## Protocol Section
### Identification Module
**NCT ID:** NCT00922779

**Brief Title:** A Study of Ribavirin in Combination With PEGASYS (Peginterferon Alfa-2a (40KD))in Patients With Chronic Hepatitis C

**Official Title:** Safety and Tolerability of Ribavirin (RO 20-9963) in Combination With Peginterferon Alfa-2a (40 kD)in Patients With Chronic Hepatitis C

#### Organization Study ID Info
**ID:** ML16709
#### Organization
**Class:** INDUSTRY
**Full Name:** Hoffmann-La Roche
### Status Module
#### Completion Date
**Date:** 2012-06

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2016-01-20

**Type:** ESTIMATED

**Last Update Submit Date:** 2015-12-11

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2012-06

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2016-01-20

**Type:** ESTIMATED

**Results First Submit Date:** 2015-12-11

**Results First Submit QC Date:** 2015-12-11

#### Start Date
**Date:** 2002-06

**Status Verified Date:** 2015-12

#### Study First Post Date
**Date:** 2009-06-17
**Type:** ESTIMATED
**Study First Submit Date:** 2009-06-16
**Study First Submit QC Date:** 2009-06-16
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Hoffmann-La Roche

#### Responsible Party

**Type:** SPONSOR

### Description Module

**Brief Summary:** This single arm study will evaluate the safety and tolerability of ribavirin in combination with PEGASYS in patients with chronic hepatitis C. Patients will receive ribavirin 800mg, or 1000-1200mg po daily, according to HCV genotype and body weight (\< and \>75kg)in combination with PEGASYS 180micrograms sc weekly. The anticipated time on study treatment is 3-12 months, and the target sample size is \>500 individuals.

### Conditions Module

**Conditions:**

- Hepatitis C, Chronic

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 6661

**Type:** ACTUAL

**Phases:**

- PHASE4

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Drug: peginterferon alfa-2a [Pegasys]

- Drug: ribavirin

**Label:** 1

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- 1

**Description:** 180micrograms sc weekly for 12-48 weeks

**Name:** peginterferon alfa-2a [Pegasys]

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- 1

**Description:** 800mg, or 1000-1200mg, po daily (dependent on HCV genotype and body weight)

**Name:** ribavirin

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Number of participants with non-serious AEs were exclusive of serious AEs.

**Measure:** Number of Participants With Non-Serious Adverse Events (AEs) And Serious Adverse Events (SAEs)

**Time Frame:** From signing of informed consent up to end of study (up to Week 72)

#### Secondary Outcomes

**Description:** SVR at 24 weeks after end of therapy was defined as a negative result of HCV Ribonucleic Acid (HCV RNA) qualitative assay 24 weeks after end of therapy. Percentage of participants with SVR was calculated as \[number of participants with negative results of HCV RNA qualitative assay 24 weeks after end of therapy divided by the total number of participants analyzed\] multiplied by 100. The participants who failed to undergo tests at 24 weeks after completion of therapy were considered not amenable to therapy.

**Measure:** Percentage of Participants With Sustained Virological Response (SVR) at 24 Weeks After End of Therapy

**Time Frame:** 24 weeks after end of therapy (Week 72)

**Description:** HCV RNA levels of \< 50 International Units per milliliter (IU/mL) were defined as undetectable HCV RNA. The percentage of participants with undetectable HCV RNA was calculated as \[number of participants with undetectable HCV RNA divided by the total number of participants analyzed\] multiplied by 100 for Weeks 12, 24 and 48.

**Measure:** Percentage of Participants With Undetectable HCV RNA at Weeks 12, 24 and 48 After Therapy Initiation

**Time Frame:** Weeks 12,24 and 48 After Therapy Initiation

**Description:** Change in hemoglobin level (compared to baseline) was reported as "significant decrease", "Normal" (no change), "Increase", "Decrease", and "Missing". Significant decrease was defined as per Investigator's discretion.

