Trial Outcomes & Findings for A Study of Induction Dosing With Peginterferon Alfa-2a and Ribavirin in Participants With Chronic Hepatitis C (CHC) Genotype 1 Infection (NCT NCT00192647)

NCT ID: NCT00192647

Last Updated: 2016-08-04

Results Overview

Sustained virological response was calculated as the percentage of participants with undetectable (less than \[\<\] 15 international units per milliliter \[IU/mL\]) hepatitis C virus (HCV) ribonucleic acid (RNA) as measured by the Roche TaqMan HCV Test 24 weeks after completion of the scheduled 48-week treatment period.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 896 participants
• Primary outcome timeframe: Week 72
• Results posted on: 2016-08-04

Participant Flow

Out of total 896 randomized participants, 25 participants (15 in the induction group and 10 in the standard group) did not receive study drug.

Participant milestones

Measure	PEG-IFN Alfa-2a+Ribavirin - Induction Treatment Participants received 12 weeks of induction therapy with peginterferon (PEG-IFN) alfa-2a (Pegasys), 360 micrograms (mcg) subcutaneous (SC) once weekly, along with ribavirin, 1000 or 1200 milligrams (mg) orally daily in divided doses, with the dose determined based on body weight. Thereafter, the dose of PEG-IFN alfa-2a was reduced to 180 mcg SC once weekly and the ribavirin dose was maintained for the next 36 weeks of treatment.	PEG-IFN Alfa-2a+Ribavirin - Standard Treatment Participants received 48 weeks of standard therapy with PEG-IFN alfa-2a, 180 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight.
Overall Study STARTED	448	448
Overall Study Treated	433	438
Overall Study COMPLETED	320	302
Overall Study NOT COMPLETED	128	146

Reasons for withdrawal

Measure	PEG-IFN Alfa-2a+Ribavirin - Induction Treatment Participants received 12 weeks of induction therapy with peginterferon (PEG-IFN) alfa-2a (Pegasys), 360 micrograms (mcg) subcutaneous (SC) once weekly, along with ribavirin, 1000 or 1200 milligrams (mg) orally daily in divided doses, with the dose determined based on body weight. Thereafter, the dose of PEG-IFN alfa-2a was reduced to 180 mcg SC once weekly and the ribavirin dose was maintained for the next 36 weeks of treatment.	PEG-IFN Alfa-2a+Ribavirin - Standard Treatment Participants received 48 weeks of standard therapy with PEG-IFN alfa-2a, 180 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight.
Overall Study Death	1	1
Overall Study Adverse Event	35	29
Overall Study Laboratory Test Abnormality	4	2
Overall Study Insufficient Therapeutic Response	53	83
Overall Study Entry Criteria Violation	6	6
Overall Study Protocol Violation	3	1
Overall Study Refused Treatment/Did not Cooperate	10	8
Overall Study Failure to Return	11	13
Overall Study Other/Administrative	5	3

Baseline Characteristics

A Study of Induction Dosing With Peginterferon Alfa-2a and Ribavirin in Participants With Chronic Hepatitis C (CHC) Genotype 1 Infection

Baseline characteristics by cohort

Measure	PEG-IFN Alfa-2a+Ribavirin - Induction Treatment n=433 Participants Participants received 12 weeks of induction therapy with PEG-IFN alfa-2a, 360 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight. Thereafter, the dose of PEG-IFN alfa-2a was reduced to 180 mcg SC once weekly and the ribavirin dose was maintained for the next 36 weeks of treatment.	PEG-IFN Alfa-2a+Ribavirin - Standard Treatment n=438 Participants Participants received 48 weeks of standard therapy with PEG-IFN alfa-2a, 180 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight.	Total n=871 Participants Total of all reporting groups
Age, Continuous	43.6 years STANDARD_DEVIATION 9.55 • n=5 Participants	43.3 years STANDARD_DEVIATION 9.19 • n=7 Participants	43.4 years STANDARD_DEVIATION 9.37 • n=5 Participants
Sex: Female, Male Female	135 Participants n=5 Participants	153 Participants n=7 Participants	288 Participants n=5 Participants
Sex: Female, Male Male	298 Participants n=5 Participants	285 Participants n=7 Participants	583 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 72

Population: ITT analysis population

Sustained virological response was calculated as the percentage of participants with undetectable (less than [<] 15 international units per milliliter [IU/mL]) hepatitis C virus (HCV) ribonucleic acid (RNA) as measured by the Roche TaqMan HCV Test 24 weeks after completion of the scheduled 48-week treatment period.

