Trial Outcomes & Findings for A Study of Peginterferon Alfa-2a (Pegasys) When Administered in Combination With Ribavirin in Patients With Chronic Hepatitis C (CHC) (NCT NCT02641379)
NCT ID: NCT02641379
Last Updated: 2016-08-04
Results Overview
Relapse rate (RR) was defined as the percentage of participants with non-detectable HCV RNA (\< 100 copies/ml) at the end of treatment and detectable HCV RNA at the end of follow-up. End of treatment was defined as Week 48 for Group A and Week 72 for Group B, respectively. The end of follow-up was defined as Week 72 for Group A and Week 96 for Group B, respectively. Relapse rate for treatment Groups A and B, stratified for genotype (Genotype I and Genotype IV) and Week 4 response (\< 600 units/milliliter \[U/ml\] and \>= 600 U/ml) is presented.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
737 participants
Primary outcome timeframe
Up to Week 96
Results posted on
2016-08-04
Participant Flow
This study was conducted in 2 parts. Part 1 was conducted from 16 May 2003 to 12 September 2008 at 21 centers in Austria; Part 2 of this study was conducted from 19 October 2009 to 15 November 2013 at 15 centers in Austria.
A total of 545 participants were enrolled in Part 1, of which 5 participants were treated but were not included in any analysis population due to a missing post-baseline safety assessment. A total of 176 participants were enrolled in Part 2 of this study.
Participant milestones
| Measure |
PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1)
Eligible participants received pegylated interferon alpha-2a (PEG-IFN alfa-2a) at a dose of 180 microgram (mcg) subcutaneously (SC) once weekly for a total of 48 weeks and ribavirin at a dose of 1,000 milligram/day (mg/day) \[for participants with a body weight \</= 75 kilogram (kg)\] or 1,200 mg/day (for participants with a body weight \> 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A based on the presence of an early virological response (EVR) defined as non-detectable serum hepatitis C virus ribonucleic acid (HCV RNA) \[\< 600 international units/milliliter (IU/ml)\] by quantitative polymerase chain reaction (PCR) or a 2-log10 decrease or greater compared to baseline serum HCV RNA, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
|
PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1)
Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight \</= 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally for a total of 72 weeks. After Week 48, participants were administered a lower dose of PEG-IFN alfa-2a of 135 mcg/week until Week 72. Participants were randomized to Group B based on the presence of an EVR defined as non-detectable serum HCV RNA (\< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline in serum HCV RNA by quantitative PCR, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
|
PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 1)
Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight \</= 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally; initially for 24 weeks. Participants without an EVR at Week 12 (\< 2-log10 decrease in HCV RNA as compared with baseline) were assigned to Group C and received treatment until Week 24. If HCV RNA became non-detectable at Week 24 then treatment was continued for a total of 72 weeks. Participants were administered a lower dose of PEG-IFN alfa-2a after Week 48 (135 mcg/week, until Week 72). Participants with detectable HCV RNA (≥ 50 IU/ml) at Week 24 were required to discontinue treatment. Participants had a treatment-free follow-up period of 24 weeks.
|
PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 1)
Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight \</= 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally for a total of 24 weeks. Participants with a rapid virological response (RVR) at Week 4 of treatment \[HCV RNA level, \<50 IU/ml by qualitative PCR assay, COBAS Amplicor HCV Test, version 2.0\] were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks.
|
PEG-IFN Alfa-2a + Ribavirin (Not Randomized) (Part 1)
Eligible participants who were not randomized to any treatment group in Part 1 of the study were included in this group. These participants were a part of the safety analysis population which included participants who received at least on dose of (either) the study drug (PEG-IFN alfa-2a and/or ribavirin) and had at least one post-baseline safety assessment.
|
PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A1) (Part 2)
Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight \</= 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A1 if they showed positive HCV RNA level (≥ 15 IU/ml, TaqMan® HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or \> 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
|
PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B1) (Part 2)
Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 72 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight \</= 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally for a total of 72 weeks. Participants were randomized to Group B1 if they showed positive HCV RNA level (≥ 15 IU/ml, TaqMan® HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or \> 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
|
PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 2)
Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight \</= 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally; initially for 24 weeks. Participants without a \> 2-log10 drop of HCV RNA level at Week 12 were assigned to Group C (Part 2). For participants who were HCV RNA-positive at Week 24, treatment was stopped. For participants who were negative for HCV RNA at Week 24, treatment was continued for a total of 72 weeks. Participants had a treatment-free follow-up period of 24 weeks.
|
PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 2)
Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight \</= 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally for a total of 24 weeks. Participants with a negative HCV-RNA level at Week 4 (\< 15 IU/ml, TaqMan HCV Test) were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks.
|
PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2)
Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dosage of 1,000 mg/day (for participants with a body weight ≤ 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally for a total of 48 weeks. Participants with a positive HCV RNA level at Week 4 (≥ 15 IU/ml, TaqMan HCV Test) and negative HCV RNA level at Week 8 (≤ 15 IU/ml, TaqMan HCV Test) were assigned to Group E. Participants had a treatment-free follow-up period of 24 weeks.
|
PEG-IFN Alfa-2a + Ribavirin (Not Assigned) (Part 2)
Eligible participants who were not assigned to any treatment group in Part 2 were included in this group. These participants were a part of the safety analysis population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a and/or ribavirin) and had at least one post-baseline safety assessment.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
142
|
152
|
78
|
156
|
17
|
36
|
25
|
20
|
42
|
45
|
8
|
|
Overall Study
COMPLETED
|
107
|
101
|
7
|
139
|
0
|
20
|
12
|
1
|
36
|
36
|
0
|
|
Overall Study
NOT COMPLETED
|
35
|
51
|
71
|
17
|
17
|
16
|
13
|
19
|
6
|
9
|
8
|
Reasons for withdrawal
| Measure |
PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1)
Eligible participants received pegylated interferon alpha-2a (PEG-IFN alfa-2a) at a dose of 180 microgram (mcg) subcutaneously (SC) once weekly for a total of 48 weeks and ribavirin at a dose of 1,000 milligram/day (mg/day) \[for participants with a body weight \</= 75 kilogram (kg)\] or 1,200 mg/day (for participants with a body weight \> 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A based on the presence of an early virological response (EVR) defined as non-detectable serum hepatitis C virus ribonucleic acid (HCV RNA) \[\< 600 international units/milliliter (IU/ml)\] by quantitative polymerase chain reaction (PCR) or a 2-log10 decrease or greater compared to baseline serum HCV RNA, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
|
PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1)
Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight \</= 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally for a total of 72 weeks. After Week 48, participants were administered a lower dose of PEG-IFN alfa-2a of 135 mcg/week until Week 72. Participants were randomized to Group B based on the presence of an EVR defined as non-detectable serum HCV RNA (\< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline in serum HCV RNA by quantitative PCR, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
|
PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 1)
Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight \</= 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally; initially for 24 weeks. Participants without an EVR at Week 12 (\< 2-log10 decrease in HCV RNA as compared with baseline) were assigned to Group C and received treatment until Week 24. If HCV RNA became non-detectable at Week 24 then treatment was continued for a total of 72 weeks. Participants were administered a lower dose of PEG-IFN alfa-2a after Week 48 (135 mcg/week, until Week 72). Participants with detectable HCV RNA (≥ 50 IU/ml) at Week 24 were required to discontinue treatment. Participants had a treatment-free follow-up period of 24 weeks.
|
PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 1)
Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight \</= 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally for a total of 24 weeks. Participants with a rapid virological response (RVR) at Week 4 of treatment \[HCV RNA level, \<50 IU/ml by qualitative PCR assay, COBAS Amplicor HCV Test, version 2.0\] were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks.
|
PEG-IFN Alfa-2a + Ribavirin (Not Randomized) (Part 1)
Eligible participants who were not randomized to any treatment group in Part 1 of the study were included in this group. These participants were a part of the safety analysis population which included participants who received at least on dose of (either) the study drug (PEG-IFN alfa-2a and/or ribavirin) and had at least one post-baseline safety assessment.
|
PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A1) (Part 2)
Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight \</= 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A1 if they showed positive HCV RNA level (≥ 15 IU/ml, TaqMan® HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or \> 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
|
PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B1) (Part 2)
Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 72 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight \</= 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally for a total of 72 weeks. Participants were randomized to Group B1 if they showed positive HCV RNA level (≥ 15 IU/ml, TaqMan® HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or \> 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
|
PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 2)
Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight \</= 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally; initially for 24 weeks. Participants without a \> 2-log10 drop of HCV RNA level at Week 12 were assigned to Group C (Part 2). For participants who were HCV RNA-positive at Week 24, treatment was stopped. For participants who were negative for HCV RNA at Week 24, treatment was continued for a total of 72 weeks. Participants had a treatment-free follow-up period of 24 weeks.
|
PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 2)
Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight \</= 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally for a total of 24 weeks. Participants with a negative HCV-RNA level at Week 4 (\< 15 IU/ml, TaqMan HCV Test) were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks.
|
PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2)
Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dosage of 1,000 mg/day (for participants with a body weight ≤ 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally for a total of 48 weeks. Participants with a positive HCV RNA level at Week 4 (≥ 15 IU/ml, TaqMan HCV Test) and negative HCV RNA level at Week 8 (≤ 15 IU/ml, TaqMan HCV Test) were assigned to Group E. Participants had a treatment-free follow-up period of 24 weeks.
|
PEG-IFN Alfa-2a + Ribavirin (Not Assigned) (Part 2)
Eligible participants who were not assigned to any treatment group in Part 2 were included in this group. These participants were a part of the safety analysis population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a and/or ribavirin) and had at least one post-baseline safety assessment.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Exclusion criterion during screening
|
1
|
0
|
0
|
1
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal of informed consent
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Adverse Event
|
7
|
8
|
2
|
2
|
5
|
1
|
5
|
0
|
1
|
1
|
5
|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
2
|
0
|
0
|
2
|
0
|
5
|
0
|
0
|
0
|
|
Overall Study
Participant unable to attend study visit
|
4
|
10
|
1
|
2
|
5
|
1
|
1
|
1
|
0
|
2
|
0
|
|
Overall Study
Participant's compliance
|
0
|
1
|
0
|
1
|
0
|
2
|
0
|
0
|
1
|
1
|
1
|
|
Overall Study
Participant cannot be reached
|
4
|
4
|
0
|
8
|
2
|
1
|
0
|
1
|
0
|
2
|
1
|
|
Overall Study
PCR positive at Week 24
|
15
|
21
|
62
|
0
|
0
|
6
|
3
|
8
|
0
|
1
|
0
|
|
Overall Study
PCR positive at follow up 2
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Participant showed relapse
|
1
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Participant stopped study/treatment
|
1
|
3
|
1
|
0
|
0
|
1
|
2
|
0
|
1
|
0
|
0
|
|
Overall Study
Therapy stopped due to misunderstanding
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Financial problems
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
PCR positive at Week 68
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
PCR positive at Week 48
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
PCR not performed at Week 12
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
No PCR at baseline
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
PCR positive at Week 28
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
PCR sample for Week 4 not drawn
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Inclusion criteria not fulfilled
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Baseline viral load unavailable
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Blood could not be drawn
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Participation in sili rescue study
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Source data not found
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Participant showed weight reduction
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Non-response Week 12
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
No 2 Log drop at Week 12
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Negative PCR result
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Participant's PCR high
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Participant treated after Week 24
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Missing PCR result at Week 8
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
PCR positive
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Study of Peginterferon Alfa-2a (Pegasys) When Administered in Combination With Ribavirin in Patients With Chronic Hepatitis C (CHC)
Baseline characteristics by cohort
| Measure |
PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1)
n=142 Participants
Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and ribavirin at a dose of 1,000 mg/day (for participants with a body weight \</= 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A based on the presence of an EVR defined as non-detectable serum HCV RNA (\< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline serum HCV RNA, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
|
PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1)
n=152 Participants
Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight \</= 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally for a total of 72 weeks. After Week 48, participants were administered a lower dose of PEG-IFN alfa-2a of 135 mcg/week until Week 72. Participants were randomized to Group B based on the presence of an EVR defined as non-detectable serum HCV RNA (\< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline in serum HCV RNA by quantitative PCR, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
|
PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 1)
n=78 Participants
Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight \</= 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally; initially for 24 weeks. Participants without an EVR at Week 12 (\< 2-log10 decrease in HCV RNA as compared with baseline) were assigned to Group C and received treatment until Week 24. If HCV RNA became non-detectable at Week 24 then treatment was continued for a total of 72 weeks. Participants were administered a lower dose of PEG-IFN alfa-2a after Week 48 (135 mcg/week, until Week 72). Participants with detectable HCV RNA (\>= 50 IU/ml) at Week 24 were required to discontinue treatment. Participants had a treatment-free follow-up period of 24 weeks.
|
PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 1)
n=156 Participants
Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight \</= 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally for a total of 24 weeks. Participants with a RVR at Week 4 of treatment \[HCV RNA level, \<50 IU/ml by qualitative PCR assay, COBAS Amplicor HCV Test, version 2.0\] were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks.
|
PEG-IFN Alfa-2a + Ribavirin (Not Randomized) (Part 1)
n=12 Participants
Eligible participants who were not randomized to any treatment group in Part 1 of the study were included in this group. These participants were a part of the safety analysis population which included participants who received at least on dose of (either) the study drug (PEG-IFN alfa-2a and/or ribavirin) and had at least one post-baseline safety assessment.
|
PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A1) (Part 2)
n=36 Participants
Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight \</= 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A1 if they showed positive HCV RNA level (\>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or \> 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
|
PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B1) (Part 2)
n=25 Participants
Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 72 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight \</= 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally for a total of 72 weeks. Participants were randomized to Group B1 if they showed positive HCV RNA level (\>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or \> 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
|
PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 2)
n=20 Participants
Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight \</= 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally; initially for 24 weeks. Participants without a \> 2-log10 drop of HCV RNA level at Week 12 were assigned to Group C (Part 2). For participants who were HCV RNA-positive at Week 24, treatment was stopped. For participants who were negative for HCV RNA at Week 24, treatment was continued for a total of 72 weeks. Participants had a treatment-free follow-up period of 24 weeks.
|
PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 2)
n=42 Participants
Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight \</= 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally for a total of 24 weeks. Participants with a negative HCV-RNA level at Week 4 (\< 15 IU/ml, TaqMan HCV Test) were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks.
|
PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2)
n=45 Participants
Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dosage of 1,000 mg/day (for participants with a body weight \</= 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally for a total of 48 weeks. Participants with a positive HCV RNA level at Week 4 (\>/= 15 IU/ml, TaqMan HCV Test) and negative HCV RNA level at Week 8 (\</= 15 IU/ml, TaqMan HCV Test) were assigned to Group E. Participants had a treatment-free follow-up period of 24 weeks.
|
PEG-IFN Alfa-2a + Ribavirin (Not Assigned) (Part 2)
n=8 Participants
Eligible participants who were not assigned to any treatment group in Part 2 were included in this group. These participants were a part of the safety analysis population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a and/or ribavirin) and had at least one post-baseline safety assessment.
|
Total
n=716 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
45.0 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
44.2 years
STANDARD_DEVIATION 10.2 • n=7 Participants
|
46.6 years
STANDARD_DEVIATION 9.0 • n=5 Participants
|
40.5 years
STANDARD_DEVIATION 11.7 • n=4 Participants
|
46.5 years
STANDARD_DEVIATION 9.5 • n=21 Participants
|
44.6 years
STANDARD_DEVIATION 9.1 • n=8 Participants
|
47.3 years
STANDARD_DEVIATION 9.8 • n=8 Participants
|
46.6 years
STANDARD_DEVIATION 8.7 • n=24 Participants
|
37.8 years
STANDARD_DEVIATION 11.1 • n=42 Participants
|
41.1 years
STANDARD_DEVIATION 10.2 • n=42 Participants
|
43.6 years
STANDARD_DEVIATION 15.4 • n=42 Participants
|
43.5 years
STANDARD_DEVIATION 10.78 • n=42 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
57 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
5 Participants
n=24 Participants
|
17 Participants
n=42 Participants
|
20 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
246 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
92 Participants
n=5 Participants
|
99 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
99 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
28 Participants
n=8 Participants
|
17 Participants
n=8 Participants
|
15 Participants
n=24 Participants
|
25 Participants
n=42 Participants
|
25 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
470 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Up to Week 96Population: The ITT population included all participants randomized and allocated to receive treatments. Here, 'n' = number of participants analyzed according to genotype and Week 4 response.