**Measure:** Percentage of Participants With Change in Hemoglobin Level

**Time Frame:** Baseline, Weeks 2, 4, 8, 12, 24, 36, 48 and follow-up Weeks 4 (Week 52), 12 (Week 60), and 24 (Week 72)

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* adult patients, \>=18 years of age;
* serological evidence of chronic hepatitis C;
* detectable serum HCV-RNA;
* liver biopsy findings consistent with a diagnosis of chronic hepatitis C.

Exclusion Criteria:

* history or other evidence of a medical condition associated with chronic liver disease other than HCV;
* co-infection with active hepatitis A or B;
* hepatocellular carcinoma;
* patients with severe cardiovascular disease whose condition may worsen due to acute anemia.

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Arkhangelsk

**Country:** Russian Federation

**Zip:** 163000

**Location 2:**

**City:** Barnaul

**Country:** Russian Federation

**Zip:** 656010

**Location 3:**

**City:** Barnaul

**Country:** Russian Federation

**Zip:** 656045

**Location 4:**

**City:** Blagoveshchensk

**Country:** Russian Federation

**Zip:** 675007

**Location 5:**

**City:** Cheboksary

**Country:** Russian Federation

**Zip:** 428016

**Location 6:**

**City:** Chelyabinsk

**Country:** Russian Federation

**Zip:** 454048

**Location 7:**

**City:** Chelyabinsk

**Country:** Russian Federation

**Zip:** 454052

**Location 8:**

**City:** Chelyabinsk

**Country:** Russian Federation

**Zip:** 454071

**Location 9:**

**City:** Cherepovets

**Country:** Russian Federation

**Zip:** 162600

**Location 10:**

**City:** Chita

**Country:** Russian Federation

**Zip:** 672090

**Location 11:**

**City:** Ekaterinburg

**Country:** Russian Federation

**Zip:** 620020

**Location 12:**

**City:** Ekaterinburg

**Country:** Russian Federation

**Zip:** 620042

**Location 13:**

**City:** Ekaterinburg

**Country:** Russian Federation

**Zip:** 620102

**Location 14:**

**City:** Irkutsk

**Country:** Russian Federation

**Zip:** 664043

**Location 15:**

**City:** Irkutsk

**Country:** Russian Federation

**Zip:** 664047

**Location 16:**

**City:** Irkutsk

**Country:** Russian Federation

**Zip:** 664079

**Location 17:**

**City:** Izhevsk

**Country:** Russian Federation

**Zip:** 426067

**Location 18:**

**City:** Kazan

**Country:** Russian Federation

**Zip:** 420097

**Location 19:**

**City:** Kemerovo

**Country:** Russian Federation

**Zip:** 650000

**Location 20:**

**City:** Kemerovo

**Country:** Russian Federation

**Zip:** 650036

**Location 21:**

**City:** Kemerovo

**Country:** Russian Federation

**Zip:** 650099

**Location 22:**

**City:** Khabarovsk

**Country:** Russian Federation

**Zip:** 680009

**Location 23:**

**City:** Khabarovsk

**Country:** Russian Federation

**Zip:** 680022

**Location 24:**

**City:** Khabarovsk

**Country:** Russian Federation

**Zip:** 680031

**Location 25:**

**City:** Kirov

**Country:** Russian Federation

**Zip:** 610000

**Location 26:**

**City:** Krasnodar

**Country:** Russian Federation

**Zip:** 350012

**Location 27:**

**City:** Krasnodar

**Country:** Russian Federation

**Zip:** 350015

**Location 28:**

