Latino Study - A Study of PEGASYS (Peginterferon Alfa-2a... | NCT00107653

Label	Type	Description	Intervention Names
Latino	Experimental	Participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).	Drug: Ribavirin Drug: Peginterferon alfa-2a
Non-Latino White	Experimental	Participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.	Drug: Ribavirin Drug: Peginterferon alfa-2a

Name	Type	Description	Arm Group Labels	Other Names
Ribavirin	Drug	1000-1200mg po daily for 48 weeks	Latino
Peginterferon alfa-2a

Measure	Description	Time Frame
Percentage of Participants With Sustained Virologic Response at Week 72	Sustained Virologic Response (SVR) is defined as percentage of participants with an undetectable hepatitis C virus-RNA (HCV-RNA) measurement (<28 International Unit (IU)/millilitre (mL)) assessed 24 weeks post-treatment (week 72) which was assessed by Roche High Pure System/COBAS TaqMan HCV Test.	At Week 72

Measure	Description	Time Frame
Percentage of Participants Achieving Virologic Response	Percentage of participants achieving a virologic response defined as an undetectable HCV-RNA measurement (HCV-RNA <28 IU/mL by Roche High Pure System/COBAS TaqMan HCV Test)	At Weeks 4, 12, 24, 48, 60, and 72
Percentage of Participants With Early Virologic Response at Week 4

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
		Scottsdale	Arizona	85259	United States

PubMed Identifier	Type	Citation	Retractions
19144941	Derived	Rodriguez-Torres M, Jeffers LJ, Sheikh MY, Rossaro L, Ankoma-Sey V, Hamzeh FM, Martin P; Latino Study Group. Peginterferon alfa-2a and ribavirin in Latino and non-Latino whites with hepatitis C. N Engl J Med. 2009 Jan 15;360(3):257-67. doi: 10.1056/NEJMoa0805062.

ID	Title	Description
FG000	Latino	Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Participants With Sustained Virologic Response at Week 72

Sustained Virologic Response (SVR) is defined as percentage of participants with an undetectable hepatitis C virus-RNA (HCV-RNA) measurement (<28 International Unit (IU)/millilitre (mL)) assessed 24 weeks post-treatment (week 72) which was assessed by Roche High Pure System/COBAS TaqMan HCV Test.

Intent-to-Treat (ITT) Population included all participants who were enrolled and took at least 1 dose of study drug (Pegasys or Copegus).

Posted

Number

Percentage of participants

At Week 72

ID	Title	Description
OG000	Latino	Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
OG001	Non-Latino White	Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.

Units	Counts
Participants	OG000269 OG001300

Title

Denominators

Categories

Title	Measurements
	OG00033.5 OG00149.3

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	SVR for Latino Versus (VS) Non-Latino White	Normal approximation to the binomial.		<0.0001	P-values are calculated based on the difference in proportion between Latino and Non-Latino White group	SVR for Study Group Difference	-0.16	Standard Error of the Mean	0.041	2-Sided	95	-0.24	-0.08			The estimated value is the difference in proportion of participants (Latino minus Non-Latino White) with SVR. The 95% Confidence Interval is based on normal approximation to the binomial.	No	Superiority or Other

Secondary

Percentage of Participants Achieving Virologic Response

Percentage of participants achieving a virologic response defined as an undetectable HCV-RNA measurement (HCV-RNA <28 IU/mL by Roche High Pure System/COBAS TaqMan HCV Test)

ITT Population included all participants who were enrolled and took at least 1 dose of study drug (Pegasys or Copegus).

Posted

Number

Percentage of participants

At Weeks 4, 12, 24, 48, 60, and 72

ID	Title	Description
OG000	Latino	Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
OG001	Non-Latino White	Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.

Secondary

Percentage of Participants With Early Virologic Response at Week 4

Percentage of participants with an early virologic response defined as an HCVRNA >=1 log10 drop from baseline or undetectable HCV-RNA measurement at Week 4 (lower limit of detection 28 IU/mL).

ITT Population included all participants who were enrolled and took at least 1 dose of study drug (Pegasys or Copegus).

Posted

Number

Percentage of participants

At Week 4

ID	Title	Description
OG000	Latino	Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
OG001	Non-Latino White	Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.

Secondary

Percentage of Participants With Early Virologic Response at Week 12

Percentage of participants with an early virologic response defined as an HCV-RNA >=2 log10 drop from baseline or undetectable HCV-RNA measurement at Week 12 (lower limit of detection 28 IU/mL).