Outcome measures

Measure	PEG-IFN Alfa-2a+Ribavirin - Induction Treatment n=433 Participants Participants received 12 weeks of induction therapy with PEG-IFN alfa-2a, 360 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight. Thereafter, the dose of PEG-IFN alfa-2a was reduced to 180 mcg SC once weekly and the ribavirin dose was maintained for the next 36 weeks of treatment.	PEG-IFN Alfa-2a+Ribavirin - Standard Treatment n=438 Participants Participants received 48 weeks of standard therapy with PEG-IFN alfa-2a, 180 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight.
Percentage of Participants With Sustained Virological Response According to Scheduled Treatment Period	53 percentage of participants	50 percentage of participants

SECONDARY outcome

Timeframe: Weeks 48

Population: ITT analysis population

Virological response at the end of the scheduled treatment period was defined as the percentage of participants with undetectable (<15 IU/mL) HCV RNA as measured by the Roche TaqMan HCV Test at Week 48.

Outcome measures

Measure	PEG-IFN Alfa-2a+Ribavirin - Induction Treatment n=433 Participants Participants received 12 weeks of induction therapy with PEG-IFN alfa-2a, 360 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight. Thereafter, the dose of PEG-IFN alfa-2a was reduced to 180 mcg SC once weekly and the ribavirin dose was maintained for the next 36 weeks of treatment.	PEG-IFN Alfa-2a+Ribavirin - Standard Treatment n=438 Participants Participants received 48 weeks of standard therapy with PEG-IFN alfa-2a, 180 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight.
Percentage of Participants With End-of-Treatment Virological Response According to Scheduled Treatment Period	70 percentage of participants	66 percentage of participants

SECONDARY outcome

Timeframe: Weeks 4, 8, 12, and 24

Population: ITT analysis population

Virological response was defined as undetectable HCV RNA (<15 IU/mL) as measured by the Roche TaqMan HCV Test. Participants without HCV RNA measurements at a study week are considered non responders at that study week.

Outcome measures

Measure	PEG-IFN Alfa-2a+Ribavirin - Induction Treatment n=433 Participants Participants received 12 weeks of induction therapy with PEG-IFN alfa-2a, 360 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight. Thereafter, the dose of PEG-IFN alfa-2a was reduced to 180 mcg SC once weekly and the ribavirin dose was maintained for the next 36 weeks of treatment.	PEG-IFN Alfa-2a+Ribavirin - Standard Treatment n=438 Participants Participants received 48 weeks of standard therapy with PEG-IFN alfa-2a, 180 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight.
Percentage of Participants With Virological Responses Over Time Week 4	36.0 percentage of participants	26.3 percentage of participants
Percentage of Participants With Virological Responses Over Time Week 8	60.5 percentage of participants	49.8 percentage of participants
Percentage of Participants With Virological Responses Over Time Week 12	74.4 percentage of participants	61.6 percentage of participants
Percentage of Participants With Virological Responses Over Time Week 24	75.1 percentage of participants	67.8 percentage of participants

SECONDARY outcome

Timeframe: Actual end of treatment (Week 48) up to last follow up (maximum up to Week 72)

Population: ITT analysis population. Here, number of participants analyzed signifies participants who had end of treatment virologic response and had HCV RNA measurement available during follow-up.

Relapse was determined based on virological response at the actual end of treatment and was calculated by dividing the number of participants who achieved a virological response at end of treatment but later had detectable HCV RNA at the last assessment post-treatment by the number of participants with a virological response at end of treatment, defined as undetectable HCV RNA (<15 IU/mL). Participants who achieved a virological response at end of treatment but did not have any HCV RNA assessment during follow-up were excluded and were not considered as having relapsed. However, if no assessment was available within the end of-treatment time window but the participant had a sustained virological response according to the actual treatment period, backward imputation was used and the participant was considered to have achieved an end-of-treatment virological response in the analysis.

