0.00%
0/15
|
0.00%
0/34
|
0.00%
0/48
|
0.00%
0/49
|
0.00%
0/49
|
0.00%
0/97
|
0.00%
0/65
|
0.70%
1/143 • Number of events 1
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.00%
0/15
|
0.00%
0/34
|
0.00%
0/48
|
0.00%
0/49
|
0.00%
0/49
|
0.00%
0/97
|
1.5%
1/65 • Number of events 1
|
0.00%
0/143
|
|
Injury, poisoning and procedural complications
CONTUSION
|
0.00%
0/15
|
0.00%
0/34
|
0.00%
0/48
|
0.00%
0/49
|
2.0%
1/49 • Number of events 1
|
0.00%
0/97
|
0.00%
0/65
|
0.00%
0/143
|
|
Metabolism and nutrition disorders
FOOD INTOLERANCE
|
0.00%
0/15
|
0.00%
0/34
|
0.00%
0/48
|
2.0%
1/49 • Number of events 1
|
0.00%
0/49
|
0.00%
0/97
|
0.00%
0/65
|
0.00%
0/143
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BLADDER NEOPLASM
|
6.7%
1/15 • Number of events 1
|
0.00%
0/34
|
0.00%
0/48
|
0.00%
0/49
|
0.00%
0/49
|
0.00%
0/97
|
0.00%
0/65
|
0.00%
0/143
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
HEPATIC NEOPLASM MALIGNANT
|
0.00%
0/15
|
0.00%
0/34
|
0.00%
0/48
|
0.00%
0/49
|
0.00%
0/49
|
0.00%
0/97
|
0.00%
0/65
|
1.4%
2/143 • Number of events 3
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SQUAMOUS CELL CARCINOMA
|
0.00%
0/15
|
0.00%
0/34
|
0.00%
0/48
|
0.00%
0/49
|
0.00%
0/49
|
1.0%
1/97 • Number of events 1
|
0.00%
0/65
|
0.00%
0/143
|
|
Nervous system disorders
CERVICOBRACHIAL SYNDROME
|
0.00%
0/15
|
0.00%
0/34
|
0.00%
0/48
|
0.00%
0/49
|
0.00%
0/49
|
0.00%
0/97
|
0.00%
0/65
|
0.70%
1/143 • Number of events 1
|
|
Nervous system disorders
CONVULSION
|
6.7%
1/15 • Number of events 1
|
0.00%
0/34
|
0.00%
0/48
|
2.0%
1/49 • Number of events 1
|
0.00%
0/49
|
0.00%
0/97
|
0.00%
0/65
|
0.00%
0/143
|
|
Nervous system disorders
RADIAL NERVE PALSY
|
0.00%
0/15
|
0.00%
0/34
|
0.00%
0/48
|
0.00%
0/49
|
0.00%
0/49
|
1.0%
1/97 • Number of events 1
|
0.00%
0/65
|
0.00%
0/143
|
|
Nervous system disorders
SYNCOPE
|
0.00%
0/15
|
0.00%
0/34
|
0.00%
0/48
|
2.0%
1/49 • Number of events 1
|
0.00%
0/49
|
0.00%
0/97
|
0.00%
0/65
|
0.70%
1/143 • Number of events 1
|
|
Reproductive system and breast disorders
ENDOMETRIOSIS
|
0.00%
0/15
|
0.00%
0/34
|
0.00%
0/48
|
0.00%
0/49
|
0.00%
0/49
|
1.0%
1/97 • Number of events 1
|
0.00%
0/65
|
0.00%
0/143
|
|
Reproductive system and breast disorders
PROSTATITIS
|
0.00%
0/15
|
0.00%
0/34
|
0.00%
0/48
|
0.00%
0/49
|
0.00%
0/49
|
0.00%
0/97
|
1.5%
1/65 • Number of events 1
|
0.00%
0/143
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
0.00%
0/15
|
0.00%
0/34
|
0.00%
0/48
|
0.00%
0/49
|
2.0%
1/49 • Number of events 1
|
0.00%
0/97
|
0.00%
0/65
|
0.00%
0/143
|
|
Respiratory, thoracic and mediastinal disorders
PLEURISY
|
0.00%
0/15
|
0.00%
0/34
|
2.1%
1/48 • Number of events 1
|
0.00%
0/49
|
0.00%
0/49
|
0.00%
0/97
|
0.00%
0/65
|
0.00%
0/143
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.00%
0/15
|
0.00%
0/34
|
0.00%
0/48
|
0.00%
0/49
|
0.00%
0/49
|
0.00%
0/97
|
0.00%
0/65
|
0.70%
1/143 • Number of events 1
|
|
Surgical and medical procedures
LIVER TRANSPLANT
|
0.00%
0/15
|
0.00%
0/34
|
0.00%
0/48
|
0.00%
0/49
|
0.00%
0/49
|
0.00%
0/97
|
0.00%
0/65
|
0.70%
1/143 • Number of events 1
|
|
Vascular disorders
HYPERTENSIVE CRISIS
|
6.7%
1/15 • Number of events 1
|
0.00%
0/34
|
0.00%
0/48
|
0.00%
0/49
|
0.00%
0/49
|
0.00%
0/97
|
0.00%
0/65
|
0.00%
0/143
|
Other adverse events
| Measure |
PEG + RBV
n=15 participants at risk
Arm 1A: A single dose of PEG was given first, followed 1 week later by PEG + RBV for 12 weeks. If participant was HCV-RNA negative, PEG + RBV was continued for another 36 weeks.
|
PEG + RBV + BOC 400 (24 Weeks)
n=34 participants at risk
Arm 1B: A single dose of PEG was given first, followed 1 week later by PEG + RBV for 12 weeks. If HCV-RNA was detectable, BOC 400 was added for another 36 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
PEG + BOC 100 (48 Weeks)
n=48 participants at risk
Arm 2: A single dose of PEG was given first, followed 1 week later by PEG + BOC 100 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
PEG + BOC 200 (48 Weeks)
n=49 participants at risk
Arm 3: A single dose of PEG was given first, followed 1 week later by PEG + BOC 200 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
PEG + RBV + BOC 400 (48 Weeks)
n=49 participants at risk
Arm 5: A single dose of PEG was given first, followed 1 week later by PEG + RBV + BOC 400. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
PEG + BOC 400 (24 + 48 Weeks)
n=97 participants at risk
Arms 4 + 6: A single dose of PEG was given first, followed 1 week later by PEG + BOC (24 or 48 weeks). By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
PEG + BOC 800 (24 Weeks)
n=65 participants at risk
Arm 7: A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
|
PEG + RBV + BOC 800
n=143 participants at risk
Arm 8: By protocol amendment 2, participants from all arms except Arm 1A were rolled over into PEG + RBV + BOC 800 for the remainder of the treatment period.
