Trial Outcomes & Findings for Safety and Efficacy of Vaniprevir (MK7009) Administered With Pegylated-Interferon and Ribavirin (MK-7009-007) (NCT NCT00704184)
NCT ID: NCT00704184
Last Updated: 2018-10-09
Results Overview
Rapid Viral Response (RVR) was declared if Hepatitis C Virus (HCV) ribonucleic acid (RNA) was undetectable at Week 4.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
95 participants
Primary outcome timeframe
Week 4
Results posted on
2018-10-09
Participant Flow
During the double-blind phase (Day 1 to Day 28), participants took Vaniprevir or Placebo in combination with Pegylated Interferon (Peg-IFN)/Ribavirin. During the open-label phase (Day 29 to Week 48), participants took Peg-IFN/Ribavirin only.
Participant milestones
| Measure |
Placebo + Peg-IFN/Ribavirin
Participants took double-blind Placebo + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
|
Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavirin
Participants took double-blind Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
|
Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin
Participants took double-blind Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
|
Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin
Participants took double-blind Vaniprevir 600 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
|
Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin
Participants took double-blind Vaniprevir 800 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
|
|---|---|---|---|---|---|
|
Double-Blind Treatment
STARTED
|
20
|
18
|
20
|
18
|
19
|
|
Double-Blind Treatment
Treated
|
19
|
18
|
20
|
18
|
19
|
|
Double-Blind Treatment
COMPLETED
|
19
|
18
|
20
|
18
|
19
|
|
Double-Blind Treatment
NOT COMPLETED
|
1
|
0
|
0
|
0
|
0
|
|
Open-Label Treatment
STARTED
|
19
|
18
|
20
|
18
|
19
|
|
Open-Label Treatment
COMPLETED
|
18
|
16
|
16
|
13
|
16
|
|
Open-Label Treatment
NOT COMPLETED
|
1
|
2
|
4
|
5
|
3
|
Reasons for withdrawal
| Measure |
Placebo + Peg-IFN/Ribavirin
Participants took double-blind Placebo + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
|
Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavirin
Participants took double-blind Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
|
Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin
Participants took double-blind Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
|
Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin
Participants took double-blind Vaniprevir 600 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
|
Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin
Participants took double-blind Vaniprevir 800 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
|
|---|---|---|---|---|---|
|
Double-Blind Treatment
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
0
|
|
Open-Label Treatment
Adverse Event
|
0
|
0
|
2
|
0
|
1
|
|
Open-Label Treatment
Lack of Efficacy
|
0
|
2
|
2
|
2
|
1
|
|
Open-Label Treatment
Physician Decision
|
0
|
0
|
0
|
0
|
1
|
|
Open-Label Treatment
Withdrawal by Subject
|
1
|
0
|
0
|
3
|
0
|
Baseline Characteristics
Safety and Efficacy of Vaniprevir (MK7009) Administered With Pegylated-Interferon and Ribavirin (MK-7009-007)
Baseline characteristics by cohort
| Measure |
Placebo + Peg-IFN/Ribavirin
n=19 Participants
Participants took double-blind Placebo + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
|
Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavirin
n=18 Participants
Participants took double-blind Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
|
Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin
n=20 Participants
Participants took double-blind Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
|
Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin
n=18 Participants
Participants took double-blind Vaniprevir 600 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
|
Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin
n=19 Participants
Participants took double-blind Vaniprevir 800 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
|
Total
n=94 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
47.8 Years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
46.7 Years
STANDARD_DEVIATION 10.2 • n=7 Participants
|
42.0 Years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
50.1 Years
STANDARD_DEVIATION 8.4 • n=4 Participants
|
45.1 Years
STANDARD_DEVIATION 12.0 • n=21 Participants
|
46.2 Years
STANDARD_DEVIATION 10.5 • n=8 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
39 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
55 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Week 4Population: The Per Protocol population included all participants who did not have clinically important deviations from protocol-specified criteria. Only participants with an HCV RNA result at the Week 4 time point were included in the analysis.
Rapid Viral Response (RVR) was declared if Hepatitis C Virus (HCV) ribonucleic acid (RNA) was undetectable at Week 4.