**City:** Krasnodar

**Country:** Russian Federation

**Zip:** 350086

**Location 29:**

**City:** Krasnoyarsk

**Country:** Russian Federation

**Zip:** 660022

**Location 30:**

**City:** Krasnoyarsk

**Country:** Russian Federation

**Zip:** 660049

**Location 31:**

**City:** Lipetsk

**Country:** Russian Federation

**Zip:** 398043

**Location 32:**

**City:** Makhachkala

**Country:** Russian Federation

**Zip:** 367008

**Location 33:**

**City:** Moscow

**Country:** Russian Federation

**Zip:** 103875

**Location 34:**

**City:** Moscow

**Country:** Russian Federation

**Zip:** 105203

**Location 35:**

**City:** Moscow

**Country:** Russian Federation

**Zip:** 109325

**Location 36:**

**City:** Moscow

**Country:** Russian Federation

**Zip:** 111020

**Location 37:**

**City:** Moscow

**Country:** Russian Federation

**Zip:** 111123

**Location 38:**

**City:** Moscow

**Country:** Russian Federation

**Zip:** 115201

**Location 39:**

**City:** Moscow

**Country:** Russian Federation

**Zip:** 115446

**Location 40:**

**City:** Moscow

**Country:** Russian Federation

**Zip:** 115516

**Location 41:**

**City:** Moscow

**Country:** Russian Federation

**Zip:** 115682

**Location 42:**

**City:** Moscow

**Country:** Russian Federation

**Zip:** 119002

**Location 43:**

**City:** Moscow

**Country:** Russian Federation

**Zip:** 119881

**Location 44:**

**City:** Moscow

**Country:** Russian Federation

**Zip:** 121293

**Location 45:**

**City:** Moscow

**Country:** Russian Federation

**Zip:** 123098

**Location 46:**

**City:** Moscow

**Country:** Russian Federation

**Zip:** 123367

**Location 47:**

**City:** Moscow

**Country:** Russian Federation

**Zip:** 125101

**Location 48:**

**City:** Moscow

**Country:** Russian Federation

**Zip:** 125367

**Location 49:**

**City:** Moscow

**Country:** Russian Federation

**Zip:** 127247

**Location 50:**

**City:** Moscow

**Country:** Russian Federation

**Zip:** 129110

**Location 51:**

**City:** Moscow

**Country:** Russian Federation

**Zip:** 143420

**Location 52:**

**City:** Moscow

**Country:** Russian Federation

**Location 53:**

**City:** Nizhny Novgorod

**Country:** Russian Federation

**Zip:** 603022

**Location 54:**

**City:** Novokuznetsk

**Country:** Russian Federation

**Zip:** 654018

**Location 55:**

**City:** Novokuznetsk

**Country:** Russian Federation

**Zip:** 654029

**Location 56:**

**City:** Novosibirsk

**Country:** Russian Federation

**Zip:** 630016

**Location 57:**

**City:** Novouralsk

**Country:** Russian Federation

**Zip:** 624130

**Location 58:**

**City:** Omsk

**Country:** Russian Federation

**Zip:** 644010

**Location 59:**

**City:** Orenburg

**Country:** Russian Federation

**Zip:** 460035

**Location 60:**

**City:** Petropavlovsk-Kamchatskiy

**Country:** Russian Federation

**Zip:** 683003

**Location 61:**

**City:** Rostov-na-donu

**Country:** Russian Federation

**Zip:** 344022

**Location 62:**

**City:** Salekhard

**Country:** Russian Federation

**Zip:** 629001

**Location 63:**

**City:** Samara

**Country:** Russian Federation

**Zip:** 443011

**Location 64:**

**City:** Samara

