Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-30 @ 12:30 PM
Study NCT ID:
NCT00446134
Status:
COMPLETED
Last Update Posted:
2012-07-27
First Post:
2007-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Taribavirin Phase 2 Dose Finding Study for the Treatment of Hepatitis C Virus (HCV)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019698', 'term': 'Hepatitis C, Chronic'}], 'ancestors': [{'id': 'D006526', 'term': 'Hepatitis C'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006521', 'term': 'Hepatitis, Chronic'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C026956', 'term': 'taribavirin'}, {'id': 'D012254', 'term': 'Ribavirin'}], 'ancestors': [{'id': 'D012263', 'term': 'Ribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ralph.doyle@valeant.com', 'phone': '908-927-1782', 'title': 'Senior Director Clinical Development', 'organization': 'Valeant Pharmaceuticals International, Inc.'}, 'certainAgreement': {'otherDetails': 'Agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Valeant supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Treatment Week Follow-Up 24', 'description': 'A treatment-emergent adverse event (AE) was defined as any AE that began after the first dose of double-blind study study, or began earlier yet worsened after the first dose, to 30 days after the last dose. The AEs were reported by at least 5% of patients in any treatment group and the Safety Population of 275 was used in the analysis.', 'eventGroups': [{'id': 'EG000', 'title': 'Taribavirin 20 mg/kg/Day', 'description': 'Oral taribavirin 20 mg/kg/day (actual doses were 20-24 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)', 'otherNumAtRisk': 67, 'otherNumAffected': 66, 'seriousNumAtRisk': 67, 'seriousNumAffected': 7}, {'id': 'EG001', 'title': 'Taribavirin 25 mg/kg/Day', 'description': 'Oral taribavirin tablet 25 mg/kg/day actual doses were 25-29 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)', 'otherNumAtRisk': 70, 'otherNumAffected': 68, 'seriousNumAtRisk': 70, 'seriousNumAffected': 6}, {'id': 'EG002', 'title': 'Taribavirin 30 mg/kg/Day', 'description': 'Oral taribavirin 30 mg/kg/day actual doses were 30-34 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)', 'otherNumAtRisk': 68, 'otherNumAffected': 68, 'seriousNumAtRisk': 68, 'seriousNumAffected': 6}, {'id': 'EG003', 'title': 'Ribavirin 800 mg/Day', 'description': 'Oral ribavirin 800 mg/day (body weight \\<65 kg), 1000 mg/day (body weight 65-84 kg), 1200 mg/day (body weight 85-104 kg) or 1400 mg/day (body weight greater than or equal to 105 kg) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)', 'otherNumAtRisk': 70, 'otherNumAffected': 69, 'seriousNumAtRisk': 70, 'seriousNumAffected': 9}], 'otherEvents': [{'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 44, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 37, 'numAffected': 37}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 43, 'numAffected': 43}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 36, 'numAffected': 36}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 30, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 24, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 29, 'numAffected': 29}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 29, 'numAffected': 29}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Influenza-like Illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 20, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 21, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 27, 'numAffected': 27}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 24, 'numAffected': 24}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 27, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 27, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 25, 'numAffected': 25}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 16, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 23, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 26, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 23, 'numAffected': 23}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 17, 'numAffected': 17}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 30, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 35, 'numAffected': 35}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 22, 'numAffected': 22}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 28, 'numAffected': 28}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 21, 'numAffected': 21}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 18, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 16, 'numAffected': 16}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 21, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Decreased Appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 24, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 17, 'numAffected': 17}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Injection Site Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 20, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 17, 'numAffected': 17}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 23, 'numAffected': 