Trial Outcomes & Findings for A Phase 2b, Safety and Efficacy Study of Boceprevir in Patients Coinfected With HIV and Hepatitis C (P05411 AM4) (NCT NCT00959699)
NCT ID: NCT00959699
Last Updated: 2017-04-07
Results Overview
SVR24 is defined as undetectable plasma hepatitis C virus ribonucleic acid (HCV-RNA) at 24 weeks after the end of all study treatment. If there was no value in the FW24 visit window, the closest value available chronologically after this window was used; if a value was still missing after that, the value from Follow-up Week 12 (FW12) was used. HCV-RNA is detected by a nucleic acid amplification test and the lower limit of detection for this assay is 9.3 IU/mL.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
99 participants
Primary outcome timeframe
Up to Week 72
Results posted on
2017-04-07
Participant Flow
One participant in the pegylated interferon alfa-2b (PegIFN-2b) + ribavirin (RBV) + boceprevir group withdrew from the study after randomization but prior to administration of any study treatment.
Participant milestones
| Measure |
PegIFN-2b + RBV
PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600-1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by placebo to boceprevir plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up (Control Arm). Participants who do not achieve HCV-RNA \<9.3 IU/mL by Treatment Week 24 (TW24) are eligible to cross-over and receive boceprevir along with the PegIFN-2b and RBV for up to 44 weeks.
|
PegIFN-2b + RBV + Boceprevir
PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600- 1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by boceprevir (800 mg, orally, 3 times per day) plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up.
|
|---|---|---|
|
Treatment Period
STARTED
|
34
|
65
|
|
Treatment Period
Treated
|
34
|
64
|
|
Treatment Period
COMPLETED
|
11
|
40
|
|
Treatment Period
NOT COMPLETED
|
23
|
25
|
|
Follow-up Period
STARTED
|
33
|
62
|
|
Follow-up Period
COMPLETED
|
27
|
56
|
|
Follow-up Period
NOT COMPLETED
|
6
|
6
|
Reasons for withdrawal
| Measure |
PegIFN-2b + RBV
PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600-1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by placebo to boceprevir plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up (Control Arm). Participants who do not achieve HCV-RNA \<9.3 IU/mL by Treatment Week 24 (TW24) are eligible to cross-over and receive boceprevir along with the PegIFN-2b and RBV for up to 44 weeks.
|
PegIFN-2b + RBV + Boceprevir
PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600- 1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by boceprevir (800 mg, orally, 3 times per day) plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up.
|
|---|---|---|
|
Treatment Period
Adverse Event
|
3
|
13
|
|
Treatment Period
Lack of Efficacy
|
15
|
6
|
|
Treatment Period
Lost to Follow-up
|
0
|
1
|
|
Treatment Period
Withdrawal by Subject
|
1
|
3
|
|
Treatment Period
Non-Compliance with Protocol
|
0
|
1
|
|
Treatment Period
Did not receive treatment
|
0
|
1
|
|
Treatment Period
Futility/crossover to boceprevir
|
4
|
0
|
|
Follow-up Period
Lost to Follow-up
|
3
|
2
|
|
Follow-up Period
Withdrawal by Subject
|
3
|
4
|
Baseline Characteristics
A Phase 2b, Safety and Efficacy Study of Boceprevir in Patients Coinfected With HIV and Hepatitis C (P05411 AM4)
Baseline characteristics by cohort
| Measure |
PegIFN-2b + RBV
n=34 Participants
PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600-1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by placebo to boceprevir plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up (Control Arm). Participants who do not achieve HCV-RNA \<9.3 IU/mL by Treatment Week 24 (TW24) are eligible to cross-over and receive boceprevir along with the PegIFN-2b and RBV for up to 44 weeks.
|
PegIFN-2b + RBV + Boceprevir
n=64 Participants
PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600- 1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by boceprevir (800 mg, orally, 3 times per day) plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up.
|
Total
n=98 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.1 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
42.9 years
STANDARD_DEVIATION 8.3 • n=7 Participants
|
43.6 years
STANDARD_DEVIATION 8.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to Week 72Population: All randomized participants receiving at least one dose of any study medication (Full Analysis Set); this includes 3 participants who did not enter the Follow-Up Period.