**Country:** Russian Federation

**Zip:** 443021

**Location 65:**

**City:** Saratov

**Country:** Russian Federation

**Zip:** 410026

**Location 66:**

**City:** Saratov

**Country:** Russian Federation

**Zip:** 410028

**Location 67:**

**City:** Saratov

**Country:** Russian Federation

**Zip:** 410040

**Location 68:**

**City:** Soshi

**Country:** Russian Federation

**Zip:** 354057

**Location 69:**

**City:** St Petersburg

**Country:** Russian Federation

**Zip:** 194044

**Location 70:**

**City:** St Petersburg

**Country:** Russian Federation

**Zip:** 194291

**Location 71:**

**City:** St Petersburg

**Country:** Russian Federation

**Zip:** 195067

**Location 72:**

**City:** St Petersburg

**Country:** Russian Federation

**Zip:** 195275

**Location 73:**

**City:** St Petersburg

**Country:** Russian Federation

**Zip:** 197022

**Location 74:**

**City:** St Petersburg

**Country:** Russian Federation

**Zip:** 198103

**Location 75:**

**City:** St Petersburg

**Country:** Russian Federation

**Zip:** 199034

**Location 76:**

**City:** St. Petersburg

**Country:** Russian Federation

**Zip:** 191167

**Location 77:**

**City:** Stavropol

**Country:** Russian Federation

**Zip:** 355017

**Location 78:**

**City:** Surgut

**Country:** Russian Federation

**Zip:** 628400

**Location 79:**

**City:** Tjumen

**Country:** Russian Federation

**Zip:** 629806

**Location 80:**

**City:** Tomsk

**Country:** Russian Federation

**Zip:** 634050

**Location 81:**

**City:** Tumen

**Country:** Russian Federation

**Zip:** 625002

**Location 82:**

**City:** Tumen

**Country:** Russian Federation

**Zip:** 625017

**Location 83:**

**City:** Tumen

**Country:** Russian Federation

**Zip:** 625026

**Location 84:**

**City:** UFA

**Country:** Russian Federation

**Zip:** 450000

**Location 85:**

**City:** UFA

**Country:** Russian Federation

**Zip:** 450005

**Location 86:**

**City:** Ulan-ude

**Country:** Russian Federation

**Zip:** 670042

**Location 87:**

**City:** Vladivostok

**Country:** Russian Federation

**Zip:** 690011

**Location 88:**

**City:** Vladivostok

**Country:** Russian Federation

**Zip:** 690065

**Location 89:**

**City:** Volgograd

**Country:** Russian Federation

**Zip:** 400040

**Location 90:**

**City:** Volgograd

**Country:** Russian Federation

**Zip:** 400138

**Location 91:**

**City:** Yakutsk

**Country:** Russian Federation

**Zip:** 677000

**Location 92:**

**City:** Yujno-sakhalinsk

**Country:** Russian Federation

**Zip:** 690000

**Location 93:**

**City:** Yujno-sakhalinsk

**Country:** Russian Federation

**Zip:** 693000

#### Overall Officials

**Official 1:**

**Affiliation:** Hoffmann-La Roche

**Name:** Clinical Trials

**Role:** STUDY_DIRECTOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000008107

- Term: Liver Diseases

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000006525

- Term: Hepatitis, Viral, Human

- ID: D000014777

- Term: Virus Diseases

- ID: D000007239

- Term: Infections

- ID: D000004769

- Term: Enterovirus Infections

- ID: D000010850

- Term: Picornaviridae Infections

- ID: D000012327

- Term: RNA Virus Infections

- ID: D000086982