23}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 18, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 18, 'numAffected': 18}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 18, 'numAffected': 18}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Dry Skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Pruritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Loose Stools', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Injection Site Reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Hypotrichosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Weight Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 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'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Vision Blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 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0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Upper Gastrointestinal Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Musculoskeletal Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Metabolic Encaphalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Status Epilepticus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Cerebrovascular Accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Acute Respiratory Distress Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Accidental Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Fibula Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Tibia Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Gastric Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Oesophageal Adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Oesophageal Squamous Cell Carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}, {'term': 'Deep Vein Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (7.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Patients With Either Undetectable Serum HCV RNA (<100 Copies/ml) or at Least a 2-log Decrease From Baseline in Serum Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Treatment Week 12.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}, {'value': '70', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Taribavirin 20 mg/kg/Day', 'description': 'Oral taribavirin 20 mg/kg/day (actual doses were 20-24 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)'}, {'id': 'OG001', 'title': 'Taribavirin 25 mg/kg/Day', 'description': 'Oral taribavirin tablet 25 mg/kg/day actual doses were 25-29 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)'}, {'id': 'OG002', 'title': 'Taribavirin 30 mg/kg/Day', 'description': 'Oral taribavirin 30 mg/kg/day actual doses were 30-34 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)'}, {'id': 'OG003', 'title': 'Ribavirin 800 mg/Day', 'description': 'Oral ribavirin 800 mg/day (body weight \\<65 kg), 1000 mg/day (body weight 65-84 kg), 1200 mg/day (body weight 85-104 kg) or 1400 mg/day (body weight greater than or equal to 105 kg) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)'}], 'classes': [{'title': 'Early Virologic Response (EVR) (less than 100)', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}]}]}, {'title': 'No EVR (non-responder, Total)', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}]}, {'title': 'Detectable (greater than 100 copies/mL at TW 12)', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}]}, {'title': 'Discontinued (Prior to TW 12)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}]}, {'title': 'Missing (No value at TW 12)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.167', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Other', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.75', 'ciLowerLimit': '-3.65', 'ciUpperLimit': '29.15', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '5', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The study will have 70% to detect non-inferiority of taribavirin versus ribavirin using a non-inferiority margin of 12%.'}, {'pValue': '0.611', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Difference of Proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.71', 'ciLowerLimit': '-10.76', 'ciUpperLimit': '22.19', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '5', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The study will have 70% to detect non-inferiority of taribavirin versus ribavirin using a non-inferiority margin of 12%.'}, {'pValue': '0.736', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference of Proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.98', 'ciLowerLimit': '-13.67', 'ciUpperLimit': '19.63', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '5', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The study will have 70% to detect non-inferiority of taribavirin versus ribavirin using a non-inferiority margin of 12%.'}, {'pValue': '0.485', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of Proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.04', 'ciLowerLimit': '-9.28', 'ciUpperLimit': '23.35', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '5', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The study will have 70% to detect non-inferiority of taribavirin versus taribavirin using a non-inferiority margin of 12%.'