Outcome measures

Measure	PEG-IFN Alfa-2a+Ribavirin - Induction Treatment n=297 Participants Participants received 12 weeks of induction therapy with PEG-IFN alfa-2a, 360 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight. Thereafter, the dose of PEG-IFN alfa-2a was reduced to 180 mcg SC once weekly and the ribavirin dose was maintained for the next 36 weeks of treatment.	PEG-IFN Alfa-2a+Ribavirin - Standard Treatment n=280 Participants Participants received 48 weeks of standard therapy with PEG-IFN alfa-2a, 180 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight.
Percentage of Participants With Relapse of End-of-treatment Virological Response	24 percentage of participants	22 percentage of participants

SECONDARY outcome

Timeframe: Weeks 4, 12, and 72

Population: ITT analysis population; participants who did not have an HCV RNA measurement at Week 4 or 12 and at Week 72 were excluded from the analysis. Here, number of participants analyzed = number of participants evaluable for this outcome measure; 'n' = number of participants analyzed at specified time point for reported group, respectively.

The ability of virological responses to predict sustained virological response according to the scheduled treatment periods was assessed in terms of positive predictive value (PPV) and negative predictive value (NPV). The PPV indicates probability of achievement of viral suppression (undetectable HCV RNA) for achieving a sustained virological response and the NPV indicates probability of not achieving viral suppression for not achieving a sustained virological response. The PPV at Week 4 or 12 was calculated as the number of participants who achieved viral suppression both at Week 4 or 12 and at Week 72 divided by the number of participants who achieved viral suppression at Week 4 or 12, multiplied by 100. The NPV at Week 4 or 12 was calculated as the number of participants who failed to achieve viral suppression at Week 4 or 12 and at Week 72 divided by the number of participants who failed to achieve viral suppression at Week 4 or 12, multiplied by 100.

Outcome measures

Measure	PEG-IFN Alfa-2a+Ribavirin - Induction Treatment n=416 Participants Participants received 12 weeks of induction therapy with PEG-IFN alfa-2a, 360 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight. Thereafter, the dose of PEG-IFN alfa-2a was reduced to 180 mcg SC once weekly and the ribavirin dose was maintained for the next 36 weeks of treatment.	PEG-IFN Alfa-2a+Ribavirin - Standard Treatment n=419 Participants Participants received 48 weeks of standard therapy with PEG-IFN alfa-2a, 180 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight.
Percentage of Participants With Predictive Values of Virological Response for Sustained Virological Response Week 4: NPV (n= 416, 419)	60 percentage of participants	60 percentage of participants
Percentage of Participants With Predictive Values of Virological Response for Sustained Virological Response Week 12: PPV (n= 412, 413)	66 percentage of participants	72 percentage of participants
Percentage of Participants With Predictive Values of Virological Response for Sustained Virological Response Week 12: NPV (n= 412, 413)	87 percentage of participants	87 percentage of participants
Percentage of Participants With Predictive Values of Virological Response for Sustained Virological Response Week 4: PPV (n= 416, 419)	76 percentage of participants	80 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Weeks 4, 8, 12, 24, and at end of treatment (EoT) (maximum up to Week 48)

Population: ITT analysis population; Here, number of participants analyzed = number of participants evaluable for this outcome measure; 'n' = number of participants analyzed at specified time point for reported group, respectively.

The mean decrease in log10 HCV RNA levels from baseline was assessed in both the induction group and the standard group.

Outcome measures

Measure	PEG-IFN Alfa-2a+Ribavirin - Induction Treatment n=427 Participants Participants received 12 weeks of induction therapy with PEG-IFN alfa-2a, 360 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight. Thereafter, the dose of PEG-IFN alfa-2a was reduced to 180 mcg SC once weekly and the ribavirin dose was maintained for the next 36 weeks of treatment.	PEG-IFN Alfa-2a+Ribavirin - Standard Treatment n=431 Participants Participants received 48 weeks of standard therapy with PEG-IFN alfa-2a, 180 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight.
Change From Baseline in Log10 HCV RNA Values Baseline (n=427,431)	6.19 Log 10 IU/mL Standard Deviation 0.72	6.17 Log 10 IU/mL Standard Deviation 0.76
Change From Baseline in Log10 HCV RNA Values Change at Week 4 (n=410,412)	-3.42 Log 10 IU/mL Standard Deviation 1.59	-2.75 Log 10 IU/mL Standard Deviation 1.71
Change From Baseline in Log10 HCV RNA Values Change at Week 8 (n=399,406)	-4.26 Log 10 IU/mL Standard Deviation 1.36	-3.68 Log 10 IU/mL Standard Deviation 1.72
Change From Baseline in Log10 HCV RNA Values Change at EoT (n=425,426)	-4.49 Log 10 IU/mL Standard Deviation 1.44	-4.13 Log 10 IU/mL Standard Deviation 1.76
Change From Baseline in Log10 HCV RNA Values Change at Week 12 (n=406,407)	-4.57 Log 10 IU/mL Standard Deviation 1.21	-4.04 Log 10 IU/mL Standard Deviation 1.67
Change From Baseline in Log10 HCV RNA Values Change at Week 24 (n=369,369)	-4.58 Log 10 IU/mL Standard Deviation 1.37	-4.28 Log 10 IU/mL Standard Deviation 1.70