Relapse rate (RR) was defined as the percentage of participants with non-detectable HCV RNA (\< 100 copies/ml) at the end of treatment and detectable HCV RNA at the end of follow-up. End of treatment was defined as Week 48 for Group A and Week 72 for Group B, respectively. The end of follow-up was defined as Week 72 for Group A and Week 96 for Group B, respectively. Relapse rate for treatment Groups A and B, stratified for genotype (Genotype I and Genotype IV) and Week 4 response (\< 600 units/milliliter \[U/ml\] and \>= 600 U/ml) is presented.
Outcome measures
| Measure |
PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1)
n=142 Participants
Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and ribavirin at a dose of 1,000 mg/day (for participants with a body weight \</= 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A based on the presence of an EVR defined as non-detectable serum HCV RNA (\< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline serum HCV RNA, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
|
PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1)
n=152 Participants
Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight \</= 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally for a total of 72 weeks. After Week 48, participants were administered a lower dose of PEG-IFN alfa-2a of 135 mcg/week until Week 72. Participants were randomized to Group B based on the presence of an EVR defined as non-detectable serum HCV RNA (\< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline in serum HCV RNA by quantitative PCR, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
|
PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2)
Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dosage of 1,000 mg/day (for participants with a body weight ≤ 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally for a total of 48 weeks. Participants with a positive HCV RNA level at Week 4 (≥ 15 IU/ml) and negative HCV RNA level at Week 8 (≤ 15 IU/ml) were assigned to group E. Participants had a treatment-free follow-up period of 24 weeks.
|
PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 1)
Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight \</= 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally for a total of 24 weeks. Participants with a RVR at Week 4 of treatment \[HCV RNA level, \<50 IU/ml by qualitative PCR assay, COBAS Amplicor HCV Test, version 2.0\] were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks.
|
PEG-IFN Alfa-2a + Ribavirin (Not Randomized) (Part 1)
Eligible participants who were not randomized to any treatment group in Part 1 of the study were included in this group. These participants were a part of the safety analysis population which included participants who received at least on dose of (either) the study drug (PEG-IFN alfa-2a and/or ribavirin) and had at least one post-baseline safety assessment.
|
PEG-IFN Alfa-2a + Ribavirin (Not Assigned) (Part 2)
Eligible participants who were not assigned to any treatment group in Part 2 were included in this group. These participants were a part of the safety analysis population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a and/or ribavirin) and had at least one post-baseline safety assessment.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Relapse Rate in Groups A and B by Genotype at the End of Follow-up (Part 1)
Genotype I, Week 4 response < 600 U/ml,n= 130, 136
|
22.0 Percentage of participants
Interval 10.6 to 37.6
|
8.3 Percentage of participants
Interval 1.8 to 22.5
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Relapse Rate in Groups A and B by Genotype at the End of Follow-up (Part 1)
Genotype I,Week 4 response >=600 U/ml, n =130, 136
|
52.7 Percentage of participants
Interval 38.8 to 66.3
|
30.0 Percentage of participants
Interval 17.9 to 44.6
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Relapse Rate in Groups A and B by Genotype at the End of Follow-up (Part 1)
Genotype IV, Week 4 response < 600 U/ml, n =12, 16
|
0.0 Percentage of participants
Interval 0.0 to 52.2
|
42.9 Percentage of participants
Interval 9.9 to 81.6
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Relapse Rate in Groups A and B by Genotype at the End of Follow-up (Part 1)
Genotype IV, Week 4 response >=600 U/ml, n =12, 16
|
80.0 Percentage of participants
Interval 28.4 to 99.5
|
80.0 Percentage of participants
Interval 28.4 to 99.5
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Week 96Population: The ITT population included all participants randomized and allocated to receive treatments. Here, 'n' = the number of participants analyzed according to genotype.
The Sustained Virological Response (SVR) was defined as the percentage of participants in each group with non-detectable HCV RNA result at 24 weeks post completion of the treatment period (HCV RNA \< 15 IU/ml at Week 72 of Groups A1 and E, and at Week 96 of Group B1). Participants without a HCV RNA results at this time point were considered as non-responders. The end of follow-up was defined as Week 72 for Groups A1 and E, and Week 96 for Group B1. The SVR for treatment Groups A1 + B1 and E, stratified for genotype (Genotype I and Genotype IV) is presented.
Outcome measures
| Measure |
PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1)
n=33 Participants
Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and ribavirin at a dose of 1,000 mg/day (for participants with a body weight \</= 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A based on the presence of an EVR defined as non-detectable serum HCV RNA (\< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline serum HCV RNA, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
|
PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1)
n=23 Participants
Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight \</= 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally for a total of 72 weeks. After Week 48, participants were administered a lower dose of PEG-IFN alfa-2a of 135 mcg/week until Week 72. Participants were randomized to Group B based on the presence of an EVR defined as non-detectable serum HCV RNA (\< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline in serum HCV RNA by quantitative PCR, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
|
PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2)
n=45 Participants
Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dosage of 1,000 mg/day (for participants with a body weight ≤ 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally for a total of 48 weeks. Participants with a positive HCV RNA level at Week 4 (≥ 15 IU/ml) and negative HCV RNA level at Week 8 (≤ 15 IU/ml) were assigned to group E. Participants had a treatment-free follow-up period of 24 weeks.
|
PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 1)
Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight \</= 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally for a total of 24 weeks. Participants with a RVR at Week 4 of treatment \[HCV RNA level, \<50 IU/ml by qualitative PCR assay, COBAS Amplicor HCV Test, version 2.0\] were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks.
|
PEG-IFN Alfa-2a + Ribavirin (Not Randomized) (Part 1)
Eligible participants who were not randomized to any treatment group in Part 1 of the study were included in this group. These participants were a part of the safety analysis population which included participants who received at least on dose of (either) the study drug (PEG-IFN alfa-2a and/or ribavirin) and had at least one post-baseline safety assessment.
|
PEG-IFN Alfa-2a + Ribavirin (Not Assigned) (Part 2)
Eligible participants who were not assigned to any treatment group in Part 2 were included in this group. These participants were a part of the safety analysis population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a and/or ribavirin) and had at least one post-baseline safety assessment.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Sustained Virological Response in Groups A1, B1, and E by Genotype at the End of Follow-up (Part 2)
Genotype I, n = 33, 23, 39
|
30.3 Percentage of participants
Interval 15.6 to 48.7
|
34.8 Percentage of participants
Interval 16.4 to 57.3
|
64.1 Percentage of participants
Interval 47.2 to 78.8
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Sustained Virological Response in Groups A1, B1, and E by Genotype at the End of Follow-up (Part 2)
Genotype IV, n = 3, 2, 6
|
33.3 Percentage of participants
Interval 0.8 to 90.6
|
0.0 Percentage of participants
Interval 0.0 to 84.2
|
50.0 Percentage of participants
Interval 11.8 to 88.2
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Week 72Population: The ITT population included all participants randomized and allocated to receive treatments.
End of treatment response (ETR) rate was defined as the percentage of participants in each group with non-detectable HCV RNA at completion of the treatment period (HCV negative at Week 24 of Group D, Week 48 of Group A and at Week 72 of Groups B and C). Participants without a HCV RNA results at this time point were considered as non-responders. End of the treatment period was defined as Week 48 for Group A, Week 72 for Groups B and C, and Week 24 for Group D.
Outcome measures
| Measure |
PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1)
n=142 Participants
Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and ribavirin at a dose of 1,000 mg/day (for participants with a body weight \</= 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A based on the presence of an EVR defined as non-detectable serum HCV RNA (\< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline serum HCV RNA, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
|
PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1)
n=152 Participants
Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight \</= 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally for a total of 72 weeks. After Week 48, participants were administered a lower dose of PEG-IFN alfa-2a of 135 mcg/week until Week 72. Participants were randomized to Group B based on the presence of an EVR defined as non-detectable serum HCV RNA (\< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline in serum HCV RNA by quantitative PCR, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
|
PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2)
n=78 Participants
Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dosage of 1,000 mg/day (for participants with a body weight ≤ 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally for a total of 48 weeks. Participants with a positive HCV RNA level at Week 4 (≥ 15 IU/ml) and negative HCV RNA level at Week 8 (≤ 15 IU/ml) were assigned to group E. Participants had a treatment-free follow-up period of 24 weeks.
|
PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 1)
n=156 Participants
Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight \</= 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally for a total of 24 weeks. Participants with a RVR at Week 4 of treatment \[HCV RNA level, \<50 IU/ml by qualitative PCR assay, COBAS Amplicor HCV Test, version 2.0\] were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks.
|
PEG-IFN Alfa-2a + Ribavirin (Not Randomized) (Part 1)
Eligible participants who were not randomized to any treatment group in Part 1 of the study were included in this group. These participants were a part of the safety analysis population which included participants who received at least on dose of (either) the study drug (PEG-IFN alfa-2a and/or ribavirin) and had at least one post-baseline safety assessment.
|
PEG-IFN Alfa-2a + Ribavirin (Not Assigned) (Part 2)
Eligible participants who were not assigned to any treatment group in Part 2 were included in this group. These participants were a part of the safety analysis population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a and/or ribavirin) and had at least one post-baseline safety assessment.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Virological Response Rate in Groups A, B, C, and D at the End of Treatment Period (Part 1)
|
74.6 Percentage of participants
Interval 66.7 to 81.6
|
64.5 Percentage of participants
Interval 56.3 to 72.1
|
9.0 Percentage of participants
Interval 3.7 to 17.6
|
92.3 Percentage of participants
Interval 86.9 to 96.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Week 96Population: The ITT population included all participants randomized and allocated to receive treatments.
The SVR was defined as the percentage of participants in each group with a non-detectable HCV RNA result at 24 weeks post-completion of the treatment period (HCV RNA \< 15 IU/ml at Week 48 of Group D, at Week 72 of Group A, and at Week 96 of Groups B and C). Participants without a HCV RNA PCR at this time point were considered as non-responders in this calculation. The end of follow-up was defined as Week 72 for Group A, Week 96 for Groups B and C, and Week 48 for Group D.
Outcome measures
| Measure |
PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1)
n=142 Participants
Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and ribavirin at a dose of 1,000 mg/day (for participants with a body weight \</= 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A based on the presence of an EVR defined as non-detectable serum HCV RNA (\< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline serum HCV RNA, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
|
PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1)
n=152 Participants
Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight \</= 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally for a total of 72 weeks. After Week 48, participants were administered a lower dose of PEG-IFN alfa-2a of 135 mcg/week until Week 72. Participants were randomized to Group B based on the presence of an EVR defined as non-detectable serum HCV RNA (\< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline in serum HCV RNA by quantitative PCR, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
|
PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2)
n=78 Participants
Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dosage of 1,000 mg/day (for participants with a body weight ≤ 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally for a total of 48 weeks. Participants with a positive HCV RNA level at Week 4 (≥ 15 IU/ml) and negative HCV RNA level at Week 8 (≤ 15 IU/ml) were assigned to group E. Participants had a treatment-free follow-up period of 24 weeks.
|
PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 1)
n=156 Participants
Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight \</= 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally for a total of 24 weeks. Participants with a RVR at Week 4 of treatment \[HCV RNA level, \<50 IU/ml by qualitative PCR assay, COBAS Amplicor HCV Test, version 2.0\] were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks.
|
PEG-IFN Alfa-2a + Ribavirin (Not Randomized) (Part 1)
Eligible participants who were not randomized to any treatment group in Part 1 of the study were included in this group. These participants were a part of the safety analysis population which included participants who received at least on dose of (either) the study drug (PEG-IFN alfa-2a and/or ribavirin) and had at least one post-baseline safety assessment.
|
PEG-IFN Alfa-2a + Ribavirin (Not Assigned) (Part 2)
Eligible participants who were not assigned to any treatment group in Part 2 were included in this group. These participants were a part of the safety analysis population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a and/or ribavirin) and had at least one post-baseline safety assessment.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Sustained Virological Response in Groups A, B, C, and D at the End of Follow-up (Part 1)
|
45.1 Percentage of participants
Interval 36.7 to 53.6
|
48.0 Percentage of participants
Interval 39.9 to 56.3
|
6.4 Percentage of participants
Interval 2.1 to 14.3
|
73.7 Percentage of participants
Interval 66.1 to 80.4
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Week 24, Week 48, Week 72, and Week 96Population: The ITT population included all participants randomized and allocated to receive treatments. Here, 'n' = the number of participants analyzed at a given time point.
