A Study of Induction Dosing With PEGASYS (Peginterferon A... | NCT00394277

Label	Type	Intervention Names
PEG-IFN 180 µg + Ribavirin 1200 mg	Experimental	Drug: peginterferon alfa-2a Drug: Ribavirin
PEG-IFN 180 µg + Ribavirin 1400/1600 mg	Experimental	Drug: peginterferon alfa-2a Drug: Ribavirin
PEG-IFN 360/180 µg + Ribavirin 1200 mg	Experimental	Drug: Ribavirin Drug: peginterferon alfa-2a
PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg	Experimental	Drug: peginterferon alfa-2a Drug: Ribavirin

Name	Type	Description	Arm Group Labels	Other Names
peginterferon alfa-2a	Drug	180 µg sc weekly for 48 weeks	PEG-IFN 180 µg + Ribavirin 1200 mg PEG-IFN 180 µg + Ribavirin 1400/1600 mg

Measure	Description	Time Frame
Sustained Virological Response (SVR)-24 (Scheduled Treatment Period)	SVR-24 according to the scheduled treatment period was defined as the percentage of patients with undetectable HCV RNA at 24 weeks after completion of the treatment period (a single last HCV RNA PCR <15 IU/mL measured at or after week 68 (ie, on or after study day 477).	Week 72

Measure	Description	Time Frame
SVR-24 (Actual Treatment Period)	SVR-24 according to the actual treatment period was defined as the percentage of patients with undetectable HCV RNA at least 20 weeks after the last dose of study drug.	24 weeks after end of treatment
SVR-12 (Scheduled Treatment Period)

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
		Birmingham	Alabama	35294	United States

PubMed Identifier	Type	Citation	Retractions
20816836	Derived	Reddy KR, Shiffman ML, Rodriguez-Torres M, Cheinquer H, Abdurakhmanov D, Bakulin I, Morozov V, Silva GF, Geyvandova N, Stanciu C, Rabbia M, McKenna M, Thommes JA, Harrison SA; PROGRESS Study Investigators. Induction pegylated interferon alfa-2a and high dose ribavirin do not increase SVR in heavy patients with HCV genotype 1 and high viral loads. Gastroenterology. 2010 Dec;139(6):1972-83. doi: 10.1053/j.gastro.2010.08.051. Epub 2010 Sep 30.

ID	Title	Description
FG000	PEG-IFN 180 µg + Ribavirin 1200 mg	PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily).
FG001	PEG-IFN 180 µg + Ribavirin 1400/1600 mg

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

Sustained Virological Response (SVR)-24 (Scheduled Treatment Period)

SVR-24 according to the scheduled treatment period was defined as the percentage of patients with undetectable HCV RNA at 24 weeks after completion of the treatment period (a single last HCV RNA PCR <15 IU/mL measured at or after week 68 (ie, on or after study day 477).

Intent-to-treat population (all patients treated with at least one dose of either study medication)

Posted

Number

Percentage of patients

Week 72

ID	Title	Description
OG000	PEG-IFN 180 µg + Ribavirin 1200 mg	PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily).
OG001	PEG-IFN 180 µg + Ribavirin 1400/1600 mg	PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to <95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.
OG002	PEG-IFN 360/180 µg + Ribavirin 1200 mg	PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily).
OG003	PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg	PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to <95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.

Units	Counts
Participants	OG000191 OG001189 OG002382 OG003

Title

Denominators

Categories

Title	Measurements
	OG00037.7 OG00142.9 OG00243.5 OG003

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 OG003	This reflects the primary protocol-specified comparison (standard Pegasys induction dosing arms versus pooled Pegasys induction dosing arms). The study was designed to have at least 86% power for testing the null hypothesis of no difference between these two pooled groups, with assumed response rates of 28%, 32%, 36%, and 43% in the four treatment arms.	Cochran-Mantel-Haenszel	P-value obtained from CMH test, stratified by country and ribavirin dose strata.	0.584	All secondary comparisons were tested at a two-sided significance level of 0.05.	Odds Ratio (OR)	1.075				95	0.831	1.391				No

Secondary

SVR-24 (Actual Treatment Period)

SVR-24 according to the actual treatment period was defined as the percentage of patients with undetectable HCV RNA at least 20 weeks after the last dose of study drug.