ITT Population included all participants who were enrolled and took at least 1 dose of study drug (Pegasys or Copegus).

Posted

Number

Percentage of participants

At Week 12

ID	Title	Description
OG000	Latino	Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
OG001	Non-Latino White	Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.

Secondary

Change From Baseline in HCV-RNA Log10 Titers Over the Period Of Time

The table below shows HCV-RNA log10 titers change from baseline values by study week and by study group. Analysis was performed for participants with a baseline and at least 1 post-baseline HCV-RNA assessment. HCV-RNA quantitation was performed using Roche High Pure System/COBAS® TaqMan® HCV Monitor Test. HCV-RNA measurement lower limit of detection was 28 IU/mL.

ITT Population included all participants who were enrolled and took at least 1 dose of study drug (Pegasys or Copegus). 'n'=number of evaluable participants available at specified time point.

Posted

Least Squares Mean

Standard Error

Log10 IU/mL

From Baseline (Week 0) to Weeks 4, 12, 24, 48, 60 and 72

ID	Title	Description
OG000	Latino	Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
OG001	Non-Latino White	Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.

Secondary

Percentage of Participants With Biochemical Response

Biochemical response was defined as normal serum alanine transaminase (ALT) measurement. For ALT measurement the normal range is 5-37 IU/L.

ITT Population included all participants who were enrolled and took at least 1 dose of study drug (Pegasys or Copegus).

Posted

Number

Percentage of participants

At Weeks 4, 12, 24, 48, 60 and 72

ID	Title	Description
OG000	Latino	Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
OG001	Non-Latino White	Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.

Secondary

Percentage of Participants With ISHAK Histological Activity Index Response

ISHAK Histological Activity Index (HAI) activity response is defined as a decrease from baseline of at least 2 points (≥2 points drop from baseline) in the ISHAK modified HAI (necroinflammatory) score at week 72. ISHAK modified HAI activity (necroinflammatory) score is a total score of periportal ± bridging (P/B) necrosis + confluent necrosis + focal necrosis + portal inflammation (maximum score for each participant = 18). Where P/B necrosis grading as 0 = absent; 1 = mild; 2 = mild/moderate; 3 = moderate; 4 = severe; Confluent necrosis grading as 0 = absent; 1 = focal; 2 = zone 3 some areas; 3 = zone 3 most areas; 4 = zone 3 occasional portal; 5 = zone 3 multiple; 6 = panacinar necrosis and Focal necrosis grading as 0: absent; 1: < = 1 focus; 2: 2 to 4 foci; 3: 5 to 10 foci; 4: > 10 foci; Portal Inflammation grading: 0 = none; 1 = mild; 2 = moderate; 3 = moderate/marked; 4 = marked/all portal.

ITT Population included all participants who were enrolled and took at least 1 dose of study drug (Pegasys or Copegus). Analysis was performed for ITT participants with paired biopsy.

Posted

Number

Percentage of participants

At Week 72

ID	Title	Description
OG000	Latino	Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).

Secondary

Mean Change From Baseline in ISHAK HAI Activity (Necroinflammatory) at Week 72

ISHAK modified HAI activity (necroinflammatory) score is a total score of P/B necrosis + confluent necrosis + focal necrosis + portal inflammation (maximum score for each Participant = 18). Where P/B necrosis grading as 0 = absent; 1 = mild; 2 = mild/moderate; 3 = moderate; 4 = severe; Confluent necrosis as 0 = absent; 1 = focal; 2 = zone 3 some areas; 3 = zone 3 most areas; 4 = zone 3 occasional portal; 5= zone 3 multiple; 6= panacinar necrosis and Focal necrosis as 0: absent; 1: <= 1 focus; 2: 2 to 4 foci; 3: 5 to 10 foci; 4: > 10 foci; Portal Inflammation: 0 = none; 1 = mild; 2 = moderate; 3 = moderate/marked; 4 = marked/all portal. The difference between study groups in change from baseline in ISHAK modified HAI activity score at week 72 was tested using an analysis of covariance (ANCOVA) model with ethnicity and baseline ISHAK HAI score as the fixed effects.

ITT Population included all participants who were enrolled and took at least 1 dose of study drug (Pegasys or Copegus). Analysis was performed for ITT participants with paired biopsy.

Posted

Mean

Standard Error

Score on a scale

From Baseline (Week 0) to Week 72

ID	Title	Description
OG000	Latino	Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).

Secondary

Mean Change From Baseline in Fibrosis Score Based on ISHAK at Week 72

ISHAK Histological Activity Index (HAI) activity response is defined as a decrease from baseline of at least 2 points (≥2 points drop from baseline) score at week 72. Baseline prognostic factors in the original model include ethnicity, sex, age, baseline ALT quotient, baseline HCV-RNA level, and ISHAK fibrosis and activity scores at baseline. ISHAK modified HAI fibrosis scale by fibrosis grading category as F0= no fibrosis; F1= some portal areas; F2= most portal areas; F3= bridging fibrosis; F4= bridging and portal to central; F5 = marked bridging; F6 = Cirrhosis; where '0' being the best and '6' being the worst. Decrease in score from baseline indicates improvement. The difference between study groups in change from baseline in ISHAK modified HAI activity score at week 72 was analysed.

ITT Population included all participants who were enrolled and took at least 1 dose of study drug (Pegasys or Copegus). Analysis was performed for ITT participants with paired biopsy. 'n'=number of evaluable participants available at specified time point.

Posted

Mean

Standard Error

Score on a scale

From Baseline (Week 0) to Week 72

ID	Title	Description
OG000	Latino	Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).

Secondary

Percentage of Participants With Improved, Stable and Worsened ISHAK Fibrosis Score

Overall ISHAK Fibrosis Score is defined as Improved: >= 1 category decrease in fibrosis scale; Stable: no change in fibrosis scale; Worsened: >1 category increase in fibrosis scale.

ITT Population included all participants who were enrolled and took at least 1 dose of study drug (Pegasys or Copegus). Analysis was performed for ITT participants with paired biopsy.

Posted

Number

Percentage of participants

At Week 72

ID	Title	Description
OG000	Latino	Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
OG001	Non-Latino White	Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.

Secondary

Mean Change From Baseline in Activity and Fibrosis Scores Based on METAVIR Activity at Week 72

METAVIR activity scores are categorised as histological activity (A) 0 = none; A1 = mild; A2 = moderate; A3 = severe where '0' being 'No activity' and '3' being 'the sever activity'. Changes in liver inflammation defined as Improved: Participants whose METAVIR activity score at up to Month-72 decreases by 1 or more units compared to baseline; stable: Participants whose METAVIR activity score at up to Month-72 is the same as the baseline score; worsened: Participants whose METAVIR activity score at up to Month-72 increases by 1 or more units compared to baseline. METAVIR fibrosis scores are categorised as fibrosis (F) 0 = no fibrosis; F1 = without septa; F 2 = with septa; F3 = many septa; F4 = cirrhosis where; '0' being the best and '4' being the worst. Decrease in score from baseline indicates improvement. The difference between study groups in change from baseline in activity and fibrosis scores based on METAVIR at week 72 was analysed.

ITT Population included all participants who were enrolled and took at least 1 dose of study drug (Pegasys or Copegus). Analysis was performed for ITT participants with paired biopsy.

Posted

Mean

Standard Error

Score on a scale

From Baseline (Week 0) to Week 72

ID	Title	Description
OG000	Latino	Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).

Secondary

Percentage of Participants With Improved, Stable, and Worsened METAVIR Activity Score

METAVIR activity scale included activity defines as, Improved: >= 1 category decrease in activity score; stable: no change in activity score; worsened: > = 1 category increase in activity score.

ITT Population included all participants who were enrolled and took at least 1 dose of study drug (Pegasys or Copegus). Analysis was performed for ITT participants with paired biopsy.

Posted

Number

Percentage of participants

At Week 72

ID	Title	Description
OG000	Latino	Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
OG001	Non-Latino White	Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.

Secondary

Percentage of Participants With Improved, Stable, and Worsened METAVIR Fibrosis Score

METAVIR fibrosis score is categorized as, Improved: >= 1 category decrease in activity score; stable: no change in activity score; worsened: >= 1 category increase in activity score.

ITT Population included all participants who were enrolled and took at least 1 dose of study drug (Pegasys or Copegus). Analysis was performed for ITT participants with paired biopsy.

Posted

Number

Percentage of participants

At Week 72

ID	Title	Description
OG000	Latino	Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
OG001	Non-Latino White	Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.

Secondary

Mean Change From Baseline in Fat Score at Week 72

Grading categories for the fat scale were as follows: 1 = <5% hepatocytes; 2 = 6 - 33% hepatocytes; 3 = 34 - 66% hepatocytes; 4 = 67 - 100% hepatocytes.

ITT Population included all participants who were enrolled and took at least 1 dose of study drug (Pegasys or Copegus). Analysis was performed for ITT participants with paired biopsy.

Posted

Mean

Standard Error

Score on a scale

From Baseline (Week 0) to Week 72

ID	Title	Description
OG000	Latino	Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
OG001	Non-Latino White	Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.

Secondary

Percentage of Participants With Improved, Stable and Worsened Fat Score From Baseline to Week 72

Fat scores are categorised as Improved: > 1 category decrease in fat scale; stable: no change in fat scale; worsened: >= 1 category increase in fat scale.

ITT Population included all participants who were enrolled and took at least 1 dose of study drug (Pegasys or Copegus). Analysis was performed for ITT participants with paired biopsy.

Posted

Number

Percentage of participants

From Baseline (Week 0) to Week 72

ID	Title	Description
OG000	Latino	Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
OG001	Non-Latino White	Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.

Secondary

Percentage of Participants With Non-zero Nonalcoholic Steatohepatitis Score

The Nonalcoholic Steatohepatitis (NASH) included an assessment of sinusoidal fibrosis, Mallory bodies, and hepatocyte ballooning (HB). Grading categories for the NASH scales were as: Sinusoidal fibrosis: 0 = absent; 1 = involvement of some lobules; 2 = involvement of most lobules, without diffuse interstitial sinusoidal collagen deposition; 3 = Involvement of most or all lobules;, with diffuse interstitial fibrosis involving some or most of the lobules Mallory bodies: 0 = absent; 1 = involvement of some lobules; 2 = involvement of most lobules; 3= involvement of most or all lobules; and Hepatocyte ballooning: 0 = absent; 1 = involvement of some lobules; 2 = involvement of most lobules; 3= involvement of most or all lobules.

ITT Population included all participants who were enrolled and took at least 1 dose of study drug (Pegasys or Copegus). Analysis was performed for ITT participants with paired biopsy.

Posted

Number

Percentage of participants

At Week 72

ID	Title	Description
OG000	Latino	Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
OG001

Secondary

Mean Change in Fatigue Severity Scale Score and Fatigue Severity Scale Score Item 10 Visual Analog Scale Score From Baseline at Week 48 and Week 72

The Fatigue Severity Scale (FSS) is a 10-item self-report questionnaire designed to assess tiredness, lack of energy, or total body give-out. Participants were to react to nine statements regarding fatigue over the previous 2 weeks, each on a scale (1 = completely agree, 7 = completely disagree). The FSS is the average of the scores on the 9 questions; ranging from 1-7, with lower scores indicating less fatigue. In addition, participants were to react to how much fatigue they had in the past 2 weeks by marking on a visual analogue scale (VAS) labelled at one end with "no fatigue" ('0' being the best) and at the other end with "greater fatigue" ('100' being the worst). Longer distance on the scale from "no fatigue" indicated "greater fatigue". FSS values are presented based on questionnaire and visual analog scale. FSS values at week 48 and 72 are presented based on questionnaire and visual analog scale.

ITT Population included all participants who were enrolled and took at least 1 dose of study drug (Pegasys or Copegus). 'n'=number of evaluable participants available at specified time point.

Posted

Mean

Standard Error

Score on a scale

Baseline (Week 0), Week 48 and Week 72

ID	Title	Description
OG000	Latino	Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).

Secondary

Mean Change in 36-item Short Form Health Survey Total and Domain Scores From Baseline at Week 48 and 72

The 36-item Short Form Health Survey (SF-36) is a 36-item self-report questionnaire that includes 8 domain scales The 8 domains are incorporated into 2 components: mental and physical. The mental component (MC) includes social functioning, role limitations-emotional, mental health, and vitality. The physical component (PC) includes physical functioning, role limitations-physical, bodily pain, and general health perception. Raw domain scores are transformed to a 0 to 100 scale, [0=worst score (or quality of life) and 100=best score]. Two summary scale scores were computed based on weighted combinations of the 8 domain scores (Physical and the Mental Component) where no minimum or maximum score; higher score indicate better health status. The difference between study groups in change from baseline in SF-36 score at week 48 and 72 was analysed.

Posted

Mean

Standard Error

Score on a scale

Baseline (Week 0), Week 48 and Week 72

ID	Title	Description
OG000	Latino	Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).

Secondary

Number of Participants With Any Adverse Events and Serious Adverse Events

An adverse event (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An adverse event could therefore be any unfavorable or 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. Pre-existing conditions that worsened during the study were reported as adverse events. A serious adverse event (SAE) was any untoward medical occurrence that at any dose results in death, is life threatening, requires hospitalization or prolongation of hospitalization, or results in disability/incapacity, or congenital anomaly/birth defect.

The Safety Population included participants who received at least 1 dose of any study drug and had at least 1 post baseline safety assessment.

Posted

Number

Participants

Up to Week 72

ID	Title	Description
OG000	Latino	Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).

Secondary

Number of Participants With Marked Abnormal Laboratory Parameters

The below table includes participants with marked abnormal lab parameters. Standard reference ranges include: Hematocrit: (fraction) 0.37 - 0.49, Hemoglobin 130 - 180 g/L, Platelets 150 - 350 10^9/L, White Blood Cell (WBC) 4.5 - 11.0 10^9/L, Lymphocytes 1.00 - 4.80 10^9/L, Neutrophils 1.80 - 7.70 10^9/L, Aspartate aminotransferase (AST) 0-40 U/L, ALT 0 - 55 U/L, Total bilirubin 0 - 17 μmol/L, Thyroxine T4 58 - 140 nmol/L, Thyroid Stimulating Hormone (TSH) 0.0 - 5.0 million units (mU)/L, Albumin 35.0 - 55.0 g/L, Chloride 100 - 108 mmol/L, Calcium 2.10 - 2.60 mmol/L, Phosphate 0.84 - 1.45 mmol/L, Uric acid 214 - 506 μmol/L.

The Safety Population included participants who received at least 1 dose of any study drug and had at least 1 post baseline safety assessment. 'n'=number of evaluable participants available at specified time point.

Posted

Number

Participants

Up to Week 72

ID	Title	Description
OG000	Latino	Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
OG001	Non-Latino White

Secondary

Number of Participants With Premature Withdrawals Due to Adverse Events or Laboratory Abnormalities

The table below includes participants with premature withdrawals due to adverse events or laboratory abnormalities.

The Safety Population included participants who received at least 1 dose of any study drug and had at least 1 post baseline safety assessment.