The Short Form-36 (SF-36) is a quality of life instrument consisting of a 36-item questionnaire. The SF-36 items were scored and transformed according to the SF-36 Health Survey Manual and Interpretation Guide. Summary scores for SF-36 dimensions (physical functioning, role functioning, bodily pain, general health, vitality, social functioning, mental health, health transition) as well as physical and mental summary measures were compiled after imputation of mean scores for missing items if more than 50% of dimension-related items were available. Scores for health transition ranged from 0 (worst) to 5 (best). Scores for all other dimensions ranged from 0 (worst) to 100 (best). The mean SF-36 scores are presented at Baseline (Day 1), Week 24, Week 48, Week 72 (for Groups A and B) and at Week 96 (for Group B). Lower score indicate worsening.
Outcome measures
| Measure |
PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1)
n=106 Participants
Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and ribavirin at a dose of 1,000 mg/day (for participants with a body weight \</= 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A based on the presence of an EVR defined as non-detectable serum HCV RNA (\< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline serum HCV RNA, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
|
PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1)
n=123 Participants
Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight \</= 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally for a total of 72 weeks. After Week 48, participants were administered a lower dose of PEG-IFN alfa-2a of 135 mcg/week until Week 72. Participants were randomized to Group B based on the presence of an EVR defined as non-detectable serum HCV RNA (\< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline in serum HCV RNA by quantitative PCR, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
|
PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2)
Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dosage of 1,000 mg/day (for participants with a body weight ≤ 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally for a total of 48 weeks. Participants with a positive HCV RNA level at Week 4 (≥ 15 IU/ml) and negative HCV RNA level at Week 8 (≤ 15 IU/ml) were assigned to group E. Participants had a treatment-free follow-up period of 24 weeks.
|
PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 1)
Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight \</= 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally for a total of 24 weeks. Participants with a RVR at Week 4 of treatment \[HCV RNA level, \<50 IU/ml by qualitative PCR assay, COBAS Amplicor HCV Test, version 2.0\] were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks.
|
PEG-IFN Alfa-2a + Ribavirin (Not Randomized) (Part 1)
Eligible participants who were not randomized to any treatment group in Part 1 of the study were included in this group. These participants were a part of the safety analysis population which included participants who received at least on dose of (either) the study drug (PEG-IFN alfa-2a and/or ribavirin) and had at least one post-baseline safety assessment.
|
PEG-IFN Alfa-2a + Ribavirin (Not Assigned) (Part 2)
Eligible participants who were not assigned to any treatment group in Part 2 were included in this group. These participants were a part of the safety analysis population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a and/or ribavirin) and had at least one post-baseline safety assessment.
|
|---|---|---|---|---|---|---|
|
Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1)
Role Functioning - Physical, Week 96, n = 0, 58
|
NA scores on a scale
Standard Deviation NA
No participants were available for analysis in this arm at Week 96.
|
84.5 scores on a scale
Standard Deviation 29.9
|
—
|
—
|
—
|
—
|
|
Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1)
Bodily Pain, Baseline, n = 103, 120
|
82.3 scores on a scale
Standard Deviation 22.5
|
83.5 scores on a scale
Standard Deviation 22.9
|
—
|
—
|
—
|
—
|
|
Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1)
Bodily Pain, Week 72, n = 64, 70
|
85.4 scores on a scale
Standard Deviation 23.2
|
67.3 scores on a scale
Standard Deviation 29.3
|
—
|
—
|
—
|
—
|
|
Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1)
Bodily Pain, Week 96, n = 0, 61
|
NA scores on a scale
Standard Deviation NA
No participants were available for analysis in this arm at Week 96.
|
90.2 scores on a scale
Standard Deviation 19.8
|
—
|
—
|
—
|
—
|
|
Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1)
General Health, Baseline, n = 102, 119
|
64.5 scores on a scale
Standard Deviation 17.9
|
66.3 scores on a scale
Standard Deviation 19.7
|
—
|
—
|
—
|
—
|
|
Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1)
General Health, Week 24, n = 75, 83
|
58.9 scores on a scale
Standard Deviation 19.0
|
55.1 scores on a scale
Standard Deviation 22.8
|
—
|
—
|
—
|
—
|
|
Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1)
General Health, Week 48, n = 63, 74
|
58.1 scores on a scale
Standard Deviation 20.2
|
56.3 scores on a scale
Standard Deviation 19.2
|
—
|
—
|
—
|
—
|
|
Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1)
General Health, Week 72, n = 65, 62
|
71.7 scores on a scale
Standard Deviation 18.8
|
60.1 scores on a scale
Standard Deviation 19.3
|
—
|
—
|
—
|
—
|
|
Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1)
General Health, Week 96, n = 0, 59
|
NA scores on a scale
Standard Deviation NA
No participants were available for analysis in this arm at Week 96.
|
70.3 scores on a scale
Standard Deviation 18.5
|
—
|
—
|
—
|
—
|
|
Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1)
Vitality, Baseline, n = 103, 116
|
56.8 scores on a scale
Standard Deviation 20.9
|
58.9 scores on a scale
Standard Deviation 22.5
|
—
|
—
|
—
|
—
|
|
Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1)
Vitality, Week 24, n = 75, 88
|
40.3 scores on a scale
Standard Deviation 24.0
|
40.6 scores on a scale
Standard Deviation 23.6
|
—
|
—
|
—
|
—
|
|
Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1)
Vitality, Week 48, n = 66, 77
|
40.6 scores on a scale
Standard Deviation 23.8
|
41.2 scores on a scale
Standard Deviation 21.2
|
—
|
—
|
—
|
—
|
|
Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1)
Vitality, Week 72, n = 63, 67
|
66.9 scores on a scale
Standard Deviation 18.9
|
43.5 scores on a scale
Standard Deviation 22.4
|
—
|
—
|
—
|
—
|
|
Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1)
Vitality, Week 96, n = 0, 59
|
NA scores on a scale
Standard Deviation NA
No participants were available for analysis in this arm at Week 96.
|
62.9 scores on a scale
Standard Deviation 21.1
|
—
|
—
|
—
|
—
|
|
Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1)
Social Functioning, Baseline, n = 105, 121
|
79.8 scores on a scale
Standard Deviation 21.9
|
81.6 scores on a scale
Standard Deviation 22.0
|
—
|
—
|
—
|
—
|
|
Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1)
Social Functioning, Week 24, n = 77, 91
|
64.4 scores on a scale
Standard Deviation 28.5
|
64.1 scores on a scale
Standard Deviation 30.3
|
—
|
—
|
—
|
—
|
|
Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1)
Social Functioning, Week 48, n = 67, 78
|
71.6 scores on a scale
Standard Deviation 24.0
|
57.2 scores on a scale
Standard Deviation 27.5
|
—
|
—
|
—
|
—
|
|
Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1)
Social Functioning, Week 72, n = 65, 70
|
86.3 scores on a scale
Standard Deviation 22.3
|
63.8 scores on a scale
Standard Deviation 29.4
|
—
|
—
|
—
|
—
|
|
Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1)
Social Functioning, Week 96, n = 0, 61
|
NA scores on a scale
Standard Deviation NA
No participants were available for analysis in this arm at Week 96.
|
83.4 scores on a scale
Standard Deviation 23.4
|
—
|
—
|
—
|
—
|
|
Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1)
Role Functioning - Emotional,Baseline,n = 104, 120
|
71.5 scores on a scale
Standard Deviation 39.3
|
75.8 scores on a scale
Standard Deviation 36.6
|
—
|
—
|
—
|
—
|
|
Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1)
Role Functioning - Emotional, Week 24, n = 76, 88
|
36.8 scores on a scale
Standard Deviation 42.4
|
43.9 scores on a scale
Standard Deviation 43.3
|
—
|
—
|
—
|
—
|
|
Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1)
Role Functioning - Emotional, Week 48, n = 66, 74
|
41.7 scores on a scale
Standard Deviation 41.0
|
42.8 scores on a scale
Standard Deviation 42.9
|
—
|
—
|
—
|
—
|
|
Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1)
Role Functioning - Emotional, Week 72, n = 65, 66
|
80.5 scores on a scale
Standard Deviation 32.8
|
43.4 scores on a scale
Standard Deviation 43.4
|
—
|
—
|
—
|
—
|
|
Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1)
Role Functioning - Emotional, Week 96, n = 0, 58
|
NA scores on a scale
Standard Deviation NA
No participants were available for analysis in this arm at Week 96.
|
84.5 scores on a scale
Standard Deviation 31.4
|
—
|
—
|
—
|
—
|
|
Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1)
Mental Health, Baseline, n = 103, 115
|
69.6 scores on a scale
Standard Deviation 18.7
|
71.9 scores on a scale
Standard Deviation 19.1
|
—
|
—
|
—
|
—
|
|
Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1)
Mental Health, Week 24, n = 76, 88
|
60.7 scores on a scale
Standard Deviation 19.3
|
57.9 scores on a scale
Standard Deviation 21.5
|
—
|
—
|
—
|
—
|
|
Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1)
Mental Health, Week 48, n = 66, 77
|
62.6 scores on a scale
Standard Deviation 19.8
|
59.6 scores on a scale
Standard Deviation 20.7
|
—
|
—
|
—
|
—
|
|
Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1)
Mental Health, Week 72, n = 63, 67
|
76.3 scores on a scale
Standard Deviation 16.2
|
60.8 scores on a scale
Standard Deviation 18.5
|
—
|
—
|
—
|
—
|
|
Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1)
Mental Health, Week 96, n = 0, 59
|
NA scores on a scale
Standard Deviation NA
No participants were available for analysis in this arm at Week 96.
|
72.3 scores on a scale
Standard Deviation 14.6
|
—
|
—
|
—
|
—
|
|
Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1)
Reported Health Transition, Baseline, n = 105, 123
|
3.1 scores on a scale
Standard Deviation 0.9
|
3.0 scores on a scale
Standard Deviation 0.9
|
—
|
—
|
—
|
—
|
|
Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1)
Reported Health Transition, Week 24, n = 77, 90
|
3.5 scores on a scale
Standard Deviation 1.2
|
3.2 scores on a scale
Standard Deviation 1.2
|
—
|
—
|
—
|
—
|
|
Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1)
Reported Health Transition, Week 48, n = 67, 77
|
3.2 scores on a scale
Standard Deviation 1.3
|
3.0 scores on a scale
Standard Deviation 1.3
|
—
|
—
|
—
|
—
|
|
Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1)
Reported Health Transition, Week 72, n = 65, 69
|
1.6 scores on a scale
Standard Deviation 0.9
|
2.3 scores on a scale
Standard Deviation 1.1
|
—
|
—
|
—
|
—
|
|
Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1)
Reported Health Transition, Week 96, n = 0, 61
|
NA scores on a scale
Standard Deviation NA
No participants were available for analysis in this arm at Week 96.
|
1.3 scores on a scale
Standard Deviation 0.7
|
—
|
—
|
—
|
—
|
|
Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1)
Physical Functioning, Baseline, n = 106, 121
|
86.9 scores on a scale
Standard Deviation 15.1
|
87.0 scores on a scale
Standard Deviation 17.8
|
—
|
—
|
—
|
—
|
|
Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1)
Physical Functioning, Week 24, n = 77, 90
|
61.8 scores on a scale
Standard Deviation 28.2
|
69.2 scores on a scale
Standard Deviation 22.6
|
—
|
—
|
—
|
—
|
|
Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1)
Physical Functioning, Week 48, n = 67, 77
|
66.1 scores on a scale
Standard Deviation 26.2
|
66.8 scores on a scale
Standard Deviation 23.1
|
—
|
—
|
—
|
—
|
|
Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1)
Physical Functioning, Week 72, n = 65, 68
|
89.8 scores on a scale
Standard Deviation 14.1
|
70.3 scores on a scale
Standard Deviation 24.6
|
—
|
—
|
—
|
—
|
|
Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1)
Physical Functioning, Week 96, n = 0, 59
|
NA scores on a scale
Standard Deviation NA
No participants were available for analysis in this arm at Week 96.
|
87.0 scores on a scale
Standard Deviation 20.4
|
—
|
—
|
—
|
—
|
|
Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1)
Role Functioning - Physical, Baseline,n = 105, 120
|
74.7 scores on a scale
Standard Deviation 36.3
|
76.2 scores on a scale
Standard Deviation 36.9
|
—
|
—
|
—
|
—
|
|
Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1)
Role Functioning - Physical, Week 24, n = 77, 88
|
39.0 scores on a scale
Standard Deviation 43.0
|
45.7 scores on a scale
Standard Deviation 41.9
|
—
|
—
|
—
|
—
|
|
Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1)
Role Functioning - Physical, Week 48, n = 66, 76
|
40.7 scores on a scale
Standard Deviation 39.9
|
42.2 scores on a scale
Standard Deviation 44.0
|
—
|
—
|
—
|
—
|
|
Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1)
Role Functioning - Physical, Week 72, n = 65, 67
|
81.5 scores on a scale
Standard Deviation 32.9
|
47.4 scores on a scale
Standard Deviation 43.5
|
—
|
—
|
—
|
—
|
|
Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1)
Bodily Pain, Week 24, n = 76, 91
|
68.2 scores on a scale
Standard Deviation 31.1
|
70.0 scores on a scale
Standard Deviation 29.6
|
—
|
—
|
—
|
—
|
|
Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1)
Bodily Pain, Week 48, n = 67, 77
|
69.5 scores on a scale
Standard Deviation 28.6
|
66.8 scores on a scale
Standard Deviation 30.6
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Week 24, Week 48 and Week 72, and Week 96Population: The ITT population included all participants randomized and allocated to receive treatments. Here, 'n' = the number of participants analyzed at a given time point.
The Fatigue Severity Scale (FSS) is an instrument consisting of 10 self-administered questions. The FSS items were scored by calculating the average response to all answered items (including the 9 questions and the fatigue symptoms). Each of the 9 questions had answers within a score range of 1-7. A score of 1 for any question indicates less fatigue in everyday life and a score of 7 indicates a higher likelihood of fatigue in everyday life. The mean FSS scores are presented at Baseline (Day 1), Week 24, Week 48 and Week 72 (for Groups A and B) and at Week 96 (for Group B).