- Term: Blood-Borne Infections

- ID: D000003141

- Term: Communicable Diseases

- ID: D000018178

- Term: Flaviviridae Infections

- ID: D000006521

- Term: Hepatitis, Chronic

- ID: D000002908

- Term: Chronic Disease

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M9592

- Name: Hepatitis A

- Relevance: HIGH

- As Found: Hepatitis

- ID: M9591

- Name: Hepatitis

- Relevance: HIGH

- As Found: Hepatitis

- ID: M9607

- Name: Hepatitis, Chronic

- Relevance: LOW

- As Found: Unknown

- ID: M9611

- Name: Hepatitis C

- Relevance: HIGH

- As Found: Hepatitis C

- ID: M21613

- Name: Hepatitis C, Chronic

- Relevance: HIGH

- As Found: Hepatitis C, Chronic

- ID: M11107

- Name: Liver Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M9610

- Name: Hepatitis, Viral, Human

- Relevance: LOW

- As Found: Unknown

- ID: M17522

- Name: Virus Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7930

- Name: Enterovirus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M13745

- Name: Picornaviridae Infections

- Relevance: LOW

- As Found: Unknown

- ID: M15149

- Name: RNA Virus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M2593

- Name: Blood-Borne Infections

- Relevance: LOW

- As Found: Unknown

- ID: M20324

- Name: Flaviviridae Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6147

- Name: Chronic Disease

- Relevance: LOW

- As Found: Unknown

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000006506

- Term: Hepatitis A

- ID: D000006526

- Term: Hepatitis C

- ID: D000019698

- Term: Hepatitis C, Chronic

- ID: D000006505

- Term: Hepatitis

### Intervention Browse Module - Ancestors

- ID: D000000963

- Term: Antimetabolites

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000000998

- Term: Antiviral Agents

- ID: D000000890

- Term: Anti-Infective Agents

### Intervention Browse Module - Browse Branches

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M15083

- Name: Ribavirin

- Relevance: HIGH

- As Found: Bevacizumab

- ID: M247369

- Name: Peginterferon alfa-2a

- Relevance: HIGH

- As Found: Longitudinal

- ID: M4281

- Name: Antimetabolites

- Relevance: LOW

- As Found: Unknown

- ID: M4314

- Name: Antiviral Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4214

- Name: Anti-Infective Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000012254

- Term: Ribavirin

- ID: C000100416

- Term: Peginterferon alfa-2a

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** Ribavirin + Peginterferon Alfa-2a

**Description:** Participants with genotype 1 received ribavirin oral tablets daily depending on the body weight. Participants with body weight of less than 75 kg received dose of 400 mg (2 tablets of 200 mg) in morning and 600 mg (3 tablets of 200 mg) in evening, and participants with body weight of 75 kg or more, received dose of 600 mg (3 tablets of 200 mg) in the morning and evening along with PEG-INF Alfa-2a 180 µg/mL SC injection once weekly for 12 to 48 weeks. Participants with other genotypes received ribavirin dose of 400 mg (2 tablets of 200 mg) in morning and evening along with PEG-INF Alfa-2a 180 µg/mL SC injection once weekly for 12 to 24 weeks.