Adverse Events

PEG-IFN Alfa-2a+Ribavirin - Induction Treatment

Serious events: 46 serious events

Other events: 428 other events

Deaths: 0 deaths

PEG-IFN Alfa-2a+Ribavirin - Standard Treatment

Serious events: 45 serious events

Other events: 430 other events

Deaths: 0 deaths

Serious adverse events

Measure	PEG-IFN Alfa-2a+Ribavirin - Induction Treatment n=433 participants at risk Participants received 12 weeks of induction therapy with PEG-IFN alfa-2a, 360 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight. Thereafter, the dose of PEG-IFN alfa-2a was reduced to 180 mcg SC once weekly and the ribavirin dose was maintained for the next 36 weeks of treatment.	PEG-IFN Alfa-2a+Ribavirin - Standard Treatment n=438 participants at risk Participants received 48 weeks of standard therapy with PEG-IFN alfa-2a, 180 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight.
Infections and infestations Pneumonia	0.92% 4/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	0.23% 1/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Infections and infestations Appendicitis	0.69% 3/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	0.00% 0/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Infections and infestations Bronchopneumonia	0.46% 2/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	0.00% 0/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Infections and infestations Sepsis	0.23% 1/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	0.23% 1/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Infections and infestations Arthritis bacterial	0.00% 0/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	0.23% 1/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Infections and infestations Bartholin's abscess	0.23% 1/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	0.00% 0/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Infections and infestations Furuncle	0.00% 0/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	0.23% 1/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Infections and infestations Gastroenteritis	0.23% 1/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	0.00% 0/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Infections and infestations Klebsiella infection	0.00% 0/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	0.23% 1/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Infections and infestations Localised infection	0.00% 0/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	0.23% 1/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Infections and infestations Lower respiratory tract infection	0.00% 0/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	0.23% 1/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Infections and infestations Osteomyelitis	0.00% 0/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	0.23% 1/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Infections and infestations Sinusitis	0.23% 1/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	0.00% 0/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Infections and infestations Tonsillitis	0.00% 0/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	0.23% 1/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Infections and infestations Urinary tract infection	0.23% 1/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	0.00% 0/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	0.46% 2/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Gastrointestinal disorders Colitis	0.46% 2/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	0.00% 0/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Gastrointestinal disorders Nausea	0.23% 1/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	0.23% 1/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Gastrointestinal disorders Oesophageal varices haemorrhage	0.46% 2/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	0.00% 0/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Gastrointestinal disorders Abdominal pain	0.23% 1/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	0.00% 0/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Gastrointestinal disorders Abdominal strangulated hernia	0.23% 1/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	0.00% 0/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Gastrointestinal disorders Constipation	0.00% 0/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	0.23% 1/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Gastrointestinal disorders Diarrhoea	0.23% 1/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	0.00% 0/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Gastrointestinal disorders Erosive duodenitis	0.23% 1/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	0.00% 0/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Gastrointestinal disorders Faecaloma	0.23% 1/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	0.00% 0/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Gastrointestinal disorders Gastric stenosis	0.23% 1/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	0.00% 0/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Gastrointestinal disorders Gastritis	0.00% 0/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	0.23% 1/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Gastrointestinal disorders Mallory-Weiss syndrome	0.00% 0/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	0.23% 1/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Gastrointestinal disorders Varices oesophageal	0.00% 0/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	0.23% 1/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Gastrointestinal disorders Vomiting	0.00% 0/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	0.23% 1/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Psychiatric disorders Depression	0.23% 1/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	0.68% 3/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Psychiatric disorders Suicide attempt	0.23% 1/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	0.68% 3/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Psychiatric disorders Alcohol withdrawal syndrome	0.00% 0/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	0.23% 1/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Psychiatric disorders Anxiety	0.23% 1/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	0.00% 0/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Psychiatric disorders Delirium	0.23% 1/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	0.00% 0/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Psychiatric disorders Delirium tremens	0.00% 0/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	0.23% 1/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Psychiatric disorders Depression suicidal	0.23% 1/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	0.00% 0/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Psychiatric disorders Suicidal ideation	0.00% 0/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	0.23% 1/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Injury, poisoning and procedural complications Accidental overdose	1.4% 6/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	0.00% 0/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Injury, poisoning and procedural complications Accident	