Outcome measures
| Measure |
Placebo + Peg-IFN/Ribavirin
n=18 Participants
Participants took double-blind Placebo + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
|
Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavirin
n=16 Participants
Participants took double-blind Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
|
Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin
n=19 Participants
Participants took double-blind Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
|
Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin
n=16 Participants
Participants took double-blind Vaniprevir 600 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
|
Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin
n=18 Participants
Participants took double-blind Vaniprevir 800 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
|
|---|---|---|---|---|---|
|
Percentage of Participants Achieving RVR
|
5.6 Percentage of Participants
|
75.0 Percentage of Participants
|
78.9 Percentage of Participants
|
68.8 Percentage of Participants
|
83.3 Percentage of Participants
|
PRIMARY outcome
Timeframe: Up to Day 42Population: The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
The number of participants experiencing AEs in each treatment group was monitored during the Vaniprevir/Placebo treatment (Day 1 to Day 28) and safety follow-up (Day 29 to Day 42) periods.
Outcome measures
| Measure |
Placebo + Peg-IFN/Ribavirin
n=19 Participants
Participants took double-blind Placebo + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
|
Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavirin
n=18 Participants
Participants took double-blind Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
|
Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin
n=20 Participants
Participants took double-blind Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
|
Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin
n=18 Participants
Participants took double-blind Vaniprevir 600 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
|
Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin
n=19 Participants
Participants took double-blind Vaniprevir 800 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
|
|---|---|---|---|---|---|
|
Number of Participants Experiencing an Adverse Event (AE)
|
18 Participants
|
15 Participants
|
18 Participants
|
16 Participants
|
18 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 28Population: The Safety Population consists of all randomized participants who received at least 1 dose of study therapy
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of study therapy, whether or not considered related to the use of the product.
Outcome measures
| Measure |
Placebo + Peg-IFN/Ribavirin
n=19 Participants
Participants took double-blind Placebo + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
|
Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavirin
n=18 Participants
Participants took double-blind Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
|
Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin
n=20 Participants
Participants took double-blind Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
|
Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin
n=18 Participants
Participants took double-blind Vaniprevir 600 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
|
Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin
n=19 Participants
Participants took double-blind Vaniprevir 800 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
|
|---|---|---|---|---|---|
|
Number of Participants Discontinuing From Study Therapy Due to AEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 4Population: The Per Protocol population included all participants who did not have clinically important deviations from protocol-specified criteria. Only participants with an HCV RNA result at the Week 4 time point were included in the analysis.
The number of participants with at least a 2-log10 decrease from baseline in HCV RNA following 4 weeks of treatment with Placebo or Vaniprevir.
Outcome measures
| Measure |
Placebo + Peg-IFN/Ribavirin
n=18 Participants
Participants took double-blind Placebo + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
|
Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavirin
n=16 Participants
Participants took double-blind Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
|
Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin
n=19 Participants
Participants took double-blind Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
|
Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin
n=16 Participants
Participants took double-blind Vaniprevir 600 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
|
Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin
n=18 Participants
Participants took double-blind Vaniprevir 800 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
|
|---|---|---|---|---|---|
|
Number of Participants With ≥2-log10 Decrease in HCV RNA
|
16 Number of Participants
|
16 Number of Participants
|
19 Number of Participants
|
16 Number of Participants
|
17 Number of Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 4Population: The Per Protocol population included all participants who did not have clinically important deviations from protocol-specified criteria. Only participants with an HCV RNA result at the Week 4 time point were included in the analysis.
The number of participants with at least a 3-log10 decrease from baseline in HCV RNA following 4 weeks of treatment with Placebo or Vaniprevir.
Outcome measures
| Measure |
Placebo + Peg-IFN/Ribavirin
n=18 Participants
Participants took double-blind Placebo + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
|
Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavirin
n=16 Participants
Participants took double-blind Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
|
Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin
n=19 Participants
Participants took double-blind Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
|
Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin
n=16 Participants
Participants took double-blind Vaniprevir 600 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
|
Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin
n=18 Participants
Participants took double-blind Vaniprevir 800 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
|
|---|---|---|---|---|---|
|
Number of Participants With ≥3-log10 Decrease in HCV RNA
|
15 Number of Participants
|
16 Number of Participants
|
19 Number of Participants
|
16 Number of Participants
|
17 Number of Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 4Population: The Per Protocol population included all participants who did not have clinically important deviations from protocol-specified criteria. Only participants with an HCV RNA result at the Week 4 time point were included in the analysis.