**ID:** EG000

**Other Num Affected:** 1674

**Other Num at Risk:** 6661

**Serious Number Affected:** 67

**Serious Number At Risk:** 6661

**Title:** Ribavirin + Peginterferon Alfa-2a

**Frequency Threshold:** 5

#### Other Events

**Term:** Asthenia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 15.0

**Term:** Influenza like illness

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 15.0

**Term:** Pyrexia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 15.0

**Term:** Anaemia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA 15.0

**Term:** Weight loss poor

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 15.0

#### Serious Events

**Term:** Pyelonephritis acute

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 6661

**Term:** Acute tonsillitis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 6661

**Term:** Appendicitis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 6661

**Term:** Chronic hepatitis C

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 6661

**Term:** Enteritis infectious

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 6661

**Term:** Furuncle

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 6661

**Term:** Hepatitis G

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 6661

**Term:** Pneumonia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 6661

**Term:** Urinary tract infection

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 6661

**Term:** Cholecystitis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 6661

**Term:** Cholelithiasis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 6661

**Term:** Hepatic cirrhosis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 6661

**Term:** Hepatic failure

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 6661

**Term:** Cholecystitis acute

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 6661

**Term:** Hyperbilirubinaemia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 6661

**Term:** Myocardial infarction

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 6661

**Term:** Cardiovascular insufficiency

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 6661

**Term:** Coronary artery disease

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 6661

**Term:** Tachycardia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 6661

**Term:** Ventricular extrasystoles

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 6661

**Term:** Completed suicide

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 6661

**Term:** Depression

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 6661

**Term:** Delusional disorder, persecutory type

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 6661

**Term:** Schizophrenia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 6661

**Term:** Food poisoning

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 6661

**Term:** Gastric ulcer haemorrhage

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 6661

**Term:** Gastrointestinal haemorrhage

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 6661

**Term:** Pancreatitis acute

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 6661

**Term:** Asthenia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 6661

**Term:** Death

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 6661

**Term:** Pyrexia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 6661

**Term:** Autonomic nervous system imbalance

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 6661

**Term:** Cranial nerve disorder

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 6661

**Term:** IIIrd nerve disorder

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 6661

**Term:** Intracranial pressure increased

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 6661

**Term:** Vascular encephalopathy

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 6661

**Term:** Toxic skin eruption

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 6661

**Term:** Angioedema

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 6661

**Term:** Dermatitis allergic

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 6661

**Term:** Deep vein thrombosis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 6661

**Term:** Thrombophlebitis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 6661

**Term:** Vasculitis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 6661

**Term:** Pancytopenia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 6661

**Term:** Thrombocytopenia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 6661

**Term:** Autoimmune thyroiditis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Endocrine disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 6661

**Term:** Hyperthyroidism

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Endocrine disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 6661

**Term:** Hypothyroidism

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Endocrine disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 6661

**Term:** Injury

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 6661

**Term:** Spinal compression fracture

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 6661

**Term:** Diabetes mellitus

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 6661

**Term:** Hyperglycaemia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 6661

**Term:** Type 1 diabetes mellitus

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 6661

**Term:** Mixed connective tissue disease

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 6661

**Term:** Rheumatoid arthritis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 6661

**Term:** Brain neoplasm

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 6661

**Term:** Breast cancer

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 6661

**Term:** Asthma

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 6661

**Term:** Bronchial obstruction

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 6661

**Term:** Von Willebrand's disease

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Congenital, familial and genetic disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 6661

**Term:** Sudden hearing loss

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Ear and labyrinth disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 6661

**Term:** Macular oedema

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 6661

**Term:** Sarcoidosis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Immune system disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 6661

**Term:** Renal impairment

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 6661

**Term:** Metrorrhagia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Reproductive system and breast disorders

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 6661

**Term:** Chronic tonsillitis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 15.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 6661

**Time Frame:** From signing of informed consent up to end of study (up to Week 72)

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 6661

**Units:** Participants

### Group

**ID:** BG000

**Title:** Ribavirin + Peginterferon Alfa-2a

**Description:** Participants with genotype 1 received ribavirin oral tablets daily depending on the body weight. Participants with body weight of less than 75 kg received dose of 400 mg (2 tablets of 200 mg) in morning and 600 mg (3 tablets of 200 mg) in evening, and participants with body weight of 75 kg or more, received dose of 600 mg (3 tablets of 200 mg) in the morning and evening along with PEG-INF Alfa-2a 180 µg/mL SC injection once weekly for 12 to 48 weeks. Participants with other genotypes received ribavirin dose of 400 mg (2 tablets of 200 mg) in morning and evening along with PEG-INF Alfa-2a 180 µg/mL SC injection once weekly for 12 to 24 weeks.

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 9.81

**Value:** 34.21

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 4396

**Class Title:** Male

#### Measurement

**Group ID:** BG000

**Value:** 2250

**Class Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 15

**Class Title:** Missing

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Description:** Here, number of participants analyzed for baseline measure "age" was 6622.
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** Years
### Measure 2
**Parameter Type:** NUMBER
**Title:** Sex/Gender, Customized
**Unit of Measure:** Participants
**Population Description:** Baseline population included all enrolled participants.
## Results Section - More Information Module
### Certain Agreement
**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.
**Restriction Type:** OTHER
**Restrictive Agreement:** True
### Point of Contact
**Email:** genentech@druginfo.com
**Organization:** Hoffmann-LaRoche
**Phone:** 800-821-8590
**Title:** Medical Communications
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
### Outcome Measure 3
### Outcome Measure 4
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2058
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 67
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 50.9
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 58.8
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 69.7
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 24.8
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 13.5
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 32.4
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 11.7
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 32.3
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 10.0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 27.9
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 21.0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 6.9
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 35.1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 9.1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 35.4
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 15.3
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5.1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 31.5
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 12.8
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 38.9
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 15.2
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 4.7
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 30.1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 11.1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 34.9
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 13.6
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 4.6
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 25.4
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 21.5
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 16.2
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 4.1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1.7
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 9.1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 69.0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 13.7
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3.8
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1.7
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 7.7
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 73.1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 11.5
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 18.5
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 6.8
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 19.6
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 43.7
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5.8
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 23.0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 10.2
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 16.1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 44.8
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 4.7
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 27.5
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 12.2
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 15.5
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 40.2
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Number of participants with non-serious AEs were exclusive of serious AEs.
**Parameter Type:** NUMBER
**Population Description:** Safety analysis population included all participants who received at least one therapeutic dose of ribavirin.
**Reporting Status:** POSTED
**Time Frame:** From signing of informed consent up to end of study (up to Week 72)
**Title:** Number of Participants With Non-Serious Adverse Events (AEs) And Serious Adverse Events (SAEs)
**Type:** PRIMARY
**Unit of Measure:** Participants
##### Group
**Description:** Participants with genotype 1 received ribavirin oral tablets daily depending on the body weight. Participants with body weight of less than 75 kg received dose of 400 mg (2 tablets of 200 mg) in morning and 600 mg (3 tablets of 200 mg) in evening, and participants with body weight of 75 kg or more, received dose of 600 mg (3 tablets of 200 mg) in the morning and evening along with PEG-INF Alfa-2a 180 µg/mL SC injection once weekly for 12 to 48 weeks. Participants with other genotypes received ribavirin dose of 400 mg (2 tablets of 200 mg) in morning and evening along with PEG-INF Alfa-2a 180 µg/mL SC injection once weekly for 12 to 24 weeks.
**ID:** OG000
**Title:** Ribavirin + Peginterferon Alfa-2a
#### Outcome Measure 2
**Description:** SVR at 24 weeks after end of therapy was defined as a negative result of HCV Ribonucleic Acid (HCV RNA) qualitative assay 24 weeks after end of therapy. Percentage of participants with SVR was calculated as \[number of participants with negative results of HCV RNA qualitative assay 24 weeks after end of therapy divided by the total number of participants analyzed\] multiplied by 100. The participants who failed to undergo tests at 24 weeks after completion of therapy were considered not amenable to therapy.
**Parameter Type:** NUMBER
**Population Description:** Intent-to-treat (ITT) population included all participants who received at least one therapeutic dose of ribavirin.
**Reporting Status:** POSTED
**Time Frame:** 24 weeks after end of therapy (Week 72)
**Title:** Percentage of Participants With Sustained Virological Response (SVR) at 24 Weeks After End of Therapy
**Type:** SECONDARY
**Unit of Measure:** Percentage of Participants
##### Group
**Description:** Participants with genotype 1 received ribavirin oral tablets daily depending on the body weight. Participants with body weight of less than 75 kg received dose of 400 mg (2 tablets of 200 mg) in morning and 600 mg (3 tablets of 200 mg) in evening, and participants with body weight of 75 kg or more, received dose of 600 mg (3 tablets of 200 mg) in the morning and evening along with PEG-INF Alfa-2a 180 µg/mL SC injection once weekly for 12 to 48 weeks. Participants with other genotypes received ribavirin dose of 400 mg (2 tablets of 200 mg) in morning and evening along with PEG-INF Alfa-2a 180 µg/mL SC injection once weekly for 12 to 24 weeks.
**ID:** OG000
**Title:** Ribavirin + Peginterferon Alfa-2a
#### Outcome Measure 3
**Description:** HCV RNA levels of \< 50 International Units per milliliter (IU/mL) were defined as undetectable HCV RNA. The percentage of participants with undetectable HCV RNA was calculated as \[number of participants with undetectable HCV RNA divided by the total number of participants analyzed\] multiplied by 100 for Weeks 12, 24 and 48.
**Parameter Type:** NUMBER
**Population Description:** ITT Population.
**Reporting Status:** POSTED
**Time Frame:** Weeks 12,24 and 48 After Therapy Initiation
**Title:** Percentage of Participants With Undetectable HCV RNA at Weeks 12, 24 and 48 After Therapy Initiation
**Type:** SECONDARY
**Unit of Measure:** Percentage of Participants
##### Group
**Description:** Participants with genotype 1 received ribavirin oral tablets daily depending on the body weight. Participants with body weight of less than 75 kg received dose of 400 mg (2 tablets of 200 mg) in morning and 600 mg (3 tablets of 200 mg) in evening, and participants with body weight of 75 kg or more, received dose of 600 mg (3 tablets of 200 mg) in the morning and evening along with PEG-INF Alfa-2a 180 µg/mL SC injection once weekly for 12 to 48 weeks. Participants with other genotypes received ribavirin dose of 400 mg (2 tablets of 200 mg) in morning and evening along with PEG-INF Alfa-2a 180 µg/mL SC injection once weekly for 12 to 24 weeks.
**ID:** OG000
**Title:** Ribavirin + Peginterferon Alfa-2a
#### Outcome Measure 4
**Description:** Change in hemoglobin level (compared to baseline) was reported as "significant decrease", "Normal" (no change), "Increase", "Decrease", and "Missing". Significant decrease was defined as per Investigator's discretion.
**Parameter Type:** NUMBER
**Population Description:** ITT Population.
**Reporting Status:** POSTED
**Time Frame:** Baseline, Weeks 2, 4, 8, 12, 24, 36, 48 and follow-up Weeks 4 (Week 52), 12 (Week 60), and 24 (Week 72)
**Title:** Percentage of Participants With Change in Hemoglobin Level
**Type:** SECONDARY
**Unit of Measure:** Percentage of Participants
##### Group
**Description:** Participants with genotype 1 received ribavirin oral tablets daily depending on the body weight. Participants with body weight of less than 75 kg received dose of 400 mg (2 tablets of 200 mg) in morning and 600 mg (3 tablets of 200 mg) in evening, and participants with body weight of 75 kg or more, received dose of 600 mg (3 tablets of 200 mg) in the morning and evening along with PEG-INF Alfa-2a 180 µg/mL SC injection once weekly for 12 to 48 weeks. Participants with other genotypes received ribavirin dose of 400 mg (2 tablets of 200 mg) in morning and evening along with PEG-INF Alfa-2a 180 µg/mL SC injection once weekly for 12 to 24 weeks.
**ID:** OG000
**Title:** Ribavirin + Peginterferon Alfa-2a
### Participant Flow Module
#### Group
**Description:** Participants with genotype 1 received ribavirin oral tablets daily depending on the body weight. Participants with body weight of less than 75 kilograms (kg) received dose of 400 milligrams (mg) (2 tablets of 200 mg) in morning and 600 mg (3 tablets of 200 mg) in evening, and participants with body weight of 75 kg or more, received dose of 600 mg (3 tablets of 200 mg) in the morning and evening along with Peginterferon (PEG-INF) Alfa-2a 180 micrograms per milliliter (µg/mL) subcutaneous (SC) injection once weekly for 12 to 48 weeks. Participants with other genotypes received ribavirin dose of 400 mg (2 tablets of 200 mg) in morning and evening along with PEG-INF Alfa-2a 180 µg/mL SC injection once weekly for 12 to 24 weeks.
**ID:** FG000
**Title:** Ribavirin + Peginterferon Alfa-2a
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Adverse Event
###### Reason
**Group ID:** FG000
**Number of Subjects:** 67
##### Withdraw
**Type:** Pregnancy
###### Reason
**Group ID:** FG000
**Number of Subjects:** 7
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 308
##### Withdraw
**Type:** Lost to Follow-up
###### Reason
**Group ID:** FG000
**Number of Subjects:** 44
##### Withdraw
**Type:** Other
###### Reason
**Group ID:** FG000
**Number of Subjects:** 27
##### Withdraw
**Type:** Missing
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1874
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 6661
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 4334
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 2327
**Recruitment Details:** A total of 7799 participants were screened, of which 6661 participants were included in the study.
**Has Results:** True