Posted

Number

Participants

Up to Week 72

ID	Title	Description
OG000	Latino	Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
OG001	Non-Latino White	Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Cellulitis	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0005 affected269 at risk EG0012 affected299 at risk
Pneumonia	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0000 affected269 at risk EG0014 affected299 at risk
Appendicitis	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0002 affected269 at risk EG0011 affected299 at risk
Abscess limb	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0002 affected269 at risk EG0010 affected299 at risk
Bronchitis	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0001 affected269 at risk EG0011 affected299 at risk
Diverticulitis	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0001 affected269 at risk EG0011 affected299 at risk
Arthritis bacterial	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0001 affected269 at risk EG0010 affected299 at risk
Bursitis infective	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0001 affected269 at risk EG0010 affected299 at risk
Kidney infection	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0001 affected269 at risk EG0010 affected299 at risk
Neurosyphilis	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0001 affected269 at risk EG0010 affected299 at risk
Pelvic infection	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0000 affected269 at risk EG0011 affected299 at risk
Pneumonia staphylococcal	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0000 affected269 at risk EG0011 affected299 at risk
Rectal abscess	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0001 affected269 at risk EG0010 affected299 at risk
Septic shock	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0001 affected269 at risk EG0010 affected299 at risk
Sinusitis	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0000 affected269 at risk EG0011 affected299 at risk
Urinary tract infection	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0000 affected269 at risk EG0011 affected299 at risk
Viral infection	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0001 affected269 at risk EG0010 affected299 at risk
Depression	Psychiatric disorders	MedDRA 10.1	Systematic Assessment	EG0004 affected269 at risk EG0014 affected299 at risk
Suicidal ideation	Psychiatric disorders	MedDRA 10.1	Systematic Assessment	EG0003 affected269 at risk EG0015 affected299 at risk
Suicide attempt	Psychiatric disorders	MedDRA 10.1	Systematic Assessment	EG0002 affected269 at risk EG0010 affected299 at risk
Agitation	Psychiatric disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected269 at risk EG0011 affected299 at risk
Anxiety disorder	Psychiatric disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected269 at risk EG0011 affected299 at risk
Bipolar II disorder	Psychiatric disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected269 at risk EG0011 affected299 at risk
Homicidal ideation	Psychiatric disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected269 at risk EG0011 affected299 at risk
Mental status changes	Psychiatric disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected269 at risk EG0010 affected299 at risk
Psychotic disorder	Psychiatric disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected269 at risk EG0011 affected299 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected269 at risk EG0011 affected299 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected269 at risk EG0011 affected299 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected269 at risk EG0011 affected299 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected269 at risk EG0011 affected299 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected269 at risk EG0010 affected299 at risk
Haematemesis	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected269 at risk EG0010 affected299 at risk
Inflammatory bowel disease	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected269 at risk EG0011 affected299 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected269 at risk EG0011 affected299 at risk
Pancreatic mass	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected269 at risk EG0010 affected299 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected269 at risk EG0010 affected299 at risk
Peritonitis	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected269 at risk EG0010 affected299 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected269 at risk EG0011 affected299 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected269 at risk EG0015 affected299 at risk
Haemolytic anaemia	Blood and lymphatic system disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected269 at risk EG0011 affected299 at risk
Haemorrhagic anaemia	Blood and lymphatic system disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected269 at risk EG0010 affected299 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected269 at risk EG0011 affected299 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA 10.1	Systematic Assessment	EG0000 affected269 at risk EG0012 affected299 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA 10.1	Systematic Assessment	EG0001 affected269 at risk EG0011 affected299 at risk
Burns second degree	Injury, poisoning and procedural complications	MedDRA 10.1	Systematic Assessment	EG0000 affected269 at risk EG0011 affected299 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 10.1	Systematic Assessment	EG0001 affected269 at risk EG0010 affected299 at risk
Procedural complication	Injury, poisoning and procedural complications	MedDRA 10.1	Systematic Assessment	EG0000 affected269 at risk EG0011 affected299 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 10.1	Systematic Assessment	EG0000 affected269 at risk EG0011 affected299 at risk
Skin laceration	Injury, poisoning and procedural complications	MedDRA 10.1	Systematic Assessment	EG0000 affected269 at risk EG0011 affected299 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected269 at risk EG0010 affected299 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected269 at risk EG0011 affected299 at risk
Nasal cyst	Respiratory, thoracic and mediastinal disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected269 at risk EG0011 affected299 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected269 at risk EG0011 affected299 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected269 at risk EG0011 affected299 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected269 at risk EG0011 affected299 at risk
Chest pain	General disorders	MedDRA 10.1	Systematic Assessment	EG0002 affected269 at risk EG0012 affected299 at risk
Non-cardiac chest pain	General disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected269 at risk EG0010 affected299 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 10.1	Systematic Assessment	EG0002 affected269 at risk EG0011 affected299 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected269 at risk EG0011 affected299 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected269 at risk EG0011 affected299 at risk
Convulsion	Nervous system disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected269 at risk EG0010 affected299 at risk
Guillain-Barre syndrome	Nervous system disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected269 at risk EG0011 affected299 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected269 at risk EG0010 affected299 at risk
Syncope	Nervous system disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected269 at risk EG0011 affected299 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected269 at risk EG0011 affected299 at risk
Cataract subcapsular	Eye disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected269 at risk EG0011 affected299 at risk
Retinal exudates	Eye disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected269 at risk EG0011 affected299 at risk
Retinal ischaemia	Eye disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected269 at risk EG0011 affected299 at risk
Retinopathy	Eye disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected269 at risk EG0011 affected299 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected269 at risk EG0010 affected299 at risk
Hypertension	Vascular disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected269 at risk EG0010 affected299 at risk
Vasculitis	Vascular disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected269 at risk EG0010 affected299 at risk
Venous stasis	Vascular disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected269 at risk EG0011 affected299 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected269 at risk EG0011 affected299 at risk
Haemobilia	Hepatobiliary disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected269 at risk EG0010 affected299 at risk
Hepatic failure	Hepatobiliary disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected269 at risk EG0011 affected299 at risk
Hepatitis toxic	Hepatobiliary disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected269 at risk EG0011 affected299 at risk
Decubitus ulcer	Skin and subcutaneous tissue disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected269 at risk EG0010 affected299 at risk
Pigmentation disorder	Skin and subcutaneous tissue disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected269 at risk EG0010 affected299 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected269 at risk EG0011 affected299 at risk
Angina pectoris	Cardiac disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected269 at risk EG0011 affected299 at risk
Pericardial effusion	Cardiac disorders	MedDRA 10.1	Systematic Assessment	EG0000 affected269 at risk EG0011 affected299 at risk
Haemoglobin decreased	Investigations	MedDRA 10.1	Systematic Assessment	EG0000 affected269 at risk EG0011 affected299 at risk
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected269 at risk EG0010 affected299 at risk
Thyroid cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.1	Systematic Assessment	EG0000 affected269 at risk EG0011 affected299 at risk
Ovarian cyst	Reproductive system and breast disorders	MedDRA 10.1	Systematic Assessment	EG0001 affected269 at risk EG0010 affected299 at risk
Activities of daily living impaired	Social circumstances	MedDRA 10.1	Systematic Assessment	EG0000 affected269 at risk EG0011 affected299 at risk