Outcome measures
| Measure |
PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1)
n=104 Participants
Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and ribavirin at a dose of 1,000 mg/day (for participants with a body weight \</= 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A based on the presence of an EVR defined as non-detectable serum HCV RNA (\< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline serum HCV RNA, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
|
PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1)
n=114 Participants
Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight \</= 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally for a total of 72 weeks. After Week 48, participants were administered a lower dose of PEG-IFN alfa-2a of 135 mcg/week until Week 72. Participants were randomized to Group B based on the presence of an EVR defined as non-detectable serum HCV RNA (\< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline in serum HCV RNA by quantitative PCR, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
|
PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2)
Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dosage of 1,000 mg/day (for participants with a body weight ≤ 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally for a total of 48 weeks. Participants with a positive HCV RNA level at Week 4 (≥ 15 IU/ml) and negative HCV RNA level at Week 8 (≤ 15 IU/ml) were assigned to group E. Participants had a treatment-free follow-up period of 24 weeks.
|
PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 1)
Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight \</= 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally for a total of 24 weeks. Participants with a RVR at Week 4 of treatment \[HCV RNA level, \<50 IU/ml by qualitative PCR assay, COBAS Amplicor HCV Test, version 2.0\] were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks.
|
PEG-IFN Alfa-2a + Ribavirin (Not Randomized) (Part 1)
Eligible participants who were not randomized to any treatment group in Part 1 of the study were included in this group. These participants were a part of the safety analysis population which included participants who received at least on dose of (either) the study drug (PEG-IFN alfa-2a and/or ribavirin) and had at least one post-baseline safety assessment.
|
PEG-IFN Alfa-2a + Ribavirin (Not Assigned) (Part 2)
Eligible participants who were not assigned to any treatment group in Part 2 were included in this group. These participants were a part of the safety analysis population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a and/or ribavirin) and had at least one post-baseline safety assessment.
|
|---|---|---|---|---|---|---|
|
Mean Fatigue Severity Scale Scores for Groups A and B Over Time (Part 1)
Baseline, n = 104, 114
|
3.6 scores on a scale
Standard Deviation 1.5
|
3.4 scores on a scale
Standard Deviation 1.7
|
—
|
—
|
—
|
—
|
|
Mean Fatigue Severity Scale Scores for Groups A and B Over Time (Part 1)
Week 24, n = 69, 77
|
4.5 scores on a scale
Standard Deviation 1.7
|
4.7 scores on a scale
Standard Deviation 1.7
|
—
|
—
|
—
|
—
|
|
Mean Fatigue Severity Scale Scores for Groups A and B Over Time (Part 1)
Week 48, n = 59, 63
|
4.7 scores on a scale
Standard Deviation 1.6
|
4.7 scores on a scale
Standard Deviation 1.5
|
—
|
—
|
—
|
—
|
|
Mean Fatigue Severity Scale Scores for Groups A and B Over Time (Part 1)
Week 72, n = 58, 62
|
3.0 scores on a scale
Standard Deviation 1.5
|
4.3 scores on a scale
Standard Deviation 1.8
|
—
|
—
|
—
|
—
|
|
Mean Fatigue Severity Scale Scores for Groups A and B Over Time (Part 1)
Week 96, n = 0, 57
|
NA scores on a scale
Standard Deviation NA
No participants were available for analysis in this arm at Week 96.
|
3.4 scores on a scale
Standard Deviation 1.5
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1)Population: The safety population included all participants who received at least on dose of (either) study drug and had at least one post-baseline safety assessment.
Liver fibrosis stage was scored using the METAVIR system (Grade 0 to 4). Grade 0 indicates no fibrosis, Grade 1 indicates stellate enlargement of portal tract but without septa formation, Grade 2 indicates enlargement of portal tract with rare septa formation, Grade 3 indicates numerous septa without cirrhosis and grade 4 indicates cirrhosis. The number of participants with fibrosis grades ranging from 0 to 4 at Baseline is presented.
Outcome measures
| Measure |
PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1)
n=142 Participants
Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and ribavirin at a dose of 1,000 mg/day (for participants with a body weight \</= 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A based on the presence of an EVR defined as non-detectable serum HCV RNA (\< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline serum HCV RNA, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
|
PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1)
n=152 Participants
Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight \</= 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally for a total of 72 weeks. After Week 48, participants were administered a lower dose of PEG-IFN alfa-2a of 135 mcg/week until Week 72. Participants were randomized to Group B based on the presence of an EVR defined as non-detectable serum HCV RNA (\< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline in serum HCV RNA by quantitative PCR, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
|
PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2)
n=77 Participants
Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dosage of 1,000 mg/day (for participants with a body weight ≤ 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally for a total of 48 weeks. Participants with a positive HCV RNA level at Week 4 (≥ 15 IU/ml) and negative HCV RNA level at Week 8 (≤ 15 IU/ml) were assigned to group E. Participants had a treatment-free follow-up period of 24 weeks.
|
PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 1)
n=156 Participants
Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight \</= 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally for a total of 24 weeks. Participants with a RVR at Week 4 of treatment \[HCV RNA level, \<50 IU/ml by qualitative PCR assay, COBAS Amplicor HCV Test, version 2.0\] were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks.
|
PEG-IFN Alfa-2a + Ribavirin (Not Randomized) (Part 1)
n=11 Participants
Eligible participants who were not randomized to any treatment group in Part 1 of the study were included in this group. These participants were a part of the safety analysis population which included participants who received at least on dose of (either) the study drug (PEG-IFN alfa-2a and/or ribavirin) and had at least one post-baseline safety assessment.
|
PEG-IFN Alfa-2a + Ribavirin (Not Assigned) (Part 2)
Eligible participants who were not assigned to any treatment group in Part 2 were included in this group. These participants were a part of the safety analysis population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a and/or ribavirin) and had at least one post-baseline safety assessment.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Fibrosis Grades 0 to 4 at Baseline (Part 1)
Grade 4
|
11 Number of participants
|
16 Number of participants
|
11 Number of participants
|
14 Number of participants
|
0 Number of participants
|
—
|
|
Number of Participants With Fibrosis Grades 0 to 4 at Baseline (Part 1)
Grade 0
|
11 Number of participants
|
15 Number of participants
|
8 Number of participants
|
17 Number of participants
|
1 Number of participants
|
—
|
|
Number of Participants With Fibrosis Grades 0 to 4 at Baseline (Part 1)
Grade 1
|
38 Number of participants
|
40 Number of participants
|
20 Number of participants
|
57 Number of participants
|
1 Number of participants
|
—
|
|
Number of Participants With Fibrosis Grades 0 to 4 at Baseline (Part 1)
Grade 2
|
64 Number of participants
|
68 Number of participants
|
23 Number of participants
|
58 Number of participants
|
6 Number of participants
|
—
|
|
Number of Participants With Fibrosis Grades 0 to 4 at Baseline (Part 1)
Grade 3
|
18 Number of participants
|
13 Number of participants
|
15 Number of participants
|
10 Number of participants
|
3 Number of participants
|
—
|
SECONDARY outcome
Timeframe: Up to Week 96Population: The safety population included all participants who received at least on dose of (either) study drug and had at least one post-baseline safety assessment.
An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.
Outcome measures
| Measure |
PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1)
n=142 Participants
Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and ribavirin at a dose of 1,000 mg/day (for participants with a body weight \</= 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A based on the presence of an EVR defined as non-detectable serum HCV RNA (\< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline serum HCV RNA, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
|
PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1)
n=152 Participants
Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight \</= 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally for a total of 72 weeks. After Week 48, participants were administered a lower dose of PEG-IFN alfa-2a of 135 mcg/week until Week 72. Participants were randomized to Group B based on the presence of an EVR defined as non-detectable serum HCV RNA (\< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline in serum HCV RNA by quantitative PCR, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
|
PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2)
n=78 Participants
Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dosage of 1,000 mg/day (for participants with a body weight ≤ 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally for a total of 48 weeks. Participants with a positive HCV RNA level at Week 4 (≥ 15 IU/ml) and negative HCV RNA level at Week 8 (≤ 15 IU/ml) were assigned to group E. Participants had a treatment-free follow-up period of 24 weeks.
|
PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 1)
n=156 Participants
Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight \</= 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally for a total of 24 weeks. Participants with a RVR at Week 4 of treatment \[HCV RNA level, \<50 IU/ml by qualitative PCR assay, COBAS Amplicor HCV Test, version 2.0\] were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks.
|
PEG-IFN Alfa-2a + Ribavirin (Not Randomized) (Part 1)
n=12 Participants
Eligible participants who were not randomized to any treatment group in Part 1 of the study were included in this group. These participants were a part of the safety analysis population which included participants who received at least on dose of (either) the study drug (PEG-IFN alfa-2a and/or ribavirin) and had at least one post-baseline safety assessment.
|
PEG-IFN Alfa-2a + Ribavirin (Not Assigned) (Part 2)
Eligible participants who were not assigned to any treatment group in Part 2 were included in this group. These participants were a part of the safety analysis population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a and/or ribavirin) and had at least one post-baseline safety assessment.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events and Serious Adverse Events (Part 1)
Number of participants with any AE
|
140 Number of participants
|
149 Number of participants
|
76 Number of participants
|
153 Number of participants
|
10 Number of participants
|
—
|
|
Number of Participants With Adverse Events and Serious Adverse Events (Part 1)
Number of participants with any SAE
|
22 Number of participants
|
28 Number of participants
|
8 Number of participants
|
14 Number of participants
|
2 Number of participants
|
—
|
SECONDARY outcome
Timeframe: Up to Week 96Population: The ITT population included all participants randomized and allocated to receive treatments.
Virological relapse rate was defined as percentage of participants with non-detectable HCV RNA (\< 15 IU/ml) at the EoT and detectable HCV RNA (≥ 15 IU/ml) at the end of FU. The end of treatment was defined as Week 48 in Group A1 and Week 72 in Group B1 and the end of follow-up was defined as Week 72 in Group A1 and Week 96 in Group B1.
Outcome measures
| Measure |
PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1)
n=36 Participants
Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and ribavirin at a dose of 1,000 mg/day (for participants with a body weight \</= 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A based on the presence of an EVR defined as non-detectable serum HCV RNA (\< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline serum HCV RNA, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
|
PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1)
n=25 Participants
Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight \</= 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally for a total of 72 weeks. After Week 48, participants were administered a lower dose of PEG-IFN alfa-2a of 135 mcg/week until Week 72. Participants were randomized to Group B based on the presence of an EVR defined as non-detectable serum HCV RNA (\< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline in serum HCV RNA by quantitative PCR, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
|
PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2)
Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dosage of 1,000 mg/day (for participants with a body weight ≤ 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally for a total of 48 weeks. Participants with a positive HCV RNA level at Week 4 (≥ 15 IU/ml) and negative HCV RNA level at Week 8 (≤ 15 IU/ml) were assigned to group E. Participants had a treatment-free follow-up period of 24 weeks.
|
PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 1)
Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight \</= 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally for a total of 24 weeks. Participants with a RVR at Week 4 of treatment \[HCV RNA level, \<50 IU/ml by qualitative PCR assay, COBAS Amplicor HCV Test, version 2.0\] were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks.
|
PEG-IFN Alfa-2a + Ribavirin (Not Randomized) (Part 1)
Eligible participants who were not randomized to any treatment group in Part 1 of the study were included in this group. These participants were a part of the safety analysis population which included participants who received at least on dose of (either) the study drug (PEG-IFN alfa-2a and/or ribavirin) and had at least one post-baseline safety assessment.
|
PEG-IFN Alfa-2a + Ribavirin (Not Assigned) (Part 2)
Eligible participants who were not assigned to any treatment group in Part 2 were included in this group. These participants were a part of the safety analysis population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a and/or ribavirin) and had at least one post-baseline safety assessment.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Relapse Rates in Groups A1 and B1 at the End of Follow-up (Part 2)
|
41.2 Percentage of participants
Interval 18.4 to 67.1
|
38.5 Percentage of participants
Interval 13.9 to 68.4
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Week 72Population: The ITT population included all participants randomized and allocated to receive treatments.
ETR virological response rate at the end of treatment period was defined as the percentage of participants in each group with non-detectable HCV RNA at completion of the treatment period (HCV RNA quantitative PCR result \< 15 IU/ml at Week 24 for Group D, at Week 48 for Group A1, at Week 72 for Groups B1 and C). Participants without a HCV RNA PCR (missing values) at this time point were considered as non-responders in this calculation. The end of treatment period was defined as Week 48 for Group A1, Week 72 for Groups B1 and C1, and Week 24 for Group D.
Outcome measures
| Measure |
PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1)
n=36 Participants
Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and ribavirin at a dose of 1,000 mg/day (for participants with a body weight \</= 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A based on the presence of an EVR defined as non-detectable serum HCV RNA (\< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline serum HCV RNA, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
|
PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1)
n=25 Participants
Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight \</= 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally for a total of 72 weeks. After Week 48, participants were administered a lower dose of PEG-IFN alfa-2a of 135 mcg/week until Week 72. Participants were randomized to Group B based on the presence of an EVR defined as non-detectable serum HCV RNA (\< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline in serum HCV RNA by quantitative PCR, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
|
PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2)
n=20 Participants
Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dosage of 1,000 mg/day (for participants with a body weight ≤ 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally for a total of 48 weeks. Participants with a positive HCV RNA level at Week 4 (≥ 15 IU/ml) and negative HCV RNA level at Week 8 (≤ 15 IU/ml) were assigned to group E. Participants had a treatment-free follow-up period of 24 weeks.
|
PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 1)
n=42 Participants
Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight \</= 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally for a total of 24 weeks. Participants with a RVR at Week 4 of treatment \[HCV RNA level, \<50 IU/ml by qualitative PCR assay, COBAS Amplicor HCV Test, version 2.0\] were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks.
|
PEG-IFN Alfa-2a + Ribavirin (Not Randomized) (Part 1)
Eligible participants who were not randomized to any treatment group in Part 1 of the study were included in this group. These participants were a part of the safety analysis population which included participants who received at least on dose of (either) the study drug (PEG-IFN alfa-2a and/or ribavirin) and had at least one post-baseline safety assessment.
|
PEG-IFN Alfa-2a + Ribavirin (Not Assigned) (Part 2)
Eligible participants who were not assigned to any treatment group in Part 2 were included in this group. These participants were a part of the safety analysis population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a and/or ribavirin) and had at least one post-baseline safety assessment.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Virological Response Rates in Group A1, B1, C and D at the End of the Treatment Period (Part 2)
|
47.2 Percentage of participants
Interval 30.4 to 64.5
|
52.0 Percentage of participants
Interval 31.3 to 72.2
|
5.0 Percentage of participants
Interval 0.1 to 24.9
|
90.5 Percentage of participants
Interval 77.4 to 97.3
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Week 96Population: The ITT population included all participants randomized and allocated to receive treatments.