The mean changes from baseline in log10 HCV RNA in each vaniprevir group was compared against control treatment at Week 4.
Outcome measures
| Measure |
Placebo + Peg-IFN/Ribavirin
n=18 Participants
Participants took double-blind Placebo + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
|
Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavirin
n=16 Participants
Participants took double-blind Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
|
Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin
n=19 Participants
Participants took double-blind Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
|
Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin
n=17 Participants
Participants took double-blind Vaniprevir 600 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
|
Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin
n=18 Participants
Participants took double-blind Vaniprevir 800 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
|
|---|---|---|---|---|---|
|
Mean Log Change From Baseline in HCV RNA
|
-3.6 Log10 IU/mL
Standard Deviation 1.3
|
-6.1 Log10 IU/mL
Standard Deviation 1.1
|
-6.3 Log10 IU/mL
Standard Deviation 0.7
|
-6.2 Log10 IU/mL
Standard Deviation 0.6
|
-6.3 Log10 IU/mL
Standard Deviation 1.4
|
Adverse Events
Placebo + Peg-IFN/Ribavirin
Serious events: 1 serious events
Other events: 19 other events
Deaths: 0 deaths
Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavirin
Serious events: 3 serious events
Other events: 16 other events
Deaths: 0 deaths
Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin
Serious events: 1 serious events
Other events: 20 other events
Deaths: 0 deaths
Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin
Serious events: 2 serious events
Other events: 17 other events
Deaths: 0 deaths
Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin
Serious events: 2 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo + Peg-IFN/Ribavirin
n=19 participants at risk
Participants took double-blind Placebo + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
|
Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavirin
n=18 participants at risk
Participants took double-blind Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
|
Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin
n=20 participants at risk
Participants took double-blind Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
|
Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin
n=18 participants at risk
Participants took double-blind Vaniprevir 600 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
|
Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin
n=19 participants at risk
Participants took double-blind Vaniprevir 800 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
|
|---|---|---|---|---|---|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.6%
1/18 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.6%
1/18 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Infections and infestations
Empyema
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.0%
1/20 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.6%
1/18 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.6%
1/18 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Infections and infestations
Septic shock
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.0%
1/20 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.3%
1/19 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.6%
1/18 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
5.3%
1/19 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.3%
1/19 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
Other adverse events
| Measure |
Placebo + Peg-IFN/Ribavirin
n=19 participants at risk
Participants took double-blind Placebo + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
|
Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavirin
n=18 participants at risk
Participants took double-blind Vaniprevir 300 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
|
Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavirin
n=20 participants at risk
Participants took double-blind Vaniprevir 600 mg b.i.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
|
Vaniprevir 600 mg q.d. + Peg-IFN/Ribavirin
n=18 participants at risk
Participants took double-blind Vaniprevir 600 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
|
Vaniprevir 800 mg q.d. + Peg-IFN/Ribavirin
n=19 participants at risk
Participants took double-blind Vaniprevir 800 mg q.d. + Peg-IFN/Ribavarin from Week 1 to Week 4, followed by open-label Peg-IFN/Ribavarin from Week 5 to Week 48.