ID	Term
D006526	Hepatitis C
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D006525	Hepatitis, Viral, Human
D014777	Virus Diseases
D018178	Flaviviridae Infections
D012327	RNA Virus Infections
D006521	Hepatitis, Chronic
D006505	Hepatitis
D008107	Liver Diseases
D004066	Digestive System Diseases
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D012263	Ribonucleosides
D009705	Nucleosides
D009706	Nucleic Acids, Nucleotides, and Nucleosides

ID	Title	Description
BG000	Latino	Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
BG001	Non-Latino White	Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Latino	Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).			42	269	256	269
EG001	Non-Latino White	Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.			48	299	290	299

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Fatigue	General disorders	MedDRA 10.1	Systematic Assessment	EG000167 affected269 at risk EG001205 affected299 at risk
PYREXIA	General disorders	MedDRA 10.1	Systematic Assessment	EG00067 affected269 at risk EG00186 affected299 at risk
INFLUENZA LIKE ILLNESS	General disorders	MedDRA 10.1	Systematic Assessment	EG00078 affected269 at risk EG00174 affected299 at risk
IRRITABILITY	General disorders	MedDRA 10.1	Systematic Assessment	EG00045 affected269 at risk EG00184 affected299 at risk
CHILLS	General disorders	MedDRA 10.1	Systematic Assessment	EG00050 affected269 at risk EG00157 affected299 at risk
PAIN	General disorders	MedDRA 10.1	Systematic Assessment	EG00040 affected269 at risk EG00143 affected299 at risk
INJECTION SITE REACTION	General disorders	MedDRA 10.1	Systematic Assessment	EG00018 affected269 at risk EG00125 affected299 at risk
INJECTION SITE ERYTHEMA	General disorders	MedDRA 10.1	Systematic Assessment	EG0008 affected269 at risk EG00123 affected299 at risk
ASTHENIA	General disorders	MedDRA 10.1	Systematic Assessment	EG00012 affected269 at risk EG00118 affected299 at risk
NAUSEA	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG00084 affected269 at risk EG001117 affected299 at risk
DIARRHOEA	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG00057 affected269 at risk EG00165 affected299 at risk
VOMITING	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG00029 affected269 at risk EG00142 affected299 at risk
CONSTIPATION	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG00022 affected269 at risk EG00122 affected299 at risk
ABDOMINAL PAIN	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG00022 affected269 at risk EG00121 affected299 at risk
DYSPEPSIA	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG00022 affected269 at risk EG00120 affected299 at risk
ABDOMINAL PAIN UPPER	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG00017 affected269 at risk EG00117 affected299 at risk
GASTROOESOPHAGEAL REFLUX DISEASE	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG00012 affected269 at risk EG00119 affected299 at risk
DRY MOUTH	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG00011 affected269 at risk EG00120 affected299 at risk
STOMATITIS	Gastrointestinal disorders	MedDRA 10.1	Systematic Assessment	EG0007 affected269 at risk EG00123 affected299 at risk
INSOMNIA	Psychiatric disorders	MedDRA 10.1	Systematic Assessment	EG00091 affected269 at risk EG001140 affected299 at risk
DEPRESSION	Psychiatric disorders	MedDRA 10.1	Systematic Assessment	EG00069 affected269 at risk EG00179 affected299 at risk
ANXIETY	Psychiatric disorders	MedDRA 10.1	Systematic Assessment	EG00030 affected269 at risk EG00151 affected299 at risk
AGITATION	Psychiatric disorders	MedDRA 10.1	Systematic Assessment	EG0006 affected269 at risk EG00119 affected299 at risk
HEADACHE	Nervous system disorders	MedDRA 10.1	Systematic Assessment	EG000128 affected269 at risk EG001156 affected299 at risk
DIZZINESS	Nervous system disorders	MedDRA 10.1	Systematic Assessment	EG00046 affected269 at risk EG00159 affected299 at risk