Intent-to-treat population (all patients treated with at least one dose of either study medication)

Posted

Number

Percentage of patients

24 weeks after end of treatment

ID	Title	Description
OG000	PEG-IFN 180 µg + Ribavirin 1200 mg	PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily).
OG001	PEG-IFN 180 µg + Ribavirin 1400/1600 mg	PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to <95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.
OG002	PEG-IFN 360/180 µg + Ribavirin 1200 mg	PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily).

Secondary

SVR-12 (Scheduled Treatment Period)

SVR-12 according to the scheduled treatment period was defined as the percentage of patients with undetectable HCV RNA at 12 weeks after the scheduled treatment period (a single last HCV RNA PCR <15 IU/mL measured at or after week 60).

Intent-to-treat population (all patients treated with at least one dose of either study medication)

Posted

Number

Percentage of patients

12 weeks after end of treatment

ID	Title	Description
OG000	PEG-IFN 180 µg + Ribavirin 1200 mg	PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily).
OG001	PEG-IFN 180 µg + Ribavirin 1400/1600 mg	PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to <95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.
OG002	PEG-IFN 360/180 µg + Ribavirin 1200 mg	PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily).

Secondary

SVR-12 (Actual Treatment Period)

SVR-12 according to the actual treatment period was defined as the percentage of patients with undetectable HCV RNA at least 12 weeks after the last dose of study drug.

Intent-to-treat population (all patients treated with at least one dose of either study medication)

Posted

Number

Percentage of patients

12 weeks after end of treatment

ID	Title	Description
OG000	PEG-IFN 180 µg + Ribavirin 1200 mg	PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily).
OG001	PEG-IFN 180 µg + Ribavirin 1400/1600 mg	PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to <95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.
OG002	PEG-IFN 360/180 µg + Ribavirin 1200 mg	PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily).