The SVR was defined as the percentage of participants in each group with non-detectable HCV RNA result at 24 weeks post completion of the treatment period (HCV RNA \< 15 IU/ml at Week 48 of Group D and at Week 96 of Group C). Participants without a HCV RNA results at this time point were considered as non-responders. The end of follow-up was defined as Week 96 for Group C and Week 48 for Group D.
Outcome measures
| Measure |
PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1)
n=20 Participants
Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and ribavirin at a dose of 1,000 mg/day (for participants with a body weight \</= 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A based on the presence of an EVR defined as non-detectable serum HCV RNA (\< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline serum HCV RNA, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
|
PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1)
n=42 Participants
Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight \</= 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally for a total of 72 weeks. After Week 48, participants were administered a lower dose of PEG-IFN alfa-2a of 135 mcg/week until Week 72. Participants were randomized to Group B based on the presence of an EVR defined as non-detectable serum HCV RNA (\< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline in serum HCV RNA by quantitative PCR, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
|
PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2)
Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dosage of 1,000 mg/day (for participants with a body weight ≤ 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally for a total of 48 weeks. Participants with a positive HCV RNA level at Week 4 (≥ 15 IU/ml) and negative HCV RNA level at Week 8 (≤ 15 IU/ml) were assigned to group E. Participants had a treatment-free follow-up period of 24 weeks.
|
PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 1)
Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight \</= 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally for a total of 24 weeks. Participants with a RVR at Week 4 of treatment \[HCV RNA level, \<50 IU/ml by qualitative PCR assay, COBAS Amplicor HCV Test, version 2.0\] were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks.
|
PEG-IFN Alfa-2a + Ribavirin (Not Randomized) (Part 1)
Eligible participants who were not randomized to any treatment group in Part 1 of the study were included in this group. These participants were a part of the safety analysis population which included participants who received at least on dose of (either) the study drug (PEG-IFN alfa-2a and/or ribavirin) and had at least one post-baseline safety assessment.
|
PEG-IFN Alfa-2a + Ribavirin (Not Assigned) (Part 2)
Eligible participants who were not assigned to any treatment group in Part 2 were included in this group. These participants were a part of the safety analysis population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a and/or ribavirin) and had at least one post-baseline safety assessment.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Sustained Virological Response in Groups C and D by Genotype at the End of Follow-up (Part 2)
|
0.0 Percentage of participants
Interval 0.0 to 16.8
|
73.8 Percentage of participants
Interval 58.0 to 86.1
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Week 24, Week 48, Week 72, and Week 96Population: The ITT population included all participants randomized and allocated to receive treatments. Here, 'n' = the number of participants analyzed at a given time point.
The SF-36 is a quality of life instrument consisting of a 36-item questionnaire. The SF-36 items were scored and transformed according to the SF-36 Health Survey Manual \& Interpretation Guide. Summary scores for SF-36 dimensions (physical functioning, role functioning, bodily pain, general health, vitality, social functioning, mental health, health transition) as well as physical and mental summary measures were compiled after imputation of mean scores for missing items if more than 50% of dimension-related items were available. Scores for health transition ranged from 0 (worst) to 5 (best). Scores for all other dimensions ranged from 0 (worst) to 100 (best). The mean SF-36 scores were presented at Baseline (Day 1), Week 24, Week 48, Week 72 (for Groups A1, B1 and C) and at Week 96 (for Groups B1 and C). Lower score indicate worsening.
Outcome measures
| Measure |
PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1)
n=22 Participants
Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and ribavirin at a dose of 1,000 mg/day (for participants with a body weight \</= 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A based on the presence of an EVR defined as non-detectable serum HCV RNA (\< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline serum HCV RNA, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
|
PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1)
n=19 Participants
Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight \</= 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally for a total of 72 weeks. After Week 48, participants were administered a lower dose of PEG-IFN alfa-2a of 135 mcg/week until Week 72. Participants were randomized to Group B based on the presence of an EVR defined as non-detectable serum HCV RNA (\< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline in serum HCV RNA by quantitative PCR, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
|
PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2)
n=15 Participants
Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dosage of 1,000 mg/day (for participants with a body weight ≤ 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally for a total of 48 weeks. Participants with a positive HCV RNA level at Week 4 (≥ 15 IU/ml) and negative HCV RNA level at Week 8 (≤ 15 IU/ml) were assigned to group E. Participants had a treatment-free follow-up period of 24 weeks.
|
PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 1)
Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight \</= 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally for a total of 24 weeks. Participants with a RVR at Week 4 of treatment \[HCV RNA level, \<50 IU/ml by qualitative PCR assay, COBAS Amplicor HCV Test, version 2.0\] were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks.
|
PEG-IFN Alfa-2a + Ribavirin (Not Randomized) (Part 1)
Eligible participants who were not randomized to any treatment group in Part 1 of the study were included in this group. These participants were a part of the safety analysis population which included participants who received at least on dose of (either) the study drug (PEG-IFN alfa-2a and/or ribavirin) and had at least one post-baseline safety assessment.
|
PEG-IFN Alfa-2a + Ribavirin (Not Assigned) (Part 2)
Eligible participants who were not assigned to any treatment group in Part 2 were included in this group. These participants were a part of the safety analysis population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a and/or ribavirin) and had at least one post-baseline safety assessment.
|
|---|---|---|---|---|---|---|
|
Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2)
Physical functioning, Week 48, n = 13, 8, 0
|
66.5 scores on a scale
Standard Deviation 22.8
|
76.3 scores on a scale
Standard Deviation 19.8
|
NA scores on a scale
Standard Deviation NA
No participants were available for analysis in this arm at Week 48.
|
—
|
—
|
—
|
|
Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2)
Physical functioning, Week 96, n = 0, 6, 0
|
NA scores on a scale
Standard Deviation NA
No participants were available for analysis in this arm at Week 96.
|
85.8 scores on a scale
Standard Deviation 17.7
|
NA scores on a scale
Standard Deviation NA
No participants were available for analysis in this arm at Week 96.
|
—
|
—
|
—
|
|
Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2)
Role Functioning - Physical, Week 24, n= 17, 13, 8
|
41.2 scores on a scale
Standard Deviation 44.1
|
15.4 scores on a scale
Standard Deviation 33.1
|
43.8 scores on a scale
Standard Deviation 43.8
|
—
|
—
|
—
|
|
Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2)
Role Functioning - Physical, Week 48, n = 13, 8, 0
|
41.0 scores on a scale
Standard Deviation 41.3
|
56.3 scores on a scale
Standard Deviation 39.5
|
NA scores on a scale
Standard Deviation NA
No participants were available for analysis in this arm at Week 48.
|
—
|
—
|
—
|
|
Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2)
Role Functioning - Physical, Week 96, n = 0, 5, 0
|
NA scores on a scale
Standard Deviation NA
No participants were available for analysis in this arm at Week 96.
|
70.0 scores on a scale
Standard Deviation 32.6
|
NA scores on a scale
Standard Deviation NA
No participants were available for analysis in this arm at Week 96.
|
—
|
—
|
—
|
|
Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2)
Bodily Pain, Baseline, n = 21, 19, 15
|
75.3 scores on a scale
Standard Deviation 26.7
|
76.3 scores on a scale
Standard Deviation 25.5
|
66.5 scores on a scale
Standard Deviation 31.7
|
—
|
—
|
—
|
|
Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2)
Bodily Pain, Week 96, n = 0, 6, 0
|
NA scores on a scale
Standard Deviation NA
No participants were available for analysis in this arm at Week 96.
|
74.5 scores on a scale
Standard Deviation 19.3
|
NA scores on a scale
Standard Deviation NA
No participants were available for analysis in this arm at Week 96.
|
—
|
—
|
—
|
|
Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2)
Social Functioning, Week 48, n = 13, 8, 0
|
62.5 scores on a scale
Standard Deviation 27.5
|
78.1 scores on a scale
Standard Deviation 27.3
|
NA scores on a scale
Standard Deviation NA
No participants were available for analysis in this arm at Week 48.
|
—
|
—
|
—
|
|
Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2)
Role Functioning - Emotional, Week 72, n= 10, 7, 1
|
56.7 scores on a scale
Standard Deviation 49.8
|
81.0 scores on a scale
Standard Deviation 37.8
|
0.0 scores on a scale
Standard Deviation 0.0
|
—
|
—
|
—
|
|
Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2)
Role Functioning - Emotional, Week 96, n = 0, 5, 0
|
NA scores on a scale
Standard Deviation NA
No participants were available for analysis in this arm at Week 96.
|
60.0 scores on a scale
Standard Deviation 43.5
|
NA scores on a scale
Standard Deviation NA
No participants were available for analysis in this arm at Week 96.
|
—
|
—
|
—
|
|
Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2)
Mental Health, Baseline, n = 21, 18, 15
|
71.6 scores on a scale
Standard Deviation 18.1
|
62.9 scores on a scale
Standard Deviation 22.0
|
62.1 scores on a scale
Standard Deviation 20.8
|
—
|
—
|
—
|
|
Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2)
Physical functioning, Baseline, n = 22, 18, 15
|
82.5 scores on a scale
Standard Deviation 22.5
|
83.1 scores on a scale
Standard Deviation 17.7
|
78.5 scores on a scale
Standard Deviation 28.8
|
—
|
—
|
—
|
|
Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2)
Physical functioning, Week 24, n = 17, 13, 9
|
61.8 scores on a scale
Standard Deviation 25.8
|
51.2 scores on a scale
Standard Deviation 25.2
|
72.2 scores on a scale
Standard Deviation 24.9
|
—
|
—
|
—
|
|
Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2)
Physical functioning, Week 72, n = 10, 7, 1
|
77.0 scores on a scale
Standard Deviation 18.4
|
80.7 scores on a scale
Standard Deviation 9.3
|
45.0 scores on a scale
Standard Deviation NA
Data is available only for one participant. Therefore, there is no standard deviation.
|
—
|
—
|
—
|
|
Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2)
Role Functioning- Physical, Baseline,n =22, 18, 15
|
75.0 scores on a scale
Standard Deviation 33.6
|
62.0 scores on a scale
Standard Deviation 42.1
|
53.3 scores on a scale
Standard Deviation 41.0
|
—
|
—
|
—
|
|
Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2)
Role Functioning - Physical,, Week 72, n= 10, 7,1
|
60.0 scores on a scale
Standard Deviation 47.4
|
82.1 scores on a scale
Standard Deviation 37.4
|
0.0 scores on a scale
Standard Deviation 0.0
|
—
|
—
|
—
|
|
Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2)
Bodily Pain, Week 24, n = 17, 13, 8
|
57.9 scores on a scale
Standard Deviation 28.5
|
45.9 scores on a scale
Standard Deviation 27.9
|
54.9 scores on a scale
Standard Deviation 17.8
|
—
|
—
|
—
|
|
Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2)
Bodily Pain, Week 48, n = 13, 8, 0
|
66.4 scores on a scale
Standard Deviation 31.6
|
54.6 scores on a scale
Standard Deviation 19.2
|
NA scores on a scale
Standard Deviation NA
No participants were available for analysis in this arm at Week 48.
|
—
|
—
|
—
|
|
Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2)
Bodily Pain, Week 72, n = 10, 7, 1
|
71.1 scores on a scale
Standard Deviation 30.1
|
70.4 scores on a scale
Standard Deviation 15.0
|
62.0 scores on a scale
Standard Deviation NA
Data is available only for one participant. Therefore, there is no standard deviation.
|
—
|
—
|
—
|
|
Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2)
General Health, Baseline, n = 22, 16, 14
|
61.8 scores on a scale
Standard Deviation 18.8
|
56.7 scores on a scale
Standard Deviation 21.7
|
53.4 scores on a scale
Standard Deviation 19.1
|
—
|
—
|
—
|
|
Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2)
General Health, Week 24, n = 17, 11, 8
|
52.8 scores on a scale
Standard Deviation 23.6
|
37.1 scores on a scale
Standard Deviation 14.1
|
57.1 scores on a scale
Standard Deviation 24.4
|
—
|
—
|
—
|
|
Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2)
General Health, Week 48, n = 12, 8, 0
|
54.4 scores on a scale
Standard Deviation 21.0
|
56.3 scores on a scale
Standard Deviation 23.8
|
NA scores on a scale
Standard Deviation NA
No participants were available for analysis in this arm at Week 48.
|
—
|
—
|
—
|
|
Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2)
General Health, Week 72, n = 10, 7, 1
|
55.0 scores on a scale
Standard Deviation 21.8
|
59.9 scores on a scale
Standard Deviation 16.5
|
35.0 scores on a scale
Standard Deviation NA
Data is available only for one participant. Therefore, there is no standard deviation.
|
—
|
—
|
—
|
|
Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2)
General Health, Week 96, n = 0, 6, 0
|
NA scores on a scale
Standard Deviation NA
No participants were available for analysis in this arm at Week 96.
|
52.8 scores on a scale
Standard Deviation 18.8
|
NA scores on a scale
Standard Deviation NA
No participants were available for analysis in this arm at Week 96.
|
—
|
—
|
—
|
|
Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2)
Vitality, Baseline, n = 21, 18, 15
|
54.0 scores on a scale
Standard Deviation 21.9
|
52.5 scores on a scale
Standard Deviation 19.3
|
45.0 scores on a scale
Standard Deviation 16.0
|
—
|
—
|
—
|
|
Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2)
Vitality, Week 24, n = 17, 11, 8
|
37.8 scores on a scale
Standard Deviation 13.9
|
31.2 scores on a scale
Standard Deviation 21.7
|
43.1 scores on a scale
Standard Deviation 17.9
|
—
|
—
|
—
|
|
Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2)
Vitality, Week 48, n = 13, 8, 0
|
43.2 scores on a scale
Standard Deviation 22.1
|
48.1 scores on a scale
Standard Deviation 17.3
|
NA scores on a scale
Standard Deviation NA
No participants were available for analysis in this arm at Week 48.
|
—
|
—
|
—
|
|
Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2)
Vitality, Week 72, n = 9, 7, 1
|
47.2 scores on a scale
Standard Deviation 23.1
|
60.2 scores on a scale
Standard Deviation 16.7
|
40.0 scores on a scale
Standard Deviation NA
Data is available only for one participant. Therefore, there is no standard deviation.
|
—
|
—
|
—
|
|
Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2)
Vitality, Week 96, n = 0, 6, 0
|
NA scores on a scale
Standard Deviation NA
No participants were available for analysis in this arm at Week 96.