0.00% 0/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	0.23% 1/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Injury, poisoning and procedural complications Facial bones fracture	0.23% 1/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	0.00% 0/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Injury, poisoning and procedural complications Foreign body trauma	0.00% 0/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	0.23% 1/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Injury, poisoning and procedural complications Multiple injuries	0.00% 0/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	0.23% 1/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Injury, poisoning and procedural complications Overdose	0.00% 0/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	0.23% 1/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.23% 1/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	0.00% 0/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Injury, poisoning and procedural complications Spinal cord injury	0.23% 1/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	0.00% 0/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	0.68% 3/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.23% 1/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	0.23% 1/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.23% 1/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	0.00% 0/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	0.23% 1/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Respiratory, thoracic and mediastinal disorders Pharyngeal haemorrhage	0.23% 1/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	0.00% 0/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Respiratory, thoracic and mediastinal disorders Pleurisy	0.23% 1/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	0.00% 0/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Respiratory, thoracic and mediastinal disorders Pulmonary granuloma	0.00% 0/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	0.23% 1/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Respiratory, thoracic and mediastinal disorders Pulmonary sarcoidosis	0.00% 0/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	0.23% 1/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Nervous system disorders Cognitive disorder	0.23% 1/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	0.23% 1/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Nervous system disorders Headache	0.00% 0/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	0.23% 1/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Nervous system disorders Presyncope	0.00% 0/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	0.23% 1/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Nervous system disorders Syncope	0.00% 0/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	0.23% 1/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Blood and lymphatic system disorders Anaemia	0.00% 0/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	0.46% 2/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Blood and lymphatic system disorders Autoimmune thrombocytopenia	0.23% 1/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	0.00% 0/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Blood and lymphatic system disorders Neutropenia	0.23% 1/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	0.00% 0/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Cardiac disorders Acute myocardial infarction	0.00% 0/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	0.23% 1/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Cardiac disorders Angina pectoris	0.00% 0/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	0.23% 1/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Cardiac disorders Mitral valve incompetence	0.00% 0/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	0.23% 1/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Metabolism and nutrition disorders Diabetes mellitus	0.23% 1/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	0.00% 0/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Metabolism and nutrition disorders Type 1 diabetes mellitus	0.00% 0/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	0.23% 1/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.23% 1/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	0.00% 0/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Endocrine disorders Hyperthyroidism	0.23% 1/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	0.23% 1/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
General disorders Chest pain	0.00% 0/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	0.23% 1/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
General disorders Non-cardiac chest pain	0.23% 1/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	0.00% 0/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Musculoskeletal and connective tissue disorders Arthropathy	0.23% 1/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	0.00% 0/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	0.23% 1/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.23% 1/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	0.00% 0/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Reproductive system and breast disorders Bartholin's cyst	0.23% 1/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	0.00% 0/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Reproductive system and breast disorders Epididymal cyst	0.00% 0/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	0.23% 1/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Vascular disorders Aortic dissection	0.23% 1/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	0.23% 1/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Ear and labyrinth disorders Tympanic membrane perforation	0.00% 0/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	0.23% 1/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Eye disorders Optic Ischaemic Neuropathy	0.23% 1/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	0.00% 0/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Hepatobiliary disorders Cholelithiasis	0.23% 1/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	0.00% 0/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Investigations Heart rate irregular	0.23% 1/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	0.00% 0/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.23% 1/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	0.00% 0/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Renal and urinary disorders Hypotonic urinary bladder	0.00% 0/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	0.23% 1/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Skin and subcutaneous tissue disorders Psoriasis	0.00% 0/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	0.23% 1/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Surgical and medical procedures Finger amputation	0.00% 0/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	0.23% 1/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Musculoskeletal and connective tissue disorders Compartment syndrome	0.00% 0/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	0.23% 1/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.