SVR24 is defined as undetectable plasma hepatitis C virus ribonucleic acid (HCV-RNA) at 24 weeks after the end of all study treatment. If there was no value in the FW24 visit window, the closest value available chronologically after this window was used; if a value was still missing after that, the value from Follow-up Week 12 (FW12) was used. HCV-RNA is detected by a nucleic acid amplification test and the lower limit of detection for this assay is 9.3 IU/mL.
Outcome measures
| Measure |
PegIFN-2b + RBV
n=34 Participants
PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600-1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by placebo to boceprevir plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up (Control Arm). Participants who do not achieve HCV-RNA \<9.3 IU/mL by Treatment Week 24 (TW24) are eligible to cross-over and receive boceprevir along with the PegIFN-2b and RBV for up to 44 weeks.
|
PegIFN-2b + RBV + Boceprevir
n=64 Participants
PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600- 1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by boceprevir (800 mg, orally, 3 times per day) plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up.
|
|---|---|---|
|
Percentage of Participants Achieving Sustained Viral Response (SVR) at Follow-up Week 24 (FW24) Among Randomized Participants Who Received At Least One Dose of Trial Medication
|
29.4 percentage of participants
Interval 14.1 to 53.3
|
62.5 percentage of participants
|
SECONDARY outcome
Timeframe: Up to Week 72Population: All randomized participants receiving one dose of boceprevir (PegIFN-2b + RBV + Boceprevir group) or placebo to boceprevir (PegIFN-2b + RBV group), defined as the Modified Intent-to-Treat Population; this includes 2 participants who did not enter the Follow-up Period.
SVR24 is defined as undetectable plasma HCV-RNA 24 weeks after the end of all study treatment. If there was no value in the FW24 visit window, the closest value available chronologically after this window was used; if a value was still missing after that, the value from FW12 was used. HCV-RNA is detected by a nucleic acid amplification test and the lower limit of detection for this assay is 9.3 IU/mL.
Outcome measures
| Measure |
PegIFN-2b + RBV
n=33 Participants
PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600-1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by placebo to boceprevir plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up (Control Arm). Participants who do not achieve HCV-RNA \<9.3 IU/mL by Treatment Week 24 (TW24) are eligible to cross-over and receive boceprevir along with the PegIFN-2b and RBV for up to 44 weeks.
|
PegIFN-2b + RBV + Boceprevir
n=62 Participants
PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600- 1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by boceprevir (800 mg, orally, 3 times per day) plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up.
|
|---|---|---|
|
Percentage of Participants Achieving SVR24 Among Randomized Participants Who Received At Least One Dose of Boceprevir (Experimental) or Placebo (Control)
|
30.3 percentage of participants
|
64.5 percentage of participants
|
SECONDARY outcome
Timeframe: Up to Week 12Population: All randomized participants receiving at least one dose of any study medication (Full Analysis Set); this includes 3 participants who did not enter the Follow-Up Period. No participants had undetectable HCV-RNA at Week 2; the "n" value in the table below represents the number of participants with EVR at that time point.
EVR was defined as undetectable HCV-RNA at Treatment Week (TW) 2, 4, 8, or 12. HCV-RNA was detected by a nucleic acid amplification test and the lower limit of detection for this assay is 9.3 IU/mL.
Outcome measures
| Measure |
PegIFN-2b + RBV
n=34 Participants
PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600-1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by placebo to boceprevir plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up (Control Arm). Participants who do not achieve HCV-RNA \<9.3 IU/mL by Treatment Week 24 (TW24) are eligible to cross-over and receive boceprevir along with the PegIFN-2b and RBV for up to 44 weeks.
|
PegIFN-2b + RBV + Boceprevir
n=64 Participants
PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600- 1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by boceprevir (800 mg, orally, 3 times per day) plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up.
|
|---|---|---|
|
Percentage of Participants With Early Virologic Response (EVR) Who Achieved SVR24
HCV-RNA undetectable at Week 2 (n=0, 0)
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Early Virologic Response (EVR) Who Achieved SVR24
HCV-RNA undetectable at Week 4 (n=3, 3)
|
100 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants With Early Virologic Response (EVR) Who Achieved SVR24
HCV-RNA undetectable at Week 8 (n=5, 27)
|
100 percentage of participants
|
92.6 percentage of participants
|
|
Percentage of Participants With Early Virologic Response (EVR) Who Achieved SVR24
HCV-RNA undetectable at Week 12 (n=8, 38)
|
87.5 percentage of participants
|
92.1 percentage of participants
|
SECONDARY outcome
Timeframe: Up to Week 60Population: All randomized participants receiving at least one dose of any study medication (Full Analysis Set); this includes 3 participants who did not enter the Follow-Up Period.