|
56.9 scores on a scale
Standard Deviation 15.1
|
NA scores on a scale
Standard Deviation NA
No participants were available for analysis in this arm at Week 96.
|
—
|
—
|
—
|
|
Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2)
Social Functioning, Baseline, n = 22, 19, 15
|
84.7 scores on a scale
Standard Deviation 18.5
|
78.9 scores on a scale
Standard Deviation 25.0
|
72.5 scores on a scale
Standard Deviation 33.5
|
—
|
—
|
—
|
|
Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2)
Social Functioning, Week 24, n = 17, 13, 8
|
64.7 scores on a scale
Standard Deviation 26.6
|
56.7 scores on a scale
Standard Deviation 23.2
|
65.6 scores on a scale
Standard Deviation 23.9
|
—
|
—
|
—
|
|
Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2)
Social Functioning, Week 72, n = 10, 7, 1
|
77.5 scores on a scale
Standard Deviation 20.2
|
78.6 scores on a scale
Standard Deviation 15.7
|
25.0 scores on a scale
Standard Deviation NA
Data is available only for one participant. Therefore, there is no standard deviation.
|
—
|
—
|
—
|
|
Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2)
Social Functioning, Week 96, n = 0, 6, 0
|
NA scores on a scale
Standard Deviation NA
No participants were available for analysis in this arm at Week 96.
|
83.3 scores on a scale
Standard Deviation 17.1
|
NA scores on a scale
Standard Deviation NA
No participants were available for analysis in this arm at Week 96.
|
—
|
—
|
—
|
|
Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2)
Role Functioning -Emotional,Baseline,n =22, 18, 15
|
71.2 scores on a scale
Standard Deviation 38.9
|
62.0 scores on a scale
Standard Deviation 42.7
|
53.3 scores on a scale
Standard Deviation 45.1
|
—
|
—
|
—
|
|
Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2)
Role Functioning-Emotional, Week 24, n=17, 13, 8
|
43.1 scores on a scale
Standard Deviation 43.7
|
20.5 scores on a scale
Standard Deviation 37.4
|
45.8 scores on a scale
Standard Deviation 50.2
|
—
|
—
|
—
|
|
Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2)
Role Functioning - Emotional, Week 48, n= 13, 8, 0
|
43.6 scores on a scale
Standard Deviation 39.4
|
54.2 scores on a scale
Standard Deviation 46.9
|
NA scores on a scale
Standard Deviation NA
No participants were available for analysis in this arm at Week 48.
|
—
|
—
|
—
|
|
Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2)
Mental Health, Week 24, n = 17, 11, 8
|
58.8 scores on a scale
Standard Deviation 21.5
|
46.2 scores on a scale
Standard Deviation 18.6
|
62.0 scores on a scale
Standard Deviation 19.9
|
—
|
—
|
—
|
|
Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2)
Mental Health, Week 48, n = 13, 8, 0
|
57.4 scores on a scale
Standard Deviation 24.0
|
61.0 scores on a scale
Standard Deviation 16.8
|
NA scores on a scale
Standard Deviation NA
No participants were available for analysis in this arm at Week 48.
|
—
|
—
|
—
|
|
Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2)
Mental Health, Week 72, n = 9, 7, 1
|
66.7 scores on a scale
Standard Deviation 24.0
|
66.9 scores on a scale
Standard Deviation 17.8
|
36.0 scores on a scale
Standard Deviation NA
Data is available only for one participant. Therefore, there is no standard deviation.
|
—
|
—
|
—
|
|
Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2)
Mental Health, Week 96, n = 0, 6, 0
|
NA scores on a scale
Standard Deviation NA
No participants were available for analysis in this arm at Week 96.
|
58.3 scores on a scale
Standard Deviation 15.1
|
NA scores on a scale
Standard Deviation NA
No participants were available for analysis in this arm at Week 96.
|
—
|
—
|
—
|
|
Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2)
Reported Health Transition,Baseline, n =22, 19, 15
|
3.0 scores on a scale
Standard Deviation 1.1
|
2.9 scores on a scale
Standard Deviation 0.9
|
3.3 scores on a scale
Standard Deviation 1.0
|
—
|
—
|
—
|
|
Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2)
Reported Health Transition, Week 24, 17, 13, 9
|
3.8 scores on a scale
Standard Deviation 1.0
|
3.5 scores on a scale
Standard Deviation 1.2
|
3.2 scores on a scale
Standard Deviation 1.1
|
—
|
—
|
—
|
|
Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2)
Reported Health Transition, Week 48, n = 13, 8, 0
|
2.9 scores on a scale
Standard Deviation 1.1
|
2.9 scores on a scale
Standard Deviation 1.1
|
NA scores on a scale
Standard Deviation NA
No participants were available for analysis in this arm at Week 48.
|
—
|
—
|
—
|
|
Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2)
Reported Health Transition, Week 72, n = 10, 7, 1
|
2.8 scores on a scale
Standard Deviation 1.2
|
2.6 scores on a scale
Standard Deviation 1.3
|
4.0 scores on a scale
Standard Deviation NA
Data is available only for one participant. Therefore, there is no standard deviation.
|
—
|
—
|
—
|
|
Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2)
Reported Health Transition, Week 96, n = 0, 6, 0
|
NA scores on a scale
Standard Deviation NA
No participants were available for analysis in this arm at Week 96.
|
2.0 scores on a scale
Standard Deviation 0.9
|
NA scores on a scale
Standard Deviation NA
No participants were available for analysis in this arm at Week 96.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Week 24, Week 48 and Week 72, and Week 96Population: The ITT population included all participants randomized and allocated to receive treatments. Here, 'n' = the number of participants analyzed for a given time point.
The FSS is an instrument consisting of 10 self-administered questions. The FSS items were scored by calculating the average response to all answered items (including the 9 questions and the fatigue symptoms). Each of the 9 questions had answers within a score range of 1-7. A score of 1 for any question indicates less fatigue in everyday life and a score of 7 indicates a higher likelihood of fatigue in everyday life. The mean FSS scores are presented at Baseline (Day 1), Week 24, Week 48 and Week 72 (for Groups A1, B1 and C) and at Week 96 (for Groups B1 and C).
Outcome measures
| Measure |
PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1)
n=22 Participants
Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and ribavirin at a dose of 1,000 mg/day (for participants with a body weight \</= 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A based on the presence of an EVR defined as non-detectable serum HCV RNA (\< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline serum HCV RNA, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
|
PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1)
n=17 Participants
Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight \</= 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally for a total of 72 weeks. After Week 48, participants were administered a lower dose of PEG-IFN alfa-2a of 135 mcg/week until Week 72. Participants were randomized to Group B based on the presence of an EVR defined as non-detectable serum HCV RNA (\< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline in serum HCV RNA by quantitative PCR, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
|
PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2)
n=15 Participants
Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dosage of 1,000 mg/day (for participants with a body weight ≤ 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally for a total of 48 weeks. Participants with a positive HCV RNA level at Week 4 (≥ 15 IU/ml) and negative HCV RNA level at Week 8 (≤ 15 IU/ml) were assigned to group E. Participants had a treatment-free follow-up period of 24 weeks.
|
PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 1)
Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight \</= 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally for a total of 24 weeks. Participants with a RVR at Week 4 of treatment \[HCV RNA level, \<50 IU/ml by qualitative PCR assay, COBAS Amplicor HCV Test, version 2.0\] were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks.
|
PEG-IFN Alfa-2a + Ribavirin (Not Randomized) (Part 1)
Eligible participants who were not randomized to any treatment group in Part 1 of the study were included in this group. These participants were a part of the safety analysis population which included participants who received at least on dose of (either) the study drug (PEG-IFN alfa-2a and/or ribavirin) and had at least one post-baseline safety assessment.
|
PEG-IFN Alfa-2a + Ribavirin (Not Assigned) (Part 2)
Eligible participants who were not assigned to any treatment group in Part 2 were included in this group. These participants were a part of the safety analysis population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a and/or ribavirin) and had at least one post-baseline safety assessment.
|
|---|---|---|---|---|---|---|
|
Mean Fatigue Severity Scale Scores for Groups A1, B1 and C Over Time (Part 2)
Baseline, n = 22, 17, 15
|
3.7 scores on a scale
Standard Deviation 1.6
|
3.8 scores on a scale
Standard Deviation 2.0
|
3.9 scores on a scale
Standard Deviation 1.9
|
—
|
—
|
—
|
|
Mean Fatigue Severity Scale Scores for Groups A1, B1 and C Over Time (Part 2)
Week 24, n = 17, 15, 9
|
4.2 scores on a scale
Standard Deviation 1.7
|
4.9 scores on a scale
Standard Deviation 1.6
|
4.8 scores on a scale
Standard Deviation 1.6
|
—
|
—
|
—
|
|
Mean Fatigue Severity Scale Scores for Groups A1, B1 and C Over Time (Part 2)
Week 48, n = 11, 7, 0
|
4.0 scores on a scale
Standard Deviation 1.5
|
4.5 scores on a scale
Standard Deviation 1.3
|
NA scores on a scale
Standard Deviation NA
No participants were available for analysis in this arm at Week 48.
|
—
|
—
|
—
|
|
Mean Fatigue Severity Scale Scores for Groups A1, B1 and C Over Time (Part 2)
Week 72, n = 8, 7, 1
|
3.9 scores on a scale
Standard Deviation 1.9
|
3.8 scores on a scale
Standard Deviation 2.2
|
5.3 scores on a scale
Standard Deviation NA
Data is available only for one participant. Therefore, there is no standard deviation.
|
—
|
—
|
—
|
|
Mean Fatigue Severity Scale Scores for Groups A1, B1 and C Over Time (Part 2)
Week 96, n = 0, 7, 0
|
NA scores on a scale
Standard Deviation NA
No participants were available for analysis in this arm at Week 96.
|
4.5 scores on a scale
Standard Deviation 1.9
|
NA scores on a scale
Standard Deviation NA
No participants were available for analysis in this arm at Week 96.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1)Population: The ITT population included all participants randomized and allocated to receive treatments.
Liver fibrosis stage was based upon biopsy and scored using the METAVIR system (Grade 0 to 4). Grade 0 indicates no fibrosis, Grade 1 indicates stellate enlargement of portal tract but without septa formation, Grade 2 indicates enlargement of portal tract with rare septa formation, Grade 3 indicates numerous septa without cirrhosis and grade 4 indicates cirrhosis. The number of participants with fibrosis grades ranging from 0 to 4 at Baseline (Day 1) is presented.
Outcome measures
| Measure |
PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1)
n=25 Participants
Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and ribavirin at a dose of 1,000 mg/day (for participants with a body weight \</= 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A based on the presence of an EVR defined as non-detectable serum HCV RNA (\< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline serum HCV RNA, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
|
PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1)
n=17 Participants
Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight \</= 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally for a total of 72 weeks. After Week 48, participants were administered a lower dose of PEG-IFN alfa-2a of 135 mcg/week until Week 72. Participants were randomized to Group B based on the presence of an EVR defined as non-detectable serum HCV RNA (\< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline in serum HCV RNA by quantitative PCR, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
|
PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2)
n=15 Participants
Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dosage of 1,000 mg/day (for participants with a body weight ≤ 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally for a total of 48 weeks. Participants with a positive HCV RNA level at Week 4 (≥ 15 IU/ml) and negative HCV RNA level at Week 8 (≤ 15 IU/ml) were assigned to group E. Participants had a treatment-free follow-up period of 24 weeks.
|
PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 1)
n=23 Participants
Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight \</= 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally for a total of 24 weeks. Participants with a RVR at Week 4 of treatment \[HCV RNA level, \<50 IU/ml by qualitative PCR assay, COBAS Amplicor HCV Test, version 2.0\] were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks.
|
PEG-IFN Alfa-2a + Ribavirin (Not Randomized) (Part 1)
n=26 Participants
Eligible participants who were not randomized to any treatment group in Part 1 of the study were included in this group. These participants were a part of the safety analysis population which included participants who received at least on dose of (either) the study drug (PEG-IFN alfa-2a and/or ribavirin) and had at least one post-baseline safety assessment.
|
PEG-IFN Alfa-2a + Ribavirin (Not Assigned) (Part 2)
Eligible participants who were not assigned to any treatment group in Part 2 were included in this group. These participants were a part of the safety analysis population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a and/or ribavirin) and had at least one post-baseline safety assessment.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Fibrosis Grades 0 to 4 at Baseline (Part 2)
Grade 4
|
5 Number of participants
|
4 Number of participants
|
1 Number of participants
|
0 Number of participants
|
5 Number of participants
|
—
|
|
Number of Participants With Fibrosis Grades 0 to 4 at Baseline (Part 2)
Grade 0
|
5 Number of participants
|
4 Number of participants
|
1 Number of participants
|
4 Number of participants
|
3 Number of participants
|
—
|
|
Number of Participants With Fibrosis Grades 0 to 4 at Baseline (Part 2)
Grade 1
|
6 Number of participants
|
3 Number of participants
|
2 Number of participants
|
8 Number of participants
|
9 Number of participants
|
—
|
|
Number of Participants With Fibrosis Grades 0 to 4 at Baseline (Part 2)
Grade 2
|
4 Number of participants
|
4 Number of participants
|
6 Number of participants
|
10 Number of participants
|
8 Number of participants
|
—
|
|
Number of Participants With Fibrosis Grades 0 to 4 at Baseline (Part 2)
Grade 3
|
5 Number of participants
|
2 Number of participants
|
5 Number of participants
|
1 Number of participants
|
1 Number of participants
|
—
|
SECONDARY outcome
Timeframe: Up to Week 96Population: The safety population included all participants who received at least on dose of (either) study drug and had at least one post-baseline safety assessment.
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.