DYSGEUSIA	Nervous system disorders	MedDRA 10.1	Systematic Assessment	EG00022 affected269 at risk EG00124 affected299 at risk
DISTURBANCE IN ATTENTION	Nervous system disorders	MedDRA 10.1	Systematic Assessment	EG0007 affected269 at risk EG00115 affected299 at risk
RASH	Skin and subcutaneous tissue disorders	MedDRA 10.1	Systematic Assessment	EG00062 affected269 at risk EG00197 affected299 at risk
ALOPECIA	Skin and subcutaneous tissue disorders	MedDRA 10.1	Systematic Assessment	EG00049 affected269 at risk EG00159 affected299 at risk
PRURITUS	Skin and subcutaneous tissue disorders	MedDRA 10.1	Systematic Assessment	EG00042 affected269 at risk EG00161 affected299 at risk
DRY SKIN	Skin and subcutaneous tissue disorders	MedDRA 10.1	Systematic Assessment	EG00034 affected269 at risk EG00151 affected299 at risk
MYALGIA	Musculoskeletal and connective tissue disorders	MedDRA 10.1	Systematic Assessment	EG00064 affected269 at risk EG00157 affected299 at risk
ARTHRALGIA	Musculoskeletal and connective tissue disorders	MedDRA 10.1	Systematic Assessment	EG00057 affected269 at risk EG00161 affected299 at risk
BACK PAIN	Musculoskeletal and connective tissue disorders	MedDRA 10.1	Systematic Assessment	EG00034 affected269 at risk EG00135 affected299 at risk
MUSCLE SPASMS	Musculoskeletal and connective tissue disorders	MedDRA 10.1	Systematic Assessment	EG00014 affected269 at risk EG00137 affected299 at risk
MUSCULOSKELETAL PAIN	Musculoskeletal and connective tissue disorders	MedDRA 10.1	Systematic Assessment	EG00012 affected269 at risk EG00119 affected299 at risk
PAIN IN EXTREMITY	Musculoskeletal and connective tissue disorders	MedDRA 10.1	Systematic Assessment	EG00018 affected269 at risk EG00112 affected299 at risk
COUGH	Respiratory, thoracic and mediastinal disorders	MedDRA 10.1	Systematic Assessment	EG00043 affected269 at risk EG00174 affected299 at risk
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	MedDRA 10.1	Systematic Assessment	EG00024 affected269 at risk EG00157 affected299 at risk
PHARYNGOLARYNGEAL PAIN	Respiratory, thoracic and mediastinal disorders	MedDRA 10.1	Systematic Assessment	EG00022 affected269 at risk EG00116 affected299 at risk
DYSPNOEA EXERTIONAL	Respiratory, thoracic and mediastinal disorders	MedDRA 10.1	Systematic Assessment	EG0005 affected269 at risk EG00127 affected299 at risk
ANAEMIA	Blood and lymphatic system disorders	MedDRA 10.1	Systematic Assessment	EG00059 affected269 at risk EG00173 affected299 at risk
NEUTROPENIA	Blood and lymphatic system disorders	MedDRA 10.1	Systematic Assessment	EG00031 affected269 at risk EG00140 affected299 at risk
UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG00024 affected269 at risk EG00120 affected299 at risk
NASOPHARYNGITIS	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG00015 affected269 at risk EG00120 affected299 at risk
SINUSITIS	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0007 affected269 at risk EG00120 affected299 at risk
BRONCHITIS	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0007 affected269 at risk EG00118 affected299 at risk
INFLUENZA	Infections and infestations	MedDRA 10.1	Systematic Assessment	EG0006 affected269 at risk EG00116 affected299 at risk
DECREASED APPETITE	Metabolism and nutrition disorders	MedDRA 10.1	Systematic Assessment	EG00027 affected269 at risk EG00148 affected299 at risk
ANOREXIA	Metabolism and nutrition disorders	MedDRA 10.1	Systematic Assessment	EG00035 affected269 at risk EG00120 affected299 at risk
WEIGHT DECREASED	Investigations	MedDRA 10.1	Systematic Assessment	EG00032 affected269 at risk EG00149 affected299 at risk
VISION BLURRED	Eye disorders	MedDRA 10.1	Systematic Assessment	EG00016 affected269 at risk EG00129 affected299 at risk
DRY EYE	Eye disorders	MedDRA 10.1	Systematic Assessment	EG0004 affected269 at risk EG00115 affected299 at risk
HYPERTENSION	Vascular disorders	MedDRA 10.1	Systematic Assessment	EG0008 affected269 at risk EG00117 affected299 at risk