Serious Adverse Events

Term	Organ System	Statistical Information
Pneumonia	Infections and infestations	EG0001 affected191 at risk EG0013 affected189 at risk EG0022 affected382 at risk EG0034 affected383 at risk
Appendicitis	Infections and infestations	EG0000 affected191 at risk EG0010 affected189 at risk EG0023 affected382 at risk EG003
Cellulitis	Infections and infestations	EG0001 affected191 at risk EG0010 affected189 at risk EG0022 affected382 at risk EG003
Abscess Limb	Infections and infestations	EG0001 affected191 at risk EG0010 affected189 at risk EG0021 affected382 at risk EG003
Gastroenteritis	Infections and infestations	EG0000 affected191 at risk EG0011 affected189 at risk EG0020 affected382 at risk EG003
Pyelonephritis	Infections and infestations	EG0000 affected191 at risk EG0010 affected189 at risk EG0021 affected382 at risk EG003
Pyelonephritis Acute	Infections and infestations	EG0000 affected191 at risk EG0012 affected189 at risk EG0020 affected382 at risk EG003
Anal Abscess	Infections and infestations	EG0000 affected191 at risk EG0010 affected189 at risk EG0020 affected382 at risk EG003
Bronchitis	Infections and infestations	EG0000 affected191 at risk EG0011 affected189 at risk EG0020 affected382 at risk EG003
Bursitis Infective	Infections and infestations	EG0001 affected191 at risk EG0010 affected189 at risk EG0020 affected382 at risk EG003
Gastroenteritis Viral	Infections and infestations	EG0001 affected191 at risk EG0010 affected189 at risk EG0020 affected382 at risk EG003
Injection Site Abscess	Infections and infestations	EG0001 affected191 at risk EG0010 affected189 at risk EG0020 affected382 at risk EG003
Intervertebral Discitis	Infections and infestations	EG0000 affected191 at risk EG0010 affected189 at risk EG0021 affected382 at risk EG003
Lobar Pneumonia	Infections and infestations	EG0000 affected191 at risk EG0010 affected189 at risk EG0021 affected382 at risk EG003
Lung Abscess	Infections and infestations	EG0000 affected191 at risk EG0010 affected189 at risk EG0020 affected382 at risk EG003
Lung Infection	Infections and infestations	EG0000 affected191 at risk EG0010 affected189 at risk EG0020 affected382 at risk EG003
Osteomyelitis	Infections and infestations	EG0000 affected191 at risk EG0010 affected189 at risk EG0021 affected382 at risk EG003
Pelvic Abscess	Infections and infestations	EG0000 affected191 at risk EG0010 affected189 at risk EG0020 affected382 at risk EG003
Pelvic Inflammatory Disease	Infections and infestations	EG0000 affected191 at risk EG0010 affected189 at risk EG0021 affected382 at risk EG003
Rectal Abscess	Infections and infestations	EG0000 affected191 at risk EG0010 affected189 at risk EG0020 affected382 at risk EG003
Sepsis	Infections and infestations	EG0000 affected191 at risk EG0010 affected189 at risk EG0021 affected382 at risk EG003
Subcutaneous Abscess	Infections and infestations	EG0000 affected191 at risk EG0011 affected189 at risk EG0020 affected382 at risk EG003
Depression	Psychiatric disorders	EG0000 affected191 at risk EG0013 affected189 at risk EG0021 affected382 at risk EG003
Suicidal Ideation	Psychiatric disorders	EG0000 affected191 at risk EG0010 affected189 at risk EG0022 affected382 at risk EG003
Acute Psychosis	Psychiatric disorders	EG0000 affected191 at risk EG0011 affected189 at risk EG0020 affected382 at risk EG003
Alcoholism	Psychiatric disorders	EG0001 affected191 at risk EG0010 affected189 at risk EG0020 affected382 at risk EG003
