Ignite Creation Date:
2025-12-24 @ 9:21 PM
Ignite Modification Date:
2025-12-31 @ 7:12 AM
Study NCT ID:
NCT01257204
Status:
COMPLETED
Last Update Posted:
2015-12-14
First Post:
2010-12-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study in Genotype 2 or 3 Patients With Chronic Hepatitis Virus Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006526', 'term': 'Hepatitis C'}], 'ancestors': [{'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': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C549273', 'term': 'daclatasvir'}, {'id': 'C100416', 'term': 'peginterferon alfa-2a'}, {'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': 'Clinical.Trials@bms.com', 'title': 'Bristol-Myers Squibb Study Director', 'organization': 'Bristol-Myers Squibb'}, 'certainAgreement': {'otherDetails': "Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline (Day 1) up to 24 weeks (treatment period); From end of treatment period up to Week 48 (follow-up period)', 'eventGroups': [{'id': 'EG000', 'title': 'Daclatasvir, 60 mg, 12-Week Cohort', 'description': 'Participants received daclatasvir tablets 60 mg orally, once daily, with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, for up to 12 weeks.', 'otherNumAtRisk': 50, 'otherNumAffected': 49, 'seriousNumAtRisk': 50, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Daclatasvir, 60 mg, 16-Week Cohort', 'description': 'Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, for up to 16 weeks.', 'otherNumAtRisk': 50, 'otherNumAffected': 49, 'seriousNumAtRisk': 50, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Participants received placebo matched with daclatasvir tablets orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, for up to 24 weeks.', 'otherNumAtRisk': 51, 'otherNumAffected': 48, 'seriousNumAtRisk': 51, 'seriousNumAffected': 3}, {'id': 'EG003', 'title': 'Daclatasvir, 60 mg, 12-Week Cohort: Follow-up', 'description': 'Participants received daclatasvir tablets 60 mg orally, once daily, along with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks during treatment period and entered into the follow-up period.', 'otherNumAtRisk': 49, 'otherNumAffected': 0, 'seriousNumAtRisk': 49, 'seriousNumAffected': 2}, {'id': 'EG004', 'title': 'Daclatasvir, 60 mg, 16-Week Cohort: Follow-up', 'description': 'Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, for up to 16 weeks during treatment period and entered into the follow-up period.', 'otherNumAtRisk': 47, 'otherNumAffected': 0, 'seriousNumAtRisk': 47, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Placebo: Follow-up', 'description': 'Participants received placebo matched with daclatasvir tablets orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, for up to 24 weeks during treatment period and entered into the follow-up period.', 'otherNumAtRisk': 49, 'otherNumAffected': 0, 'seriousNumAtRisk': 49, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Disturbance in attention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Sleep disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dyspnoea exertional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 19}, {'groupId': 'EG003', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 17}, {'groupId': 'EG003', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Memory impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Mood swings', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}], 'seriousEvents': [{'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Biliary colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Conversion disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Rectal ulcer haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Epicondylitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hyperbilirubinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Gastrointestinal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hepatic neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Adhesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Appendiceal Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Tonsil Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 49, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Achieving Sustained Virologic Response at Follow-up Week 24 (SVR24) for Hepatitis C Virus (HCV) Genotype 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Daclatasvir, 60 mg, 12-Week Cohort', 'description': 'Participants received daclatasvir tablets 60 mg orally, once daily, with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks.'