|
|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
6.7%
1/15 • Number of events 1
|
11.8%
4/34 • Number of events 5
|
2.1%
1/48 • Number of events 1
|
0.00%
0/49
|
16.3%
8/49 • Number of events 12
|
1.0%
1/97 • Number of events 1
|
3.1%
2/65 • Number of events 2
|
37.8%
54/143 • Number of events 58
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
6.7%
1/15 • Number of events 2
|
0.00%
0/34
|
2.1%
1/48 • Number of events 1
|
2.0%
1/49 • Number of events 1
|
4.1%
2/49 • Number of events 4
|
2.1%
2/97 • Number of events 6
|
0.00%
0/65
|
4.9%
7/143 • Number of events 13
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
20.0%
3/15 • Number of events 4
|
8.8%
3/34 • Number of events 3
|
10.4%
5/48 • Number of events 7
|
10.2%
5/49 • Number of events 5
|
18.4%
9/49 • Number of events 16
|
12.4%
12/97 • Number of events 20
|
13.8%
9/65 • Number of events 10
|
17.5%
25/143 • Number of events 37
|
|
Blood and lymphatic system disorders
SPLENOMEGALY
|
0.00%
0/15
|
2.9%
1/34 • Number of events 1
|
6.2%
3/48 • Number of events 3
|
2.0%
1/49 • Number of events 1
|
2.0%
1/49 • Number of events 1
|
1.0%
1/97 • Number of events 1
|
1.5%
1/65 • Number of events 1
|
0.70%
1/143 • Number of events 1
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
0.00%
0/15
|
0.00%
0/34
|
4.2%
2/48 • Number of events 2
|
4.1%
2/49 • Number of events 2
|
4.1%
2/49 • Number of events 2
|
5.2%
5/97 • Number of events 5
|
0.00%
0/65
|
1.4%
2/143 • Number of events 3
|
|
Cardiac disorders
PALPITATIONS
|
6.7%
1/15 • Number of events 1
|
5.9%
2/34 • Number of events 2
|
2.1%
1/48 • Number of events 1
|
0.00%
0/49
|
2.0%
1/49 • Number of events 1
|
2.1%
2/97 • Number of events 2
|
0.00%
0/65
|
3.5%
5/143 • Number of events 6
|
|
Ear and labyrinth disorders
EAR DISCOMFORT
|
0.00%
0/15
|
0.00%
0/34
|
6.2%
3/48 • Number of events 3
|
0.00%
0/49
|
6.1%
3/49 • Number of events 3
|
2.1%
2/97 • Number of events 3
|
0.00%
0/65
|
1.4%
2/143 • Number of events 2
|
|
Ear and labyrinth disorders
TINNITUS
|
0.00%
0/15
|
2.9%
1/34 • Number of events 1
|
8.3%
4/48 • Number of events 4
|
0.00%
0/49
|
8.2%
4/49 • Number of events 4
|
0.00%
0/97
|
0.00%
0/65
|
0.00%
0/143
|
|
Ear and labyrinth disorders
VERTIGO
|
6.7%
1/15 • Number of events 1
|
2.9%
1/34 • Number of events 1
|
2.1%
1/48 • Number of events 1
|
2.0%
1/49 • Number of events 1
|
4.1%
2/49 • Number of events 3
|
0.00%
0/97
|
0.00%
0/65
|
0.70%
1/143 • Number of events 1
|
|
Endocrine disorders
HYPERTHYROIDISM
|
6.7%
1/15 • Number of events 1
|
0.00%
0/34
|
2.1%
1/48 • Number of events 1
|
0.00%
0/49
|
0.00%
0/49
|
0.00%
0/97
|
0.00%
0/65
|
0.70%
1/143 • Number of events 1
|
|
Endocrine disorders
HYPOTHYROIDISM
|
6.7%
1/15 • Number of events 1
|
0.00%
0/34
|
2.1%
1/48 • Number of events 1
|
0.00%
0/49
|
2.0%
1/49 • Number of events 1
|
4.1%
4/97 • Number of events 4
|
4.6%
3/65 • Number of events 3
|
4.2%
6/143 • Number of events 8
|
|
Eye disorders
DRY EYE
|
13.3%
2/15 • Number of events 2
|
5.9%
2/34 • Number of events 2
|
2.1%
1/48 • Number of events 1
|
0.00%
0/49
|
2.0%
1/49 • Number of events 1
|
3.1%
3/97 • Number of events 3
|
0.00%
0/65
|
0.70%
1/143 • Number of events 1
|
|
Eye disorders
EYE IRRITATION
|
6.7%
1/15 • Number of events 1
|
0.00%
0/34
|
0.00%
0/48
|
0.00%
0/49
|
0.00%
0/49
|
2.1%
2/97 • Number of events 2
|
0.00%
0/65
|
0.00%
0/143
|
|
Eye disorders
EYE PRURITUS
|
6.7%
1/15 • Number of events 1
|
2.9%
1/34 • Number of events 1
|
0.00%
0/48
|
2.0%
1/49 • Number of events 1
|
0.00%
0/49
|
0.00%
0/97
|
0.00%
0/65
|
0.00%
0/143
|
|
Eye disorders
LACRIMATION INCREASED
|
6.7%
1/15 • Number of events 1
|
0.00%
0/34
|
0.00%
0/48
|
0.00%
0/49
|
2.0%
1/49 • Number of events 1
|
0.00%
0/97
|
0.00%
0/65
|
0.00%
0/143
|
|
Eye disorders
VISION BLURRED
|
6.7%
1/15 • Number of events 1
|
2.9%
1/34 • Number of events 1
|
2.1%
1/48 • Number of events 1
|
0.00%
0/49
|
4.1%
2/49 • Number of events 2
|
4.1%
4/97 • Number of events 4
|
3.1%
2/65 • Number of events 2
|
2.1%
3/143 • Number of events 3
|
|
Eye disorders
VISUAL ACUITY REDUCED
|
0.00%
0/15
|
5.9%
2/34 • Number of events 2
|
0.00%
0/48
|
0.00%
0/49
|
0.00%
0/49
|
0.00%
0/97
|
1.5%
1/65 • Number of events 1
|
1.4%
2/143 • Number of events 2
|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
0.00%
0/15
|
0.00%
0/34
|
8.3%
4/48 • Number of events 4
|
0.00%
0/49
|
0.00%
0/49
|
0.00%
0/97
|
1.5%
1/65 • Number of events 1
|
0.00%
0/143
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.00%
0/15
|
5.9%
2/34 • Number of events 2
|
8.3%
4/48 • Number of events 5
|
4.1%
2/49 • Number of events 3
|
8.2%
4/49 • Number of events 4
|
5.2%
5/97 • Number of events 6
|
4.6%
3/65 • Number of events 3