Bipolar Disorder	Psychiatric disorders	EG0000 affected191 at risk EG0010 affected189 at risk EG0020 affected382 at risk EG003
Completed Suicide	Psychiatric disorders	EG0000 affected191 at risk EG0010 affected189 at risk EG0021 affected382 at risk EG003
Dependence	Psychiatric disorders	EG0001 affected191 at risk EG0010 affected189 at risk EG0020 affected382 at risk EG003
Hostility	Psychiatric disorders	EG0000 affected191 at risk EG0010 affected189 at risk EG0021 affected382 at risk EG003
Major Depression	Psychiatric disorders	EG0000 affected191 at risk EG0010 affected189 at risk EG0021 affected382 at risk EG003
Panic Attack	Psychiatric disorders	EG0001 affected191 at risk EG0010 affected189 at risk EG0020 affected382 at risk EG003
Psychotic Disorder	Psychiatric disorders	EG0000 affected191 at risk EG0011 affected189 at risk EG0020 affected382 at risk EG003
Suicide Attempt	Psychiatric disorders	EG0000 affected191 at risk EG0011 affected189 at risk EG0020 affected382 at risk EG003
Anaemia	Blood and lymphatic system disorders	EG0000 affected191 at risk EG0012 affected189 at risk EG0022 affected382 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	EG0002 affected191 at risk EG0010 affected189 at risk EG0020 affected382 at risk EG003
Anaemia Haemolytic Autoimmune	Blood and lymphatic system disorders	EG0000 affected191 at risk EG0010 affected189 at risk EG0020 affected382 at risk EG003
Pancytopenia	Blood and lymphatic system disorders	EG0000 affected191 at risk EG0010 affected189 at risk EG0021 affected382 at risk EG003
Cerebral Haemorrhage	Nervous system disorders	EG0000 affected191 at risk EG0010 affected189 at risk EG0021 affected382 at risk EG003
Altered State of Consciousness	Nervous system disorders	EG0000 affected191 at risk EG0011 affected189 at risk EG0020 affected382 at risk EG003
Cerebrovascular Accident	Nervous system disorders	EG0001 affected191 at risk EG0010 affected189 at risk EG0020 affected382 at risk EG003
Headache	Nervous system disorders	EG0000 affected191 at risk EG0010 affected189 at risk EG0021 affected382 at risk EG003
Hepatic Encephalopathy	Nervous system disorders	EG0000 affected191 at risk EG0011 affected189 at risk EG0020 affected382 at risk EG003
Metabolic Encephalopathy	Nervous system disorders	EG0000 affected191 at risk EG0010 affected189 at risk EG0021 affected382 at risk EG003
Peripheral Motor Neuropathy	Nervous system disorders	EG0000 affected191 at risk EG0010 affected189 at risk EG0021 affected382 at risk EG003
Syncope	Nervous system disorders	EG0000 affected191 at risk EG0010 affected189 at risk EG0020 affected382 at risk EG003
Transient Ischaemic Attack	Nervous system disorders	EG0001 affected191 at risk EG0010 affected189 at risk EG0020 affected382 at risk EG003
Angina Pectoris	Cardiac disorders	EG0000 affected191 at risk EG0010 affected189 at risk EG0021 affected382 at risk EG003
Acute Coronary Syndrome	Cardiac disorders	EG0000 affected191 at risk EG0011 affected189 at risk EG0020 affected382 at risk EG003
Arrhythmia	Cardiac disorders	EG0000 affected191 at risk EG0010 affected189 at risk EG0021 affected382 at risk EG003
Atrial Fibrillation	Cardiac disorders	EG0000 affected191 at risk EG0010 affected189 at risk EG0020 affected382 at risk EG003
Cardiac Arrest	Cardiac disorders	EG0000 affected191 at risk EG0011 affected189 at risk EG0020 affected382 at risk EG003
Cardiac Failure Congestive	Cardiac disorders	EG0001 affected191 at risk EG0010 affected189 at risk EG0020 affected382 at risk EG003