|
|---|---|---|---|---|---|
|
General disorders
Chest pain
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
15.8%
3/19 • Number of events 4 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
General disorders
Pyrexia
|
10.5%
2/19 • Number of events 3 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
10.0%
2/20 • Number of events 2 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
11.1%
2/18 • Number of events 2 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
21.1%
4/19 • Number of events 4 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Blood and lymphatic system disorders
Anaemia
|
15.8%
3/19 • Number of events 3 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
11.1%
2/18 • Number of events 2 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
10.0%
2/20 • Number of events 2 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.6%
1/18 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.3%
1/19 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.3%
1/19 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Blood and lymphatic system disorders
Neutropenia
|
10.5%
2/19 • Number of events 2 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.6%
1/18 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
10.0%
2/20 • Number of events 2 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.6%
1/18 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
15.8%
3/19 • Number of events 3 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.3%
1/19 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Cardiac disorders
Angina pectoris
|
5.3%
1/19 • Number of events 2 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.0%
1/20 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.3%
1/19 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Cardiac disorders
Tachycardia
|
10.5%
2/19 • Number of events 2 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.6%
1/18 • Number of events 2 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.6%
1/18 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.6%
1/18 • Number of events 2 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.0%
1/20 • Number of events 2 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Eye disorders
Vision blurred
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.0%
1/20 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.3%
1/19 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Eye disorders
Vision acuity reduced
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.6%
1/18 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Eye disorders
Visual brightness
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.6%
1/18 • Number of events 2 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Eye disorders
Visual impairment
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.6%
1/18 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.6%
1/18 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.3%
1/19 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Eye disorders
Xerophthalmia
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.6%
1/18 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.0%
1/20 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.6%
1/18 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.0%
1/20 • Number of events 2 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.6%
1/18 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.0%
1/20 • Number of events 3 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
11.1%
2/18 • Number of events 2 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.3%
1/19 • Number of events 2 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
15.8%
3/19 • Number of events 5 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.6%
1/18 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
15.0%
3/20 • Number of events 3 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
22.2%
4/18 • Number of events 4 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
10.5%
2/19 • Number of events 2 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.6%
1/18 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Gastrointestinal disorders
Constipation
|
5.3%
1/19 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Gastrointestinal disorders
Diarrhoea
|
21.1%
4/19 • Number of events 4 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.6%
1/18 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
35.0%
7/20 • Number of events 8 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
11.1%
2/18 • Number of events 2 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
31.6%
6/19 • Number of events 7 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.6%
1/18 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
10.0%
2/20 • Number of events 2 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
11.1%
2/18 • Number of events 2 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.3%
1/19 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Gastrointestinal disorders
Duodenitis
|
5.3%
1/19 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Gastrointestinal disorders
Dyspepsia
|
21.1%
4/19 • Number of events 4 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
22.2%
4/18 • Number of events 4 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
11.1%
2/18 • Number of events 2 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
21.1%
4/19 • Number of events 4 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.6%
1/18 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
10.5%
2/19 • Number of events 2 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Gastrointestinal disorders
Gastrooesophogeal reflux disease
|
10.5%
2/19 • Number of events 2 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
11.1%
2/18 • Number of events 2 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
22.2%
4/18 • Number of events 4 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
10.0%
2/20 • Number of events 2 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Gastrointestinal disorders
Glossodynia
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.6%
1/18 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Gastrointestinal disorders
Ileus
|
5.3%
1/19 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Gastrointestinal disorders
Lip dry
|
10.5%
2/19 • Number of events 2 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.3%
1/19 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Gastrointestinal disorders
Lip erosion
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.6%
1/18 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Gastrointestinal disorders
Nausea
|
31.6%
6/19 • Number of events 7 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
27.8%
5/18 • Number of events 7 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
40.0%
8/20 • Number of events 14 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
38.9%
7/18 • Number of events 8 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
31.6%
6/19 • Number of events 6 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Gastrointestinal disorders
Oesophogeal pain
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.3%
1/19 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.6%
1/18 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Gastrointestinal disorders
Stomatitis
|
5.3%
1/19 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.6%
1/18 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
45.0%
9/20 • Number of events 16 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
22.2%
4/18 • Number of events 5 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
15.8%
3/19 • Number of events 6 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
General disorders
Asthenia
|
21.1%
4/19 • Number of events 5 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
11.1%
2/18 • Number of events 2 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
20.0%
4/20 • Number of events 6 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
22.2%
4/18 • Number of events 4 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
15.8%
3/19 • Number of events 3 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