|
2.8%
4/143 • Number of events 4
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
6.7%
1/15 • Number of events 1
|
11.8%
4/34 • Number of events 4
|
18.8%
9/48 • Number of events 12
|
18.4%
9/49 • Number of events 13
|
10.2%
5/49 • Number of events 6
|
17.5%
17/97 • Number of events 21
|
1.5%
1/65 • Number of events 1
|
7.7%
11/143 • Number of events 14
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.00%
0/15
|
5.9%
2/34 • Number of events 3
|
2.1%
1/48 • Number of events 1
|
8.2%
4/49 • Number of events 4
|
2.0%
1/49 • Number of events 1
|
3.1%
3/97 • Number of events 3
|
1.5%
1/65 • Number of events 1
|
5.6%
8/143 • Number of events 10
|
|
Gastrointestinal disorders
DIARRHOEA
|
40.0%
6/15 • Number of events 9
|
20.6%
7/34 • Number of events 8
|
22.9%
11/48 • Number of events 14
|
22.4%
11/49 • Number of events 13
|
20.4%
10/49 • Number of events 16
|
29.9%
29/97 • Number of events 41
|
32.3%
21/65 • Number of events 23
|
9.1%
13/143 • Number of events 14
|
|
Gastrointestinal disorders
DRY MOUTH
|
6.7%
1/15 • Number of events 1
|
8.8%
3/34 • Number of events 3
|
0.00%
0/48
|
4.1%
2/49 • Number of events 3
|
6.1%
3/49 • Number of events 3
|
7.2%
7/97 • Number of events 8
|
4.6%
3/65 • Number of events 3
|
3.5%
5/143 • Number of events 5
|
|
Gastrointestinal disorders
DYSPEPSIA
|
6.7%
1/15 • Number of events 1
|
5.9%
2/34 • Number of events 3
|
10.4%
5/48 • Number of events 5
|
4.1%
2/49 • Number of events 2
|
10.2%
5/49 • Number of events 5
|
6.2%
6/97 • Number of events 6
|
3.1%
2/65 • Number of events 2
|
2.8%
4/143 • Number of events 6
|
|
Gastrointestinal disorders
FLATULENCE
|
6.7%
1/15 • Number of events 1
|
0.00%
0/34
|
4.2%
2/48 • Number of events 2
|
4.1%
2/49 • Number of events 2
|
6.1%
3/49 • Number of events 3
|
6.2%
6/97 • Number of events 6
|
0.00%
0/65
|
0.70%
1/143 • Number of events 2
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
6.7%
1/15 • Number of events 1
|
2.9%
1/34 • Number of events 1
|
4.2%
2/48 • Number of events 2
|
0.00%
0/49
|
2.0%
1/49 • Number of events 1
|
4.1%
4/97 • Number of events 4
|
1.5%
1/65 • Number of events 1
|
3.5%
5/143 • Number of events 5
|
|
Gastrointestinal disorders
IRRITABLE BOWEL SYNDROME
|
6.7%
1/15 • Number of events 1
|
0.00%
0/34
|
0.00%
0/48
|
0.00%
0/49
|
0.00%
0/49
|
1.0%
1/97 • Number of events 1
|
0.00%
0/65
|
0.00%
0/143
|
|
Gastrointestinal disorders
MOUTH ULCERATION
|
6.7%
1/15 • Number of events 1
|
0.00%
0/34
|
0.00%
0/48
|
0.00%
0/49
|
0.00%
0/49
|
1.0%
1/97 • Number of events 1
|
0.00%
0/65
|
0.00%
0/143
|
|
Gastrointestinal disorders
NAUSEA
|
40.0%
6/15 • Number of events 7
|
26.5%
9/34 • Number of events 12
|
31.2%
15/48 • Number of events 17
|
26.5%
13/49 • Number of events 14
|
44.9%
22/49 • Number of events 31
|
33.0%
32/97 • Number of events 41
|
35.4%
23/65 • Number of events 23
|
15.4%
22/143 • Number of events 30
|
|
Gastrointestinal disorders
ORAL MUCOSAL BLISTERING
|
6.7%
1/15 • Number of events 1
|
0.00%
0/34
|
0.00%
0/48
|
0.00%
0/49
|
0.00%
0/49
|
0.00%
0/97
|
0.00%
0/65
|
0.00%
0/143
|
|
Gastrointestinal disorders
TOOTHACHE
|
6.7%
1/15 • Number of events 1
|
0.00%
0/34
|
2.1%
1/48 • Number of events 1
|
2.0%
1/49 • Number of events 1
|
0.00%
0/49
|
1.0%
1/97 • Number of events 1
|
1.5%
1/65 • Number of events 1
|
2.8%
4/143 • Number of events 4
|
|
Gastrointestinal disorders
VOMITING
|
13.3%
2/15 • Number of events 3
|
11.8%
4/34 • Number of events 4
|
14.6%
7/48 • Number of events 10
|
10.2%
5/49 • Number of events 5
|
20.4%
10/49 • Number of events 15
|
11.3%
11/97 • Number of events 12
|
9.2%
6/65 • Number of events 6
|
6.3%
9/143 • Number of events 14
|
|
General disorders
ASTHENIA
|
6.7%
1/15 • Number of events 1
|
26.5%
9/34 • Number of events 9
|
16.7%
8/48 • Number of events 9
|
14.3%
7/49 • Number of events 12
|
20.4%
10/49 • Number of events 15
|
20.6%
20/97 • Number of events 31
|
6.2%
4/65 • Number of events 4
|
4.9%
7/143 • Number of events 7
|
|
General disorders
CHEST PAIN
|
6.7%
1/15 • Number of events 1
|
2.9%
1/34 • Number of events 1
|
2.1%
1/48 • Number of events 1
|
4.1%
2/49 • Number of events 3
|
2.0%
1/49 • Number of events 1
|
2.1%
2/97 • Number of events 2
|
1.5%
1/65 • Number of events 1
|
2.1%
3/143 • Number of events 3
|
|
General disorders
CHILLS
|
26.7%
4/15 • Number of events 5
|
32.4%
11/34 • Number of events 16
|
39.6%
19/48 • Number of events 20
|
40.8%
20/49 • Number of events 22
|
38.8%
19/49 • Number of events 24
|
28.9%
28/97 • Number of events 33
|
41.5%
27/65 • Number of events 33
|
2.1%
3/143 • Number of events 3
|
|
General disorders
FATIGUE
|
66.7%
10/15 • Number of events 12
|
41.2%
14/34 • Number of events 16
|
52.1%