The virologic response at FW12 was considered SVR12 with an additional rule for handling missing data: participants with missing HCV-RNA assessment at FW12 but having non-missing, undetectable HCV-RNA assessments at both FW4 and FW24, were assumed to be responders for SVR12. HCV-RNA was detected by a nucleic acid amplification test and the lower limit of detection for this assay is 9.3 IU/mL.
Outcome measures
| Measure |
PegIFN-2b + RBV
n=34 Participants
PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600-1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by placebo to boceprevir plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up (Control Arm). Participants who do not achieve HCV-RNA \<9.3 IU/mL by Treatment Week 24 (TW24) are eligible to cross-over and receive boceprevir along with the PegIFN-2b and RBV for up to 44 weeks.
|
PegIFN-2b + RBV + Boceprevir
n=64 Participants
PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600- 1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by boceprevir (800 mg, orally, 3 times per day) plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up.
|
|---|---|---|
|
Percentage of Participants With Undetectable HCV-RNA at Follow-up Week 12 (FW12)
|
26.5 percentage of participants
|
62.5 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Week 4Population: All randomized participants receiving at least one dose of any study medication (Full Analysis Set); this includes 3 participants who did not enter the Follow-Up Period.
This is a measure of the change in the amount of HCV-RNA in the plasma at the end of 4 weeks of treatment. HCV-RNA was detected by a nucleic acid amplification test and the lower limit of detection for this assay is 9.3 IU/mL.
Outcome measures
| Measure |
PegIFN-2b + RBV
n=34 Participants
PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600-1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by placebo to boceprevir plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up (Control Arm). Participants who do not achieve HCV-RNA \<9.3 IU/mL by Treatment Week 24 (TW24) are eligible to cross-over and receive boceprevir along with the PegIFN-2b and RBV for up to 44 weeks.
|
PegIFN-2b + RBV + Boceprevir
n=64 Participants
PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600- 1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by boceprevir (800 mg, orally, 3 times per day) plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up.
|
|---|---|---|
|
Change From Baseline in log10 HCV-RNA at Treatment Week 4 (TW4)
Participants with <1 positive log drop
|
15 participants
|
28 participants
|
|
Change From Baseline in log10 HCV-RNA at Treatment Week 4 (TW4)
Participants with >= 1 positive log drop
|
16 participants
|
32 participants
|
|
Change From Baseline in log10 HCV-RNA at Treatment Week 4 (TW4)
Participants with undetectable HCV-RNA
|
3 participants
|
3 participants
|
|
Change From Baseline in log10 HCV-RNA at Treatment Week 4 (TW4)
Participants with missing data
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Up to Week 72Population: All randomized participants receiving at least one dose of any study medication (Full Analysis Set); this includes 3 participants who did not enter the Follow-Up Period.
Virologic breakthrough is defined as achieving undetectable HCV-RNA and subsequently having an HCV-RNA level of \>1000 IU/mL. Incomplete Virologic Response/Rebound is defined as having a one log10 increase in HCV-RNA from the participant's nadir, with an HCV-RNA \>1000 IU/mL. HCV-RNA was detected by a nucleic acid amplification test and the lower limit of detection for this assay is 9.3 IU/mL.
Outcome measures
| Measure |
PegIFN-2b + RBV
n=34 Participants
PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600-1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by placebo to boceprevir plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up (Control Arm). Participants who do not achieve HCV-RNA \<9.3 IU/mL by Treatment Week 24 (TW24) are eligible to cross-over and receive boceprevir along with the PegIFN-2b and RBV for up to 44 weeks.
|
PegIFN-2b + RBV + Boceprevir
n=64 Participants
PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600- 1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by boceprevir (800 mg, orally, 3 times per day) plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up.
|
|---|---|---|
|
Percentage of Participants With HCV Virologic Breakthrough or Incomplete Virologic Response/Rebound
Virologic breakthrough
|
0 percentage of participants
|
6.3 percentage of participants
|
|
Percentage of Participants With HCV Virologic Breakthrough or Incomplete Virologic Response/Rebound
Incomplete response
|
17.6 percentage of participants
|
9.4 percentage of participants
|
Adverse Events
PegIFN-2b+RBV
Serious events: 7 serious events
Other events: 33 other events
Deaths: 0 deaths
PegIFN-2b+RBV+Boceprevir
Serious events: 11 serious events
Other events: 62 other events
Deaths: 0 deaths
Boceprevir Crossover
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PegIFN-2b+RBV
n=34 participants at risk
PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600-1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by placebo to boceprevir plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up (Control Arm). Participants who do not achieve HCV-RNA \<9.3 IU/mL by Treatment Week 24 (TW24) are eligible to cross-over and receive boceprevir along with the PegIFN-2b and RBV for up to 44 weeks.
|
PegIFN-2b+RBV+Boceprevir
n=64 participants at risk
PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600- 1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by boceprevir (800 mg, orally, 3 times per day) plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up.
|
Boceprevir Crossover
n=4 participants at risk
(After Treatment Week 24) PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600- 1400 mg/day, orally, divided into two daily doses) plus boceprevir (800 mg, orally, 3 times per day) for up to 44 weeks with 24 weeks post-treatment follow-up.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
5.9%
2/34 • Number of events 2 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
3.1%
2/64 • Number of events 3 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
0.00%
0/4 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
|
Blood and lymphatic system disorders
LYMPHADENOPATHY
|
0.00%
0/34 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
1.6%
1/64 • Number of events 1 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
0.00%
0/4 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
|
Cardiac disorders
VENTRICULAR FIBRILLATION
|
2.9%
1/34 • Number of events 1 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
0.00%
0/64 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
0.00%
0/4 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
2.9%
1/34 • Number of events 1 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
0.00%
0/64 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
0.00%
0/4 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
|
Gastrointestinal disorders
PANCREATITIS
|
2.9%
1/34 • Number of events 1 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
0.00%
0/64 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
0.00%
0/4 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
2.9%
1/34 • Number of events 1 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
0.00%
0/64 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
0.00%
0/4 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
|
Infections and infestations
LUNG INFECTION PSEUDOMONAL
|
0.00%
0/34 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
1.6%
1/64 • Number of events 1 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
0.00%
0/4 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
|
Infections and infestations
PELVIC INFLAMMATORY DISEASE
|
0.00%
0/34 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
1.6%
1/64 • Number of events 1 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
0.00%
0/4 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
|
Infections and infestations
PNEUMONIA
|
0.00%
0/34 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
3.1%
2/64 • Number of events 2 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
0.00%
0/4 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
|
Infections and infestations
POST PROCEDURAL INFECTION
|
2.9%
1/34 • Number of events 1 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
0.00%
0/64 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
0.00%
0/4 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
|
Infections and infestations
SINUSITIS
|
0.00%
0/34 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
1.6%
1/64 • Number of events 1 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
0.00%
0/4 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.00%
0/34 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
1.6%
1/64 • Number of events 1 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
0.00%
0/4 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
|
Infections and infestations
VULVAL ABSCESS
|
2.9%
1/34 • Number of events 1 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
0.00%
0/64 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
0.00%
0/4 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
|
Injury, poisoning and procedural complications
LIGAMENT RUPTURE
|
2.9%
1/34 • Number of events 1 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
0.00%
0/64 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
0.00%
0/4 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
|
Injury, poisoning and procedural complications
MENISCUS LESION
|
2.9%
1/34 • Number of events 1 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
0.00%
0/64 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
0.00%
0/4 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
|
Injury, poisoning and procedural complications
OVERDOSE
|
2.9%
1/34 • Number of events 1 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
0.00%
0/64 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
0.00%
0/4 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
|
Metabolism and nutrition disorders
LACTIC ACIDOSIS
|
2.9%
1/34 • Number of events 1 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
0.00%
0/64 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
0.00%
0/4 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.00%
0/34 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
1.6%
1/64 • Number of events 1 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
0.00%
0/4 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
|
Nervous system disorders
SYNCOPE
|
0.00%
0/34 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
1.6%
1/64 • Number of events 1 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
0.00%
0/4 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
|
Psychiatric disorders
DEPRESSION
|
0.00%
0/34 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
1.6%
1/64 • Number of events 1 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
0.00%
0/4 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
|
Psychiatric disorders
SUICIDE ATTEMPT
|
0.00%
0/34 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
1.6%
1/64 • Number of events 1 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
0.00%
0/4 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
|
Renal and urinary disorders
RENAL FAILURE
|
2.9%
1/34 • Number of events 1 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
0.00%
0/64 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
0.00%
0/4 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
|
Renal and urinary disorders
RENAL FAILURE ACUTE
|
0.00%
0/34 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
1.6%
1/64 • Number of events 1 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
0.00%
0/4 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.00%
0/34 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
3.1%
2/64 • Number of events 2 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
0.00%
0/4 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY HYPERTENSION
|
0.00%
0/34 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
1.6%
1/64 • Number of events 1 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
0.00%
0/4 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
2.9%
1/34 • Number of events 1 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
0.00%
0/64 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
0.00%
0/4 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
|
Surgical and medical procedures
CHOLECYSTECTOMY
|
2.9%
1/34 • Number of events 1 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
0.00%
0/64 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
0.00%
0/4 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.00%
0/34 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
1.6%
1/64 • Number of events 1 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
0.00%
0/4 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
Other adverse events
| Measure |
PegIFN-2b+RBV
n=34 participants at risk
PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600-1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by placebo to boceprevir plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up (Control Arm). Participants who do not achieve HCV-RNA \<9.3 IU/mL by Treatment Week 24 (TW24) are eligible to cross-over and receive boceprevir along with the PegIFN-2b and RBV for up to 44 weeks.
|
PegIFN-2b+RBV+Boceprevir
n=64 participants at risk
PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600- 1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by boceprevir (800 mg, orally, 3 times per day) plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up.
|
Boceprevir Crossover
n=4 participants at risk
(After Treatment Week 24) PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600- 1400 mg/day, orally, divided into two daily doses) plus boceprevir (800 mg, orally, 3 times per day) for up to 44 weeks with 24 weeks post-treatment follow-up.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
23.5%
8/34 • Number of events 8 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
40.6%
26/64 • Number of events 40 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
50.0%
2/4 • Number of events 2 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
5.9%
2/34 • Number of events 2 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
18.8%
12/64 • Number of events 14 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
0.00%
0/34 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
7.8%
5/64 • Number of events 5 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
|
Cardiac disorders
PALPITATIONS
|
0.00%
0/34 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
3.1%
2/64 • Number of events 2 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
|
Congenital, familial and genetic disorders
PORPHYRIA
|
0.00%
0/34 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
0.00%
0/64 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
|
Eye disorders
DRY EYE
|
5.9%
2/34 • Number of events 2 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
3.1%
2/64 • Number of events 3 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
0.00%
0/4 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
|
Gastrointestinal disorders
ABDOMINAL DISCOMFORT
|
0.00%
0/34 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
3.1%
2/64 • Number of events 2 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
8.8%
3/34 • Number of events 3 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
4.7%
3/64 • Number of events 3 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
0.00%
0/4 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
2.9%
1/34 • Number of events 1 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
9.4%
6/64 • Number of events 7 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
0.00%
0/4 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
|
Gastrointestinal disorders
APHTHOUS STOMATITIS
|
0.00%
0/34 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
9.4%
6/64 • Number of events 6 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
0.00%
0/4 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
|
Gastrointestinal disorders
CHEILITIS
|
5.9%
2/34 • Number of events 2 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
7.8%
5/64 • Number of events 6 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
|
Gastrointestinal disorders
CONSTIPATION
|
14.7%
5/34 • Number of events 5 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
6.2%
4/64 • Number of events 4 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
|
Gastrointestinal disorders
DIARRHOEA
|
17.6%
6/34 • Number of events 8 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
32.8%
21/64 • Number of events 30 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
0.00%
0/4 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
|
Gastrointestinal disorders
DRY MOUTH
|
0.00%
0/34 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
7.8%
5/64 • Number of events 5 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
0.00%
0/4 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
|
Gastrointestinal disorders
NAUSEA
|
32.4%
11/34 • Number of events 12 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
40.6%
26/64 • Number of events 37 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
|
Gastrointestinal disorders
ORAL PAIN
|
0.00%
0/34 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
6.2%
4/64 • Number of events 4 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
0.00%
0/4 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
|
Gastrointestinal disorders
RECTAL HAEMORRHAGE
|
0.00%
0/34 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
0.00%
0/64 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
|
Gastrointestinal disorders
TONGUE DISCOLOURATION
|
5.9%
2/34 • Number of events 2 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
0.00%
0/64 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
0.00%
0/4 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
|
Gastrointestinal disorders
VOMITING
|
14.7%
5/34 • Number of events 9 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
28.1%
18/64 • Number of events 23 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
0.00%
0/4 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
|
General disorders
ASTHENIA
|
26.5%
9/34 • Number of events 9 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
34.4%
22/64 • Number of events 30 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
50.0%
2/4 • Number of events 2 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
|
General disorders
CHILLS
|
14.7%
5/34 • Number of events 5 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
7.8%
5/64 • Number of events 5 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
0.00%
0/4 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
|
General disorders
FATIGUE
|
35.3%
12/34 • Number of events 15 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
39.1%
25/64 • Number of events 35 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
0.00%
0/4 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
38.2%
13/34 • Number of events 29 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
25.0%
16/64 • Number of events 24 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
0.00%
0/4 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
|
General disorders
INJECTION SITE ERYTHEMA
|
2.9%
1/34 • Number of events 1 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
6.2%
4/64 • Number of events 4 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
0.00%
0/4 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
|
General disorders
IRRITABILITY
|
14.7%
5/34 • Number of events 5 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
15.6%
10/64 • Number of events 11 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
|
General disorders
MALAISE
|
5.9%
2/34 • Number of events 2 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
4.7%
3/64 • Number of events 3 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
0.00%
0/4 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
|
General disorders
OEDEMA PERIPHERAL
|
5.9%
2/34 • Number of events 2 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
4.7%
3/64 • Number of events 3 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
0.00%
0/4 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
|
General disorders
PAIN
|
2.9%
1/34 • Number of events 1 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
7.8%
5/64 • Number of events 5 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
0.00%
0/4 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
|
General disorders
PYREXIA
|
20.6%
7/34 • Number of events 13 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
37.5%
24/64 • Number of events 60 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
|
Infections and infestations
FOLLICULITIS
|
5.9%
2/34 • Number of events 2 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
0.00%
0/64 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
0.00%
0/4 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
|
Infections and infestations
GINGIVAL ABSCESS
|
0.00%
0/34 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
0.00%
0/64 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
|
Infections and infestations
INFLUENZA
|
11.8%
4/34 • Number of events 5 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
9.4%
6/64 • Number of events 7 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
0.00%
0/4 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
|
Infections and infestations
NASOPHARYNGITIS
|
11.8%
4/34 • Number of events 4 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
7.8%
5/64 • Number of events 5 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
0.00%
0/4 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
|
Infections and infestations
ORAL CANDIDIASIS
|
5.9%
2/34 • Number of events 2 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
4.7%
3/64 • Number of events 5 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
0.00%
0/4 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION
|
2.9%
1/34 • Number of events 1 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
3.1%
2/64 • Number of events 3 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
|
Infections and infestations
SINUSITIS
|
0.00%
0/34 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
7.8%
5/64 • Number of events 6 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
5.9%
2/34 • Number of events 2 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
1.6%
1/64 • Number of events 1 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
0.00%
0/4 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
5.9%
2/34 • Number of events 2 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
4.7%
3/64 • Number of events 3 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
0.00%
0/4 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
|
Investigations
GAMMA-GLUTAMYLTRANSFERASE INCREASED
|
5.9%
2/34 • Number of events 2 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
0.00%
0/64 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
0.00%
0/4 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
|
Investigations
TRANSAMINASES INCREASED
|
5.9%
2/34 • Number of events 2 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
0.00%
0/64 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
0.00%
0/4 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
|
Investigations
WEIGHT DECREASED
|
2.9%
1/34 • Number of events 1 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
12.5%
8/64 • Number of events 9 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
0.00%
0/4 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
17.6%
6/34 • Number of events 6 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
34.4%
22/64 • Number of events 22 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
0.00%
0/4 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
|
Metabolism and nutrition disorders
HYPERTRIGLYCERIDAEMIA
|
5.9%
2/34 • Number of events 2 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
3.1%
2/64 • Number of events 3 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
5.9%
2/34 • Number of events 2 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
10.9%
7/64 • Number of events 7 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
0.00%
0/4 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
17.6%
6/34 • Number of events 7 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
14.1%
9/64 • Number of events 12 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
0.00%
0/4 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
5.9%
2/34 • Number of events 2 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
3.1%
2/64 • Number of events 2 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
0.00%
0/4 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
5.9%
2/34 • Number of events 2 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
4.7%
3/64 • Number of events 3 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
0.00%
0/4 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
|
Nervous system disorders
DIZZINESS
|
5.9%
2/34 • Number of events 2 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
12.5%
8/64 • Number of events 9 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
|
Nervous system disorders
DYSGEUSIA
|
14.7%
5/34 • Number of events 5 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
28.1%
18/64 • Number of events 18 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
50.0%
2/4 • Number of events 2 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
|
Nervous system disorders
HEADACHE
|
17.6%