}, {'id': 'OG001', 'title': 'Daclatasvir, 60 mg, 16-Week Cohort', 'description': 'Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received placebo matching with daclatasvir tablets orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '83.3', 'groupId': 'OG000', 'lowerLimit': '73.6', 'upperLimit': '93.1'}, {'value': '82.6', 'groupId': 'OG001', 'lowerLimit': '72.5', 'upperLimit': '92.7'}, {'value': '62.5', 'groupId': 'OG002', 'lowerLimit': '49.8', 'upperLimit': '75.2'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '20.8', 'ciLowerLimit': '4.9', 'ciUpperLimit': '36.8', 'estimateComment': 'The difference in the percentage of participants with antiviral response between daclatasvir and placebo was presented with a difference estimate (daclatasvir - placebo) and 80% confidence Interval.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '20.1', 'ciLowerLimit': '3.9', 'ciUpperLimit': '36.3', 'estimateComment': 'The difference in the percentage of participants with antiviral response between daclatasvir and placebo was presented with a difference estimate (daclatasvir - placebo) and 80% confidence Interval.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Follow-up Week 24', 'description': 'SVR24 was defined as undetectable HCV RNA (HCV RNA \\<lower limit of quantitation \\[LLOQ\\], target not detected \\[TND\\]) at follow-up Week 24. The LLOQ was 25 IU/mL, and \\<LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '80% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants with hepatitis C virus genotype 2.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Rapid Virologic Response (RVR) at Week 4 for Hepatitis C Virus (HCV) Genotype 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Daclatasvir, 60 mg, 12-Week Cohort', 'description': 'Participants received daclatasvir tablets 60 mg orally, once daily, along with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks.'}, {'id': 'OG001', 'title': 'Daclatasvir, 60 mg, 16-Week Cohort', 'description': 'Participants received daclatasvir tablets 60 mg orally, once daily, along with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received placebo matching with daclatasvir tablets orally, once daily, along with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '87.5', 'groupId': 'OG000', 'lowerLimit': '78.8', 'upperLimit': '96.2'}, {'value': '73.9', 'groupId': 'OG001', 'lowerLimit': '62.2', 'upperLimit': '85.6'}, {'value': '41.7', 'groupId': 'OG002', 'lowerLimit': '28.8', 'upperLimit': '54.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 4', 'description': 'RVR was defined as undetectable HCV RNA (HCV RNA \\<lower limit of quantitation \\[LLOQ\\], target not detected \\[TND\\]) at Week 4. The LLOQ was 25 IU/mL, and \\<LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '80% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants with HCV genotype 2.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Rapid Virologic Response (RVR) at Week 4 for Hepatitis C Virus (HCV) Genotype 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Daclatasvir, 60 mg, 12-Week Cohort', 'description': 'Participants received daclatasvir tablets 60 mg orally, once daily, along with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 week s.'}, {'id': 'OG001', 'title': 'Daclatasvir, 60 mg, 16-Week Cohort', 'description': 'Participants received daclatasvir tablets 60 mg orally, once daily, along with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received placebo matching with daclatasvir tablets orally, once daily, along with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '84.6', 'groupId': 'OG000', 'lowerLimit': '75.5', 'upperLimit': '93.7'}, {'value': '74.1', 'groupId': 'OG001', 'lowerLimit': '63.3', 'upperLimit': '84.9'}, {'value': '37.0', 'groupId': 'OG002', 'lowerLimit': '25.1', 'upperLimit': '48.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 4', 'description': 'RVR was defined as undetectable HCV RNA (HCV RNA \\<lower limit of quantitation \\[LLOQ\\], target not detected \\[TND\\]) at Week 4. The LLOQ was 25 IU/mL, and \\<LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '80% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants with HCV genotype 3.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Complete Early Virologic Response (cEVR) at Week 12 for Hepatitis C Virus (HCV) Genotype 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Daclatasvir, 60 mg, 12-Week Cohort', 'description': 'Participants received daclatasvir tablets 60 mg orally, once daily, with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks.'