Outcome measures
| Measure |
PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1)
n=36 Participants
Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and ribavirin at a dose of 1,000 mg/day (for participants with a body weight \</= 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A based on the presence of an EVR defined as non-detectable serum HCV RNA (\< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline serum HCV RNA, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
|
PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1)
n=25 Participants
Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight \</= 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally for a total of 72 weeks. After Week 48, participants were administered a lower dose of PEG-IFN alfa-2a of 135 mcg/week until Week 72. Participants were randomized to Group B based on the presence of an EVR defined as non-detectable serum HCV RNA (\< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline in serum HCV RNA by quantitative PCR, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
|
PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2)
n=20 Participants
Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dosage of 1,000 mg/day (for participants with a body weight ≤ 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally for a total of 48 weeks. Participants with a positive HCV RNA level at Week 4 (≥ 15 IU/ml) and negative HCV RNA level at Week 8 (≤ 15 IU/ml) were assigned to group E. Participants had a treatment-free follow-up period of 24 weeks.
|
PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 1)
n=42 Participants
Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight \</= 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally for a total of 24 weeks. Participants with a RVR at Week 4 of treatment \[HCV RNA level, \<50 IU/ml by qualitative PCR assay, COBAS Amplicor HCV Test, version 2.0\] were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks.
|
PEG-IFN Alfa-2a + Ribavirin (Not Randomized) (Part 1)
n=45 Participants
Eligible participants who were not randomized to any treatment group in Part 1 of the study were included in this group. These participants were a part of the safety analysis population which included participants who received at least on dose of (either) the study drug (PEG-IFN alfa-2a and/or ribavirin) and had at least one post-baseline safety assessment.
|
PEG-IFN Alfa-2a + Ribavirin (Not Assigned) (Part 2)
n=8 Participants
Eligible participants who were not assigned to any treatment group in Part 2 were included in this group. These participants were a part of the safety analysis population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a and/or ribavirin) and had at least one post-baseline safety assessment.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events and Serious Adverse Events (Part 2)
Number of participants with any AE
|
36 Number of participants
|
25 Number of participants
|
19 Number of participants
|
40 Number of participants
|
43 Number of participants
|
7 Number of participants
|
|
Number of Participants With Adverse Events and Serious Adverse Events (Part 2)
Number of participants with any SAE
|
1 Number of participants
|
3 Number of participants
|
2 Number of participants
|
5 Number of participants
|
7 Number of participants
|
1 Number of participants
|
Adverse Events
PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1)
Serious events: 22 serious events
Other events: 139 other events
Deaths: 0 deaths
PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1)
Serious events: 28 serious events
Other events: 147 other events
Deaths: 0 deaths
PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 1)
Serious events: 8 serious events
Other events: 76 other events
Deaths: 0 deaths
PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 1)
Serious events: 14 serious events
Other events: 150 other events
Deaths: 0 deaths
PEG-IFN Alfa-2a + Ribavirin (Not Randomized) (Part 1)
Serious events: 2 serious events
Other events: 9 other events
Deaths: 0 deaths
PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A1) (Part 2)
Serious events: 1 serious events
Other events: 36 other events
Deaths: 0 deaths
PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B1) (Part 2)
Serious events: 3 serious events
Other events: 25 other events
Deaths: 0 deaths
PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 2)
Serious events: 2 serious events
Other events: 19 other events
Deaths: 0 deaths
PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 2)
Serious events: 5 serious events
Other events: 40 other events
Deaths: 0 deaths
PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2)
Serious events: 7 serious events
Other events: 42 other events
Deaths: 0 deaths
PEG-IFN Alfa-2a + Ribavirin (Not Assigned) (Part 2)
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1)
n=142 participants at risk
Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and ribavirin at a dose of 1,000 mg/day (for participants with a body weight \</= 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A based on the presence of an EVR defined as non-detectable serum HCV RNA (\< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline serum HCV RNA, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
|
PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1)
n=152 participants at risk
Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight \</= 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally for a total of 72 weeks. After Week 48, participants were administered a lower dose of PEG-IFN alfa-2a of 135 mcg/week until Week 72. Participants were randomized to Group B based on the presence of an EVR defined as non-detectable serum HCV RNA (\< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline in serum HCV RNA by quantitative PCR, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
|
PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 1)
n=78 participants at risk
Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight \</= 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally; initially for 24 weeks. Participants without an EVR at Week 12 (\< 2-log10 decrease in HCV RNA as compared with baseline) were assigned to Group C and received treatment until Week 24. If HCV RNA became non-detectable at Week 24 then treatment was continued for a total of 72 weeks. Participants were administered a lower dose of PEG-IFN alfa-2a after Week 48 (135 mcg/week, until Week 72). Participants with detectable HCV RNA (\>= 50 IU/ml) at Week 24 were required to discontinue treatment. Participants had a treatment-free follow-up period of 24 weeks.
|
PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 1)
n=156 participants at risk
Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight \</= 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally for a total of 24 weeks. Participants with a RVR at Week 4 of treatment \[HCV RNA level, \<50 IU/ml by qualitative PCR assay, COBAS Amplicor HCV Test, version 2.0\] were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks.
|
PEG-IFN Alfa-2a + Ribavirin (Not Randomized) (Part 1)
n=12 participants at risk
Eligible participants who were not randomized to any treatment group in Part 1 of the study were included in this group. These participants were a part of the safety analysis population which included participants who received at least on dose of (either) the study drug (PEG-IFN alfa-2a and/or ribavirin) and had at least one post-baseline safety assessment.
|
PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A1) (Part 2)
n=36 participants at risk
Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight \</= 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A1 if they showed positive HCV RNA level (\>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or \> 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
|
PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B1) (Part 2)
n=25 participants at risk
Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 72 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight \</= 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally for a total of 72 weeks. Participants were randomized to Group B1 if they showed positive HCV RNA level (\>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or \> 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
|
PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 2)
n=20 participants at risk
Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight \</= 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally; initially for 24 weeks. Participants without a \> 2-log10 drop of HCV RNA level at Week 12 were assigned to Group C (Part 2). For participants who were HCV RNA-positive at Week 24, treatment was stopped. For participants who were negative for HCV RNA at Week 24, treatment was continued for a total of 72 weeks. Participants had a treatment-free follow-up period of 24 weeks.
|
PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 2)
n=42 participants at risk
Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight \</= 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally for a total of 24 weeks. Participants with a negative HCV-RNA level at Week 4 (\< 15 IU/ml, TaqMan HCV Test) were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks.
|
PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2)
n=45 participants at risk
Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dosage of 1,000 mg/day (for participants with a body weight \</= 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally for a total of 48 weeks. Participants with a positive HCV RNA level at Week 4 (\>/= 15 IU/ml, TaqMan HCV Test) and negative HCV RNA level at Week 8 (\</= 15 IU/ml, TaqMan HCV Test) were assigned to Group E. Participants had a treatment-free follow-up period of 24 weeks.
|
PEG-IFN Alfa-2a + Ribavirin (Not Assigned) (Part 2)
n=8 participants at risk
Eligible participants who were not assigned to any treatment group in Part 2 were included in this group. These participants were a part of the safety analysis population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a and/or ribavirin) and had at least one post-baseline safety assessment.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Reproductive system and breast disorders
Ovarian Cyst
|
0.00%
0/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
8.3%
1/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian Neoplasm
|
0.00%
0/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
8.3%
1/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Pneumonia
|
1.4%
2/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.66%
1/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
12.5%
1/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.66%
1/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
2.2%
1/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
1.3%
2/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Acute hepatitis B
|
0.70%
1/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Appendicitis
|
0.70%
1/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
1.3%
1/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Enterocolitis infectious
|
0.70%
1/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Epiglottitis
|
0.00%
0/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.66%
1/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
1.3%
1/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Gingival infection
|
0.70%
1/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Infection
|
0.00%
0/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.66%
1/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.00%
0/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.66%
1/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Scrotal abscess
|
0.00%
0/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.66%
1/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
1.3%
1/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Psychiatric disorders
Depression
|
1.4%
2/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
2.6%
2/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.64%
1/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Psychiatric disorders
Suicide attempt
|
0.70%
1/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.66%
1/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.64%
1/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Psychiatric disorders
Alcohol abuse
|
0.70%
1/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
2.2%
1/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Psychiatric disorders
Depression suicidal
|
0.00%
0/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.64%
1/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Psychiatric disorders
Drug abuse
|
0.00%
0/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
2.4%
1/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Psychiatric disorders
Schizoaffective disorder
|
0.00%
0/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
2.4%
1/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Gastritis
|
0.70%
1/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.66%
1/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.64%
1/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
5.0%
1/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.70%
1/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.66%
1/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
2.4%
1/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Portal hypertensive gastropathy
|
0.00%
0/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
1.3%
1/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.64%
1/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Vascular disorders
Thrombosis
|
0.70%
1/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.66%
1/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Vascular disorders
Circulatory collapse
|
0.00%
0/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
8.3%
1/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Vascular disorders
Cryoglobulinaemia
|
0.00%
0/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
4.0%
1/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Vascular disorders
Deep vein thrombosis
|
0.70%
1/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Vascular disorders
Subclavian artery stenosis
|
0.00%
0/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.66%
1/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.64%
1/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
1.3%
2/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.64%
1/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
4.4%
2/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.70%
1/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
0.00%
0/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.66%
1/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
General disorders
Influenza Like Illness
|
0.00%
0/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.66%
1/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Eye disorders
Cataract
|
0.00%
0/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
2.4%
1/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Endocrine disorders
Basedow's Disease
|
0.70%
1/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.00%
0/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
2.8%
1/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine Leiomyoma
|
0.00%
0/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.66%
1/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
0.00%
0/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.64%
1/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
Type 2 Diabetes Mellitus
|
0.70%
1/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Ear and labyrinth disorders
Sudden Hearing Loss
|
0.70%
1/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.66%
1/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Surgical and medical procedures
Inguinal Hernia Repair
|
0.00%
0/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.66%
1/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Surgical and medical procedures
Intervertebral Disc Operation
|
0.00%
0/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.66%
1/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Surgical and medical procedures
Ovarian Cystectomy
|
0.00%
0/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.66%
1/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Surgical and medical procedures
Tonsillectomy
|
0.00%
0/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.66%
1/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Renal and urinary disorders
Cystitis Haemorrhagic
|
0.70%
1/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.70%
1/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Renal and urinary disorders
Renal Failure
|
0.00%
0/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
4.0%
1/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.70%
1/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
1.3%
1/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
|
0.00%
0/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
1.3%
1/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Hepatobiliary disorders
Cholecystitis Acute
|
0.70%
1/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.00%
0/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
1.3%
1/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Hepatobiliary disorders
Jaundice Cholestatic
|
0.00%
0/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
5.0%
1/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Social circumstances
Pregnancy Of Partner
|
0.00%
0/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
2.0%
3/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
1.3%
2/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.00%
0/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
1.3%
2/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
2.4%
1/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
4.4%
2/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.66%
1/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
4.0%
1/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Alveolitis
|
0.00%
0/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.66%
1/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.00%
0/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.66%
1/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.64%
1/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
2.4%
1/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Sarcoidosis
|
0.00%
0/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.66%
1/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.66%
1/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Nervous system disorders
Epilepsy
|
0.70%
1/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
4.0%
1/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Nervous system disorders
Carpal Tunnel Syndrome
|
0.00%
0/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.66%
1/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Nervous system disorders
Cerebral Haemorrhage
|
0.00%
0/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
2.2%
1/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Nervous system disorders
Mononeuritis
|
0.00%
0/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.66%
1/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Nervous system disorders
Syncope
|
0.70%
1/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Cardiac disorders
Acute Coronary Syndrome
|
0.00%
0/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.66%
1/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.00%
0/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.66%
1/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Cardiac disorders
Arteriosclerosis Coronary Artery
|
0.00%
0/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.66%
1/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.66%
1/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.64%
1/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
1.3%
1/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.66%
1/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
Other adverse events
| Measure |
PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1)
n=142 participants at risk
Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and ribavirin at a dose of 1,000 mg/day (for participants with a body weight \</= 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A based on the presence of an EVR defined as non-detectable serum HCV RNA (\< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline serum HCV RNA, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
|
PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1)
n=152 participants at risk
Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight \</= 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally for a total of 72 weeks. After Week 48, participants were administered a lower dose of PEG-IFN alfa-2a of 135 mcg/week until Week 72. Participants were randomized to Group B based on the presence of an EVR defined as non-detectable serum HCV RNA (\< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline in serum HCV RNA by quantitative PCR, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
|
PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 1)
n=78 participants at risk
Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight \</= 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally; initially for 24 weeks. Participants without an EVR at Week 12 (\< 2-log10 decrease in HCV RNA as compared with baseline) were assigned to Group C and received treatment until Week 24. If HCV RNA became non-detectable at Week 24 then treatment was continued for a total of 72 weeks. Participants were administered a lower dose of PEG-IFN alfa-2a after Week 48 (135 mcg/week, until Week 72). Participants with detectable HCV RNA (\>= 50 IU/ml) at Week 24 were required to discontinue treatment. Participants had a treatment-free follow-up period of 24 weeks.
|
PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 1)
n=156 participants at risk
Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight \</= 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally for a total of 24 weeks. Participants with a RVR at Week 4 of treatment \[HCV RNA level, \<50 IU/ml by qualitative PCR assay, COBAS Amplicor HCV Test, version 2.0\] were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks.
|
PEG-IFN Alfa-2a + Ribavirin (Not Randomized) (Part 1)
n=12 participants at risk
Eligible participants who were not randomized to any treatment group in Part 1 of the study were included in this group. These participants were a part of the safety analysis population which included participants who received at least on dose of (either) the study drug (PEG-IFN alfa-2a and/or ribavirin) and had at least one post-baseline safety assessment.
|
PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A1) (Part 2)
n=36 participants at risk
Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight \</= 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A1 if they showed positive HCV RNA level (\>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or \> 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
|
PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B1) (Part 2)
n=25 participants at risk
Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 72 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight \</= 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally for a total of 72 weeks. Participants were randomized to Group B1 if they showed positive HCV RNA level (\>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or \> 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
|
PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 2)
n=20 participants at risk
Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight \</= 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally; initially for 24 weeks. Participants without a \> 2-log10 drop of HCV RNA level at Week 12 were assigned to Group C (Part 2). For participants who were HCV RNA-positive at Week 24, treatment was stopped. For participants who were negative for HCV RNA at Week 24, treatment was continued for a total of 72 weeks. Participants had a treatment-free follow-up period of 24 weeks.
|
PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 2)
n=42 participants at risk
Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight \</= 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally for a total of 24 weeks. Participants with a negative HCV-RNA level at Week 4 (\< 15 IU/ml, TaqMan HCV Test) were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks.
|
PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2)
n=45 participants at risk
Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dosage of 1,000 mg/day (for participants with a body weight \</= 75 kg) or 1,200 mg/day (for participants with a body weight \> 75 kg) orally for a total of 48 weeks. Participants with a positive HCV RNA level at Week 4 (\>/= 15 IU/ml, TaqMan HCV Test) and negative HCV RNA level at Week 8 (\</= 15 IU/ml, TaqMan HCV Test) were assigned to Group E. Participants had a treatment-free follow-up period of 24 weeks.