Myocardial Infarction	Cardiac disorders	EG0001 affected191 at risk EG0010 affected189 at risk EG0020 affected382 at risk EG003
Overdose	Injury, poisoning and procedural complications	EG0000 affected191 at risk EG0011 affected189 at risk EG0021 affected382 at risk EG003
Ankle Fracture	Injury, poisoning and procedural complications	EG0000 affected191 at risk EG0010 affected189 at risk EG0020 affected382 at risk EG003
Meniscus Lesion	Injury, poisoning and procedural complications	EG0001 affected191 at risk EG0010 affected189 at risk EG0020 affected382 at risk EG003
Multiple Fractures	Injury, poisoning and procedural complications	EG0000 affected191 at risk EG0010 affected189 at risk EG0021 affected382 at risk EG003
Postoperative Fever	Injury, poisoning and procedural complications	EG0000 affected191 at risk EG0010 affected189 at risk EG0020 affected382 at risk EG003
Radius Fracture	Injury, poisoning and procedural complications	EG0000 affected191 at risk EG0010 affected189 at risk EG0020 affected382 at risk EG003
Venom Poisoning	Injury, poisoning and procedural complications	EG0000 affected191 at risk EG0010 affected189 at risk EG0020 affected382 at risk EG003
Non-Cardiac Chest Pain	General disorders	EG0001 affected191 at risk EG0010 affected189 at risk EG0020 affected382 at risk EG003
Asthenia	General disorders	EG0000 affected191 at risk EG0010 affected189 at risk EG0020 affected382 at risk EG003
Fatigue	General disorders	EG0000 affected191 at risk EG0010 affected189 at risk EG0021 affected382 at risk EG003
Gait Disturbance	General disorders	EG0000 affected191 at risk EG0010 affected189 at risk EG0021 affected382 at risk EG003
Hyperplasia	General disorders	EG0000 affected191 at risk EG0010 affected189 at risk EG0020 affected382 at risk EG003
Malaise	General disorders	EG0000 affected191 at risk EG0010 affected189 at risk EG0021 affected382 at risk EG003
Multi-Organ Failure	General disorders	EG0000 affected191 at risk EG0011 affected189 at risk EG0020 affected382 at risk EG003
Pain	General disorders	EG0000 affected191 at risk EG0010 affected189 at risk EG0020 affected382 at risk EG003
Abdominal Pain	Gastrointestinal disorders	EG0000 affected191 at risk EG0010 affected189 at risk EG0021 affected382 at risk EG003
Intestinal Obstruction	Gastrointestinal disorders	EG0000 affected191 at risk EG0010 affected189 at risk EG0020 affected382 at risk EG003
Pancreatitis Acute	Gastrointestinal disorders	EG0000 affected191 at risk EG0010 affected189 at risk EG0020 affected382 at risk EG003
Small Intestinal Obstruction	Gastrointestinal disorders	EG0000 affected191 at risk EG0010 affected189 at risk EG0021 affected382 at risk EG003
Vomiting	Gastrointestinal disorders	EG0001 affected191 at risk EG0010 affected189 at risk EG0020 affected382 at risk EG003
Cholelithiasis	Hepatobiliary disorders	EG0000 affected191 at risk EG0011 affected189 at risk EG0020 affected382 at risk EG003
Hepatic Failure	Hepatobiliary disorders	EG0000 affected191 at risk EG0010 affected189 at risk EG0021 affected382 at risk EG003
Cholecystitis	Hepatobiliary disorders	EG0000 affected191 at risk EG0010 affected189 at risk EG0020 affected382 at risk EG003
Cholecystitis Acute	Hepatobiliary disorders	EG0000 affected191 at risk EG0010 affected189 at risk EG0020 affected382 at risk EG003
Hepatorenal Syndrome	Hepatobiliary disorders	EG0000 affected191 at risk EG0011 affected189 at risk EG0020 affected382 at risk EG003
Retinal Haemorrhage	Eye disorders	EG0001 affected191 at risk EG0011 affected189 at risk EG0021 affected382 at risk EG003