25/48 • Number of events 31
|
63.3%
31/49 • Number of events 39
|
49.0%
24/49 • Number of events 33
|
46.4%
45/97 • Number of events 58
|
61.5%
40/65 • Number of events 48
|
26.6%
38/143 • Number of events 43
|
|
General disorders
FEELING HOT
|
6.7%
1/15 • Number of events 1
|
2.9%
1/34 • Number of events 1
|
0.00%
0/48
|
0.00%
0/49
|
0.00%
0/49
|
0.00%
0/97
|
0.00%
0/65
|
0.00%
0/143
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
33.3%
5/15 • Number of events 5
|
17.6%
6/34 • Number of events 6
|
14.6%
7/48 • Number of events 8
|
24.5%
12/49 • Number of events 13
|
20.4%
10/49 • Number of events 13
|
21.6%
21/97 • Number of events 24
|
23.1%
15/65 • Number of events 15
|
0.00%
0/143
|
|
General disorders
INJECTION SITE ERYTHEMA
|
26.7%
4/15 • Number of events 4
|
11.8%
4/34 • Number of events 4
|
20.8%
10/48 • Number of events 11
|
20.4%
10/49 • Number of events 10
|
22.4%
11/49 • Number of events 11
|
15.5%
15/97 • Number of events 17
|
15.4%
10/65 • Number of events 10
|
0.70%
1/143 • Number of events 1
|
|
General disorders
INJECTION SITE RASH
|
6.7%
1/15 • Number of events 1
|
5.9%
2/34 • Number of events 2
|
2.1%
1/48 • Number of events 1
|
2.0%
1/49 • Number of events 1
|
0.00%
0/49
|
0.00%
0/97
|
1.5%
1/65 • Number of events 1
|
0.00%
0/143
|
|
General disorders
INJECTION SITE REACTION
|
13.3%
2/15 • Number of events 2
|
17.6%
6/34 • Number of events 6
|
18.8%
9/48 • Number of events 9
|
10.2%
5/49 • Number of events 5
|
10.2%
5/49 • Number of events 5
|
9.3%
9/97 • Number of events 9
|
10.8%
7/65 • Number of events 7
|
0.00%
0/143
|
|
General disorders
IRRITABILITY
|
20.0%
3/15 • Number of events 3
|
26.5%
9/34 • Number of events 9
|
14.6%
7/48 • Number of events 7
|
8.2%
4/49 • Number of events 8
|
18.4%
9/49 • Number of events 10
|
12.4%
12/97 • Number of events 14
|
10.8%
7/65 • Number of events 8
|
4.9%
7/143 • Number of events 7
|
|
General disorders
MALAISE
|
6.7%
1/15 • Number of events 1
|
2.9%
1/34 • Number of events 3
|
2.1%
1/48 • Number of events 1
|
2.0%
1/49 • Number of events 1
|
0.00%
0/49
|
2.1%
2/97 • Number of events 2
|
0.00%
0/65
|
0.70%
1/143 • Number of events 1
|
|
General disorders
PAIN
|
6.7%
1/15 • Number of events 1
|
11.8%
4/34 • Number of events 6
|
8.3%
4/48 • Number of events 5
|
6.1%
3/49 • Number of events 3
|
6.1%
3/49 • Number of events 4
|
8.2%
8/97 • Number of events 8
|
4.6%
3/65 • Number of events 3
|
0.70%
1/143 • Number of events 1
|
|
General disorders
PYREXIA
|
26.7%
4/15 • Number of events 4
|
38.2%
13/34 • Number of events 15
|
39.6%
19/48 • Number of events 26
|
34.7%
17/49 • Number of events 22
|
40.8%
20/49 • Number of events 26
|
30.9%
30/97 • Number of events 39
|
35.4%
23/65 • Number of events 27
|
4.2%
6/143 • Number of events 6
|
|
Hepatobiliary disorders
HEPATOMEGALY
|
6.7%
1/15 • Number of events 1
|
5.9%
2/34 • Number of events 2
|
8.3%
4/48 • Number of events 4
|
6.1%
3/49 • Number of events 3
|
10.2%
5/49 • Number of events 5
|
9.3%
9/97 • Number of events 10
|
6.2%
4/65 • Number of events 4
|
0.70%
1/143 • Number of events 1
|
|
Immune system disorders
SEASONAL ALLERGY
|
0.00%
0/15
|
0.00%
0/34
|
2.1%
1/48 • Number of events 1
|
2.0%
1/49 • Number of events 1
|
6.1%
3/49 • Number of events 3
|
0.00%
0/97
|
0.00%
0/65
|
1.4%
2/143 • Number of events 2
|
|
Infections and infestations
BRONCHITIS
|
0.00%
0/15
|
5.9%
2/34 • Number of events 2
|
2.1%
1/48 • Number of events 1
|
6.1%
3/49 • Number of events 3
|
2.0%
1/49 • Number of events 1
|
4.1%
4/97 • Number of events 4
|
0.00%
0/65
|
3.5%
5/143 • Number of events 5
|
|
Infections and infestations
FOLLICULITIS
|
0.00%
0/15
|
5.9%
2/34 • Number of events 3
|
0.00%
0/48
|
0.00%
0/49
|
0.00%
0/49
|
2.1%
2/97 • Number of events 2
|
0.00%
0/65
|
0.00%
0/143
|
|
Infections and infestations
INFLUENZA
|
0.00%
0/15
|
0.00%
0/34
|
6.2%
3/48 • Number of events 5
|
8.2%
4/49 • Number of events 4
|
6.1%
3/49 • Number of events 3
|
4.1%
4/97 • Number of events 4
|
0.00%
0/65
|
0.70%
1/143 • Number of events 1
|
|
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION
|
6.7%
1/15 • Number of events 1
|
0.00%
0/34
|
2.1%
1/48 • Number of events 1
|
0.00%
0/49
|
0.00%
0/49
|
1.0%
1/97 • Number of events 1
|
0.00%
0/65
|
0.00%
0/143
|
|
Infections and infestations
NASOPHARYNGITIS
|
0.00%
0/15
|
0.00%
0/34
|
6.2%
3/48 • Number of events 4
|
2.0%
1/49 • Number of events 1
|
2.0%
1/49 • Number of events 2
|
4.1%
4/97 • Number of events 6
|
0.00%
0/65
|
1.4%
2/143 • Number of events 2
|
|
Infections and infestations
ORAL HERPES
|
6.7%
1/15 • Number of events 1
|
11.8%
4/34 • Number of events 4
|
2.1%
1/48 • Number of events 1
|
2.0%
1/49 • Number of events 2
|
2.0%