General disorders
Chills
|
10.5%
2/19 • Number of events 2 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.6%
1/18 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.0%
1/20 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
15.8%
3/19 • Number of events 4 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
General disorders
Discomfort
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.3%
1/19 • Number of events 2 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
General disorders
Fatigue
|
36.8%
7/19 • Number of events 7 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
16.7%
3/18 • Number of events 3 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
35.0%
7/20 • Number of events 10 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
22.2%
4/18 • Number of events 4 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
15.8%
3/19 • Number of events 3 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
General disorders
Feeling cold
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.3%
1/19 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
General disorders
Influenza like illness
|
21.1%
4/19 • Number of events 5 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
22.2%
4/18 • Number of events 4 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
20.0%
4/20 • Number of events 4 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
22.2%
4/18 • Number of events 4 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
26.3%
5/19 • Number of events 6 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
General disorders
Injection site erythema
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
11.1%
2/18 • Number of events 2 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
10.0%
2/20 • Number of events 2 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.6%
1/18 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Immune system disorders
Seasonal allergy
|
5.3%
1/19 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
General disorders
Injection site irritation
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.6%
1/18 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
General disorders
Injection site reaction
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.6%
1/18 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.0%
1/20 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
General disorders
Irritability
|
15.8%
3/19 • Number of events 4 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
11.1%
2/18 • Number of events 3 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.0%
1/20 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.3%
1/19 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
General disorders
Mucosal dryness
|
5.3%
1/19 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
General disorders
Mucosal inflammation
|
5.3%
1/19 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
General disorders
Oedema peripheral
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.0%
1/20 • Number of events 3 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.6%
1/18 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
General disorders
Pain
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
15.0%
3/20 • Number of events 3 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Infections and infestations
Bronchitis
|
5.3%
1/19 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.0%
1/20 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.6%
1/18 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Infections and infestations
Ear infection
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.6%
1/18 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Infections and infestations
Gastroenteritis
|
5.3%
1/19 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Infections and infestations
Herpes virus infection
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.3%
1/19 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.6%
1/18 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.3%
1/19 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Infections and infestations
Nasopharyngitis
|
5.3%
1/19 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.0%
1/20 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
15.8%
3/19 • Number of events 4 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Infections and infestations
Oesophageal candidiasis
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.3%
1/19 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Infections and infestations
Oral herpes
|
5.3%
1/19 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.6%
1/18 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Infections and infestations
Sinusitis
|
5.3%
1/19 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.0%
1/20 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.6%
1/18 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Infections and infestations
Tinea infection
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.6%
1/18 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Infections and infestations
Tinea pedis
|
5.3%
1/19 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Infections and infestations
Tinea versicolour
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.6%
1/18 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Infections and infestations
Tracheobronchitis
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.6%
1/18 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.3%
1/19 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.6%
1/18 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
11.1%
2/18 • Number of events 2 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
10.0%
2/20 • Number of events 2 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
11.1%
2/18 • Number of events 2 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.3%
1/19 • Number of events 5 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Infections and infestations
Viral infection
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.6%
1/18 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.3%
1/19 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.6%
1/18 • Number of events 2 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.6%
1/18 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.3%
1/19 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
5.3%
1/19 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.0%
1/20 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.6%
1/18 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Metabolism and nutrition disorders
Fluid retention
|
5.3%
1/19 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Investigations
Blood glucose increased
|
5.3%
1/19 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Investigations
Body temperature decreased
|
5.3%
1/19 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Investigations
Body temperature increased
|
5.3%
1/19 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.6%
1/18 • Number of events 2 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.6%
1/18 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.3%
1/19 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Investigations
Glucose urine present
|
5.3%
1/19 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
10.0%
2/20 • Number of events 2 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.6%
1/18 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.3%
1/19 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.6%
1/18 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.0%
1/20 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Investigations
Platelet count decreased
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.0%
1/20 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.6%
1/18 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Investigations
Weight decreased
|
10.5%
2/19 • Number of events 2 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
10.0%
2/20 • Number of events 2 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.6%
1/18 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.3%