Retinal Detachment	Eye disorders	EG0000 affected191 at risk EG0011 affected189 at risk EG0021 affected382 at risk EG003
Glaucoma	Eye disorders	EG0000 affected191 at risk EG0010 affected189 at risk EG0021 affected382 at risk EG003
Adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0000 affected191 at risk EG0010 affected189 at risk EG0020 affected382 at risk EG003
Hepatic Neoplasm Malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0001 affected191 at risk EG0010 affected189 at risk EG0020 affected382 at risk EG003
Pancreatic Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0000 affected191 at risk EG0010 affected189 at risk EG0020 affected382 at risk EG003
Pancreatic Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0000 affected191 at risk EG0010 affected189 at risk EG0021 affected382 at risk EG003
Tonsil Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0000 affected191 at risk EG0010 affected189 at risk EG0020 affected382 at risk EG003
Alveolitis Fibrosing	Respiratory, thoracic and mediastinal disorders	EG0001 affected191 at risk EG0010 affected189 at risk EG0020 affected382 at risk EG003
Haemoptysis	Respiratory, thoracic and mediastinal disorders	EG0000 affected191 at risk EG0010 affected189 at risk EG0020 affected382 at risk EG003
Pneumothorax	Respiratory, thoracic and mediastinal disorders	EG0000 affected191 at risk EG0011 affected189 at risk EG0020 affected382 at risk EG003
Dehydration	Metabolism and nutrition disorders	EG0000 affected191 at risk EG0010 affected189 at risk EG0022 affected382 at risk EG003
Diabetic Ketoacidosis	Metabolism and nutrition disorders	EG0000 affected191 at risk EG0010 affected189 at risk EG0020 affected382 at risk EG003
Back Pain	Musculoskeletal and connective tissue disorders	EG0001 affected191 at risk EG0010 affected189 at risk EG0020 affected382 at risk EG003
Fracture Nonunion	Musculoskeletal and connective tissue disorders	EG0001 affected191 at risk EG0010 affected189 at risk EG0020 affected382 at risk EG003
Intervertebral Disc Protrusion	Musculoskeletal and connective tissue disorders	EG0001 affected191 at risk EG0010 affected189 at risk EG0020 affected382 at risk EG003
Musculoskeletal Chest Pain	Musculoskeletal and connective tissue disorders	EG0001 affected191 at risk EG0010 affected189 at risk EG0020 affected382 at risk EG003
Calculus Ureteric	Renal and urinary disorders	EG0000 affected191 at risk EG0010 affected189 at risk EG0022 affected382 at risk EG003
Renal Failure Acute	Renal and urinary disorders	EG0000 affected191 at risk EG0010 affected189 at risk EG0020 affected382 at risk EG003
Tubulointerstitial Nephritis	Renal and urinary disorders	EG0000 affected191 at risk EG0010 affected189 at risk EG0020 affected382 at risk EG003
Dermatitis	Skin and subcutaneous tissue disorders	EG0000 affected191 at risk EG0010 affected189 at risk EG0021 affected382 at risk EG003
Psoriasis	Skin and subcutaneous tissue disorders	EG0000 affected191 at risk EG0010 affected189 at risk EG0021 affected382 at risk EG003
Skin Ulcer	Skin and subcutaneous tissue disorders	EG0000 affected191 at risk EG0010 affected189 at risk EG0020 affected382 at risk EG003
Hypertension	Vascular disorders	EG0000 affected191 at risk EG0010 affected189 at risk EG0020 affected382 at risk EG003
Vena Cava Thrombosis	Vascular disorders	EG0000 affected191 at risk EG0011 affected189 at risk EG0020 affected382 at risk EG003
Hyperthyroidism	Endocrine disorders	EG0000 affected191 at risk EG0010 affected189 at risk EG0020 affected382 at risk EG003