6/34 • Number of events 6 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
28.1%
18/64 • Number of events 63 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
0.00%
0/4 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
|
Nervous system disorders
PARAESTHESIA
|
5.9%
2/34 • Number of events 2 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
3.1%
2/64 • Number of events 2 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
0.00%
0/4 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
|
Nervous system disorders
SOMNOLENCE
|
2.9%
1/34 • Number of events 1 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
0.00%
0/64 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
|
Pregnancy, puerperium and perinatal conditions
PREGNANCY
|
0.00%
0/34 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
0.00%
0/64 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
|
Psychiatric disorders
AFFECT LABILITY
|
5.9%
2/34 • Number of events 2 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
1.6%
1/64 • Number of events 1 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
|
Psychiatric disorders
ANXIETY
|
14.7%
5/34 • Number of events 8 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
15.6%
10/64 • Number of events 11 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
0.00%
0/4 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
|
Psychiatric disorders
APATHY
|
2.9%
1/34 • Number of events 1 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
0.00%
0/64 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
|
Psychiatric disorders
DEPRESSED MOOD
|
2.9%
1/34 • Number of events 2 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
1.6%
1/64 • Number of events 1 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
|
Psychiatric disorders
DEPRESSION
|
11.8%
4/34 • Number of events 4 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
17.2%
11/64 • Number of events 11 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
0.00%
0/4 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
|
Psychiatric disorders
DRUG ABUSE
|
5.9%
2/34 • Number of events 2 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
0.00%
0/64 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
0.00%
0/4 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
|
Psychiatric disorders
INSOMNIA
|
26.5%
9/34 • Number of events 12 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
23.4%
15/64 • Number of events 17 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
0.00%
0/4 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
|
Psychiatric disorders
NERVOUSNESS
|
2.9%
1/34 • Number of events 1 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
1.6%
1/64 • Number of events 1 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
|
Psychiatric disorders
SLEEP DISORDER
|
2.9%
1/34 • Number of events 1 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
7.8%
5/64 • Number of events 5 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
0.00%
0/4 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
|
Reproductive system and breast disorders
METRORRHAGIA
|
5.9%
2/34 • Number of events 2 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
0.00%
0/64 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
0.00%
0/4 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
17.6%
6/34 • Number of events 6 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
14.1%
9/64 • Number of events 10 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
0.00%
0/4 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
5.9%
2/34 • Number of events 2 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
7.8%
5/64 • Number of events 5 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
0.00%
0/4 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA EXERTIONAL
|
5.9%
2/34 • Number of events 2 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
7.8%
5/64 • Number of events 5 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
0.00%
0/4 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
5.9%
2/34 • Number of events 2 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
7.8%
5/64 • Number of events 7 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
0.00%
0/4 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
|
Respiratory, thoracic and mediastinal disorders
PRODUCTIVE COUGH
|
5.9%
2/34 • Number of events 2 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
0.00%
0/64 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
0.00%
0/4 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
17.6%
6/34 • Number of events 6 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
18.8%
12/64 • Number of events 12 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
0.00%
0/4 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
8.8%
3/34 • Number of events 4 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
12.5%
8/64 • Number of events 11 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
0.00%
0/4 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
2.9%
1/34 • Number of events 1 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
6.2%
4/64 • Number of events 4 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
0.00%
0/4 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
8.8%
3/34 • Number of events 4 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
20.3%
13/64 • Number of events 16 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
|
Skin and subcutaneous tissue disorders
RASH
|
0.00%
0/34 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
7.8%
5/64 • Number of events 5 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
0.00%
0/4 • Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug. Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Investigator must provide to the sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication (including, without limitation, slides and texts of oral or other public presentations and texts of any transmission through any electronic media, eg, any computer access system such as the Internet, World Wide Web, etc.) that report any results of the trial. The sponsor shall have the right to review and comment.
- Publication restrictions are in place
Restriction type: OTHER