}, {'pValue': '0.295', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference of Proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.77', 'ciLowerLimit': '-6.72', 'ciUpperLimit': '26.26', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '5', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The study will have 70% to detect non-inferiority of taribavirin versus taribavirin using a non-inferiority margin of 12%.'}, {'pValue': '0.864', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference of Proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.73', 'ciLowerLimit': '-13.84', 'ciUpperLimit': '19.3', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '5', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The study will have 70% to detect non-inferiority of taribavirin versus taribavirin using a non-inferiority margin of 12%.'}], 'paramType': 'NUMBER', 'timeFrame': 'Treatment Week 12', 'description': 'The primary efficacy endpoint was the numbers of responders at Treatment Week (TW) 12. Responders are defined as patients achieving either viral negativity or a partial response (PR). Viral negativity is defined as \\<100 copies/mL serum HCV RNA. A PR is defined as \\< 100 copies/mL serum HCV RNA and at least a 2-log decrease from baseline in serum HCV RNA levels. Responder rates with corresponding 95% confidence intervals were estimated for each treatment group.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary efficacy analysis was performed using the Intent-to-Treat (ITT) population and 275 patients who received at least one dose of study drug were analyzed for efficacy.'}, {'type': 'SECONDARY', 'title': 'Patients With Anemia (Hemoglobin <10 g/dL) Up to Follow-up Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}, {'value': '70', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Taribavirin 20 mg/kg/Day', 'description': 'Oral taribavirin 20 mg/kg/day (actual doses were 20-24 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)'}, {'id': 'OG001', 'title': 'Taribavirin 25 mg/kg/Day', 'description': 'Oral taribavirin tablet 25 mg/kg/day actual doses were 25-29 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)'}, {'id': 'OG002', 'title': 'Taribavirin 30 mg/kg/Day', 'description': 'Oral taribavirin 30 mg/kg/day actual doses were 30-34 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)'}, {'id': 'OG003', 'title': 'Ribavirin 800 mg/Day', 'description': 'Oral ribavirin 800 mg/day (body weight \\<65 kg), 1000 mg/day (body weight 65-84 kg), 1200 mg/day (body weight 85-104 kg) or 1400 mg/day (body weight greater than or equal to 105 kg) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.0304', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '16.4', 'ciLowerLimit': '2.31', 'ciUpperLimit': '30.57', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '5', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0293', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '17.1', 'ciLowerLimit': '3.22', 'ciUpperLimit': '31.06', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '5', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.5816', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.9', 'ciLowerLimit': '-10.41', 'ciUpperLimit': '20.24', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '5', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Treatment Week Follow-Up 24', 'description': "The primary safety endpoint will be the numbers of patients with hemoglobin \\<10 g/dL (anemia) at any time during the treatment period. The comparison of anemia rates between taribavirin and ribavirin groups will be carried out using the Fisher's exact test or Chi-square test. The 95% confidence interval of the difference in proportion will be analyzed.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The secondary analysis was performed using the Safety Population and 275 patients who received at least one dose of study drug were analyzed for safety.'}, {'type': 'SECONDARY', 'title': 'Patients With Undetected Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) (<100 Copies/mL) at Treatment Week Follow-Up 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}, {'value': '70', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Taribavirin 20 mg/kg/Day', 'description': 'Oral taribavirin 20 mg/kg/day (actual doses were 20-24 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)'}, {'id': 'OG001', 'title': 'Taribavirin 25 mg/kg/Day', 'description': 'Oral taribavirin tablet 25 mg/kg/day actual doses were 25-29 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)'}, {'id': 'OG002', 'title': 'Taribavirin 30 mg/kg/Day', 'description': 'Oral taribavirin 30 mg/kg/day actual doses were 30-34 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)'}, {'id': 'OG003', 'title': 'Ribavirin 800 mg/Day', 'description': 'Oral ribavirin 800 mg/day (body weight \\<65 kg), 1000 mg/day (body weight 65-84 kg), 1200 mg/day (body weight 85-104 kg) or 1400 mg/day (body weight greater than or equal to 105 kg) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)'}], 'classes': [{'title': 'Responder Follow-Up Week 24', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}]}, {'title': 'Non-Responder Follow-Up Week 24', 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}]}]}, {'title': 'Detectable HCV RNA Follow-Up Week 24', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}]}, {'title': 'Discontinued Week Follow-Up Week 24', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.9999', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.22', 'ciLowerLimit': '-13.78', 'ciUpperLimit': '16.22', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '5', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.9999', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'ciLowerLimit': '-14.73', 'ciUpperLimit': '14.73', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '5', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.9999', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.8', 'ciLowerLimit': '-14.11', 'ciUpperLimit': '15.71', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '5', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.9999', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.22', 'ciLowerLimit': '-13.78', 'ciUpperLimit': '16.22', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '5', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.9999', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.42', 'ciLowerLimit': '-14.76', 'ciUpperLimit': '15.59', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '5', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.9999', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.8', 'ciLowerLimit': '-15.71', 'ciUpperLimit': '14.11', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '5', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Treatment Week Follow-Up 24', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was performed using the Intent-to-Treat Population (ITT); undetectable HCV RNA defined as \\<100 copies/mL;Patients with a missing value at TW 12, TW 24 were considered Non-responders (detectable); a responder is defined as a patient with undetectable HCV RNA at FW 24 after achieving EVR at TW 12 and undetectable status at TW 24'}, {'type': 'SECONDARY', 'title': 'Relapsers at Follow-Up Visit 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Taribavirin 20 mg/kg/Day', 'description': 'Oral taribavirin 20 mg/kg/day (actual doses were 20-24 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)'}, {'id': 'OG001', 'title': 'Taribavirin 25 mg/kg/Day', 'description': 'Oral taribavirin tablet 25 mg/kg/day actual doses were 25-29 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)'}, {'id': 'OG002', 'title': 'Taribavirin 30 mg/kg/Day', 'description': 'Oral taribavirin 30 mg/kg/day actual doses were 30-34 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)'}, {'id': 'OG003', 'title': 'Ribavirin 800 mg/Day', 'description': 'Oral ribavirin 800 mg/day (body weight \\<65 kg), 1000 mg/day (body weight 65-84 kg), 1200 mg/day (body weight 85-104 kg) or 1400 mg/day (body weight greater than or equal to 105 kg) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000', 'lowerLimit': '-10.08', 'upperLimit': '20.86'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '-22.98', 'upperLimit': '10.23'}, {'value': '3', 'groupId': 'OG002', 'lowerLimit': '-28.87', 'upperLimit': '17.66'}, {'value': '5', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Follow-Up Week 24', 'description': 'Includes patients who had undetectable Hepatitis Virus C (HVC) Ribonucleic Acid (RNA) at their last visit on drug.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed using patients who had undetectable HVC RNA at their last visit on drug.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Taribavirin 20 mg/kg/Day', 'description': 'Oral taribavirin 20 mg/kg/day (actual doses were 20-24 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)'}, {'id': 'FG001', 'title': 'Taribavirin 25 mg/kg/Day', 'description': 'Oral taribavirin tablet 25 mg/kg/day actual doses were 25-29 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)'}, {'id': 'FG002', 'title': 'Taribavirin 30 mg/kg/Day', 'description': 'Oral taribavirin 30 mg/kg/day actual doses were 30-34 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)'}, {'id': 'FG003', 'title': 'Ribavirin 800 mg/Day', 'description': 'Oral ribavirin 800 mg/day (body weight \\<65 kg), 1000 mg/day (body weight 65-84 kg), 1200 mg/day (body weight 85-104 kg) or 1400 mg/day (body weight greater than or equal to 105 kg) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Includes 2 patients who did not receive study drug and was not included in any other analysis', 'groupId': 'FG000', 'numSubjects': '69'}, {'groupId': 'FG001', 'numSubjects': '70'}, {'comment': 'Includes 1 patient who did not receive study drug and was not included in any other analysis', 'groupId': 'FG002', 'numSubjects': '69'}, {'groupId': 'FG003', 'numSubjects': '70'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '26'}, {'groupId': 'FG003', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '45'}, {'groupId': 'FG002', 'numSubjects': '43'}, {'groupId': 'FG003', 'numSubjects': '45'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '13'}, {'groupId': 'FG003', 'numSubjects': '18'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '24'}, {'groupId': 'FG003', 'numSubjects': '19'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Adverse Event-Diarrhea', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Reason Not Completed', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Patients who met all entry criteria and signed an informed consent were randomized in a 1:1:1:1 ratio to one of the 4 arms by a central randomization schedule. A total of 51 clinical centers in the United States participated in the study. 278 patients were randomized; 275 patients who receive one dose of study drug were included in all analyses.', 'preAssignmentDetails': 'Randomization was stratified by screening HCV RNA viral load less than or = to 2 or greater than (\\>) 2 million copies/mL and body weight (BW) (less than or = 75 or \\>75 kg). A cap of 70% was set for patients with BWs \\>75 kg so that at least 30% of the patients in each group have BWs less than or = to 75 kg.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}, {'value': '70', 'groupId': 'BG003'}, {'value': '275', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Taribavirin 20 mg/kg/Day', 'description': 'Oral taribavirin 20 mg/kg/day (actual doses were 20-24 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)'}, {'id': 'BG001', 'title': 'Taribavirin 25 mg/kg/Day', 'description': 'Oral taribavirin tablet 25 mg/kg/day actual doses were 25-29 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)'}, {'id': 'BG002', 'title': 'Taribavirin 30 mg/kg/Day', 'description': 'Oral taribavirin 30 mg/kg/day actual doses were 30-34 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)'}, {'id': 'BG003', 'title': 'Ribavirin 800 mg/Day', 'description': 'Oral ribavirin 800 mg/day (body weight \\<65 kg), 1000 mg/day (body weight 65-84 kg), 1200 mg/day (body weight 85-104 kg) or 1400 mg/day (body weight greater than or equal to 105 kg) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '48.5', 'spread': '9.39', 'groupId': 'BG000'}, {'value': '47.5', 'spread': '9.42', 'groupId': 'BG001'}, {'value': '49.6', 'spread': '7.24', 'groupId': 'BG002'}, {'value': '49.7', 'spread': '8.30', 'groupId': 'BG003'}, {'value': '48.8', 'spread': '8.63', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}, {'value': '107', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}, {'value': '48', 'groupId': 'BG003'}, {'value': '168', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '49', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}, {'value': '178', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '37', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '81.5', 'spread': '16.9', 'groupId': 'BG000'}, {'value': '82.6', 'spread': '16.8', 'groupId': 'BG001'}, {'value': '82.2', 'spread': '18.0', 'groupId': 'BG002'}, {'value': '82.3', 'spread': '17.1', 'groupId': 'BG003'}, {'value': '82.1', 'spread': '17.09', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilograms', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) (log 10)', 'classes': [{'categories': [{'measurements': [{'value': '6.6', 'spread': '0.71', 'groupId': 'BG000'}, {'value': '6.6', 'spread': '0.78', 'groupId': 'BG001'}, {'value': '6.6', 'spread': '0.78', 'groupId': 'BG002'}, {'value': '6.5', 'spread': '0.84', 'groupId': 'BG003'}, {'value': '6.6', 'spread': '0.77', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Copies/mL', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 278}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-20', 'studyFirstSubmitDate': '2007-03-08', 'resultsFirstSubmitDate': '2011-09-20', 'studyFirstSubmitQcDate': '2007-03-09', 'lastUpdatePostDateStruct': {'date': '2012-07-27', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-06-20', 'studyFirstPostDateStruct': {'date': '2007-03-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-07-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patients With Either Undetectable Serum HCV RNA (<100 Copies/ml) or at Least a 2-log Decrease From Baseline in Serum Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Treatment Week 12.', 'timeFrame': 'Treatment Week 12', 'description': 'The primary efficacy endpoint was the numbers of responders at Treatment Week (TW) 12. Responders are defined as patients achieving either viral negativity or a partial response (PR). Viral negativity is defined as \\<100 copies/mL serum HCV RNA. A PR is defined as \\< 100 copies/mL serum HCV RNA and at least a 2-log decrease from baseline in serum HCV RNA levels. Responder rates with corresponding 95% confidence intervals were estimated for each treatment group.'}], 'secondaryOutcomes': [{'measure': 'Patients With Anemia (Hemoglobin <10 g/dL) Up to Follow-up Week 24', 'timeFrame': 'Treatment Week Follow-Up 24', 'description': "The primary safety endpoint will be the numbers of patients with hemoglobin \\<10 g/dL (anemia) at any time during the treatment period. The comparison of anemia rates between taribavirin and ribavirin groups will be carried out using the Fisher's exact test or Chi-square test. The 95% confidence interval of the difference in proportion will be analyzed."}, {'measure': 'Patients With Undetected Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) (<100 Copies/mL) at Treatment Week Follow-Up 24', 'timeFrame': 'Treatment Week Follow-Up 24'}, {'measure': 'Relapsers at Follow-Up Visit 24', 'timeFrame': 'Follow-Up Week 24', 'description': 'Includes patients who had undetectable Hepatitis Virus C (HVC) Ribonucleic Acid (RNA) at their last visit on drug.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Phase 2b Dose-Ranging Study'], 'conditions': ['Chronic Hepatitis C']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'Poordad F, Lawitz E, Pozza R, et al. Efficacy and safety of weight-based regimens of taribavirin or ribavirin, given with peginterferon alfa-2b, 12 weeks after treatment (SVR12) in naive patients with genotype 1 hepatitis C. J Hepatol. 2009;50 Suppl 1:S8'}, {'pmid': '20721883', 'type': 'RESULT', 'citation': 'Poordad F, Lawitz E, Shiffman ML, Hassanein T, Muir AJ, Bacon BR, Heise J, Halliman D, Chun E, Hammond J. Virologic response rates of weight-based taribavirin versus ribavirin in treatment-naive patients with genotype 1 chronic hepatitis C. Hepatology. 2010 Oct;52(4):1208-15. doi: 10.1002/hep.23827.'}]}, 'descriptionModule': {'briefSummary': 'The objective of the study is to select an optimal dose of taribavirin by comparing the efficacy and safety of 3 taribavirin dose levels, 20, 25, and 30 mg/kg/day, versus ribavirin 800 to 1400 mg/day based on body weight, both administered in combination with peginterferon alfa-2b to therapy-naive patients with chronic Hepatitis C Virus (HCV) genotype 1 infection.', 'detailedDescription': 'The objective of the study is to select an optimal dose of taribavirin by comparing the efficacy and safety of 3 taribavirin dose levels, 20, 25, and 30 mg/kg/day, versus ribavirin 800 mg/day to 1400 mg/day based on subject body weight, with both drugs administered in combination with peginterferon alfa-2b to therapy-naive patients with chronic Hepatitis C Virus genotype 1 infection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Subject Inclusion Criteria\n\nTo be eligible for enrollment, patients must meet all of the following criteria:\n\n1. At least 18 years of age\n2. Diagnosed with compensated chronic HCV genotype 1 infection that has not been treated with interferon, peginterferon, ribavirin or any experimental therapy for \\>28 days\n\n2a Serum HCV RNA \\>2000 copies/mL (780 IU/mL) 2b Liver biopsy performed within 3 years prior to screening consistent with chronic HCV infection 2c Criteria for compensated HCV infection, including normal prothrombin time, serum albumin and bilirubin levels (unless due to non-hepatitis factors) and no history or evidence of bleeding esophageal varices, ascites, or hepatic encephalopathy\n\n3 History of alanine aminotransferase (ALT) elevation either within 6 months prior to screening, at screening, or on retest 2 weeks after a negative screening test, or histologic evidence of HCV infection and a detectable viral load\n\n4 Platelet count ≥90,000/mm3\n\n5 Absolute neutrophil count ≥1200/mm3\n\n6 Hemoglobin ≥12.0 g/dL for females or ≥13.0 g/dL for males\n\n7 Antinuclear antibody (ANA) titer ≤1:320\n\n8 Serum creatinine \\<1.5 mg/dL\n\n9 HbA1c ≤8.5% for diabetic patients\n\n10 Normal or adequately controlled TSH on prescription medication\n\n11 Alpha fetoprotein (AFP) \\<20 ng/mL or hepatocellular carcinoma ruled out (ultrasound, CT or MRI scan) within 6 months prior to the study (Patients with an AFP \\>20 ng/mL must have ongoing hepatocellular carcinoma screening during study as part of the patient's routine medical care)\n\n12 All other clinical laboratory values within normal limits, unless judged not clinically significant by the investigator\n\n13 Sterile or infertile (defined as vasectomy, tubal ligation, postmenopausal, or hysterectomy), or willing to use an approved method of double-barrier contraception (hormonal plus barrier or barrier plus barrier, eg, diaphragm plus condom) from the time of first dose administration until 6 months after the last dose\n\n14 Capable of understanding instructions, adhering to study schedules and requirements, and willing to provided informed consent\n\nSubject Exclusion Criteria\n\nPatients who have any of the following during the screening or Day 1 visit are not eligible for enrollment in this study:\n\n1. Positive HIV or HbsAg serology\n2. Severe psychiatric or neuropsychiatric disorders including severe depression, history of suicidal ideations or suicide attempt(s). (This would include patients with a history of suicidal ideations or suicide attempt(s) that occurred when the patient was a minor or many years ago; if the event occurred while under the influence of alcohol or drugs; if the suicidal ideations or suicide attempt(s) were connected to a traumatic event; if the patient was not hospitalized or treated; if the patient has obtained psychiatric clearance for treatment)\n3. History or clinical manifestations of significant metabolic, hematological, pulmonary, ischemic or unstable heart disease, gastrointestinal, neurological, renal, urological, endocrine, ophthalmologic (including severe retinopathy), or immune mediated disease\n4. History of thalassemia or other hemoglobinopathies (even if the hemoglobin is normal)\n5. Chronic hepatic disease other than hepatitis C\n6. Organ or bone marrow transplant\n7. Chronic (greater than 30 days) use of immunosuppressive medications including steroids in doses equivalent to 10 mg of prednisone or higher, 30 days prior to and anytime during the course of the study\n8. Female patients who are breast-feeding or have a positive pregnancy test at any time during the study\n9. Males whose female partners are pregnant\n10. Patients who have had a malignancy diagnosed and/or treated within the past 5 years, except for localized squamous or basal cell cancers treated by local excision\n11. Patients who have participated in a clinical trial and have received an investigational drug within 30 days prior to screening\n12. History of alcoholism or drug addiction 1 year prior to screening\n13. The use of methadone, buprenorphine or any similar drug, regardless of the prescribed indication or the length of time the patient has been on the drug\n14. Chronic (\\>4 weeks duration) diarrhea, including irritable bowel disease\n15. Fibrosis score F4 (cirrhosis) based on Metavir or equivalent index\n16. Weight \\>128 kg or \\<40 kg\n17. Patients infected with mixed HCV genotypes"}, 'identificationModule': {'nctId': 'NCT00446134', 'briefTitle': 'Taribavirin Phase 2 Dose Finding Study for the Treatment of Hepatitis C Virus (HCV)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bausch Health Americas, Inc.'}, 'officialTitle': 'Phase 2 Comparison of Weight-based Doses of Taribavirin Combined With Peginterferon Alfa-2b Versus Ribavirin Combined With Peginterferon Alfa-2b in Therapy-naïve Patients With Chronic Hepatitis C Virus Genotype 1 Infection', 'orgStudyIdInfo': {'id': 'RNA003142-204'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1: Drug', 'description': 'Oral taribavirin tablet 20 mg/kg/day (Actual doses were 20-24 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)', 'interventionNames': ['Drug: Taribavirin']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2: Drug', 'description': 'Oral taribavirin tablet 25 mg/kg/day (Actual doses were 25-29 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)', 'interventionNames': ['Drug: Taribavirin']}, {'type': 'EXPERIMENTAL', 'label': 'Group 3: Drug', 'description': 'Oral taribavirin 30 mg/kg/day (Actual doses were 30-34 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)', 'interventionNames': ['Drug: Taribavirin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 4: Drug', 'description': 'Oral ribavirin 800 mg/day (body weight \\<65 kg), 1000 mg/day (body weight 65-84 kg), 1200 mg/day (body weight 85-104 kg) or 1400 mg/day (body weight greater than or equal to 105 kg) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)', 'interventionNames': ['Drug: Ribavirin']}], 'interventions': [{'name': 'Taribavirin', 'type': 'DRUG', 'otherNames': ['Viramidine', 'RNA003142-204'], 'description': 'Oral (200 mg) Tablet: 20mg/kg/day BID, patients will be treated for a total of 48 weeks. in addition, all patients will receive peginterferon alfa-2b (PEG-Intron) by weekly subcutaneous injection. Patients who complete treatment with study drug or discontinue treatment prematurely will enter a 24-week follow-up period.', 'armGroupLabels': ['Group 1: Drug']}, {'name': 'Taribavirin', 'type': 'DRUG', 'otherNames': ['Viramidine', 'RNA003142-204'], 'description': 'Oral (200 mg) Tablet: 25mg/kg/day BID, patients will be treated for a total of 48 weeks. in addition, all patients will receive peginterferon alfa-2b (PEG-Intron) by weekly subcutaneous injection. Patients who complete treatment with study drug or discontinue treatment prematurely will enter a 24-week follow-up period.', 'armGroupLabels': ['Group 2: Drug']}, {'name': 'Taribavirin', 'type': 'DRUG', 'otherNames': ['Viramidine', 'RNA003142-204'], 'description': 'Oral (200mg)Tablet: 30mg/kg/day BID, patients will be treated for a total of 48 weeks. in addition, all patients will receive peginterferon alfa-2b (PEG-Intron) by weekly subcutaneous injection. Patients who complete treatment with study drug or discontinue treatment prematurely will enter a 24-week follow-up period.', 'armGroupLabels': ['Group 3: Drug']}, {'name': 'Ribavirin', 'type': 'DRUG', 'otherNames': ['Rebetol', 'Copegus', 'Ribasphere', 'Virazole'], 'description': 'Oral (200mg)Tablet: 800 mg/day, 1000 mg/day, 1200 mg/day, or 1400 mg/day BID, patients will be treated for a total of 48 weeks. in addition, all patients will receive peginterferon alfa-2b (PEG-Intron) by weekly subcutaneous injection. Patients who complete treatment with study drug or discontinue treatment prematurely will enter a 24-week follow-up period.', 'armGroupLabels': ['Group 4: Drug']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars-Sinai Medical Center, 8635 W. 3rd Street, Suite 590W', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Fred Poordad, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cedars-Sinai Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bausch Health Americas, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}