Other Adverse Events

Term	Organ System	Statistical Information
Pyrexia	General disorders	EG00083 affected191 at risk EG00178 affected189 at risk EG002176 affected382 at risk EG003205 affected383 at risk
Fatigue	General disorders	EG00066 affected191 at risk EG001102 affected189 at risk EG002184 affected382 at risk EG003
Chills	General disorders	EG00042 affected191 at risk EG00155 affected189 at risk EG002122 affected382 at risk EG003
Asthenia	General disorders	EG00028 affected191 at risk EG00135 affected189 at risk EG00284 affected382 at risk EG003
Irritability	General disorders	EG00034 affected191 at risk EG00129 affected189 at risk EG00264 affected382 at risk EG003
Pain	General disorders	EG00010 affected191 at risk EG00118 affected189 at risk EG00224 affected382 at risk EG003
Injection Site Erythema	General disorders	EG00016 affected191 at risk EG00114 affected189 at risk EG00228 affected382 at risk EG003
Injection Site Reaction	General disorders	EG00012 affected191 at risk EG00113 affected189 at risk EG00220 affected382 at risk EG003
Malaise	General disorders	EG00010 affected191 at risk EG00110 affected189 at risk EG00214 affected382 at risk EG003
Nausea	Gastrointestinal disorders	EG00041 affected191 at risk EG00142 affected189 at risk EG002112 affected382 at risk EG003
Diarrhoea	Gastrointestinal disorders	EG00025 affected191 at risk EG00127 affected189 at risk EG00262 affected382 at risk EG003
Vomiting	Gastrointestinal disorders	EG00012 affected191 at risk EG00119 affected189 at risk EG00242 affected382 at risk EG003
Abdominal Pain Upper	Gastrointestinal disorders	EG00011 affected191 at risk EG00118 affected189 at risk EG00228 affected382 at risk EG003
Dyspepsia	Gastrointestinal disorders	EG0009 affected191 at risk EG00112 affected189 at risk EG00225 affected382 at risk EG003
Dry Mouth	Gastrointestinal disorders	EG0005 affected191 at risk EG00114 affected189 at risk EG00223 affected382 at risk EG003
Abdominal Pain	Gastrointestinal disorders	EG0006 affected191 at risk EG00110 affected189 at risk EG00215 affected382 at risk EG003
Constipation	Gastrointestinal disorders	EG0005 affected191 at risk EG00113 affected189 at risk EG0029 affected382 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	EG00046 affected191 at risk EG00144 affected189 at risk EG002111 affected382 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	EG00050 affected191 at risk EG00149 affected189 at risk EG00288 affected382 at risk EG003
Back Pain	Musculoskeletal and connective tissue disorders	EG00021 affected191 at risk EG00122 affected189 at risk EG00228 affected382 at risk EG003
Muscle Spasms	Musculoskeletal and connective tissue disorders	EG0008 affected191 at risk EG00112 affected189 at risk EG00213 affected382 at risk EG003
Rash	Skin and subcutaneous tissue disorders	EG00038 affected191 at risk EG00140 affected189 at risk EG00265 affected382 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	EG00034 affected191 at risk EG00127 affected189 at risk EG00276 affected382 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	EG00023 affected191 at risk EG00120 affected189 at risk EG00271 affected382 at risk EG003
Dry Skin	Skin and subcutaneous tissue disorders	EG00023 affected191 at risk EG00122 affected189 at risk EG00238 affected382 at risk EG003
Headache	Nervous system disorders	EG00075 affected191 at risk EG00176 affected189 at risk EG002151 affected382 at risk EG003
Dizziness	Nervous system disorders	EG00014 affected191 at risk EG00127 affected189 at risk EG00244 affected382 at risk EG003
Disturbance in Attention	Nervous system disorders	EG0005 affected191 at risk EG0016 affected189 at risk EG00220 affected382 at risk EG003
Insomnia	Psychiatric disorders	EG00046 affected191 at risk EG00145 affected189 at risk EG00298 affected382 at risk EG003
Depression	Psychiatric disorders	EG00031 affected191 at risk EG00133 affected189 at risk EG00265 affected382 at risk EG003
Anxiety	Psychiatric disorders	EG00011 affected191 at risk EG00118 affected189 at risk EG00231 affected382 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	EG00027 affected191 at risk EG00135 affected189 at risk EG00259 affected382 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	EG00015 affected191 at risk EG00115 affected189 at risk EG00239 affected382 at risk EG003
Oropharyngeal Pain	Respiratory, thoracic and mediastinal disorders	EG00012 affected191 at risk EG00111 affected189 at risk EG00216 affected382 at risk EG003
Dyspnoea Exertional	Respiratory, thoracic and mediastinal disorders	EG0006 affected191 at risk EG00113 affected189 at risk EG00217 affected382 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	EG00010 affected191 at risk EG00110 affected189 at risk EG0029 affected382 at risk EG003
Anaemia	Blood and lymphatic system disorders	EG00023 affected191 at risk EG00122 affected189 at risk EG00238 affected382 at risk EG003
Neutropenia	Blood and lymphatic system disorders	EG0009 affected191 at risk EG00116 affected189 at risk EG00229 affected382 at risk EG003
Decreased Appetite	Metabolism and nutrition disorders	EG00030 affected191 at risk EG00131 affected189 at risk EG00273 affected382 at risk EG003
Weight Decreased	Investigations	EG00031 affected191 at risk EG00131 affected189 at risk EG00254 affected382 at risk EG003
Hypertension	Vascular disorders	EG0007 affected191 at risk EG00111 affected189 at risk EG00216 affected382 at risk EG003
Upper Respiratory Tract Infection	Infections and infestations	EG00011 affected191 at risk EG0017 affected189 at risk EG00211 affected382 at risk EG003

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

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

ID	Title	Description
BG000	PEG-IFN 180 µg + Ribavirin 1200 mg	PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily).
BG001	PEG-IFN 180 µg + Ribavirin 1400/1600 mg	PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to <95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.
BG002	PEG-IFN 360/180 µg + Ribavirin 1200 mg	PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily).
BG003	PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg	PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to <95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.
BG004	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	PEG-IFN 180 µg + Ribavirin 1200 mg	PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily).	22	191	186	191
EG001	PEG-IFN 180 µg + Ribavirin 1400/1600 mg	PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to <95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.	20	189	179	189
EG002	PEG-IFN 360/180 µg + Ribavirin 1200 mg	PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily).	36	382	370	382
EG003	PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg	PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to <95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.	39	383	373	383