1/19 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Metabolism and nutrition disorders
Appetite disorder
|
5.3%
1/19 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
10.5%
2/19 • Number of events 3 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
22.2%
4/18 • Number of events 4 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
30.0%
6/20 • Number of events 6 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
11.1%
2/18 • Number of events 2 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.3%
1/19 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.5%
2/19 • Number of events 2 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
16.7%
3/18 • Number of events 4 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
10.0%
2/20 • Number of events 4 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
16.7%
3/18 • Number of events 3 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
5.3%
1/19 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.3%
1/19 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
15.0%
3/20 • Number of events 5 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
15.8%
3/19 • Number of events 3 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.3%
1/19 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.3%
1/19 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
5.3%
1/19 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
5.3%
1/19 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
11.1%
2/18 • Number of events 2 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.0%
1/20 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
11.1%
2/18 • Number of events 2 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.3%
1/19 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
15.8%
3/19 • Number of events 3 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.6%
1/18 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.0%
1/20 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.6%
1/18 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Musculoskeletal and connective tissue disorders
Myosclerosis
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.3%
1/19 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.0%
1/20 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.6%
1/18 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.0%
1/20 • Number of events 4 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.3%
1/19 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.6%
1/18 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.3%
1/19 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Nervous system disorders
Cervicobrachial syndrome
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.3%
1/19 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Nervous system disorders
Coordination abnormal
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.6%
1/18 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.6%
1/18 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.6%
1/18 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.0%
1/20 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.6%
1/18 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
10.5%
2/19 • Number of events 3 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.6%
1/18 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.3%
1/19 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Nervous system disorders
Head discomfort
|
5.3%
1/19 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Nervous system disorders
Headache
|
36.8%
7/19 • Number of events 10 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
22.2%
4/18 • Number of events 4 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
45.0%
9/20 • Number of events 12 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
44.4%
8/18 • Number of events 9 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
26.3%
5/19 • Number of events 6 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Nervous system disorders
Hyperaesthesia
|
5.3%
1/19 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Nervous system disorders
Intercostal neuralgia
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.6%
1/18 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.6%
1/18 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.0%
1/20 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.3%
1/19 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Nervous system disorders
Poor quality sleep
|
5.3%
1/19 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.6%
1/18 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.6%
1/18 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Nervous system disorders
Restless legs syndrome
|
5.3%
1/19 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.0%
1/20 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.3%
1/19 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
11.1%
2/18 • Number of events 2 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.3%
1/19 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.6%
1/18 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Psychiatric disorders
Agitation
|
5.3%
1/19 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Psychiatric disorders
Anxiety
|
5.3%
1/19 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
11.1%
2/18 • Number of events 2 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.0%
1/20 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.3%
1/19 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.6%
1/18 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
15.0%
3/20 • Number of events 3 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Psychiatric disorders
Depression
|
15.8%
3/19 • Number of events 3 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
16.7%
3/18 • Number of events 3 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
10.0%
2/20 • Number of events 2 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
16.7%
3/18 • Number of events 3 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.6%
1/18 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Psychiatric disorders
Dysthymic disorder
|
5.3%
1/19 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Psychiatric disorders
Initial insomnia
|
5.3%
1/19 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Psychiatric disorders
Insomnia
|
10.5%
2/19 • Number of events 2 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
22.2%
4/18 • Number of events 4 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
20.0%
4/20 • Number of events 4 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
27.8%
5/18 • Number of events 5 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
10.5%
2/19 • Number of events 2 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Psychiatric disorders
Libido decreased
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.6%
1/18 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Psychiatric disorders
Mood swings
|
5.3%
1/19 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.6%
1/18 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Psychiatric disorders
Nervousness
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.3%
1/19 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Psychiatric disorders
Restlessness
|
10.5%
2/19 • Number of events 2 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Psychiatric disorders
Sleep disorder
|
10.5%
2/19 • Number of events 2 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.6%
1/18 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Renal and urinary disorders
Urine odour abnormal
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.6%
1/18 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.6%
1/18 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.3%
1/19 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
11.1%
2/18 • Number of events 3 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.8%
3/19 • Number of events 3 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
16.7%
3/18 • Number of events 4 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
10.0%
2/20 • Number of events 3 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
11.1%
2/18 • Number of events 2 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.3%
1/19 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.6%
1/18 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
26.3%
5/19 • Number of events 5 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
16.7%
3/18 • Number of events 3 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.0%
1/20 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.6%
1/18 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
10.5%
2/19 • Number of events 2 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.0%
1/20 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.6%
1/18 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.3%
1/19 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.6%
1/18 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
10.0%
2/20 • Number of events 2 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal ulcer
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.6%
1/18 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.6%
1/18 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.0%
1/20 • Number of events 2 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.3%
1/19 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
10.0%
2/20 • Number of events 2 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
10.5%
2/19 • Number of events 2 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.6%
1/18 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
15.8%
3/19 • Number of events 3 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.0%
1/20 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
16.7%
3/18 • Number of events 3 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
10.5%
2/19 • Number of events 2 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.0%
1/20 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
16.7%
3/18 • Number of events 3 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
31.6%
6/19 • Number of events 6 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.6%
1/18 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
15.0%
3/20 • Number of events 3 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.6%
1/18 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.3%
1/19 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
11.1%
2/18 • Number of events 2 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
15.0%
3/20 • Number of events 4 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.3%
1/19 • Number of events 2 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Skin and subcutaneous tissue disorders
Eczema nummular
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.3%
1/19 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
10.5%
2/19 • Number of events 2 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.6%
1/18 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.6%
1/18 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
15.0%
3/20 • Number of events 4 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Skin and subcutaneous tissue disorders
Hypotrichosis
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.6%
1/18 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
5.3%
1/19 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.6%
1/18 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.0%
1/20 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.6%
1/18 • Number of events 2 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
21.1%
4/19 • Number of events 8 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
22.2%
4/18 • Number of events 4 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.6%
1/18 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
21.1%
4/19 • Number of events 4 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Skin and subcutaneous tissue disorders
Rash
|
21.1%
4/19 • Number of events 5 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
16.7%
3/18 • Number of events 6 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
10.0%
2/20 • Number of events 2 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
16.7%
3/18 • Number of events 3 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
10.5%
2/19 • Number of events 3 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.6%
1/18 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.0%
1/20 • Number of events 2 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
5.3%
1/19 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.6%
1/18 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.3%
1/19 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
11.1%
2/18 • Number of events 2 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.0%
1/20 • Number of events 2 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Skin and subcutaneous tissue disorders
Skin reaction
|
5.3%
1/19 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.6%
1/18 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Skin and subcutaneous tissue disorders
Xeroderma
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.6%
1/18 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Vascular disorders
Hot flush
|
5.3%
1/19 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.6%
1/18 • Number of events 2 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Vascular disorders
Hyperaemia
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.3%
1/19 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Vascular disorders
Hypertension
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
11.1%
2/18 • Number of events 2 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.3%
1/19 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.6%
1/18 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.6%
1/18 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Eye disorders
Dry eye
|
5.3%
1/19 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.6%
1/18 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.6%
1/18 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.3%
1/19 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Eye disorders
Eye irritation
|
5.3%
1/19 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.6%
1/18 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.0%
1/20 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.3%
1/19 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Eye disorders
Eye pain
|
5.3%
1/19 • Number of events 2 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Eye disorders
Eye pruritus
|
5.3%
1/19 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Eye disorders
Eye swelling
|
5.3%
1/19 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Eye disorders
Eyelid function disorder
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.6%
1/18 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Eye disorders
Ocular icterus
|
5.3%
1/19 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Eye disorders
Photopsia
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.6%
1/18 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Eye disorders
Diplopia
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.6%
1/18 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.6%
1/18 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/20 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/18 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.0%
1/20 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
5.6%
1/18 • Number of events 1 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
0.00%
0/19 • AEs were monitored for 18 months in the study, including the Vaniprevir/Placebo + Peg-IFN Ribavirin treatment/follow-up period (Day 1 to Day 42) and subsequent Peg-IFN/Ribavirin treatment/follow-up period (Day 43 to Week 72).
The Safety Population consists of all randomized participants who received at least 1 dose of study therapy.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The SPONSOR must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the SPONSOR as confidential must be deleted prior to submission. SPONSOR review can be expedited to meet publication guidelines.
- Publication restrictions are in place
Restriction type: OTHER