|
PEG-IFN Alfa-2a + Ribavirin (Not Assigned) (Part 2)
n=8 participants at risk
Eligible participants who were not assigned to any treatment group in Part 2 were included in this group. These participants were a part of the safety analysis population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a and/or ribavirin) and had at least one post-baseline safety assessment.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
General disorders
Fatigue
|
60.6%
86/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
61.8%
94/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
44.9%
35/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
46.2%
72/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
33.3%
4/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
55.6%
20/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
56.0%
14/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
55.0%
11/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
50.0%
21/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
66.7%
30/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
12.5%
1/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
General disorders
Influenza Like Illness
|
42.3%
60/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
37.5%
57/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
52.6%
41/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
39.1%
61/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
41.7%
5/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
41.7%
15/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
56.0%
14/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
35.0%
7/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
31.0%
13/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
31.1%
14/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
12.5%
1/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
General disorders
Pyrexia
|
20.4%
29/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
22.4%
34/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
11.5%
9/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
9.0%
14/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
16.7%
2/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
13.9%
5/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
20.0%
5/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
14.3%
6/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
15.6%
7/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
General disorders
Asthenia
|
2.8%
4/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
5.3%
8/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
1.3%
1/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.64%
1/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
2.8%
1/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
5.0%
1/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
2.2%
1/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
General disorders
Chills
|
2.8%
4/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
3.3%
5/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
2.6%
2/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.64%
1/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
2.8%
1/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
4.0%
1/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
4.8%
2/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
12.5%
1/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
General disorders
Chest Pain
|
2.8%
4/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
1.3%
2/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
1.3%
1/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
1.3%
2/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
5.6%
2/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
4.0%
1/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
5.0%
1/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
4.4%
2/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
General disorders
Irritability
|
1.4%
2/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.66%
1/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
1.3%
1/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
1.3%
2/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
5.6%
2/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
5.0%
1/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
General disorders
Injection Site erythema
|
0.00%
0/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
1.3%
2/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
1.3%
1/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.64%
1/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
8.0%
2/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
2.4%
1/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
General disorders
Application Site erythema
|
0.00%
0/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
8.3%
1/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
24.6%
35/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
25.7%
39/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
19.2%
15/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
15.4%
24/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
16.7%
2/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
16.7%
6/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
28.0%
7/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
5.0%
1/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
11.9%
5/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
15.6%
7/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
12.5%
1/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
25.4%
36/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
17.8%
27/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
24.4%
19/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
11.5%
18/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
16.7%
2/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
16.7%
6/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
20.0%
5/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
15.0%
3/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
19.0%
8/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
28.9%
13/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
12.5%
1/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
20.4%
29/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
25.7%
39/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
10.3%
8/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
17.3%
27/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
11.1%
4/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
12.0%
3/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
5.0%
1/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
16.7%
7/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
15.6%
7/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
12.0%
17/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
20.4%
31/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
10.3%
8/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
12.2%
19/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
8.3%
1/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
19.4%
7/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
24.0%
6/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
10.0%
2/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
2.4%
1/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
17.8%
8/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Skin Fissures
|
7.7%
11/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
7.9%
12/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
3.8%
6/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
2.4%
1/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
2.2%
1/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
3.5%
5/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
10.5%
16/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
1.3%
1/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
1.3%
2/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
5.6%
2/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
4.0%
1/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
6.7%
3/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
2.1%
3/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
2.6%
4/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
2.6%
2/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
2.6%
4/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
5.6%
2/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
5.0%
1/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
4.8%
2/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
2.1%
3/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
1.3%
1/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
8.3%
1/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
2.8%
1/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
4.0%
1/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Psychiatric disorders
Depression
|
21.1%
30/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
28.9%
44/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
25.6%
20/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
17.3%
27/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
19.4%
7/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
4.0%
1/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
5.0%
1/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
11.9%
5/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
15.6%
7/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
12.5%
1/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Psychiatric disorders
Insomnia
|
11.3%
16/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
15.8%
24/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
11.5%
9/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
10.3%
16/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
8.3%
1/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
13.9%
5/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
12.0%
3/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
11.9%
5/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
11.1%
5/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Psychiatric disorders
Sleep Disorder
|
13.4%
19/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
17.8%
27/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
10.3%
8/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
8.3%
13/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
8.3%
1/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
5.6%
2/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
8.0%
2/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
2.4%
1/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
4.4%
2/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Psychiatric disorders
Depressed Mood
|
4.9%
7/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
4.6%
7/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
3.8%
3/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
5.1%
8/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
8.3%
3/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
9.5%
4/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
2.2%
1/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Psychiatric disorders
Aggression
|
3.5%
5/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
5.3%
8/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
5.1%
4/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
1.9%
3/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
8.3%
1/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
2.8%
1/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
5.0%
1/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
6.7%
3/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Psychiatric disorders
Panic Attack
|
1.4%
2/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.66%
1/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
1.3%
1/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
8.3%
1/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
2.4%
1/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Psychiatric disorders
Affect Lability
|
0.00%
0/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
1.3%
2/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
1.3%
1/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
2.2%
1/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
12.5%
1/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Psychiatric disorders
Libido Decreased
|
0.70%
1/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
8.3%
1/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
4.4%
2/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Psychiatric disorders
Alcoholism
|
0.00%
0/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
2.8%
1/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
12.5%
1/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Psychiatric disorders
Apathy
|
0.00%
0/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
12.5%
1/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Psychiatric disorders
Paranoia
|
0.00%
0/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
12.5%
1/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Nausea
|
19.0%
27/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
14.5%
22/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
14.1%
11/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
9.6%
15/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
27.8%
10/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
12.0%
3/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
10.0%
2/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
16.7%
7/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
15.6%
7/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
12.5%
1/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
14.1%
20/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
10.5%
16/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
14.1%
11/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
14.7%
23/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
8.3%
1/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
2.8%
1/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
4.0%
1/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
9.5%
4/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
15.6%
7/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Diarrhoea
|
14.8%
21/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
11.8%
18/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
3.8%
3/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
8.3%
13/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
11.1%
4/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
4.0%
1/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
10.0%
2/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
9.5%
4/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
4.4%
2/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Dyspepsia
|
4.9%
7/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
9.2%
14/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
1.3%
1/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
3.8%
6/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
2.8%
1/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
4.8%
2/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
2.2%
1/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Vomiting
|
4.2%
6/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
4.6%
7/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
1.3%
1/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
4.5%
7/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
16.7%
2/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
5.6%
2/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
4.0%
1/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
5.0%
1/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
4.8%
2/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
2.2%
1/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
12.5%
1/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Abdominal Pain
|
4.2%
6/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
7.2%
11/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
1.3%
2/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
8.3%
1/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
4.0%
1/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
2.2%
1/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Toothache
|
1.4%
2/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
5.3%
8/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
1.3%
1/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
1.3%
2/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
5.6%
2/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
2.4%
1/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
2.2%
1/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Dry Mouth
|
2.1%
3/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
3.3%
5/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
1.3%
1/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.64%
1/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
8.3%
1/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
5.6%
2/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
4.0%
1/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
5.0%
1/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
2.4%
1/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Constipation
|
2.8%
4/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
3.3%
5/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
1.3%
1/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
8.0%
2/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Gastrointestinal disorders
Flatulence
|
0.70%
1/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
3.3%
5/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
1.3%
1/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.64%
1/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
2.8%
1/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
4.0%
1/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
5.0%
1/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Blood and lymphatic system disorders
Anaemia
|
22.5%
32/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
21.7%
33/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
11.5%
9/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
14.7%
23/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
19.4%
7/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
20.0%
5/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
15.0%
3/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
7.1%
3/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
22.2%
10/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
12.5%
1/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Blood and lymphatic system disorders
Leukopenia
|
21.8%
31/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
13.2%
20/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
14.1%
11/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
12.2%
19/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
8.3%
3/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
8.0%
2/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
2.4%
1/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
6.7%
3/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
6.3%
9/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
9.9%
15/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
5.1%
4/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
1.9%
3/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
5.6%
2/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
8.0%
2/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
9.5%
4/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
15.6%
7/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.8%
4/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
5.3%
8/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
2.6%
2/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
1.9%
3/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
5.6%
2/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
4.0%
1/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
5.0%
1/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
1.4%
2/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
3.3%
5/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
2.6%
2/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.64%
1/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
8.0%
2/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
5.0%
1/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
2.2%
1/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Blood and lymphatic system disorders
Haemolysis
|
0.00%
0/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
12.5%
1/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.8%
21/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
15.8%
24/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
15.4%
12/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
13.5%
21/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
22.2%
8/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
24.0%
6/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
10.0%
2/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
9.5%
4/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
17.8%
8/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
18.3%
26/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
16.4%
25/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
12.8%
10/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
8.3%
13/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
25.0%
3/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
11.1%
4/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
8.0%
2/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
7.1%
3/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
6.7%
3/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
12.5%
1/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional
|
4.2%
6/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
5.3%
8/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
3.8%
3/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
2.6%
4/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
5.6%
2/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
8.0%
2/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
15.0%
3/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
2.4%
1/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
6.7%
3/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
7.7%
11/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
7.2%
11/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
5.8%
9/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
4.0%
1/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.5%
5/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
3.9%
6/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
1.3%
1/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
2.6%
4/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
2.8%
1/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
5.0%
1/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
2.4%
1/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.9%
24/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
17.8%
27/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
12.8%
10/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
8.3%
13/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
19.4%
7/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
24.0%
6/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
10.0%
2/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
7.1%
3/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
15.6%
7/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.5%
12/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
15.1%
23/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
10.3%
8/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
10.3%
16/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
16.7%
6/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
12.0%
3/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
4.8%
2/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
4.4%
2/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
7.0%
10/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
5.9%
9/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
2.6%
2/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
3.8%
6/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
4.0%
1/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
5.0%
1/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
9.5%
4/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
6.7%
3/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
3.5%
5/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
5.9%
9/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
1.3%
1/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
1.9%
3/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
4.0%
1/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
2.2%
1/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
2.1%
3/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
2.0%
3/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
1.3%
1/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
6.7%
3/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
11.3%
16/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
17.1%
26/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
7.7%
6/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
14.1%
22/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
27.8%
10/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
12.0%
3/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
15.0%
3/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
9.5%
4/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
8.9%
4/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
12.5%
1/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
12.0%
17/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
10.5%
16/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
11.5%
9/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
10.9%
17/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
8.3%
3/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
4.0%
1/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
5.0%
1/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
2.4%
1/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
2.2%
1/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
13.4%
19/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
11.2%
17/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
10.3%
8/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
4.5%
7/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
2.8%
1/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
4.0%
1/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
2.2%
1/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
Appetite Disorder
|
0.00%
0/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
8.3%
1/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Nervous system disorders
Headache
|
29.6%
42/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
25.0%
38/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
12.8%
10/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
16.7%
26/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
8.3%
1/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
22.2%
8/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
12.0%
3/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
25.0%
5/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
19.0%
8/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
22.2%
10/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
12.5%
1/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.66%
1/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
1.3%
2/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
5.6%
2/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
8.0%
2/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
2.4%
1/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Nasopharyngitis
|
11.3%
16/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
15.1%
23/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
7.7%
6/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
5.8%
9/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
5.6%
2/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
4.0%
1/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
5.0%
1/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
4.4%
2/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Bronchitis
|
3.5%
5/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
9.2%
14/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
6.4%
5/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
4.5%
7/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
5.6%
2/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
4.0%
1/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
9.5%
4/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
4.4%
2/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Influenza
|
3.5%
5/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
4.6%
7/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
2.6%
2/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
3.2%
5/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
2.8%
1/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
4.0%
1/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
5.0%
1/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Urinary Tract Infection
|
2.8%
4/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
2.0%
3/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
2.6%
2/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.64%
1/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
2.8%
1/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
4.0%
1/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
4.8%
2/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
6.7%
3/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Oral Herpes
|
2.8%
4/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
3.3%
5/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
1.3%
1/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.64%
1/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
8.0%
2/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
5.0%
1/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
2.2%
1/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Rhinitis
|
1.4%
2/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
4.6%
7/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
2.6%
2/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.64%
1/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
2.8%
1/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
4.0%
1/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
5.0%
1/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Abscess
|
1.4%
2/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
3.9%
6/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
8.3%
1/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Infections and infestations
Pulpitis Dental
|
0.00%
0/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
1.3%
2/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
5.0%
1/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Endocrine disorders
Hypothyroidism
|
5.6%
8/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
15.1%
23/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
5.1%
4/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
5.1%
8/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
2.8%
1/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
4.0%
1/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
2.2%
1/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Endocrine disorders
Hyperthyroidism
|
4.9%
7/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
6.6%
10/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
3.8%
3/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
3.8%
6/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
8.3%
1/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
5.6%
2/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
2.4%
1/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Ear and labyrinth disorders
Vertigo
|
11.3%
16/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
13.2%
20/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
10.3%
8/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
5.8%
9/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
8.3%
3/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
8.0%
2/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
5.0%
1/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
2.4%
1/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
2.2%
1/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Investigations
Weight Decreased
|
12.0%
17/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
9.2%
14/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
3.8%
3/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
5.8%
9/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
2.8%
1/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
4.0%
1/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
10.0%
2/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
2.2%
1/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Eye disorders
Visual Impairment
|
2.8%
4/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
5.3%
8/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
1.3%
1/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
1.9%
3/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
2.8%
1/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Eye disorders
Conjunctivitis
|
2.1%
3/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
3.9%
6/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
1.3%
1/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.64%
1/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
4.0%
1/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
5.0%
1/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
2.4%
1/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
2.2%
1/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Eye disorders
Dry Eye
|
2.1%
3/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
2.0%
3/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
1.3%
1/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
1.9%
3/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
2.8%
1/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
4.0%
1/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
5.0%
1/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
2.2%
1/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Eye disorders
Abnormal Sensation In Eye
|
0.00%
0/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
12.5%
1/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Eye disorders
Retinal Detachment
|
0.00%
0/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
8.3%
1/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Cardiac disorders
Cardiovascular Disorder
|
2.1%
3/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
5.3%
8/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Cardiac disorders
Ventricular Tachycardia
|
0.00%
0/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
8.3%
1/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.64%
1/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
8.3%
1/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/142 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/152 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/78 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/156 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/12 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/36 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/25 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
5.0%
1/20 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/42 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/45 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
0.00%
0/8 • Up to Week 96
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
|
Additional Information
Roche Trial Information Hotline
F. Hoffmann-La Roche AG
Phone: +41 61 6878333
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER