A Study of Peginterferon Alfa-2a (Pegasys) When Administe... | NCT02641379 | Trialant
NCT02641379
Sponsor
Hoffmann-La Roche
Status
Completed
Last Update Posted
Aug 4, 2016Estimated
Enrollment
737Actual
Phase
Phase 4
Conditions
Hepatitis C, Chronic
Interventions
Peginterferon alfa-2a
Ribavirin
Countries
Austria
Protocol Section
Identification Module
NCT ID
NCT02641379
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
ML17131
Secondary IDs
Not provided
Brief Title
A Study of Peginterferon Alfa-2a (Pegasys) When Administered in Combination With Ribavirin in Patients With Chronic Hepatitis C (CHC)
Official Title
Randomized, Multicenter Study to Find Optimal Treatment Duration in Patients With Chronic Hepatitis C and Subtype 1 or 4 Depending on HCV RNA Level at Week 8 and Week 12
Acronym
Not provided
Organization
Hoffmann-La RocheINDUSTRY
Status Module
Record Verification Date
Jun 2016
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
May 2003
Primary Completion Date
Nov 2013Actual
Completion Date
Nov 2013Actual
First Submitted Date
Dec 11, 2015
First Submission Date that Met QC Criteria
Dec 22, 2015
First Posted Date
Dec 29, 2015Estimated
Results Waived
Not provided
Results First Submitted Date
Apr 28, 2016
Results First Submitted that Met QC Criteria
Jun 23, 2016
Results First Posted Date
Aug 4, 2016Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jun 23, 2016
Last Update Posted Date
Aug 4, 2016Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Hoffmann-La RocheINDUSTRY
Collaborators
Not provided
Oversight Module
No data available
No data is available for this block.
Description Module
Brief Summary
This study will compare the efficacy and safety of 2 different treatment durations of peginterferon alfa-2a (Pegasys) plus ribavirin in patients with CHC. The anticipated time on study treatment is 1-2 years, and the target sample size is greater than (>) 500 individuals.
Detailed Description
Not provided
Conditions Module
Conditions
Hepatitis C, Chronic
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 4
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
737Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
PEG-IFN 24 weeks
Experimental
Participants will receive PEG-IFN (180 microgram [mcg]), subcutaneously (sc), once weekly for 24 weeks and Ribavirin 1000-1200 milligram per day (mg/day) (<75 kilogram (kg); >75 kg) for 24 weeks.
Drug: Peginterferon alfa-2a
Drug: Ribavirin
PEG-IFN 24/72 weeks
Experimental
Participants will receive PEG-IFN (180 mcg), sc, once weekly and Ribavirin 1000-1200 mg/day (<75kg; >75 kg) till week 24; if patient is still HCV RNA positive. Treatment will be stopped if participant is HCV RNA negative at week 24 -treatment with PEG-IFN (180 mcg), sc, once weekly and Ribavirin 1000-1200 mg/day (<75kg; >75 kg) till week 72
Drug: Peginterferon alfa-2a
Drug: Ribavirin
PEG-IFN 48 weeks
Experimental
Participants will receive PEG-IFN (180 mcg), sc, once weekly for 48 weeks and Ribavirin 1000-1200 mg/day (<75kg; >75 kg) for 48 weeks.
Drug: Peginterferon alfa-2a
Drug: Ribavirin
PEG-IFN 72 weeks
Experimental
Participants will receive PEG-IFN (180 mcg), sc, once weekly for 72 weeks and Ribavirin 1000-1200 mg/day (<75 kg; > 75 kg) for 72 weeks.
Drug: Peginterferon alfa-2a
Drug: Ribavirin
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Peginterferon alfa-2a
Drug
PEG-IFN is available as 180 microgram (mcg) per 0.5 mL, prefilled syringe and pen for single dose sc. injection\n
PEG-IFN 24 weeks
PEG-IFN 24/72 weeks
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants With Relapse Rate in Groups A and B by Genotype at the End of Follow-up (Part 1)
Relapse rate (RR) was defined as the percentage of participants with non-detectable HCV RNA (< 100 copies/ml) at the end of treatment and detectable HCV RNA at the end of follow-up. End of treatment was defined as Week 48 for Group A and Week 72 for Group B, respectively. The end of follow-up was defined as Week 72 for Group A and Week 96 for Group B, respectively. Relapse rate for treatment Groups A and B, stratified for genotype (Genotype I and Genotype IV) and Week 4 response (< 600 units/milliliter [U/ml] and >= 600 U/ml) is presented.
Up to Week 96
Percentage of Participants Achieving Sustained Virological Response in Groups A1, B1, and E by Genotype at the End of Follow-up (Part 2)
The Sustained Virological Response (SVR) was defined as the percentage of participants in each group with non-detectable HCV RNA result at 24 weeks post completion of the treatment period (HCV RNA < 15 IU/ml at Week 72 of Groups A1 and E, and at Week 96 of Group B1). Participants without a HCV RNA results at this time point were considered as non-responders. The end of follow-up was defined as Week 72 for Groups A1 and E, and Week 96 for Group B1. The SVR for treatment Groups A1 + B1 and E, stratified for genotype (Genotype I and Genotype IV) is presented.
Up to Week 96
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants With Virological Response Rate in Groups A, B, C, and D at the End of Treatment Period (Part 1)
End of treatment response (ETR) rate was defined as the percentage of participants in each group with non-detectable HCV RNA at completion of the treatment period (HCV negative at Week 24 of Group D, Week 48 of Group A and at Week 72 of Groups B and C). Participants without a HCV RNA results at this time point were considered as non-responders. End of the treatment period was defined as Week 48 for Group A, Week 72 for Groups B and C, and Week 24 for Group D.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Male and female patients with chronic hepatitis C and genotype 1 (1a or 1b) or genotype 4
Age between 18 and 70 years
Serologic evidence of chronic hepatitis C infection by an anti-HCV antibody test
Present with at least one elevated serum alanine-aminotransferase (ALT) level higher than normal in the last 6 months before therapy start including the screening period
Positive HCV-RNA level in serum
Laboratory parameters (within 35 days prior to study start): -Hepatitis A anti - IgM negativity, HIV-Ab negativity, HBsAg negativity, Hemoglobin values > 12 g/dl in women or > 13 g/dl in men, Leukocyte count (WBC) > 3 000 /mcl, Platelets count > 100 000/mcl, Creatinine not 1.5 times higher than normal, normal TSH, normal uric acid with a maximum tolerance of 15 % in patients without history of gout
Liver biopsy findings within 6 months prior to study therapy consistent with the diagnosis of chronic hepatitis C infection with or without compensated cirrhosis. Biopsies older than 1 year are eligible only after direct communication with the principal investigator
Negative urine or blood pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of study drug. If there is no laboratory report existing, the physician should make an entry in the medical history that the pregnancy test was negative.
All fertile females receiving ribavirin must be using two forms of effective contraception during treatment and during the 6 months after treatment end. All fertile men with female partners must be using two forms of effective contraception during treatment and during the 7 months after treatment end.
Written informed consent obtained
Exclusion Criteria:
Any IFN and / or Pegylated IFN and ribavirin therapy at any previous time
Class B or C cirrhosis as coded by Child Pugh classification
Women with ongoing pregnancy or breast feeding
Therapy with any systemic anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) 6 months prior to the first dose of study drug
Any investigational drug 6 weeks prior to the first dose of study drug
Drug addiction within 1 year prior to study start (patients participating in an official methadone program are eligible)
Diabetes mellitus in patients receiving an insulin therapy
Hemophiliac patients (due to the increased risk of requested liver biopsy)
History or other evidence of a medical condition associated with chronic liver disease other than HCV (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures)
History or other evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease
History of severe psychiatric disease, especially depression. Severe psychiatric disease is defined as treatment with an antidepressant medication or a major tranquilizer at therapeutic doses for major depression or psychosis, respectively, for at least 3 months at any previous time or any history of the following: a suicidal attempt, hospitalization for psychiatric disease, or a period of disability due to a psychiatric disease. Exception: if there is a current psychiatric report which certifies there is no contraindication to interferon therapy, patient may be included
History of immunologically mediated disease (e.g., inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis, rheumatoid arthritis etc.)
History or other evidence of chronic pulmonary disease associated with functional limitation
History of a severe seizure disorder or current anticonvulsant use
History of severe cardiac disease and severe coronary heart disease within the last 6 months (angina pectoris, congestive heart failure, recent myocardial infarction, severe hypertension or significant arrhythmia). If there is clinical suspicion of coronary heart disease cardiologic workup of the patient prior to study entry is recommended.
History of thyroid disease poorly controlled on prescribed medications, elevated thyroid stimulating hormone (TSH) concentrations with elevation of antibodies to thyroid peroxidase and any clinical manifestations of thyroid disease
History or other evidence of severe illness, malignancy or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study
History of major organ transplantation with an existing functional graft
Evidence of severe retinopathy (e.g. CMV retinitis, macula degeneration)
Inability or unwillingness to provide informed consent or abide by the requirements of the study
Any patient with an increased baseline risk for anemia (e.g. thalassemia, spherocytosis, history of GI bleeding, etc) or for whom anemia would be medically problematic
Patients with documented or presumed coronary artery disease or cerebrovascular disease should not be enrolled if, in the judgment of the investigator, an acute decrease in hemoglobin by up to 4 g/dL would not be well-tolerated
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
70 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Clinical Trials
Hoffmann-La Roche
Study Chair
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Feldkirch
6800
Austria
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
A total of 545 participants were enrolled in Part 1, of which 5 participants were treated but were not included in any analysis population due to a missing post-baseline safety assessment. A total of 176 participants were enrolled in Part 2 of this study.
Recruitment Details
This study was conducted in 2 parts. Part 1 was conducted from 16 May 2003 to 12 September 2008 at 21 centers in Austria; Part 2 of this study was conducted from 19 October 2009 to 15 November 2013 at 15 centers in Austria.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1)
Eligible participants received pegylated interferon alpha-2a (PEG-IFN alfa-2a) at a dose of 180 microgram (mcg) subcutaneously (SC) once weekly for a total of 48 weeks and ribavirin at a dose of 1,000 milligram/day (mg/day) [for participants with a body weight </= 75 kilogram (kg)] or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A based on the presence of an early virological response (EVR) defined as non-detectable serum hepatitis C virus ribonucleic acid (HCV RNA) [< 600 international units/milliliter (IU/ml)] by quantitative polymerase chain reaction (PCR) or a 2-log10 decrease or greater compared to baseline serum HCV RNA, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
PEG-IFN 48 weeks
PEG-IFN 72 weeks
Pegasys
Ribavirin
Drug
Ribavirin is available as 200 mg tablets
PEG-IFN 24 weeks
PEG-IFN 24/72 weeks
PEG-IFN 48 weeks
PEG-IFN 72 weeks
Up to Week 72
Percentage of Participants Achieving Sustained Virological Response in Groups A, B, C, and D at the End of Follow-up (Part 1)
The SVR was defined as the percentage of participants in each group with a non-detectable HCV RNA result at 24 weeks post-completion of the treatment period (HCV RNA < 15 IU/ml at Week 48 of Group D, at Week 72 of Group A, and at Week 96 of Groups B and C). Participants without a HCV RNA PCR at this time point were considered as non-responders in this calculation. The end of follow-up was defined as Week 72 for Group A, Week 96 for Groups B and C, and Week 48 for Group D.
Up to Week 96
Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1)
The Short Form-36 (SF-36) is a quality of life instrument consisting of a 36-item questionnaire. The SF-36 items were scored and transformed according to the SF-36 Health Survey Manual and Interpretation Guide. Summary scores for SF-36 dimensions (physical functioning, role functioning, bodily pain, general health, vitality, social functioning, mental health, health transition) as well as physical and mental summary measures were compiled after imputation of mean scores for missing items if more than 50% of dimension-related items were available. Scores for health transition ranged from 0 (worst) to 5 (best). Scores for all other dimensions ranged from 0 (worst) to 100 (best). The mean SF-36 scores are presented at Baseline (Day 1), Week 24, Week 48, Week 72 (for Groups A and B) and at Week 96 (for Group B). Lower score indicate worsening.
Mean Fatigue Severity Scale Scores for Groups A and B Over Time (Part 1)
The Fatigue Severity Scale (FSS) is an instrument consisting of 10 self-administered questions. The FSS items were scored by calculating the average response to all answered items (including the 9 questions and the fatigue symptoms). Each of the 9 questions had answers within a score range of 1-7. A score of 1 for any question indicates less fatigue in everyday life and a score of 7 indicates a higher likelihood of fatigue in everyday life. The mean FSS scores are presented at Baseline (Day 1), Week 24, Week 48 and Week 72 (for Groups A and B) and at Week 96 (for Group B).
Baseline (Day 1), Week 24, Week 48 and Week 72, and Week 96
Number of Participants With Fibrosis Grades 0 to 4 at Baseline (Part 1)
Liver fibrosis stage was scored using the METAVIR system (Grade 0 to 4). Grade 0 indicates no fibrosis, Grade 1 indicates stellate enlargement of portal tract but without septa formation, Grade 2 indicates enlargement of portal tract with rare septa formation, Grade 3 indicates numerous septa without cirrhosis and grade 4 indicates cirrhosis. The number of participants with fibrosis grades ranging from 0 to 4 at Baseline is presented.
Baseline (Day 1)
Number of Participants With Adverse Events and Serious Adverse Events (Part 1)
An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.
Up to Week 96
Percentage of Participants With Relapse Rates in Groups A1 and B1 at the End of Follow-up (Part 2)
Virological relapse rate was defined as percentage of participants with non-detectable HCV RNA (< 15 IU/ml) at the EoT and detectable HCV RNA (≥ 15 IU/ml) at the end of FU. The end of treatment was defined as Week 48 in Group A1 and Week 72 in Group B1 and the end of follow-up was defined as Week 72 in Group A1 and Week 96 in Group B1.
Up to Week 96
Percentage of Participants With Virological Response Rates in Group A1, B1, C and D at the End of the Treatment Period (Part 2)
ETR virological response rate at the end of treatment period was defined as the percentage of participants in each group with non-detectable HCV RNA at completion of the treatment period (HCV RNA quantitative PCR result < 15 IU/ml at Week 24 for Group D, at Week 48 for Group A1, at Week 72 for Groups B1 and C). Participants without a HCV RNA PCR (missing values) at this time point were considered as non-responders in this calculation. The end of treatment period was defined as Week 48 for Group A1, Week 72 for Groups B1 and C1, and Week 24 for Group D.
Up to Week 72
Percentage of Participants Achieving Sustained Virological Response in Groups C and D by Genotype at the End of Follow-up (Part 2)
The SVR was defined as the percentage of participants in each group with non-detectable HCV RNA result at 24 weeks post completion of the treatment period (HCV RNA < 15 IU/ml at Week 48 of Group D and at Week 96 of Group C). Participants without a HCV RNA results at this time point were considered as non-responders. The end of follow-up was defined as Week 96 for Group C and Week 48 for Group D.
Up to Week 96
Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2)
The SF-36 is a quality of life instrument consisting of a 36-item questionnaire. The SF-36 items were scored and transformed according to the SF-36 Health Survey Manual & Interpretation Guide. Summary scores for SF-36 dimensions (physical functioning, role functioning, bodily pain, general health, vitality, social functioning, mental health, health transition) as well as physical and mental summary measures were compiled after imputation of mean scores for missing items if more than 50% of dimension-related items were available. Scores for health transition ranged from 0 (worst) to 5 (best). Scores for all other dimensions ranged from 0 (worst) to 100 (best). The mean SF-36 scores were presented at Baseline (Day 1), Week 24, Week 48, Week 72 (for Groups A1, B1 and C) and at Week 96 (for Groups B1 and C). Lower score indicate worsening.
Mean Fatigue Severity Scale Scores for Groups A1, B1 and C Over Time (Part 2)
The FSS is an instrument consisting of 10 self-administered questions. The FSS items were scored by calculating the average response to all answered items (including the 9 questions and the fatigue symptoms). Each of the 9 questions had answers within a score range of 1-7. A score of 1 for any question indicates less fatigue in everyday life and a score of 7 indicates a higher likelihood of fatigue in everyday life. The mean FSS scores are presented at Baseline (Day 1), Week 24, Week 48 and Week 72 (for Groups A1, B1 and C) and at Week 96 (for Groups B1 and C).
Baseline (Day 1), Week 24, Week 48 and Week 72, and Week 96
Number of Participants With Fibrosis Grades 0 to 4 at Baseline (Part 2)
Liver fibrosis stage was based upon biopsy and scored using the METAVIR system (Grade 0 to 4). Grade 0 indicates no fibrosis, Grade 1 indicates stellate enlargement of portal tract but without septa formation, Grade 2 indicates enlargement of portal tract with rare septa formation, Grade 3 indicates numerous septa without cirrhosis and grade 4 indicates cirrhosis. The number of participants with fibrosis grades ranging from 0 to 4 at Baseline (Day 1) is presented.
Baseline (Day 1)
Number of Participants With Adverse Events and Serious Adverse Events (Part 2)
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.
Up to Week 96
Gratwein
8112
Austria
Graz
8020
Austria
Graz
8036
Austria
Innsbruck
6020
Austria
Krems
3500
Austria
Linz
4010
Austria
Linz
4020
Austria
Oberndorf
5110
Austria
Oberpullendorf
7350
Austria
Ried-innkreis
4910
Austria
Salzburg
5020
Austria
Vienna
1030
Austria
Vienna
1090
Austria
Vienna
1100
Austria
Vienna
1130
Austria
Vienna
1140
Austria
Vienna
1160
Austria
Villach
9500
Austria
Wels
4600
Austria
Wiener Neustadt
2700
Austria
FG001
PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1)
Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. After Week 48, participants were administered a lower dose of PEG-IFN alfa-2a of 135 mcg/week until Week 72. Participants were randomized to Group B based on the presence of an EVR defined as non-detectable serum HCV RNA (< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline in serum HCV RNA by quantitative PCR, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
FG002
PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 1)
Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally; initially for 24 weeks. Participants without an EVR at Week 12 (< 2-log10 decrease in HCV RNA as compared with baseline) were assigned to Group C and received treatment until Week 24. If HCV RNA became non-detectable at Week 24 then treatment was continued for a total of 72 weeks. Participants were administered a lower dose of PEG-IFN alfa-2a after Week 48 (135 mcg/week, until Week 72). Participants with detectable HCV RNA (≥ 50 IU/ml) at Week 24 were required to discontinue treatment. Participants had a treatment-free follow-up period of 24 weeks.
Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 24 weeks. Participants with a rapid virological response (RVR) at Week 4 of treatment [HCV RNA level, <50 IU/ml by qualitative PCR assay, COBAS Amplicor HCV Test, version 2.0] were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks.
Eligible participants who were not randomized to any treatment group in Part 1 of the study were included in this group. These participants were a part of the safety analysis population which included participants who received at least on dose of (either) the study drug (PEG-IFN alfa-2a and/or ribavirin) and had at least one post-baseline safety assessment.
Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A1 if they showed positive HCV RNA level (≥ 15 IU/ml, TaqMan® HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 72 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. Participants were randomized to Group B1 if they showed positive HCV RNA level (≥ 15 IU/ml, TaqMan® HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
FG007
PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 2)
Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally; initially for 24 weeks. Participants without a > 2-log10 drop of HCV RNA level at Week 12 were assigned to Group C (Part 2). For participants who were HCV RNA-positive at Week 24, treatment was stopped. For participants who were negative for HCV RNA at Week 24, treatment was continued for a total of 72 weeks. Participants had a treatment-free follow-up period of 24 weeks.
Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 24 weeks. Participants with a negative HCV-RNA level at Week 4 (< 15 IU/ml, TaqMan HCV Test) were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks.
Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dosage of 1,000 mg/day (for participants with a body weight ≤ 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants with a positive HCV RNA level at Week 4 (≥ 15 IU/ml, TaqMan HCV Test) and negative HCV RNA level at Week 8 (≤ 15 IU/ml, TaqMan HCV Test) were assigned to Group E. Participants had a treatment-free follow-up period of 24 weeks.
Eligible participants who were not assigned to any treatment group in Part 2 were included in this group. These participants were a part of the safety analysis population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a and/or ribavirin) and had at least one post-baseline safety assessment.
FG000142 subjects
FG001152 subjects
FG00278 subjects
FG003156 subjects
FG00417 subjects
FG00536 subjects
FG00625 subjects
FG00720 subjects
FG00842 subjects
FG00945 subjects
FG0108 subjects
COMPLETED
FG000107 subjects
FG001101 subjects
FG0027 subjects
FG003139 subjects
FG0040 subjects
FG00520 subjects
FG00612 subjects
FG0071 subjects
FG00836 subjects
FG00936 subjects
FG0100 subjects
NOT COMPLETED
FG00035 subjects
FG00151 subjects
FG00271 subjects
FG00317 subjects
FG00417 subjects
FG00516 subjects
FG00613 subjects
FG00719 subjects
FG0086 subjects
FG0099 subjects
FG0108 subjects
Type
Comment
Reasons
Exclusion criterion during screening
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0042 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
Withdrawal of informed consent
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Adverse Event
FG0007 subjects
FG0018 subjects
FG0022 subjects
FG0032 subjects
FG004
Lack of Efficacy
FG0000 subjects
FG0010 subjects
FG0022 subjects
FG0030 subjects
FG004
Participant unable to attend study visit
FG0004 subjects
FG00110 subjects
FG0021 subjects
FG0032 subjects
FG004
Participant's compliance
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0031 subjects
FG004
Participant cannot be reached
FG0004 subjects
FG0014 subjects
FG0020 subjects
FG0038 subjects
FG004
PCR positive at Week 24
FG00015 subjects
FG00121 subjects
FG00262 subjects
FG0030 subjects
FG004
PCR positive at follow up 2
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Participant showed relapse
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Participant stopped study/treatment
FG0001 subjects
FG0013 subjects
FG0021 subjects
FG0030 subjects
FG004
Therapy stopped due to misunderstanding
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Financial problems
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
PCR positive at Week 68
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
PCR positive at Week 48
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
PCR not performed at Week 12
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
No PCR at baseline
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
PCR positive at Week 28
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
PCR sample for Week 4 not drawn
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Inclusion criteria not fulfilled
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Baseline viral load unavailable
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Blood could not be drawn
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Participation in sili rescue study
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Source data not found
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Participant showed weight reduction
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Non-response Week 12
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
No 2 Log drop at Week 12
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Negative PCR result
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Participant's PCR high
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Participant treated after Week 24
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Missing PCR result at Week 8
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
PCR positive
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Baseline characteristics are presented for the safety population which included all participants who received at least on dose of (either) study drug and had at least one post-baseline safety assessment.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1)
Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A based on the presence of an EVR defined as non-detectable serum HCV RNA (< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline serum HCV RNA, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
BG001
PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1)
Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. After Week 48, participants were administered a lower dose of PEG-IFN alfa-2a of 135 mcg/week until Week 72. Participants were randomized to Group B based on the presence of an EVR defined as non-detectable serum HCV RNA (< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline in serum HCV RNA by quantitative PCR, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
BG002
PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 1)
Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally; initially for 24 weeks. Participants without an EVR at Week 12 (< 2-log10 decrease in HCV RNA as compared with baseline) were assigned to Group C and received treatment until Week 24. If HCV RNA became non-detectable at Week 24 then treatment was continued for a total of 72 weeks. Participants were administered a lower dose of PEG-IFN alfa-2a after Week 48 (135 mcg/week, until Week 72). Participants with detectable HCV RNA (>= 50 IU/ml) at Week 24 were required to discontinue treatment. Participants had a treatment-free follow-up period of 24 weeks.
Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 24 weeks. Participants with a RVR at Week 4 of treatment [HCV RNA level, <50 IU/ml by qualitative PCR assay, COBAS Amplicor HCV Test, version 2.0] were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks.
Eligible participants who were not randomized to any treatment group in Part 1 of the study were included in this group. These participants were a part of the safety analysis population which included participants who received at least on dose of (either) the study drug (PEG-IFN alfa-2a and/or ribavirin) and had at least one post-baseline safety assessment.
Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A1 if they showed positive HCV RNA level (>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 72 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. Participants were randomized to Group B1 if they showed positive HCV RNA level (>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
BG007
PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 2)
Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally; initially for 24 weeks. Participants without a > 2-log10 drop of HCV RNA level at Week 12 were assigned to Group C (Part 2). For participants who were HCV RNA-positive at Week 24, treatment was stopped. For participants who were negative for HCV RNA at Week 24, treatment was continued for a total of 72 weeks. Participants had a treatment-free follow-up period of 24 weeks.
Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 24 weeks. Participants with a negative HCV-RNA level at Week 4 (< 15 IU/ml, TaqMan HCV Test) were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks.
Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dosage of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants with a positive HCV RNA level at Week 4 (>/= 15 IU/ml, TaqMan HCV Test) and negative HCV RNA level at Week 8 (\
Eligible participants who were not assigned to any treatment group in Part 2 were included in this group. These participants were a part of the safety analysis population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a and/or ribavirin) and had at least one post-baseline safety assessment.
BG011
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000142
BG001152
BG00278
BG003156
BG00412
BG00536
BG00625
BG00720
BG00842
BG00945
BG0108
BG011716
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00045.0± 10.7
BG00144.2± 10.2
BG00246.6± 9.0
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00050
BG00153
BG002
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 Relapse Rate in Groups A and B by Genotype at the End of Follow-up (Part 1)
Relapse rate (RR) was defined as the percentage of participants with non-detectable HCV RNA (< 100 copies/ml) at the end of treatment and detectable HCV RNA at the end of follow-up. End of treatment was defined as Week 48 for Group A and Week 72 for Group B, respectively. The end of follow-up was defined as Week 72 for Group A and Week 96 for Group B, respectively. Relapse rate for treatment Groups A and B, stratified for genotype (Genotype I and Genotype IV) and Week 4 response (< 600 units/milliliter [U/ml] and >= 600 U/ml) is presented.
The ITT population included all participants randomized and allocated to receive treatments. Here, 'n' = number of participants analyzed according to genotype and Week 4 response.
Posted
Number
95% Confidence Interval
Percentage of participants
Up to Week 96
ID
Title
Description
OG000
PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1)
Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A based on the presence of an EVR defined as non-detectable serum HCV RNA (< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline serum HCV RNA, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
OG001
PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1)
Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. After Week 48, participants were administered a lower dose of PEG-IFN alfa-2a of 135 mcg/week until Week 72. Participants were randomized to Group B based on the presence of an EVR defined as non-detectable serum HCV RNA (< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline in serum HCV RNA by quantitative PCR, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
Units
Counts
Participants
OG000142
OG001152
Title
Denominators
Categories
Genotype I, Week 4 response < 600 U/ml,n= 130, 136
Title
Measurements
OG00022.0(10.6 to 37.6)
OG0018.3(1.8 to 22.5)
Genotype I,Week 4 response >=600 U/ml, n =130, 136
Title
Measurements
OG000
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
For Genotype I, Week 4 response < 600 U/ml: Comparison of Group A versus Group B was carried out using the Chi-Square test.
Chi-squared
0.1002
No
Superiority or Other
OG000
OG001
For Genotype I, Week 4 response >= 600 U/ml: Comparison of Group A versus Group B was carried out using the Chi-Square test.
Primary
Percentage of Participants Achieving Sustained Virological Response in Groups A1, B1, and E by Genotype at the End of Follow-up (Part 2)
The Sustained Virological Response (SVR) was defined as the percentage of participants in each group with non-detectable HCV RNA result at 24 weeks post completion of the treatment period (HCV RNA < 15 IU/ml at Week 72 of Groups A1 and E, and at Week 96 of Group B1). Participants without a HCV RNA results at this time point were considered as non-responders. The end of follow-up was defined as Week 72 for Groups A1 and E, and Week 96 for Group B1. The SVR for treatment Groups A1 + B1 and E, stratified for genotype (Genotype I and Genotype IV) is presented.
The ITT population included all participants randomized and allocated to receive treatments. Here, 'n' = the number of participants analyzed according to genotype.
Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A1 if they showed positive HCV RNA level (>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
Secondary
Percentage of Participants With Virological Response Rate in Groups A, B, C, and D at the End of Treatment Period (Part 1)
End of treatment response (ETR) rate was defined as the percentage of participants in each group with non-detectable HCV RNA at completion of the treatment period (HCV negative at Week 24 of Group D, Week 48 of Group A and at Week 72 of Groups B and C). Participants without a HCV RNA results at this time point were considered as non-responders. End of the treatment period was defined as Week 48 for Group A, Week 72 for Groups B and C, and Week 24 for Group D.
The ITT population included all participants randomized and allocated to receive treatments.
Posted
Number
95% Confidence Interval
Percentage of participants
Up to Week 72
ID
Title
Description
OG000
PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1)
Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A based on the presence of an EVR defined as non-detectable serum HCV RNA (< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline serum HCV RNA, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
OG001
PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1)
Secondary
Percentage of Participants Achieving Sustained Virological Response in Groups A, B, C, and D at the End of Follow-up (Part 1)
The SVR was defined as the percentage of participants in each group with a non-detectable HCV RNA result at 24 weeks post-completion of the treatment period (HCV RNA < 15 IU/ml at Week 48 of Group D, at Week 72 of Group A, and at Week 96 of Groups B and C). Participants without a HCV RNA PCR at this time point were considered as non-responders in this calculation. The end of follow-up was defined as Week 72 for Group A, Week 96 for Groups B and C, and Week 48 for Group D.
The ITT population included all participants randomized and allocated to receive treatments.
Posted
Number
95% Confidence Interval
Percentage of participants
Up to Week 96
ID
Title
Description
OG000
PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1)
Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A based on the presence of an EVR defined as non-detectable serum HCV RNA (< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline serum HCV RNA, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
OG001
PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1)
Secondary
Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1)
The Short Form-36 (SF-36) is a quality of life instrument consisting of a 36-item questionnaire. The SF-36 items were scored and transformed according to the SF-36 Health Survey Manual and Interpretation Guide. Summary scores for SF-36 dimensions (physical functioning, role functioning, bodily pain, general health, vitality, social functioning, mental health, health transition) as well as physical and mental summary measures were compiled after imputation of mean scores for missing items if more than 50% of dimension-related items were available. Scores for health transition ranged from 0 (worst) to 5 (best). Scores for all other dimensions ranged from 0 (worst) to 100 (best). The mean SF-36 scores are presented at Baseline (Day 1), Week 24, Week 48, Week 72 (for Groups A and B) and at Week 96 (for Group B). Lower score indicate worsening.
The ITT population included all participants randomized and allocated to receive treatments. Here, 'n' = the number of participants analyzed at a given time point.
PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1)
Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A based on the presence of an EVR defined as non-detectable serum HCV RNA (< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline serum HCV RNA, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
Secondary
Mean Fatigue Severity Scale Scores for Groups A and B Over Time (Part 1)
The Fatigue Severity Scale (FSS) is an instrument consisting of 10 self-administered questions. The FSS items were scored by calculating the average response to all answered items (including the 9 questions and the fatigue symptoms). Each of the 9 questions had answers within a score range of 1-7. A score of 1 for any question indicates less fatigue in everyday life and a score of 7 indicates a higher likelihood of fatigue in everyday life. The mean FSS scores are presented at Baseline (Day 1), Week 24, Week 48 and Week 72 (for Groups A and B) and at Week 96 (for Group B).
The ITT population included all participants randomized and allocated to receive treatments. Here, 'n' = the number of participants analyzed at a given time point.
Posted
Mean
Standard Deviation
scores on a scale
Baseline (Day 1), Week 24, Week 48 and Week 72, and Week 96
ID
Title
Description
OG000
PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1)
Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A based on the presence of an EVR defined as non-detectable serum HCV RNA (< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline serum HCV RNA, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
OG001
Secondary
Number of Participants With Fibrosis Grades 0 to 4 at Baseline (Part 1)
Liver fibrosis stage was scored using the METAVIR system (Grade 0 to 4). Grade 0 indicates no fibrosis, Grade 1 indicates stellate enlargement of portal tract but without septa formation, Grade 2 indicates enlargement of portal tract with rare septa formation, Grade 3 indicates numerous septa without cirrhosis and grade 4 indicates cirrhosis. The number of participants with fibrosis grades ranging from 0 to 4 at Baseline is presented.
The safety population included all participants who received at least on dose of (either) study drug and had at least one post-baseline safety assessment.
Posted
Number
Number of participants
Baseline (Day 1)
ID
Title
Description
OG000
PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1)
Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A based on the presence of an EVR defined as non-detectable serum HCV RNA (< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline serum HCV RNA, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
OG001
PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1)
Secondary
Number of Participants With Adverse Events and Serious Adverse Events (Part 1)
An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.
The safety population included all participants who received at least on dose of (either) study drug and had at least one post-baseline safety assessment.
Posted
Number
Number of participants
Up to Week 96
ID
Title
Description
OG000
PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1)
Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A based on the presence of an EVR defined as non-detectable serum HCV RNA (< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline serum HCV RNA, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
Secondary
Percentage of Participants With Relapse Rates in Groups A1 and B1 at the End of Follow-up (Part 2)
Virological relapse rate was defined as percentage of participants with non-detectable HCV RNA (< 15 IU/ml) at the EoT and detectable HCV RNA (≥ 15 IU/ml) at the end of FU. The end of treatment was defined as Week 48 in Group A1 and Week 72 in Group B1 and the end of follow-up was defined as Week 72 in Group A1 and Week 96 in Group B1.
The ITT population included all participants randomized and allocated to receive treatments.
Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A1 if they showed positive HCV RNA level (>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 72 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. Participants were randomized to Group B1 if they showed positive HCV RNA level (>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
Secondary
Percentage of Participants With Virological Response Rates in Group A1, B1, C and D at the End of the Treatment Period (Part 2)
ETR virological response rate at the end of treatment period was defined as the percentage of participants in each group with non-detectable HCV RNA at completion of the treatment period (HCV RNA quantitative PCR result < 15 IU/ml at Week 24 for Group D, at Week 48 for Group A1, at Week 72 for Groups B1 and C). Participants without a HCV RNA PCR (missing values) at this time point were considered as non-responders in this calculation. The end of treatment period was defined as Week 48 for Group A1, Week 72 for Groups B1 and C1, and Week 24 for Group D.
The ITT population included all participants randomized and allocated to receive treatments.
Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A1 if they showed positive HCV RNA level (>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
Percentage of Participants Achieving Sustained Virological Response in Groups C and D by Genotype at the End of Follow-up (Part 2)
The SVR was defined as the percentage of participants in each group with non-detectable HCV RNA result at 24 weeks post completion of the treatment period (HCV RNA < 15 IU/ml at Week 48 of Group D and at Week 96 of Group C). Participants without a HCV RNA results at this time point were considered as non-responders. The end of follow-up was defined as Week 96 for Group C and Week 48 for Group D.
The ITT population included all participants randomized and allocated to receive treatments.
Posted
Number
95% Confidence Interval
Percentage of participants
Up to Week 96
ID
Title
Description
OG000
PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 2)
Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally; initially for 24 weeks. Participants without a > 2-log10 drop of HCV RNA level at Week 12 were assigned to Group C (Part 2). For participants who were HCV RNA-positive at Week 24, treatment was stopped. For participants who were negative for HCV RNA at Week 24, treatment was continued for a total of 72 weeks. Participants had a treatment-free follow-up period of 24 weeks.
Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2)
The SF-36 is a quality of life instrument consisting of a 36-item questionnaire. The SF-36 items were scored and transformed according to the SF-36 Health Survey Manual & Interpretation Guide. Summary scores for SF-36 dimensions (physical functioning, role functioning, bodily pain, general health, vitality, social functioning, mental health, health transition) as well as physical and mental summary measures were compiled after imputation of mean scores for missing items if more than 50% of dimension-related items were available. Scores for health transition ranged from 0 (worst) to 5 (best). Scores for all other dimensions ranged from 0 (worst) to 100 (best). The mean SF-36 scores were presented at Baseline (Day 1), Week 24, Week 48, Week 72 (for Groups A1, B1 and C) and at Week 96 (for Groups B1 and C). Lower score indicate worsening.
The ITT population included all participants randomized and allocated to receive treatments. Here, 'n' = the number of participants analyzed at a given time point.
Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A1 if they showed positive HCV RNA level (>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
Secondary
Mean Fatigue Severity Scale Scores for Groups A1, B1 and C Over Time (Part 2)
The FSS is an instrument consisting of 10 self-administered questions. The FSS items were scored by calculating the average response to all answered items (including the 9 questions and the fatigue symptoms). Each of the 9 questions had answers within a score range of 1-7. A score of 1 for any question indicates less fatigue in everyday life and a score of 7 indicates a higher likelihood of fatigue in everyday life. The mean FSS scores are presented at Baseline (Day 1), Week 24, Week 48 and Week 72 (for Groups A1, B1 and C) and at Week 96 (for Groups B1 and C).
The ITT population included all participants randomized and allocated to receive treatments. Here, 'n' = the number of participants analyzed for a given time point.
Posted
Mean
Standard Deviation
scores on a scale
Baseline (Day 1), Week 24, Week 48 and Week 72, and Week 96
Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A1 if they showed positive HCV RNA level (>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
OG001
Secondary
Number of Participants With Fibrosis Grades 0 to 4 at Baseline (Part 2)
Liver fibrosis stage was based upon biopsy and scored using the METAVIR system (Grade 0 to 4). Grade 0 indicates no fibrosis, Grade 1 indicates stellate enlargement of portal tract but without septa formation, Grade 2 indicates enlargement of portal tract with rare septa formation, Grade 3 indicates numerous septa without cirrhosis and grade 4 indicates cirrhosis. The number of participants with fibrosis grades ranging from 0 to 4 at Baseline (Day 1) is presented.
The ITT population included all participants randomized and allocated to receive treatments.
Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A1 if they showed positive HCV RNA level (>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 72 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. Participants were randomized to Group B1 if they showed positive HCV RNA level (>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
Secondary
Number of Participants With Adverse Events and Serious Adverse Events (Part 2)
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.
The safety population included all participants who received at least on dose of (either) study drug and had at least one post-baseline safety assessment.
Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A1 if they showed positive HCV RNA level (>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
Time Frame
Up to Week 96
Description
Adverse event data was reported for the safety population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a or ribavirin) and had at least one post-baseline safety assessment.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1)
Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A based on the presence of an EVR defined as non-detectable serum HCV RNA (< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline serum HCV RNA, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
22
142
139
142
EG001
PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1)
Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. After Week 48, participants were administered a lower dose of PEG-IFN alfa-2a of 135 mcg/week until Week 72. Participants were randomized to Group B based on the presence of an EVR defined as non-detectable serum HCV RNA (< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline in serum HCV RNA by quantitative PCR, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
28
152
147
152
EG002
PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 1)
Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally; initially for 24 weeks. Participants without an EVR at Week 12 (< 2-log10 decrease in HCV RNA as compared with baseline) were assigned to Group C and received treatment until Week 24. If HCV RNA became non-detectable at Week 24 then treatment was continued for a total of 72 weeks. Participants were administered a lower dose of PEG-IFN alfa-2a after Week 48 (135 mcg/week, until Week 72). Participants with detectable HCV RNA (>= 50 IU/ml) at Week 24 were required to discontinue treatment. Participants had a treatment-free follow-up period of 24 weeks.
Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 24 weeks. Participants with a RVR at Week 4 of treatment [HCV RNA level, <50 IU/ml by qualitative PCR assay, COBAS Amplicor HCV Test, version 2.0] were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks.
Eligible participants who were not randomized to any treatment group in Part 1 of the study were included in this group. These participants were a part of the safety analysis population which included participants who received at least on dose of (either) the study drug (PEG-IFN alfa-2a and/or ribavirin) and had at least one post-baseline safety assessment.
Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A1 if they showed positive HCV RNA level (>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 72 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. Participants were randomized to Group B1 if they showed positive HCV RNA level (>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
3
25
25
25
EG007
PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 2)
Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally; initially for 24 weeks. Participants without a > 2-log10 drop of HCV RNA level at Week 12 were assigned to Group C (Part 2). For participants who were HCV RNA-positive at Week 24, treatment was stopped. For participants who were negative for HCV RNA at Week 24, treatment was continued for a total of 72 weeks. Participants had a treatment-free follow-up period of 24 weeks.
Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 24 weeks. Participants with a negative HCV-RNA level at Week 4 (< 15 IU/ml, TaqMan HCV Test) were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks.
Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dosage of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants with a positive HCV RNA level at Week 4 (>/= 15 IU/ml, TaqMan HCV Test) and negative HCV RNA level at Week 8 (\
Eligible participants who were not assigned to any treatment group in Part 2 were included in this group. These participants were a part of the safety analysis population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a and/or ribavirin) and had at least one post-baseline safety assessment.
1
8
6
8
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Pneumonia
Infections and infestations
Systematic Assessment
EG0002 affected142 at risk
EG0011 affected152 at risk
EG0020 affected78 at risk
EG0030 affected156 at risk
EG0040 affected12 at risk
EG0050 affected36 at risk
EG0060 affected25 at risk
EG0070 affected20 at risk
EG0080 affected42 at risk
EG0090 affected45 at risk
EG0101 affected8 at risk
Abscess limb
Infections and infestations
Systematic Assessment
EG0000 affected142 at risk
EG0011 affected152 at risk
EG0020 affected78 at risk
EG003
Urinary tract infection
Infections and infestations
Systematic Assessment
EG0000 affected142 at risk
EG0012 affected152 at risk
EG0020 affected78 at risk
EG003
Acute hepatitis B
Infections and infestations
Systematic Assessment
EG0001 affected142 at risk
EG0010 affected152 at risk
EG0020 affected78 at risk
EG003
Appendicitis
Infections and infestations
Systematic Assessment
EG0001 affected142 at risk
EG0010 affected152 at risk
EG0020 affected78 at risk
EG003
Bronchitis
Infections and infestations
Systematic Assessment
EG0000 affected142 at risk
EG0010 affected152 at risk
EG0021 affected78 at risk
EG003
Enterocolitis infectious
Infections and infestations
Systematic Assessment
EG0001 affected142 at risk
EG0010 affected152 at risk
EG0020 affected78 at risk
EG003
Epiglottitis
Infections and infestations
Systematic Assessment
EG0000 affected142 at risk
EG0011 affected152 at risk
EG0020 affected78 at risk
EG003
Gastroenteritis
Infections and infestations
Systematic Assessment
EG0000 affected142 at risk
EG0010 affected152 at risk
EG0021 affected78 at risk
EG003
Gingival infection
Infections and infestations
Systematic Assessment
EG0001 affected142 at risk
EG0010 affected152 at risk
EG0020 affected78 at risk
EG003
Infection
Infections and infestations
Systematic Assessment
EG0000 affected142 at risk
EG0011 affected152 at risk
EG0020 affected78 at risk
EG003
Pulmonary tuberculosis
Infections and infestations
Systematic Assessment
EG0000 affected142 at risk
EG0011 affected152 at risk
EG0020 affected78 at risk
EG003
Scrotal abscess
Infections and infestations
Systematic Assessment
EG0000 affected142 at risk
EG0011 affected152 at risk
EG0020 affected78 at risk
EG003
Urosepsis
Infections and infestations
Systematic Assessment
EG0000 affected142 at risk
EG0010 affected152 at risk
EG0021 affected78 at risk
EG003
Depression
Psychiatric disorders
Systematic Assessment
EG0002 affected142 at risk
EG0010 affected152 at risk
EG0022 affected78 at risk
EG003
Suicide attempt
Psychiatric disorders
Systematic Assessment
EG0001 affected142 at risk
EG0011 affected152 at risk
EG0020 affected78 at risk
EG003
Alcohol abuse
Psychiatric disorders
Systematic Assessment
EG0001 affected142 at risk
EG0010 affected152 at risk
EG0020 affected78 at risk
EG003
Delirium
Psychiatric disorders
Systematic Assessment
EG0000 affected142 at risk
EG0010 affected152 at risk
EG0020 affected78 at risk
EG003
Depression suicidal
Psychiatric disorders
Systematic Assessment
EG0000 affected142 at risk
EG0010 affected152 at risk
EG0020 affected78 at risk
EG003
Drug abuse
Psychiatric disorders
Systematic Assessment
EG0000 affected142 at risk
EG0010 affected152 at risk
EG0020 affected78 at risk
EG003
Schizoaffective disorder
Psychiatric disorders
Systematic Assessment
EG0000 affected142 at risk
EG0010 affected152 at risk
EG0020 affected78 at risk
EG003
Gastritis
Gastrointestinal disorders
Systematic Assessment
EG0001 affected142 at risk
EG0011 affected152 at risk
EG0020 affected78 at risk
EG003
Abdominal pain
Gastrointestinal disorders
Systematic Assessment
EG0000 affected142 at risk
EG0010 affected152 at risk
EG0020 affected78 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
Systematic Assessment
EG0000 affected142 at risk
EG0010 affected152 at risk
EG0020 affected78 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
Systematic Assessment
EG0001 affected142 at risk
EG0010 affected152 at risk
EG0020 affected78 at risk
EG003
Nausea
Gastrointestinal disorders
Systematic Assessment
EG0000 affected142 at risk
EG0011 affected152 at risk
EG0020 affected78 at risk
EG003
Pancreatitis acute
Gastrointestinal disorders
Systematic Assessment
EG0000 affected142 at risk
EG0010 affected152 at risk
EG0020 affected78 at risk
EG003
Portal hypertensive gastropathy
Gastrointestinal disorders
Systematic Assessment
EG0000 affected142 at risk
EG0010 affected152 at risk
EG0021 affected78 at risk
EG003
Vomiting
Gastrointestinal disorders
Systematic Assessment
EG0000 affected142 at risk
EG0010 affected152 at risk
EG0020 affected78 at risk
EG003
Thrombosis
Vascular disorders
Systematic Assessment
EG0001 affected142 at risk
EG0011 affected152 at risk
EG0020 affected78 at risk
EG003
Circulatory collapse
Vascular disorders
Systematic Assessment
EG0000 affected142 at risk
EG0010 affected152 at risk
EG0020 affected78 at risk
EG003
Cryoglobulinaemia
Vascular disorders
Systematic Assessment
EG0000 affected142 at risk
EG0010 affected152 at risk
EG0020 affected78 at risk
EG003
Deep vein thrombosis
Vascular disorders
Systematic Assessment
EG0001 affected142 at risk
EG0010 affected152 at risk
EG0020 affected78 at risk
EG003
Subclavian artery stenosis
Vascular disorders
Systematic Assessment
EG0000 affected142 at risk
EG0011 affected152 at risk
EG0020 affected78 at risk
EG003
Thrombophlebitis
Vascular disorders
Systematic Assessment
EG0000 affected142 at risk
EG0010 affected152 at risk
EG0020 affected78 at risk
EG003
Anaemia
Blood and lymphatic system disorders
Systematic Assessment
EG0000 affected142 at risk
EG0012 affected152 at risk
EG0020 affected78 at risk
EG003
Pancytopenia
Blood and lymphatic system disorders
Systematic Assessment
EG0001 affected142 at risk
EG0010 affected152 at risk
EG0020 affected78 at risk
EG003
Rash Maculo-Papular
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 affected142 at risk
EG0011 affected152 at risk
EG0020 affected78 at risk
EG003
Influenza Like Illness
General disorders
Systematic Assessment
EG0000 affected142 at risk
EG0011 affected152 at risk
EG0020 affected78 at risk
EG003
Cataract
Eye disorders
Systematic Assessment
EG0000 affected142 at risk
EG0010 affected152 at risk
EG0020 affected78 at risk
EG003
Basedow's Disease
Endocrine disorders
Systematic Assessment
EG0001 affected142 at risk
EG0010 affected152 at risk
EG0020 affected78 at risk
EG003
Metrorrhagia
Reproductive system and breast disorders
Systematic Assessment
EG0000 affected142 at risk
EG0010 affected152 at risk
EG0020 affected78 at risk
EG003
Ovarian Cyst
Reproductive system and breast disorders
Systematic Assessment
EG0000 affected142 at risk
EG0010 affected152 at risk
EG0020 affected78 at risk
EG003
Ovarian Neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected142 at risk
EG0010 affected152 at risk
EG0020 affected78 at risk
EG003
Uterine Leiomyoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected142 at risk
EG0011 affected152 at risk
EG0020 affected78 at risk
EG003
Diabetes Mellitus
Metabolism and nutrition disorders
Systematic Assessment
EG0000 affected142 at risk
EG0010 affected152 at risk
EG0020 affected78 at risk
EG003
Type 2 Diabetes Mellitus
Metabolism and nutrition disorders
Systematic Assessment
EG0001 affected142 at risk
EG0010 affected152 at risk
EG0020 affected78 at risk
EG003
Sudden Hearing Loss
Ear and labyrinth disorders
Systematic Assessment
EG0001 affected142 at risk
EG0010 affected152 at risk
EG0020 affected78 at risk
EG003
Vertigo
Ear and labyrinth disorders
Systematic Assessment
EG0000 affected142 at risk
EG0011 affected152 at risk
EG0020 affected78 at risk
EG003
Inguinal Hernia Repair
Surgical and medical procedures
Systematic Assessment
EG0000 affected142 at risk
EG0011 affected152 at risk
EG0020 affected78 at risk
EG003
Intervertebral Disc Operation
Surgical and medical procedures
Systematic Assessment
EG0000 affected142 at risk
EG0011 affected152 at risk
EG0020 affected78 at risk
EG003
Ovarian Cystectomy
Surgical and medical procedures
Systematic Assessment
EG0000 affected142 at risk
EG0011 affected152 at risk
EG0020 affected78 at risk
EG003
Tonsillectomy
Surgical and medical procedures
Systematic Assessment
EG0000 affected142 at risk
EG0011 affected152 at risk
EG0020 affected78 at risk
EG003
Cystitis Haemorrhagic
Renal and urinary disorders
Systematic Assessment
EG0001 affected142 at risk
EG0010 affected152 at risk
EG0020 affected78 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
Systematic Assessment
EG0001 affected142 at risk
EG0010 affected152 at risk
EG0020 affected78 at risk
EG003
Renal Failure
Renal and urinary disorders
Systematic Assessment
EG0000 affected142 at risk
EG0010 affected152 at risk
EG0020 affected78 at risk
EG003
Back Pain
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0001 affected142 at risk
EG0010 affected152 at risk
EG0020 affected78 at risk
EG003
Bursitis
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 affected142 at risk
EG0010 affected152 at risk
EG0021 affected78 at risk
EG003
Intervertebral Disc Protrusion
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 affected142 at risk
EG0010 affected152 at risk
EG0021 affected78 at risk
EG003
Cholecystitis Acute
Hepatobiliary disorders
Systematic Assessment
EG0001 affected142 at risk
EG0010 affected152 at risk
EG0020 affected78 at risk
EG003
Hepatotoxicity
Hepatobiliary disorders
Systematic Assessment
EG0000 affected142 at risk
EG0010 affected152 at risk
EG0021 affected78 at risk
EG003
Jaundice Cholestatic
Hepatobiliary disorders
Systematic Assessment
EG0000 affected142 at risk
EG0010 affected152 at risk
EG0020 affected78 at risk
EG003
Pregnancy Of Partner
Social circumstances
Systematic Assessment
EG0000 affected142 at risk
EG0013 affected152 at risk
EG0020 affected78 at risk
EG003
Pregnancy
Pregnancy, puerperium and perinatal conditions
Systematic Assessment
EG0000 affected142 at risk
EG0010 affected152 at risk
EG0020 affected78 at risk
EG003
Laceration
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 affected142 at risk
EG0011 affected152 at risk
EG0020 affected78 at risk
EG003
Alveolitis
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 affected142 at risk
EG0011 affected152 at risk
EG0020 affected78 at risk
EG003
Chronic Obstructive Pulmonary Disease
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 affected142 at risk
EG0011 affected152 at risk
EG0020 affected78 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 affected142 at risk
EG0010 affected152 at risk
EG0020 affected78 at risk
EG003
Pulmonary Embolism
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 affected142 at risk
EG0010 affected152 at risk
EG0020 affected78 at risk
EG003
Pulmonary Sarcoidosis
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 affected142 at risk
EG0011 affected152 at risk
EG0020 affected78 at risk
EG003
Respiratory Failure
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 affected142 at risk
EG0011 affected152 at risk
EG0020 affected78 at risk
EG003
Epilepsy
Nervous system disorders
Systematic Assessment
EG0001 affected142 at risk
EG0010 affected152 at risk
EG0020 affected78 at risk
EG003
Carpal Tunnel Syndrome
Nervous system disorders
Systematic Assessment
EG0000 affected142 at risk
EG0011 affected152 at risk
EG0020 affected78 at risk
EG003
Cerebral Haemorrhage
Nervous system disorders
Systematic Assessment
EG0000 affected142 at risk
EG0010 affected152 at risk
EG0020 affected78 at risk
EG003
Mononeuritis
Nervous system disorders
Systematic Assessment
EG0000 affected142 at risk
EG0011 affected152 at risk
EG0020 affected78 at risk
EG003
Syncope
Nervous system disorders
Systematic Assessment
EG0001 affected142 at risk
EG0010 affected152 at risk
EG0020 affected78 at risk
EG003
Acute Coronary Syndrome
Cardiac disorders
Systematic Assessment
EG0000 affected142 at risk
EG0011 affected152 at risk
EG0020 affected78 at risk
EG003
Acute Myocardial Infarction
Cardiac disorders
Systematic Assessment
EG0000 affected142 at risk
EG0011 affected152 at risk
EG0020 affected78 at risk
EG003
Arteriosclerosis Coronary Artery
Cardiac disorders
Systematic Assessment
EG0000 affected142 at risk
EG0011 affected152 at risk
EG0020 affected78 at risk
EG003
Myocarditis
Cardiac disorders
Systematic Assessment
EG0000 affected142 at risk
EG0011 affected152 at risk
EG0020 affected78 at risk
EG003
Pericarditis
Cardiac disorders
Systematic Assessment
EG0000 affected142 at risk
EG0010 affected152 at risk
EG0020 affected78 at risk
EG003
Tachycardia
Cardiac disorders
Systematic Assessment
EG0000 affected142 at risk
EG0010 affected152 at risk
EG0021 affected78 at risk
EG003
Overdose
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 affected142 at risk
EG0011 affected152 at risk
EG0020 affected78 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Fatigue
General disorders
Systematic Assessment
EG00086 affected142 at risk
EG00194 affected152 at risk
EG00235 affected78 at risk
EG00372 affected156 at risk
EG0044 affected12 at risk
EG00520 affected36 at risk
EG00614 affected25 at risk
EG00711 affected20 at risk
EG00821 affected42 at risk
EG00930 affected45 at risk
EG0101 affected8 at risk
Influenza Like Illness
General disorders
Systematic Assessment
EG00060 affected142 at risk
EG00157 affected152 at risk
EG00241 affected78 at risk
EG003
Pyrexia
General disorders
Systematic Assessment
EG00029 affected142 at risk
EG00134 affected152 at risk
EG0029 affected78 at risk
EG003
Asthenia
General disorders
Systematic Assessment
EG0004 affected142 at risk
EG0018 affected152 at risk
EG0021 affected78 at risk
EG003
Chills
General disorders
Systematic Assessment
EG0004 affected142 at risk
EG0015 affected152 at risk
EG0022 affected78 at risk
EG003
Chest Pain
General disorders
Systematic Assessment
EG0004 affected142 at risk
EG0012 affected152 at risk
EG0021 affected78 at risk
EG003
Irritability
General disorders
Systematic Assessment
EG0002 affected142 at risk
EG0011 affected152 at risk
EG0021 affected78 at risk
EG003
Injection Site erythema
General disorders
Systematic Assessment
EG0000 affected142 at risk
EG0012 affected152 at risk
EG0021 affected78 at risk
EG003
Application Site erythema
General disorders
Systematic Assessment
EG0000 affected142 at risk
EG0010 affected152 at risk
EG0020 affected78 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
Systematic Assessment
EG00035 affected142 at risk
EG00139 affected152 at risk
EG00215 affected78 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
Systematic Assessment
EG00036 affected142 at risk
EG00127 affected152 at risk
EG00219 affected78 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
Systematic Assessment
EG00029 affected142 at risk
EG00139 affected152 at risk
EG0028 affected78 at risk
EG003
Dry Skin
Skin and subcutaneous tissue disorders
Systematic Assessment
EG00017 affected142 at risk
EG00131 affected152 at risk
EG0028 affected78 at risk
EG003
Skin Fissures
Skin and subcutaneous tissue disorders
Systematic Assessment
EG00011 affected142 at risk
EG00112 affected152 at risk
EG0020 affected78 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0005 affected142 at risk
EG00116 affected152 at risk
EG0021 affected78 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0003 affected142 at risk
EG0014 affected152 at risk
EG0022 affected78 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0003 affected142 at risk
EG0010 affected152 at risk
EG0021 affected78 at risk
EG003
Depression
Psychiatric disorders
Systematic Assessment
EG00030 affected142 at risk
EG00144 affected152 at risk
EG00220 affected78 at risk
EG003
Insomnia
Psychiatric disorders
Systematic Assessment
EG00016 affected142 at risk
EG00124 affected152 at risk
EG0029 affected78 at risk
EG003
Sleep Disorder
Psychiatric disorders
Systematic Assessment
EG00019 affected142 at risk
EG00127 affected152 at risk
EG0028 affected78 at risk
EG003
Depressed Mood
Psychiatric disorders
Systematic Assessment
EG0007 affected142 at risk
EG0017 affected152 at risk
EG0023 affected78 at risk
EG003
Aggression
Psychiatric disorders
Systematic Assessment
EG0005 affected142 at risk
EG0018 affected152 at risk
EG0024 affected78 at risk
EG003
Panic Attack
Psychiatric disorders
Systematic Assessment
EG0002 affected142 at risk
EG0011 affected152 at risk
EG0021 affected78 at risk
EG003
Affect Lability
Psychiatric disorders
Systematic Assessment
EG0000 affected142 at risk
EG0012 affected152 at risk
EG0021 affected78 at risk
EG003
Libido Decreased
Psychiatric disorders
Systematic Assessment
EG0001 affected142 at risk
EG0010 affected152 at risk
EG0020 affected78 at risk
EG003
Alcoholism
Psychiatric disorders
Systematic Assessment
EG0000 affected142 at risk
EG0010 affected152 at risk
EG0020 affected78 at risk
EG003
Apathy
Psychiatric disorders
Systematic Assessment
EG0000 affected142 at risk
EG0010 affected152 at risk
EG0020 affected78 at risk
EG003
Paranoia
Psychiatric disorders
Systematic Assessment
EG0000 affected142 at risk
EG0010 affected152 at risk
EG0020 affected78 at risk
EG003
Nausea
Gastrointestinal disorders
Systematic Assessment
EG00027 affected142 at risk
EG00122 affected152 at risk
EG00211 affected78 at risk
EG003
Abdominal Pain Upper
Gastrointestinal disorders
Systematic Assessment
EG00020 affected142 at risk
EG00116 affected152 at risk
EG00211 affected78 at risk
EG003
Diarrhoea
Gastrointestinal disorders
Systematic Assessment
EG00021 affected142 at risk
EG00118 affected152 at risk
EG0023 affected78 at risk
EG003
Dyspepsia
Gastrointestinal disorders
Systematic Assessment
EG0007 affected142 at risk
EG00114 affected152 at risk
EG0021 affected78 at risk
EG003
Vomiting
Gastrointestinal disorders
Systematic Assessment
EG0006 affected142 at risk
EG0017 affected152 at risk
EG0021 affected78 at risk
EG003
Abdominal Pain
Gastrointestinal disorders
Systematic Assessment
EG0006 affected142 at risk
EG00111 affected152 at risk
EG0020 affected78 at risk
EG003
Toothache
Gastrointestinal disorders
Systematic Assessment
EG0002 affected142 at risk
EG0018 affected152 at risk
EG0021 affected78 at risk
EG003
Dry Mouth
Gastrointestinal disorders
Systematic Assessment
EG0003 affected142 at risk
EG0015 affected152 at risk
EG0021 affected78 at risk
EG003
Constipation
Gastrointestinal disorders
Systematic Assessment
EG0004 affected142 at risk
EG0015 affected152 at risk
EG0021 affected78 at risk
EG003
Flatulence
Gastrointestinal disorders
Systematic Assessment
EG0001 affected142 at risk
EG0015 affected152 at risk
EG0021 affected78 at risk
EG003
Anaemia
Blood and lymphatic system disorders
Systematic Assessment
EG00032 affected142 at risk
EG00133 affected152 at risk
EG0029 affected78 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
Systematic Assessment
EG00031 affected142 at risk
EG00120 affected152 at risk
EG00211 affected78 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
Systematic Assessment
EG0009 affected142 at risk
EG00115 affected152 at risk
EG0024 affected78 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
Systematic Assessment
EG0004 affected142 at risk
EG0018 affected152 at risk
EG0022 affected78 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
Systematic Assessment
EG0002 affected142 at risk
EG0015 affected152 at risk
EG0022 affected78 at risk
EG003
Haemolysis
Blood and lymphatic system disorders
Systematic Assessment
EG0000 affected142 at risk
EG0010 affected152 at risk
EG0020 affected78 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG00021 affected142 at risk
EG00124 affected152 at risk
EG00212 affected78 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG00026 affected142 at risk
EG00125 affected152 at risk
EG00210 affected78 at risk
EG003
Dyspnoea Exertional
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0006 affected142 at risk
EG0018 affected152 at risk
EG0023 affected78 at risk
EG003
Oropharyngeal Pain
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG00011 affected142 at risk
EG00111 affected152 at risk
EG0020 affected78 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0005 affected142 at risk
EG0016 affected152 at risk
EG0021 affected78 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG00024 affected142 at risk
EG00127 affected152 at risk
EG00210 affected78 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG00012 affected142 at risk
EG00123 affected152 at risk
EG0028 affected78 at risk
EG003
Back Pain
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG00010 affected142 at risk
EG0019 affected152 at risk
EG0022 affected78 at risk
EG003
Musculoskeletal Pain
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0005 affected142 at risk
EG0019 affected152 at risk
EG0021 affected78 at risk
EG003
Pain In Extremity
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0003 affected142 at risk
EG0013 affected152 at risk
EG0021 affected78 at risk
EG003
Decreased Appetite
Metabolism and nutrition disorders
Systematic Assessment
EG00016 affected142 at risk
EG00126 affected152 at risk
EG0026 affected78 at risk
EG003
Hypertriglyceridaemia
Metabolism and nutrition disorders
Systematic Assessment
EG00017 affected142 at risk
EG00116 affected152 at risk
EG0029 affected78 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
Systematic Assessment
EG00019 affected142 at risk
EG00117 affected152 at risk
EG0028 affected78 at risk
EG003
Appetite Disorder
Metabolism and nutrition disorders
Systematic Assessment
EG0000 affected142 at risk
EG0010 affected152 at risk
EG0020 affected78 at risk
EG003
Headache
Nervous system disorders
Systematic Assessment
EG00042 affected142 at risk
EG00138 affected152 at risk
EG00210 affected78 at risk
EG003
Dizziness
Nervous system disorders
Systematic Assessment
EG0000 affected142 at risk
EG0011 affected152 at risk
EG0020 affected78 at risk
EG003
Nasopharyngitis
Infections and infestations
Systematic Assessment
EG00016 affected142 at risk
EG00123 affected152 at risk
EG0026 affected78 at risk
EG003
Bronchitis
Infections and infestations
Systematic Assessment
EG0005 affected142 at risk
EG00114 affected152 at risk
EG0025 affected78 at risk
EG003
Influenza
Infections and infestations
Systematic Assessment
EG0005 affected142 at risk
EG0017 affected152 at risk
EG0022 affected78 at risk
EG003
Urinary Tract Infection
Infections and infestations
Systematic Assessment
EG0004 affected142 at risk
EG0013 affected152 at risk
EG0022 affected78 at risk
EG003
Oral Herpes
Infections and infestations
Systematic Assessment
EG0004 affected142 at risk
EG0015 affected152 at risk
EG0021 affected78 at risk
EG003
Rhinitis
Infections and infestations
Systematic Assessment
EG0002 affected142 at risk
EG0017 affected152 at risk
EG0022 affected78 at risk
EG003
Abscess
Infections and infestations
Systematic Assessment
EG0002 affected142 at risk
EG0016 affected152 at risk
EG0020 affected78 at risk
EG003
Pulpitis Dental
Infections and infestations
Systematic Assessment
EG0000 affected142 at risk
EG0012 affected152 at risk
EG0020 affected78 at risk
EG003
Hypothyroidism
Endocrine disorders
Systematic Assessment
EG0008 affected142 at risk
EG00123 affected152 at risk
EG0024 affected78 at risk
EG003
Hyperthyroidism
Endocrine disorders
Systematic Assessment
EG0007 affected142 at risk
EG00110 affected152 at risk
EG0023 affected78 at risk
EG003
Vertigo
Ear and labyrinth disorders
Systematic Assessment
EG00016 affected142 at risk
EG00120 affected152 at risk
EG0028 affected78 at risk
EG003
Weight Decreased
Investigations
Systematic Assessment
EG00017 affected142 at risk
EG00114 affected152 at risk
EG0023 affected78 at risk
EG003
Visual Impairment
Eye disorders
Systematic Assessment
EG0004 affected142 at risk
EG0018 affected152 at risk
EG0021 affected78 at risk
EG003
Conjunctivitis
Eye disorders
Systematic Assessment
EG0003 affected142 at risk
EG0016 affected152 at risk
EG0021 affected78 at risk
EG003
Dry Eye
Eye disorders
Systematic Assessment
EG0003 affected142 at risk
EG0013 affected152 at risk
EG0021 affected78 at risk
EG003
Abnormal Sensation In Eye
Eye disorders
Systematic Assessment
EG0000 affected142 at risk
EG0010 affected152 at risk
EG0020 affected78 at risk
EG003
Retinal Detachment
Eye disorders
Systematic Assessment
EG0000 affected142 at risk
EG0010 affected152 at risk
EG0020 affected78 at risk
EG003
Cardiovascular Disorder
Cardiac disorders
Systematic Assessment
EG0003 affected142 at risk
EG0018 affected152 at risk
EG0020 affected78 at risk
EG003
Ventricular Tachycardia
Cardiac disorders
Systematic Assessment
EG0000 affected142 at risk
EG0010 affected152 at risk
EG0020 affected78 at risk
EG003
Nocturia
Renal and urinary disorders
Systematic Assessment
EG0000 affected142 at risk
EG0010 affected152 at risk
EG0020 affected78 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
Systematic Assessment
EG0000 affected142 at risk
EG0010 affected152 at risk
EG0020 affected78 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
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.
Point of Contact
Title
Organization
Phone
Extension
Email
Roche Trial Information Hotline
F. Hoffmann-La Roche AG
+41 61 6878333
global.trial_information@roche.com
ID
Term
D019698
Hepatitis C, Chronic
Ancestor Terms
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
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C100416
peginterferon alfa-2a
D012254
Ribavirin
Ancestor Terms
ID
Term
D012263
Ribonucleosides
D009705
Nucleosides
D009706
Nucleic Acids, Nucleotides, and Nucleosides
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
5 subjects
FG0051 subjects
FG0065 subjects
FG0070 subjects
FG0081 subjects
FG0091 subjects
FG0105 subjects
0 subjects
FG0052 subjects
FG0060 subjects
FG0075 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
5 subjects
FG0051 subjects
FG0061 subjects
FG0071 subjects
FG0080 subjects
FG0092 subjects
FG0100 subjects
0 subjects
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FG0060 subjects
FG0070 subjects
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FG0101 subjects
2 subjects
FG0051 subjects
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FG0080 subjects
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FG0080 subjects
FG0090 subjects
FG0100 subjects
0 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
0 subjects
FG0051 subjects
FG0062 subjects
FG0070 subjects
FG0081 subjects
FG0090 subjects
FG0100 subjects
0 subjects
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FG0060 subjects
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FG0090 subjects
FG0100 subjects
0 subjects
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FG0060 subjects
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FG0060 subjects
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FG0090 subjects
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0 subjects
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FG0060 subjects
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FG0100 subjects
0 subjects
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FG0060 subjects
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FG0080 subjects
FG0090 subjects
FG0100 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
0 subjects
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FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
1 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
2 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0081 subjects
FG0090 subjects
FG0100 subjects
0 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0081 subjects
FG0090 subjects
FG0100 subjects
0 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0101 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0091 subjects
FG0100 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0081 subjects
FG0090 subjects
FG0100 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0091 subjects
FG0100 subjects
0 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
40.5
± 11.7
BG00446.5± 9.5
BG00544.6± 9.1
BG00647.3± 9.8
BG00746.6± 8.7
BG00837.8± 11.1
BG00941.1± 10.2
BG01043.6± 15.4
BG01143.5± 10.78
21
BG00357
BG0044
BG0058
BG0068
BG0075
BG00817
BG00920
BG0103
BG011246
Male
BG00092
BG00199
BG00257
BG00399
BG0048
BG00528
BG00617
BG00715
BG00825
BG00925
BG0105
BG011470
52.7
(38.8 to 66.3)
OG00130.0(17.9 to 44.6)
Genotype IV, Week 4 response < 600 U/ml, n =12, 16
Title
Measurements
OG0000.0(0.0 to 52.2)
OG00142.9(9.9 to 81.6)
Genotype IV, Week 4 response >=600 U/ml, n =12, 16
Title
Measurements
OG00080.0(28.4 to 99.5)
OG00180.0(28.4 to 99.5)
Chi-squared
0.0184
No
Superiority or Other
OG000
OG001
For Genotype IV, Week 4 response < 600 U/ml: Comparison of Group A versus Group B was carried out using the Chi-Square test.
Chi-squared
0.0910
No
Superiority or Other
OG000
OG001
For Genotype IV, Week 4 response >= 600 U/ml: Comparison of Group A versus Group B was carried out using the Chi-Square test.
Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 72 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. Participants were randomized to Group B1 if they showed positive HCV RNA level (>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dosage of 1,000 mg/day (for participants with a body weight ≤ 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants with a positive HCV RNA level at Week 4 (≥ 15 IU/ml) and negative HCV RNA level at Week 8 (≤ 15 IU/ml) were assigned to group E. Participants had a treatment-free follow-up period of 24 weeks.
Units
Counts
Participants
OG00033
OG00123
OG00245
Title
Denominators
Categories
Genotype I, n = 33, 23, 39
Title
Measurements
OG00030.3(15.6 to 48.7)
OG00134.8(16.4 to 57.3)
OG00264.1(47.2 to 78.8)
Genotype IV, n = 3, 2, 6
Title
Measurements
OG00033.3(0.8 to 90.6)
OG0010.0(0.0 to 84.2)
OG00250.0(11.8 to 88.2)
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
OG002
Comparison of Groups A1+B1 versus group E stratified by genotype I.
Cochran-Mantel-Haenszel
0.0021
The SVR rate i.e., 32.1% participants with genotype I who achieved SVR with 95 % confidence interval of 20.3 to 46.0 in groups A1+B1 was compared with SVR rate in group E using Cochran-Mantel-Haenszel method .
No
Superiority or Other
OG000
OG001
OG002
Comparison of Groups A1+B1 versus group E stratified by genotype IV
Cochran-Mantel-Haenszel
0.3031
The SVR rate i.e., 20.0% participants with genotype IV who achieved SVR with 95 % confidence interval of 0.5 to 71.6 in groups A1+B1 was compared with SVR rate in group E using Cochran-Mantel-Haenszel method .
No
Superiority or Other
Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. After Week 48, participants were administered a lower dose of PEG-IFN alfa-2a of 135 mcg/week until Week 72. Participants were randomized to Group B based on the presence of an EVR defined as non-detectable serum HCV RNA (< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline in serum HCV RNA by quantitative PCR, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
OG002
PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 1)
Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally; initially for 24 weeks. Participants without an EVR at Week 12 (< 2-log10 decrease in HCV RNA as compared with baseline) were assigned to Group C and received treatment until Week 24. If HCV RNA became non-detectable at Week 24 then treatment was continued for a total of 72 weeks. Participants were administered a lower dose of PEG-IFN alfa-2a after Week 48 (135 mcg/week, until Week 72). Participants with detectable HCV RNA (>= 50 IU/ml) at Week 24 were required to discontinue treatment. Participants had a treatment-free follow-up period of 24 weeks.
Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 24 weeks. Participants with a RVR at Week 4 of treatment [HCV RNA level, <50 IU/ml by qualitative PCR assay, COBAS Amplicor HCV Test, version 2.0] were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks.
Units
Counts
Participants
OG000142
OG001152
OG00278
OG003156
Title
Denominators
Categories
Title
Measurements
OG00074.6(66.7 to 81.6)
OG00164.5(56.3 to 72.1)
OG0029.0(3.7 to 17.6)
OG00392.3(86.9 to 96.0)
Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. After Week 48, participants were administered a lower dose of PEG-IFN alfa-2a of 135 mcg/week until Week 72. Participants were randomized to Group B based on the presence of an EVR defined as non-detectable serum HCV RNA (< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline in serum HCV RNA by quantitative PCR, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
OG002
PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 1)
Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally; initially for 24 weeks. Participants without an EVR at Week 12 (< 2-log10 decrease in HCV RNA as compared with baseline) were assigned to Group C and received treatment until Week 24. If HCV RNA became non-detectable at Week 24 then treatment was continued for a total of 72 weeks. Participants were administered a lower dose of PEG-IFN alfa-2a after Week 48 (135 mcg/week, until Week 72). Participants with detectable HCV RNA (>= 50 IU/ml) at Week 24 were required to discontinue treatment. Participants had a treatment-free follow-up period of 24 weeks.
Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 24 weeks. Participants with a RVR at Week 4 of treatment [HCV RNA level, <50 IU/ml by qualitative PCR assay, COBAS Amplicor HCV Test, version 2.0] were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks.
Units
Counts
Participants
OG000142
OG001152
OG00278
OG003156
Title
Denominators
Categories
Title
Measurements
OG00045.1(36.7 to 53.6)
OG00148.0(39.9 to 56.3)
OG0026.4(2.1 to 14.3)
OG00373.7(66.1 to 80.4)
OG001
PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1)
Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. After Week 48, participants were administered a lower dose of PEG-IFN alfa-2a of 135 mcg/week until Week 72. Participants were randomized to Group B based on the presence of an EVR defined as non-detectable serum HCV RNA (< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline in serum HCV RNA by quantitative PCR, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
Units
Counts
Participants
OG000106
OG001123
Title
Denominators
Categories
Physical Functioning, Baseline, n = 106, 121
Title
Measurements
OG00086.9± 15.1
OG00187.0± 17.8
Physical Functioning, Week 24, n = 77, 90
Title
Measurements
OG00061.8± 28.2
OG00169.2± 22.6
Physical Functioning, Week 48, n = 67, 77
Title
Measurements
OG00066.1± 26.2
OG00166.8± 23.1
Physical Functioning, Week 72, n = 65, 68
Title
Measurements
OG00089.8± 14.1
OG00170.3± 24.6
Physical Functioning, Week 96, n = 0, 59
Title
Measurements
OG000NA± NANo participants were available for analysis in this arm at Week 96.
OG00187.0± 20.4
Role Functioning - Physical, Baseline,n = 105, 120
Title
Measurements
OG00074.7± 36.3
OG00176.2± 36.9
Role Functioning - Physical, Week 24, n = 77, 88
Title
Measurements
OG00039.0± 43.0
OG00145.7± 41.9
Role Functioning - Physical, Week 48, n = 66, 76
Title
Measurements
OG00040.7± 39.9
OG00142.2± 44.0
Role Functioning - Physical, Week 72, n = 65, 67
Title
Measurements
OG00081.5± 32.9
OG00147.4± 43.5
Role Functioning - Physical, Week 96, n = 0, 58
Title
Measurements
OG000NA± NANo participants were available for analysis in this arm at Week 96.
OG00184.5± 29.9
Bodily Pain, Baseline, n = 103, 120
Title
Measurements
OG00082.3± 22.5
OG00183.5± 22.9
Bodily Pain, Week 24, n = 76, 91
Title
Measurements
OG00068.2± 31.1
OG00170.0± 29.6
Bodily Pain, Week 48, n = 67, 77
Title
Measurements
OG00069.5± 28.6
OG00166.8± 30.6
Bodily Pain, Week 72, n = 64, 70
Title
Measurements
OG00085.4± 23.2
OG00167.3± 29.3
Bodily Pain, Week 96, n = 0, 61
Title
Measurements
OG000NA± NANo participants were available for analysis in this arm at Week 96.
OG00190.2± 19.8
General Health, Baseline, n = 102, 119
Title
Measurements
OG00064.5± 17.9
OG00166.3± 19.7
General Health, Week 24, n = 75, 83
Title
Measurements
OG00058.9± 19.0
OG00155.1± 22.8
General Health, Week 48, n = 63, 74
Title
Measurements
OG00058.1± 20.2
OG00156.3± 19.2
General Health, Week 72, n = 65, 62
Title
Measurements
OG00071.7± 18.8
OG00160.1± 19.3
General Health, Week 96, n = 0, 59
Title
Measurements
OG000NA± NANo participants were available for analysis in this arm at Week 96.
OG00170.3± 18.5
Vitality, Baseline, n = 103, 116
Title
Measurements
OG00056.8± 20.9
OG00158.9± 22.5
Vitality, Week 24, n = 75, 88
Title
Measurements
OG00040.3± 24.0
OG00140.6± 23.6
Vitality, Week 48, n = 66, 77
Title
Measurements
OG00040.6± 23.8
OG00141.2± 21.2
Vitality, Week 72, n = 63, 67
Title
Measurements
OG00066.9± 18.9
OG00143.5± 22.4
Vitality, Week 96, n = 0, 59
Title
Measurements
OG000NA± NANo participants were available for analysis in this arm at Week 96.
OG00162.9± 21.1
Social Functioning, Baseline, n = 105, 121
Title
Measurements
OG00079.8± 21.9
OG00181.6± 22.0
Social Functioning, Week 24, n = 77, 91
Title
Measurements
OG00064.4± 28.5
OG00164.1± 30.3
Social Functioning, Week 48, n = 67, 78
Title
Measurements
OG00071.6± 24.0
OG00157.2± 27.5
Social Functioning, Week 72, n = 65, 70
Title
Measurements
OG00086.3± 22.3
OG00163.8± 29.4
Social Functioning, Week 96, n = 0, 61
Title
Measurements
OG000NA± NANo participants were available for analysis in this arm at Week 96.
OG00183.4± 23.4
Role Functioning - Emotional,Baseline,n = 104, 120
Title
Measurements
OG00071.5± 39.3
OG00175.8± 36.6
Role Functioning - Emotional, Week 24, n = 76, 88
Title
Measurements
OG00036.8± 42.4
OG00143.9± 43.3
Role Functioning - Emotional, Week 48, n = 66, 74
Title
Measurements
OG00041.7± 41.0
OG00142.8± 42.9
Role Functioning - Emotional, Week 72, n = 65, 66
Title
Measurements
OG00080.5± 32.8
OG00143.4± 43.4
Role Functioning - Emotional, Week 96, n = 0, 58
Title
Measurements
OG000NA± NANo participants were available for analysis in this arm at Week 96.
OG00184.5± 31.4
Mental Health, Baseline, n = 103, 115
Title
Measurements
OG00069.6± 18.7
OG00171.9± 19.1
Mental Health, Week 24, n = 76, 88
Title
Measurements
OG00060.7± 19.3
OG00157.9± 21.5
Mental Health, Week 48, n = 66, 77
Title
Measurements
OG00062.6± 19.8
OG00159.6± 20.7
Mental Health, Week 72, n = 63, 67
Title
Measurements
OG00076.3± 16.2
OG00160.8± 18.5
Mental Health, Week 96, n = 0, 59
Title
Measurements
OG000NA± NANo participants were available for analysis in this arm at Week 96.
OG00172.3± 14.6
Reported Health Transition, Baseline, n = 105, 123
Title
Measurements
OG0003.1± 0.9
OG0013.0± 0.9
Reported Health Transition, Week 24, n = 77, 90
Title
Measurements
OG0003.5± 1.2
OG0013.2± 1.2
Reported Health Transition, Week 48, n = 67, 77
Title
Measurements
OG0003.2± 1.3
OG0013.0± 1.3
Reported Health Transition, Week 72, n = 65, 69
Title
Measurements
OG0001.6± 0.9
OG0012.3± 1.1
Reported Health Transition, Week 96, n = 0, 61
Title
Measurements
OG000NA± NANo participants were available for analysis in this arm at Week 96.
OG0011.3± 0.7
PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1)
Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. After Week 48, participants were administered a lower dose of PEG-IFN alfa-2a of 135 mcg/week until Week 72. Participants were randomized to Group B based on the presence of an EVR defined as non-detectable serum HCV RNA (< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline in serum HCV RNA by quantitative PCR, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
Units
Counts
Participants
OG000104
OG001114
Title
Denominators
Categories
Baseline, n = 104, 114
Title
Measurements
OG0003.6± 1.5
OG0013.4± 1.7
Week 24, n = 69, 77
Title
Measurements
OG0004.5± 1.7
OG0014.7± 1.7
Week 48, n = 59, 63
Title
Measurements
OG0004.7± 1.6
OG0014.7± 1.5
Week 72, n = 58, 62
Title
Measurements
OG0003.0± 1.5
OG0014.3± 1.8
Week 96, n = 0, 57
Title
Measurements
OG000NA± NANo participants were available for analysis in this arm at Week 96.
OG0013.4± 1.5
Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. After Week 48, participants were administered a lower dose of PEG-IFN alfa-2a of 135 mcg/week until Week 72. Participants were randomized to Group B based on the presence of an EVR defined as non-detectable serum HCV RNA (< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline in serum HCV RNA by quantitative PCR, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
OG002
PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 1)
Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally; initially for 24 weeks. Participants without an EVR at Week 12 (< 2-log10 decrease in HCV RNA as compared with baseline) were assigned to Group C and received treatment until Week 24. If HCV RNA became non-detectable at Week 24 then treatment was continued for a total of 72 weeks. Participants were administered a lower dose of PEG-IFN alfa-2a after Week 48 (135 mcg/week, until Week 72). Participants with detectable HCV RNA (>= 50 IU/ml) at Week 24 were required to discontinue treatment. Participants had a treatment-free follow-up period of 24 weeks.
Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 24 weeks. Participants with a RVR at Week 4 of treatment [HCV RNA level, <50 IU/ml by qualitative PCR assay, COBAS Amplicor HCV Test, version 2.0] were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks.
Eligible participants who were not randomized to any treatment group in Part 1 of the study were included in this group. These participants were a part of the safety analysis population which included participants who received at least on dose of (either) the study drug (PEG-IFN alfa-2a and/or ribavirin) and had at least one post-baseline safety assessment.
Units
Counts
Participants
OG000142
OG001152
OG00277
OG003156
OG00411
Title
Denominators
Categories
Grade 0
Title
Measurements
OG00011
OG00115
OG0028
OG00317
OG0041
Grade 1
Title
Measurements
OG00038
OG00140
OG00220
OG003
Grade 2
Title
Measurements
OG00064
OG00168
OG00223
OG003
Grade 3
Title
Measurements
OG00018
OG00113
OG00215
OG003
Grade 4
Title
Measurements
OG00011
OG00116
OG00211
OG003
OG001
PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1)
Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. After Week 48, participants were administered a lower dose of PEG-IFN alfa-2a of 135 mcg/week until Week 72. Participants were randomized to Group B based on the presence of an EVR defined as non-detectable serum HCV RNA (< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline in serum HCV RNA by quantitative PCR, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
OG002
PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 1)
Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally; initially for 24 weeks. Participants without an EVR at Week 12 (< 2-log10 decrease in HCV RNA as compared with baseline) were assigned to Group C and received treatment until Week 24. If HCV RNA became non-detectable at Week 24 then treatment was continued for a total of 72 weeks. Participants were administered a lower dose of PEG-IFN alfa-2a after Week 48 (135 mcg/week, until Week 72). Participants with detectable HCV RNA (>= 50 IU/ml) at Week 24 were required to discontinue treatment. Participants had a treatment-free follow-up period of 24 weeks.
Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 24 weeks. Participants with a RVR at Week 4 of treatment [HCV RNA level, <50 IU/ml by qualitative PCR assay, COBAS Amplicor HCV Test, version 2.0] were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks.
Eligible participants who were not randomized to any treatment group in Part 1 of the study were included in this group. These participants were a part of the safety analysis population which included participants who received at least on dose of (either) the study drug (PEG-IFN alfa-2a and/or ribavirin) and had at least one post-baseline safety assessment.
Units
Counts
Participants
OG000142
OG001152
OG00278
OG003156
OG00412
Title
Denominators
Categories
Number of participants with any AE
Title
Measurements
OG000140
OG001149
OG00276
OG003153
OG00410
Number of participants with any SAE
Title
Measurements
OG00022
OG00128
OG0028
OG003
Units
Counts
Participants
OG00036
OG00125
Title
Denominators
Categories
Title
Measurements
OG00041.2(18.4 to 67.1)
OG00138.5(13.9 to 68.4)
Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 72 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. Participants were randomized to Group B1 if they showed positive HCV RNA level (>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
OG002
PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 2)
Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally; initially for 24 weeks. Participants without a > 2-log10 drop of HCV RNA level at Week 12 were assigned to Group C (Part 2). For participants who were HCV RNA-positive at Week 24, treatment was stopped. For participants who were negative for HCV RNA at Week 24, treatment was continued for a total of 72 weeks. Participants had a treatment-free follow-up period of 24 weeks.
Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 24 weeks. Participants with a negative HCV-RNA level at Week 4 (< 15 IU/ml, TaqMan HCV Test) were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks.
Units
Counts
Participants
OG00036
OG00125
OG00220
OG00342
Title
Denominators
Categories
Title
Measurements
OG00047.2(30.4 to 64.5)
OG00152.0(31.3 to 72.2)
OG0025.0(0.1 to 24.9)
OG00390.5(77.4 to 97.3)
Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 24 weeks. Participants with a negative HCV-RNA level at Week 4 (< 15 IU/ml, TaqMan HCV Test) were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks.
Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 72 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. Participants were randomized to Group B1 if they showed positive HCV RNA level (>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
OG002
PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 2)
Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally; initially for 24 weeks. Participants without a > 2-log10 drop of HCV RNA level at Week 12 were assigned to Group C (Part 2). For participants who were HCV RNA-positive at Week 24, treatment was stopped. For participants who were negative for HCV RNA at Week 24, treatment was continued for a total of 72 weeks. Participants had a treatment-free follow-up period of 24 weeks.
Units
Counts
Participants
OG00022
OG00119
OG00215
Title
Denominators
Categories
Physical functioning, Baseline, n = 22, 18, 15
Title
Measurements
OG00082.5± 22.5
OG00183.1± 17.7
OG00278.5± 28.8
Physical functioning, Week 24, n = 17, 13, 9
Title
Measurements
OG00061.8± 25.8
OG00151.2± 25.2
OG00272.2± 24.9
Physical functioning, Week 48, n = 13, 8, 0
Title
Measurements
OG00066.5± 22.8
OG00176.3± 19.8
OG002NA± NANo participants were available for analysis in this arm at Week 48.
Physical functioning, Week 72, n = 10, 7, 1
Title
Measurements
OG00077.0± 18.4
OG00180.7± 9.3
OG00245.0± NAData is available only for one participant. Therefore, there is no standard deviation.
Physical functioning, Week 96, n = 0, 6, 0
Title
Measurements
OG000NA± NANo participants were available for analysis in this arm at Week 96.
OG00185.8± 17.7
OG002NA± NANo participants were available for analysis in this arm at Week 96.
Role Functioning- Physical, Baseline,n =22, 18, 15
Title
Measurements
OG00075.0± 33.6
OG00162.0± 42.1
OG00253.3± 41.0
Role Functioning - Physical, Week 24, n= 17, 13, 8
Title
Measurements
OG00041.2± 44.1
OG00115.4± 33.1
OG00243.8± 43.8
Role Functioning - Physical, Week 48, n = 13, 8, 0
Title
Measurements
OG00041.0± 41.3
OG00156.3± 39.5
OG002NA± NANo participants were available for analysis in this arm at Week 48.
Role Functioning - Physical,, Week 72, n= 10, 7,1
Title
Measurements
OG00060.0± 47.4
OG00182.1± 37.4
OG0020.0± 0.0
Role Functioning - Physical, Week 96, n = 0, 5, 0
Title
Measurements
OG000NA± NANo participants were available for analysis in this arm at Week 96.
OG00170.0± 32.6
OG002NA± NANo participants were available for analysis in this arm at Week 96.
Bodily Pain, Baseline, n = 21, 19, 15
Title
Measurements
OG00075.3± 26.7
OG00176.3± 25.5
OG00266.5± 31.7
Bodily Pain, Week 24, n = 17, 13, 8
Title
Measurements
OG00057.9± 28.5
OG00145.9± 27.9
OG00254.9± 17.8
Bodily Pain, Week 48, n = 13, 8, 0
Title
Measurements
OG00066.4± 31.6
OG00154.6± 19.2
OG002NA± NANo participants were available for analysis in this arm at Week 48.
Bodily Pain, Week 72, n = 10, 7, 1
Title
Measurements
OG00071.1± 30.1
OG00170.4± 15.0
OG00262.0± NAData is available only for one participant. Therefore, there is no standard deviation.
Bodily Pain, Week 96, n = 0, 6, 0
Title
Measurements
OG000NA± NANo participants were available for analysis in this arm at Week 96.
OG00174.5± 19.3
OG002NA± NANo participants were available for analysis in this arm at Week 96.
General Health, Baseline, n = 22, 16, 14
Title
Measurements
OG00061.8± 18.8
OG00156.7± 21.7
OG00253.4± 19.1
General Health, Week 24, n = 17, 11, 8
Title
Measurements
OG00052.8± 23.6
OG00137.1± 14.1
OG00257.1± 24.4
General Health, Week 48, n = 12, 8, 0
Title
Measurements
OG00054.4± 21.0
OG00156.3± 23.8
OG002NA± NANo participants were available for analysis in this arm at Week 48.
General Health, Week 72, n = 10, 7, 1
Title
Measurements
OG00055.0± 21.8
OG00159.9± 16.5
OG00235.0± NAData is available only for one participant. Therefore, there is no standard deviation.
General Health, Week 96, n = 0, 6, 0
Title
Measurements
OG000NA± NANo participants were available for analysis in this arm at Week 96.
OG00152.8± 18.8
OG002NA± NANo participants were available for analysis in this arm at Week 96.
Vitality, Baseline, n = 21, 18, 15
Title
Measurements
OG00054.0± 21.9
OG00152.5± 19.3
OG00245.0± 16.0
Vitality, Week 24, n = 17, 11, 8
Title
Measurements
OG00037.8± 13.9
OG00131.2± 21.7
OG00243.1± 17.9
Vitality, Week 48, n = 13, 8, 0
Title
Measurements
OG00043.2± 22.1
OG00148.1± 17.3
OG002NA± NANo participants were available for analysis in this arm at Week 48.
Vitality, Week 72, n = 9, 7, 1
Title
Measurements
OG00047.2± 23.1
OG00160.2± 16.7
OG00240.0± NAData is available only for one participant. Therefore, there is no standard deviation.
Vitality, Week 96, n = 0, 6, 0
Title
Measurements
OG000NA± NANo participants were available for analysis in this arm at Week 96.
OG00156.9± 15.1
OG002NA± NANo participants were available for analysis in this arm at Week 96.
Social Functioning, Baseline, n = 22, 19, 15
Title
Measurements
OG00084.7± 18.5
OG00178.9± 25.0
OG00272.5± 33.5
Social Functioning, Week 24, n = 17, 13, 8
Title
Measurements
OG00064.7± 26.6
OG00156.7± 23.2
OG00265.6± 23.9
Social Functioning, Week 48, n = 13, 8, 0
Title
Measurements
OG00062.5± 27.5
OG00178.1± 27.3
OG002NA± NANo participants were available for analysis in this arm at Week 48.
Social Functioning, Week 72, n = 10, 7, 1
Title
Measurements
OG00077.5± 20.2
OG00178.6± 15.7
OG00225.0± NAData is available only for one participant. Therefore, there is no standard deviation.
Social Functioning, Week 96, n = 0, 6, 0
Title
Measurements
OG000NA± NANo participants were available for analysis in this arm at Week 96.
OG00183.3± 17.1
OG002NA± NANo participants were available for analysis in this arm at Week 96.
Role Functioning -Emotional,Baseline,n =22, 18, 15
Title
Measurements
OG00071.2± 38.9
OG00162.0± 42.7
OG00253.3± 45.1
Role Functioning-Emotional, Week 24, n=17, 13, 8
Title
Measurements
OG00043.1± 43.7
OG00120.5± 37.4
OG00245.8± 50.2
Role Functioning - Emotional, Week 48, n= 13, 8, 0
Title
Measurements
OG00043.6± 39.4
OG00154.2± 46.9
OG002NA± NANo participants were available for analysis in this arm at Week 48.
Role Functioning - Emotional, Week 72, n= 10, 7, 1
Title
Measurements
OG00056.7± 49.8
OG00181.0± 37.8
OG0020.0± 0.0
Role Functioning - Emotional, Week 96, n = 0, 5, 0
Title
Measurements
OG000NA± NANo participants were available for analysis in this arm at Week 96.
OG00160.0± 43.5
OG002NA± NANo participants were available for analysis in this arm at Week 96.
Mental Health, Baseline, n = 21, 18, 15
Title
Measurements
OG00071.6± 18.1
OG00162.9± 22.0
OG00262.1± 20.8
Mental Health, Week 24, n = 17, 11, 8
Title
Measurements
OG00058.8± 21.5
OG00146.2± 18.6
OG00262.0± 19.9
Mental Health, Week 48, n = 13, 8, 0
Title
Measurements
OG00057.4± 24.0
OG00161.0± 16.8
OG002NA± NANo participants were available for analysis in this arm at Week 48.
Mental Health, Week 72, n = 9, 7, 1
Title
Measurements
OG00066.7± 24.0
OG00166.9± 17.8
OG00236.0± NAData is available only for one participant. Therefore, there is no standard deviation.
Mental Health, Week 96, n = 0, 6, 0
Title
Measurements
OG000NA± NANo participants were available for analysis in this arm at Week 96.
OG00158.3± 15.1
OG002NA± NANo participants were available for analysis in this arm at Week 96.
Reported Health Transition,Baseline, n =22, 19, 15
Title
Measurements
OG0003.0± 1.1
OG0012.9± 0.9
OG0023.3± 1.0
Reported Health Transition, Week 24, 17, 13, 9
Title
Measurements
OG0003.8± 1.0
OG0013.5± 1.2
OG0023.2± 1.1
Reported Health Transition, Week 48, n = 13, 8, 0
Title
Measurements
OG0002.9± 1.1
OG0012.9± 1.1
OG002NA± NANo participants were available for analysis in this arm at Week 48.
Reported Health Transition, Week 72, n = 10, 7, 1
Title
Measurements
OG0002.8± 1.2
OG0012.6± 1.3
OG0024.0± NAData is available only for one participant. Therefore, there is no standard deviation.
Reported Health Transition, Week 96, n = 0, 6, 0
Title
Measurements
OG000NA± NANo participants were available for analysis in this arm at Week 96.
OG0012.0± 0.9
OG002NA± NANo participants were available for analysis in this arm at Week 96.
Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 72 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. Participants were randomized to Group B1 if they showed positive HCV RNA level (>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
OG002
PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 2)
Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally; initially for 24 weeks. Participants without a > 2-log10 drop of HCV RNA level at Week 12 were assigned to Group C (Part 2). For participants who were HCV RNA-positive at Week 24, treatment was stopped. For participants who were negative for HCV RNA at Week 24, treatment was continued for a total of 72 weeks. Participants had a treatment-free follow-up period of 24 weeks.
Units
Counts
Participants
OG00022
OG00117
OG00215
Title
Denominators
Categories
Baseline, n = 22, 17, 15
Title
Measurements
OG0003.7± 1.6
OG0013.8± 2.0
OG0023.9± 1.9
Week 24, n = 17, 15, 9
Title
Measurements
OG0004.2± 1.7
OG0014.9± 1.6
OG0024.8± 1.6
Week 48, n = 11, 7, 0
Title
Measurements
OG0004.0± 1.5
OG0014.5± 1.3
OG002NA± NANo participants were available for analysis in this arm at Week 48.
Week 72, n = 8, 7, 1
Title
Measurements
OG0003.9± 1.9
OG0013.8± 2.2
OG0025.3± NAData is available only for one participant. Therefore, there is no standard deviation.
Week 96, n = 0, 7, 0
Title
Measurements
OG000NA± NANo participants were available for analysis in this arm at Week 96.
OG0014.5± 1.9
OG002NA± NANo participants were available for analysis in this arm at Week 96.
OG002
PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 2)
Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally; initially for 24 weeks. Participants without a > 2-log10 drop of HCV RNA level at Week 12 were assigned to Group C (Part 2). For participants who were HCV RNA-positive at Week 24, treatment was stopped. For participants who were negative for HCV RNA at Week 24, treatment was continued for a total of 72 weeks. Participants had a treatment-free follow-up period of 24 weeks.
Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 24 weeks. Participants with a negative HCV-RNA level at Week 4 (< 15 IU/ml, TaqMan HCV Test) were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks.
Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dosage of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants with a positive HCV RNA level at Week 4 (>/= 15 IU/ml, TaqMan HCV Test) and negative HCV RNA level at Week 8 (\
Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 72 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. Participants were randomized to Group B1 if they showed positive HCV RNA level (>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
OG002
PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 2)
Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally; initially for 24 weeks. Participants without a > 2-log10 drop of HCV RNA level at Week 12 were assigned to Group C (Part 2). For participants who were HCV RNA-positive at Week 24, treatment was stopped. For participants who were negative for HCV RNA at Week 24, treatment was continued for a total of 72 weeks. Participants had a treatment-free follow-up period of 24 weeks.
Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 24 weeks. Participants with a negative HCV-RNA level at Week 4 (< 15 IU/ml, TaqMan HCV Test) were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks.
Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dosage of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants with a positive HCV RNA level at Week 4 (>/= 15 IU/ml, TaqMan HCV Test) and negative HCV RNA level at Week 8 (\
Eligible participants who were not assigned to any treatment group in Part 2 were included in this group. These participants were a part of the safety analysis population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a and/or ribavirin) and had at least one post-baseline safety assessment.