Other adverse events

Measure	PEG-IFN Alfa-2a+Ribavirin - Induction Treatment n=433 participants at risk Participants received 12 weeks of induction therapy with PEG-IFN alfa-2a, 360 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight. Thereafter, the dose of PEG-IFN alfa-2a was reduced to 180 mcg SC once weekly and the ribavirin dose was maintained for the next 36 weeks of treatment.	PEG-IFN Alfa-2a+Ribavirin - Standard Treatment n=438 participants at risk Participants received 48 weeks of standard therapy with PEG-IFN alfa-2a, 180 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight.
Blood and lymphatic system disorders Anaemia	10.4% 45/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	8.9% 39/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Blood and lymphatic system disorders Neutropenia	13.2% 57/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	9.8% 43/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Eye disorders Dry eye	7.4% 32/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	5.7% 25/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Eye disorders Vision blurred	10.2% 44/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	8.9% 39/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Gastrointestinal disorders Abdominal pain	8.5% 37/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	7.1% 31/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Gastrointestinal disorders Constipation	5.1% 22/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	8.9% 39/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Gastrointestinal disorders Diarrhoea	23.1% 100/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	17.4% 76/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Gastrointestinal disorders Dry mouth	12.5% 54/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	10.0% 44/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Gastrointestinal disorders Mouth ulceration	9.9% 43/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	10.5% 46/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Gastrointestinal disorders Nausea	41.1% 178/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	38.4% 168/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Gastrointestinal disorders Vomiting	11.3% 49/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	11.0% 48/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
General disorders Asthenia	6.0% 26/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	3.9% 17/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
General disorders Chills	14.8% 64/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	7.8% 34/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
General disorders Fatigue	36.7% 159/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	39.7% 174/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
General disorders Influenza like illness	41.6% 180/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	41.8% 183/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
General disorders Injection site erythema	10.2% 44/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	10.5% 46/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
General disorders Injection site reaction	5.8% 25/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	5.3% 23/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
General disorders Irritability	25.2% 109/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	25.3% 111/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
General disorders Pyrexia	15.2% 66/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	10.7% 47/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Infections and infestations Lower respiratory tract infection	5.5% 24/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	3.4% 15/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Investigations Weight decreased	27.7% 120/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	19.9% 87/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Metabolism and nutrition disorders Decreased appetite	37.0% 160/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	25.8% 113/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Musculoskeletal and connective tissue disorders Arthralgia	18.9% 82/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	17.4% 76/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Musculoskeletal and connective tissue disorders Back pain	10.2% 44/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	8.9% 39/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Musculoskeletal and connective tissue disorders Muscle spasms	6.5% 28/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	3.9% 17/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Musculoskeletal and connective tissue disorders Myalgia	26.3% 114/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	22.1% 97/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Nervous system disorders Disturbance in attention	8.8% 38/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	10.5% 46/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Nervous system disorders Dizziness	19.4% 84/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	18.0% 79/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Nervous system disorders Dysgeusia	8.3% 36/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	7.1% 31/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Nervous system disorders Headache	52.4% 227/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	47.5% 208/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Nervous system disorders Lethargy	30.9% 134/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	28.1% 123/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Nervous system disorders Memory impairment	5.3% 23/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	7.5% 33/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Psychiatric disorders Anxiety	10.6% 46/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	9.8% 43/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Psychiatric disorders Depressed mood	4.2% 18/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	5.5% 24/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Psychiatric disorders Depression	19.2% 83/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	18.7% 82/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Psychiatric disorders Insomnia	45.0% 195/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	47.5% 208/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Psychiatric disorders Mood altered	5.8% 25/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	4.8% 21/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Psychiatric disorders Mood swings	7.4% 32/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	9.4% 41/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Respiratory, thoracic and mediastinal disorders Cough	16.2% 70/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	13.9% 61/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Respiratory, thoracic and mediastinal disorders Dyspnoea	9.0% 39/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	9.4% 41/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	11.1% 48/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	6.8% 30/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Respiratory, thoracic and mediastinal disorders Epistaxis	6.0% 26/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	4.3% 19/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal Pain	6.5% 28/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	6.6% 29/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Skin and subcutaneous tissue disorders Alopecia	28.2% 122/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	22.6% 99/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Skin and subcutaneous tissue disorders Dry skin	17.6% 76/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	19.6% 86/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Skin and subcutaneous tissue disorders Pruritus	17.6% 76/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	20.1% 88/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Skin and subcutaneous tissue disorders Rash	25.4% 110/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	26.5% 116/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.
Skin and subcutaneous tissue disorders Rash pruritic	5.5% 24/433 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.	3.7% 16/438 • Baseline up to Week 72 Safety analysis population included all participants who received at least 1 injection of PEG-IFN alfa-2a or 1 dose of ribavirin and had at least 1 post-baseline safety assessment.

Additional Information

Medical Communications

Hoffmann-La Roche

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Email: genentech@druginfo.com

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