1/49 • Number of events 1
|
7.2%
7/97 • Number of events 7
|
1.5%
1/65 • Number of events 1
|
2.1%
3/143 • Number of events 3
|
|
Infections and infestations
PHARYNGITIS STREPTOCOCCAL
|
6.7%
1/15 • Number of events 2
|
0.00%
0/34
|
4.2%
2/48 • Number of events 2
|
2.0%
1/49 • Number of events 1
|
0.00%
0/49
|
0.00%
0/97
|
0.00%
0/65
|
0.00%
0/143
|
|
Infections and infestations
SINUSITIS
|
6.7%
1/15 • Number of events 3
|
0.00%
0/34
|
10.4%
5/48 • Number of events 6
|
2.0%
1/49 • Number of events 1
|
2.0%
1/49 • Number of events 1
|
3.1%
3/97 • Number of events 3
|
0.00%
0/65
|
1.4%
2/143 • Number of events 2
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
0.00%
0/15
|
0.00%
0/34
|
6.2%
3/48 • Number of events 3
|
2.0%
1/49 • Number of events 1
|
4.1%
2/49 • Number of events 2
|
6.2%
6/97 • Number of events 7
|
0.00%
0/65
|
0.70%
1/143 • Number of events 1
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.00%
0/15
|
0.00%
0/34
|
0.00%
0/48
|
2.0%
1/49 • Number of events 1
|
8.2%
4/49 • Number of events 4
|
1.0%
1/97 • Number of events 1
|
3.1%
2/65 • Number of events 2
|
1.4%
2/143 • Number of events 5
|
|
Infections and infestations
VIRAL PHARYNGITIS
|
6.7%
1/15 • Number of events 1
|
0.00%
0/34
|
0.00%
0/48
|
0.00%
0/49
|
0.00%
0/49
|
0.00%
0/97
|
0.00%
0/65
|
0.00%
0/143
|
|
Injury, poisoning and procedural complications
CONTUSION
|
0.00%
0/15
|
0.00%
0/34
|
2.1%
1/48 • Number of events 1
|
2.0%
1/49 • Number of events 1
|
6.1%
3/49 • Number of events 4
|
2.1%
2/97 • Number of events 2
|
0.00%
0/65
|
3.5%
5/143 • Number of events 5
|
|
Injury, poisoning and procedural complications
LIMB INJURY
|
0.00%
0/15
|
0.00%
0/34
|
0.00%
0/48
|
2.0%
1/49 • Number of events 1
|
6.1%
3/49 • Number of events 3
|
2.1%
2/97 • Number of events 2
|
0.00%
0/65
|
0.00%
0/143
|
|
Injury, poisoning and procedural complications
SUNBURN
|
6.7%
1/15 • Number of events 1
|
0.00%
0/34
|
0.00%
0/48
|
2.0%
1/49 • Number of events 1
|
0.00%
0/49
|
0.00%
0/97
|
0.00%
0/65
|
0.70%
1/143 • Number of events 1
|
|
Investigations
HAEMOGLOBIN DECREASED
|
0.00%
0/15
|
2.9%
1/34 • Number of events 1
|
0.00%
0/48
|
0.00%
0/49
|
8.2%
4/49 • Number of events 4
|
0.00%
0/97
|
0.00%
0/65
|
6.3%
9/143 • Number of events 10
|
|
Investigations
WEIGHT DECREASED
|
0.00%
0/15
|
5.9%
2/34 • Number of events 2
|
2.1%
1/48 • Number of events 1
|
4.1%
2/49 • Number of events 2
|
4.1%
2/49 • Number of events 2
|
3.1%
3/97 • Number of events 3
|
4.6%
3/65 • Number of events 3
|
4.2%
6/143 • Number of events 7
|
|
Metabolism and nutrition disorders
ANOREXIA
|
6.7%
1/15 • Number of events 1
|
8.8%
3/34 • Number of events 3
|
12.5%
6/48 • Number of events 6
|
12.2%
6/49 • Number of events 7
|
6.1%
3/49 • Number of events 3
|
4.1%
4/97 • Number of events 4
|
6.2%
4/65 • Number of events 4
|
3.5%
5/143 • Number of events 5
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
6.7%
1/15 • Number of events 1
|
8.8%
3/34 • Number of events 3
|
2.1%
1/48 • Number of events 1
|
8.2%
4/49 • Number of events 4
|
8.2%
4/49 • Number of events 5
|
5.2%
5/97 • Number of events 5
|
9.2%
6/65 • Number of events 6
|
5.6%
8/143 • Number of events 8
|
|
Metabolism and nutrition disorders
HYPERINSULINISM
|
6.7%
1/15 • Number of events 1
|
0.00%
0/34
|
0.00%
0/48
|
0.00%
0/49
|
0.00%
0/49
|
0.00%
0/97
|
0.00%
0/65
|
0.00%
0/143
|
|
Metabolism and nutrition disorders
HYPERTRIGLYCERIDAEMIA
|
6.7%
1/15 • Number of events 1
|
0.00%
0/34
|
2.1%
1/48 • Number of events 2
|
2.0%
1/49 • Number of events 1
|
0.00%
0/49
|
2.1%
2/97 • Number of events 2
|
1.5%
1/65 • Number of events 1
|
0.70%
1/143 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
33.3%
5/15 • Number of events 6
|
14.7%
5/34 • Number of events 10
|
35.4%
17/48 • Number of events 28
|
30.6%
15/49 • Number of events 24
|
34.7%
17/49 • Number of events 18
|
36.1%
35/97 • Number of events 46
|
23.1%
15/65 • Number of events 22
|
5.6%
8/143 • Number of events 8
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
20.0%
3/15 • Number of events 4
|
8.8%
3/34 • Number of events 3
|
8.3%
4/48 • Number of events 4
|
12.2%
6/49 • Number of events 6
|
10.2%
5/49 • Number of events 5
|
21.6%
21/97 • Number of events 21
|
15.4%
10/65 • Number of events 10
|
6.3%
9/143 • Number of events 9
|
|
Musculoskeletal and connective tissue disorders
BONE PAIN
|
0.00%
0/15
|
5.9%
2/34 • Number of events 2
|
2.1%
1/48 • Number of events 1
|
0.00%
0/49
|
2.0%
1/49 • Number of events 1
|
3.1%
3/97 • Number of events 3
|
0.00%
0/65
|
0.70%
1/143 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
0.00%
0/15
|
2.9%
1/34 • Number of events 1
|
8.3%
4/48 • Number of events 5
|
2.0%
1/49 • Number of events 2
|
6.1%
3/49 • Number of events 3
|
3.1%
3/97 • Number of events 3
|
1.5%
1/65 • Number of events 2
|
4.2%
6/143 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL STIFFNESS
|
6.7%
1/15 • Number of events 1
|
0.00%
0/34
|
2.1%
1/48 • Number of events 1
|
2.0%
1/49 • Number of events 1
|
0.00%
0/49
|
1.0%
1/97 • Number of events 1
|
0.00%
0/65
|
1.4%
2/143 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
40.0%
6/15 • Number of events 7
|
23.5%
8/34 • Number of events 10
|
47.9%
23/48 • Number of events 28
|
32.7%
16/49 • Number of events 20
|
32.7%
16/49 • Number of events 20
|
38.1%
37/97 • Number of events 39
|
40.0%
26/65 • Number of events 32
|
4.2%
6/143 • Number of events 7
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
13.3%
2/15 • Number of events 2
|
0.00%
0/34
|
2.1%
1/48 • Number of events 1
|
4.1%
2/49 • Number of events 3
|
2.0%
1/49 • Number of events 1
|
5.2%
5/97 • Number of events 6
|
1.5%
1/65 • Number of events 1
|
3.5%
5/143 • Number of events 6
|
|
Nervous system disorders
APHASIA
|
6.7%
1/15 • Number of events 1
|
0.00%
0/34
|
0.00%
0/48
|
0.00%
0/49
|
0.00%
0/49
|
0.00%
0/97
|
0.00%
0/65
|
0.00%
0/143
|
|
Nervous system disorders
BALANCE DISORDER
|
6.7%
1/15 • Number of events 1
|
2.9%
1/34 • Number of events 1
|
2.1%
1/48 • Number of events 1
|
2.0%
1/49 • Number of events 1
|
0.00%
0/49
|
1.0%
1/97 • Number of events 1
|
0.00%
0/65
|
0.70%
1/143 • Number of events 1
|
|
Nervous system disorders
DISTURBANCE IN ATTENTION
|
0.00%
0/15
|
0.00%
0/34
|
10.4%
5/48 • Number of events 6
|
10.2%
5/49 • Number of events 5
|
4.1%
2/49 • Number of events 2
|
4.1%
4/97 • Number of events 5
|
6.2%
4/65 • Number of events 4
|
3.5%
5/143 • Number of events 5
|
|
Nervous system disorders
DIZZINESS
|
13.3%
2/15 • Number of events 2
|
29.4%
10/34 • Number of events 10
|
20.8%
10/48 • Number of events 13
|
10.2%
5/49 • Number of events 5
|
8.2%
4/49 • Number of events 4
|
7.2%
7/97 • Number of events 9
|
9.2%
6/65 • Number of events 7
|
12.6%
18/143 • Number of events 23
|
|
Nervous system disorders
DYSGEUSIA
|
20.0%
3/15 • Number of events 3
|
11.8%
4/34 • Number of events 4
|
6.2%
3/48 • Number of events 4
|
4.1%
2/49 • Number of events 2
|
26.5%
13/49 • Number of events 16
|
23.7%
23/97 • Number of events 26
|
47.7%
31/65 • Number of events 33
|
9.8%
14/143 • Number of events 14
|
|
Nervous system disorders
HEADACHE
|
46.7%
7/15 • Number of events 9
|
58.8%
20/34 • Number of events 24
|
62.5%
30/48 • Number of events 39
|
57.1%
28/49 • Number of events 47
|
51.0%
25/49 • Number of events 37
|
53.6%
52/97 • Number of events 65
|
50.8%
33/65 • Number of events 43
|
7.7%
11/143 • Number of events 16
|
|
Nervous system disorders
HYPOAESTHESIA
|
0.00%
0/15
|
5.9%
2/34 • Number of events 2
|
0.00%
0/48
|
2.0%
1/49 • Number of events 1
|
6.1%
3/49 • Number of events 5
|
1.0%
1/97 • Number of events 1
|
3.1%
2/65 • Number of events 2
|
2.1%
3/143 • Number of events 3
|
|
Nervous system disorders
HYPOKINESIA
|
6.7%
1/15 • Number of events 1
|
0.00%
0/34
|
0.00%
0/48
|
0.00%
0/49
|
0.00%
0/49
|
0.00%
0/97
|
0.00%
0/65
|
0.00%
0/143
|
|
Nervous system disorders
LETHARGY
|
6.7%
1/15 • Number of events 1
|
0.00%
0/34
|
2.1%
1/48 • Number of events 1
|
0.00%
0/49
|
2.0%
1/49 • Number of events 1
|
0.00%
0/97
|
1.5%
1/65 • Number of events 1
|
0.00%
0/143
|
|
Nervous system disorders
MEMORY IMPAIRMENT
|
0.00%
0/15
|
5.9%
2/34 • Number of events 2
|
6.2%
3/48 • Number of events 3
|
2.0%
1/49 • Number of events 1
|
6.1%
3/49 • Number of events 3
|
2.1%
2/97 • Number of events 2
|
4.6%
3/65 • Number of events 3
|
0.70%
1/143 • Number of events 1
|
|
Nervous system disorders
MIGRAINE
|
0.00%
0/15
|
5.9%
2/34 • Number of events 3
|
0.00%
0/48
|
0.00%
0/49
|
0.00%
0/49
|
4.1%
4/97 • Number of events 6
|
3.1%
2/65 • Number of events 2
|
0.00%
0/143
|
|
Nervous system disorders
SPEECH DISORDER
|
6.7%
1/15 • Number of events 1
|
0.00%
0/34
|
0.00%
0/48
|
0.00%
0/49
|
0.00%
0/49
|
0.00%
0/97
|
0.00%
0/65
|
0.00%
0/143
|
|
Nervous system disorders
TREMOR
|
0.00%
0/15
|
0.00%
0/34
|
4.2%
2/48 • Number of events 2
|
0.00%
0/49
|
6.1%
3/49 • Number of events 3
|
3.1%
3/97 • Number of events 4
|
3.1%
2/65 • Number of events 2
|
0.70%
1/143 • Number of events 1
|
|
Psychiatric disorders
ANXIETY
|
6.7%
1/15 • Number of events 3
|
11.8%
4/34 • Number of events 4
|
12.5%
6/48 • Number of events 7
|
8.2%
4/49 • Number of events 4
|
10.2%
5/49 • Number of events 5
|
8.2%
8/97 • Number of events 10
|
3.1%
2/65 • Number of events 2
|
4.2%
6/143 • Number of events 6
|
|
Psychiatric disorders
CONFUSIONAL STATE
|
6.7%
1/15 • Number of events 1
|
0.00%
0/34
|
0.00%
0/48
|
0.00%
0/49
|
2.0%
1/49 • Number of events 1
|
0.00%
0/97
|
3.1%
2/65 • Number of events 2
|
0.70%
1/143 • Number of events 1
|
|
Psychiatric disorders
DEPRESSION
|
26.7%
4/15 • Number of events 5
|
11.8%
4/34 • Number of events 5
|
25.0%
12/48 • Number of events 13
|
16.3%
8/49 • Number of events 9
|
32.7%
16/49 • Number of events 16
|
18.6%
18/97 • Number of events 19
|
7.7%
5/65 • Number of events 7
|
15.4%
22/143 • Number of events 26
|
|
Psychiatric disorders
INITIAL INSOMNIA
|
6.7%
1/15 • Number of events 2
|
0.00%
0/34
|
0.00%
0/48
|
0.00%
0/49
|
2.0%
1/49 • Number of events 1
|
0.00%
0/97
|
0.00%
0/65
|
0.00%
0/143
|
|
Psychiatric disorders
INSOMNIA
|
26.7%
4/15 • Number of events 4
|
26.5%
9/34 • Number of events 12
|
25.0%
12/48 • Number of events 14
|
22.4%
11/49 • Number of events 13
|
30.6%
15/49 • Number of events 18
|
20.6%
20/97 • Number of events 23
|
15.4%
10/65 • Number of events 10
|
16.1%
23/143 • Number of events 23
|
|
Psychiatric disorders
MOOD SWINGS
|
6.7%
1/15 • Number of events 1
|
0.00%
0/34
|
2.1%
1/48 • Number of events 1
|
0.00%
0/49
|
0.00%
0/49
|
0.00%
0/97
|
0.00%
0/65
|
0.00%
0/143
|
|
Psychiatric disorders
NERVOUSNESS
|
6.7%
1/15 • Number of events 1
|
8.8%
3/34 • Number of events 3
|
4.2%
2/48 • Number of events 4
|
0.00%
0/49
|
2.0%
1/49 • Number of events 1
|
3.1%
3/97 • Number of events 3
|
0.00%
0/65
|
0.70%
1/143 • Number of events 1
|
|
Psychiatric disorders
SLEEP DISORDER
|
6.7%
1/15 • Number of events 1
|
0.00%
0/34
|
2.1%
1/48 • Number of events 1
|
4.1%
2/49 • Number of events 3
|
2.0%
1/49 • Number of events 1
|
2.1%
2/97 • Number of events 2
|
3.1%
2/65 • Number of events 2
|
0.70%
1/143 • Number of events 1
|
|
Reproductive system and breast disorders
SEXUAL DYSFUNCTION
|
6.7%
1/15 • Number of events 1
|
0.00%
0/34
|
2.1%
1/48 • Number of events 1
|
0.00%
0/49
|
0.00%
0/49
|
0.00%
0/97
|
0.00%
0/65
|
0.70%
1/143 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
26.7%
4/15 • Number of events 4
|
20.6%
7/34 • Number of events 12
|
18.8%
9/48 • Number of events 9
|
10.2%
5/49 • Number of events 5
|
14.3%
7/49 • Number of events 8
|
10.3%
10/97 • Number of events 12
|
9.2%
6/65 • Number of events 7
|
11.9%
17/143 • Number of events 20
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
26.7%
4/15 • Number of events 4
|
11.8%
4/34 • Number of events 5
|
12.5%
6/48 • Number of events 9
|
12.2%
6/49 • Number of events 6
|
22.4%
11/49 • Number of events 14
|
11.3%
11/97 • Number of events 11
|
0.00%
0/65
|
13.3%
19/143 • Number of events 21
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA EXERTIONAL
|
0.00%
0/15
|
2.9%
1/34 • Number of events 1
|
4.2%
2/48 • Number of events 3
|
0.00%
0/49
|
10.2%
5/49 • Number of events 5
|
1.0%
1/97 • Number of events 1
|
0.00%
0/65
|
7.7%
11/143 • Number of events 11
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
6.7%
1/15 • Number of events 4
|
5.9%
2/34 • Number of events 3
|
6.2%
3/48 • Number of events 3
|
4.1%
2/49 • Number of events 2
|
6.1%
3/49 • Number of events 4
|
2.1%
2/97 • Number of events 12
|
0.00%
0/65
|
2.1%
3/143 • Number of events 26
|
|
Respiratory, thoracic and mediastinal disorders
INCREASED UPPER AIRWAY SECRETION
|
0.00%
0/15
|
5.9%
2/34 • Number of events 2
|
2.1%
1/48 • Number of events 1
|
2.0%
1/49 • Number of events 1
|
2.0%
1/49 • Number of events 1
|
3.1%
3/97 • Number of events 3
|
1.5%
1/65 • Number of events 1
|
2.1%
3/143 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
6.7%
1/15 • Number of events 1
|
0.00%
0/34
|
6.2%
3/48 • Number of events 3
|
2.0%
1/49 • Number of events 1
|
6.1%
3/49 • Number of events 4
|
1.0%
1/97 • Number of events 1
|
3.1%
2/65 • Number of events 2
|
1.4%
2/143 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
NASAL DRYNESS
|
6.7%
1/15 • Number of events 1
|
0.00%
0/34
|
2.1%
1/48 • Number of events 1
|
0.00%
0/49
|
0.00%
0/49
|
1.0%
1/97 • Number of events 1
|
0.00%
0/65
|
0.00%
0/143
|
|
Respiratory, thoracic and mediastinal disorders
PHARYNGOLARYNGEAL PAIN
|
13.3%
2/15 • Number of events 2
|
0.00%
0/34
|
10.4%
5/48 • Number of events 6
|
4.1%
2/49 • Number of events 3
|
10.2%
5/49 • Number of events 6
|
7.2%
7/97 • Number of events 7
|
4.6%
3/65 • Number of events 3
|
4.9%
7/143 • Number of events 7
|
|
Respiratory, thoracic and mediastinal disorders
PRODUCTIVE COUGH
|
6.7%
1/15 • Number of events 1
|
0.00%
0/34
|
4.2%
2/48 • Number of events 2
|
2.0%
1/49 • Number of events 1
|
0.00%
0/49
|
2.1%
2/97 • Number of events 2
|
0.00%
0/65
|
0.00%
0/143
|
|
Respiratory, thoracic and mediastinal disorders
RHINORRHOEA
|
6.7%
1/15 • Number of events 1
|
2.9%
1/34 • Number of events 2
|
0.00%
0/48
|
4.1%
2/49 • Number of events 2
|
4.1%
2/49 • Number of events 2
|
3.1%
3/97 • Number of events 3
|
1.5%
1/65 • Number of events 1
|
0.00%
0/143
|
|
Respiratory, thoracic and mediastinal disorders
SINUS CONGESTION
|
6.7%
1/15 • Number of events 1
|
2.9%
1/34 • Number of events 2
|
8.3%
4/48 • Number of events 4
|
0.00%
0/49
|
0.00%
0/49
|
4.1%
4/97 • Number of events 4
|
1.5%
1/65 • Number of events 1
|
0.70%
1/143 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
0.00%
0/15
|
14.7%
5/34 • Number of events 6
|
20.8%
10/48 • Number of events 10
|
8.2%
4/49 • Number of events 5
|
34.7%
17/49 • Number of events 18
|
21.6%
21/97 • Number of events 21
|
3.1%
2/65 • Number of events 2
|
13.3%
19/143 • Number of events 19
|
|
Skin and subcutaneous tissue disorders
DERMATITIS
|
0.00%
0/15
|
0.00%
0/34
|
2.1%
1/48 • Number of events 1
|
0.00%
0/49
|
0.00%
0/49
|
6.2%
6/97 • Number of events 6
|
0.00%
0/65
|
1.4%
2/143 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
6.7%
1/15 • Number of events 1
|
26.5%
9/34 • Number of events 9
|
12.5%
6/48 • Number of events 7
|
10.2%
5/49 • Number of events 5
|
16.3%
8/49 • Number of events 8
|
10.3%
10/97 • Number of events 10
|
3.1%
2/65 • Number of events 2
|
2.1%
3/143 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
0.00%
0/15
|
5.9%
2/34 • Number of events 2
|
4.2%
2/48 • Number of events 2
|
0.00%
0/49
|
0.00%
0/49
|
2.1%
2/97 • Number of events 2
|
0.00%
0/65
|
0.00%
0/143
|
|
Skin and subcutaneous tissue disorders
HYPERHIDROSIS
|
0.00%
0/15
|
8.8%
3/34 • Number of events 4
|
4.2%
2/48 • Number of events 3
|
6.1%
3/49 • Number of events 3
|
6.1%
3/49 • Number of events 3
|
4.1%
4/97 • Number of events 5
|
6.2%
4/65 • Number of events 4
|
0.00%
0/143
|
|
Skin and subcutaneous tissue disorders
NIGHT SWEATS
|
6.7%
1/15 • Number of events 1
|
0.00%
0/34
|
4.2%
2/48 • Number of events 2
|
0.00%
0/49
|
2.0%
1/49 • Number of events 1
|
4.1%
4/97 • Number of events 4
|
1.5%
1/65 • Number of events 1
|
0.00%
0/143
|
|
Skin and subcutaneous tissue disorders
PALMAR ERYTHEMA
|
6.7%
1/15 • Number of events 1
|
0.00%
0/34
|
2.1%
1/48 • Number of events 1
|
4.1%
2/49 • Number of events 2
|
2.0%
1/49 • Number of events 1
|
0.00%
0/97
|
1.5%
1/65 • Number of events 1
|
1.4%
2/143 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
PHOTOSENSITIVITY REACTION
|
6.7%
1/15 • Number of events 1
|
0.00%
0/34
|
4.2%
2/48 • Number of events 3
|
2.0%
1/49 • Number of events 1
|
0.00%
0/49
|
2.1%
2/97 • Number of events 2
|
1.5%
1/65 • Number of events 1
|
0.00%
0/143
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
6.7%
1/15 • Number of events 1
|
26.5%
9/34 • Number of events 12
|
16.7%
8/48 • Number of events 10
|
8.2%
4/49 • Number of events 4
|
10.2%
5/49 • Number of events 5
|
9.3%
9/97 • Number of events 9
|
3.1%
2/65 • Number of events 2
|
10.5%
15/143 • Number of events 15
|
|
Skin and subcutaneous tissue disorders
RASH
|
13.3%
2/15 • Number of events 3
|
11.8%
4/34 • Number of events 4
|
10.4%
5/48 • Number of events 5
|
6.1%
3/49 • Number of events 3
|
16.3%
8/49 • Number of events 12
|
9.3%
9/97 • Number of events 10
|
3.1%
2/65 • Number of events 2
|
6.3%
9/143 • Number of events 10
|
|
Skin and subcutaneous tissue disorders
SPIDER NAEVUS
|
6.7%
1/15 • Number of events 1
|
0.00%
0/34
|
2.1%
1/48 • Number of events 1
|
0.00%
0/49
|
0.00%
0/49
|
0.00%
0/97
|
1.5%
1/65 • Number of events 1
|
0.00%
0/143
|
|
Skin and subcutaneous tissue disorders
SWELLING FACE
|
6.7%
1/15 • Number of events 1
|
0.00%
0/34
|
0.00%
0/48
|
0.00%
0/49
|
0.00%
0/49
|
1.0%
1/97 • Number of events 1
|
0.00%
0/65
|
0.70%
1/143 • Number of events 1
|
|
Surgical and medical procedures
CYST DRAINAGE
|
6.7%
1/15 • Number of events 1
|
0.00%
0/34
|
0.00%
0/48
|
0.00%
0/49
|
0.00%
0/49
|
0.00%
0/97
|
0.00%
0/65
|
0.00%
0/143
|
|
Vascular disorders
HYPERTENSION
|
13.3%
2/15 • Number of events 3
|
2.9%
1/34 • Number of events 1
|
4.2%
2/48 • Number of events 2
|
8.2%
4/49 • Number of events 4
|
4.1%
2/49 • Number of events 2
|
4.1%
4/97 • Number of events 4
|
0.00%
0/65
|
0.70%
1/143 • Number of events 1
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The principal investigator (PI) agrees to provide review copies to the sponsor 30 days prior to submission. The sponsor shall have editorial rights and the right to review and comment on the data analysis and presentation with regard to proprietary information, accuracy of information, and to ensure that the presentation is fairly balanced and in compliance with regulations. If the parties disagree, the PI agrees to meet with the sponsor to discuss and resolve any such issues or disagreement.
- Publication restrictions are in place
Restriction type: OTHER