}, {'id': 'OG001', 'title': 'Daclatasvir, 60 mg, 16-Week Cohort', 'description': 'Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received placebo matching with daclatasvir tablets orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '91.7', 'groupId': 'OG000', 'lowerLimit': '84.4', 'upperLimit': '98.9'}, {'value': '82.6', 'groupId': 'OG001', 'lowerLimit': '72.5', 'upperLimit': '92.7'}, {'value': '75.0', 'groupId': 'OG002', 'lowerLimit': '63.7', 'upperLimit': '86.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'cEVR was defined as undetectable HCV RNA (HCV RNA \\<lower limit of quantitation \\[LLOQ\\], target not detected \\[TND\\]) at Week 12. The LLOQ was 25 IU/mL, and \\<LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '80% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants with HCV genotype 2.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Complete Early Virologic Response (cEVR) at Week 12 for Hepatitis C Virus (HCV) Genotype 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Daclatasvir, 60 mg, 12-Week Cohort', 'description': 'Participants received daclatasvir tablets 60 mg orally, once daily, with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks.'}, {'id': 'OG001', 'title': 'Dacalatasvir, 60 mg, 16-Week Cohort', 'description': 'Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received placebo matching with daclatasvir tablets orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '80.8', 'groupId': 'OG000', 'lowerLimit': '70.9', 'upperLimit': '90.7'}, {'value': '88.9', 'groupId': 'OG001', 'lowerLimit': '81.1', 'upperLimit': '96.6'}, {'value': '59.3', 'groupId': 'OG002', 'lowerLimit': '47.1', 'upperLimit': '71.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'cEVR was defined as undetectable HCV RNA (HCV RNA \\<lower limit of quantitation \\[LLOQ\\], target not detected \\[TND\\]) at Week 12. The LLOQ was 25 IU/mL, and \\<LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '80% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants with HCV genotype 3.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Sustained Virologic Response at Follow-up Week 12 (SVR12) for Hepatitis C Virus (HCV) Genotype 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Daclatasvir, 60 mg, 12-Week Cohort', 'description': 'Participants received daclatasvir tablets 60 mg orally, once daily, with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks.'}, {'id': 'OG001', 'title': 'Daclatasvir, 60 mg, 16-Week Cohort', 'description': 'Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received placebo matching with daclatasvir tablets orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '87.5', 'groupId': 'OG000', 'lowerLimit': '78.8', 'upperLimit': '96.2'}, {'value': '82.6', 'groupId': 'OG001', 'lowerLimit': '72.5', 'upperLimit': '92.7'}, {'value': '70.8', 'groupId': 'OG002', 'lowerLimit': '58.9', 'upperLimit': '82.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Follow-up Week 12', 'description': 'SVR12 was defined as undetectable HCV RNA (HCV RNA \\<lower limit of quantitation \\[LLOQ\\], target not detected \\[TND\\]) at follow-up Week 12. The LLOQ was 25 IU/mL, and \\<LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '80% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants with HCV genotype 2.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Sustained Virologic Response at Follow-up Week 12 (SVR12) for Hepatitis C Virus (HCV) Genotype 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Daclatasvir, 60 mg, 12-Week Cohort', 'description': 'Participants received daclatasvir tablets 60 mg orally, once daily, with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks.'}, {'id': 'OG001', 'title': 'Daclatasvir, 60 mg, 16-Week Cohort', 'description': 'Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received placebo matching with daclatasvir tablets orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '69.2', 'groupId': 'OG000', 'lowerLimit': '57.6', 'upperLimit': '80.8'}, {'value': '77.8', 'groupId': 'OG001', 'lowerLimit': '67.5', 'upperLimit': '88.0'}, {'value': '51.9', 'groupId': 'OG002', 'lowerLimit': '39.5', 'upperLimit': '64.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Follow-up Week 12', 'description': 'SVR12 was defined as undetectable HCV RNA (HCV RNA \\<lower limit of quantitation \\[LLOQ\\], target not detected \\[TND\\]) at follow-up Week 12. The LLOQ was 25 IU/mL, and \\<LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '80% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants with HCV genotype 3.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Virologic Failure for Hepatitis C Virus (HCV) Genotype 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Daclatasvir, 60 mg, 12-Week Cohort', 'description': 'Participants received daclatasvir tablets 60 mg orally, once daily, with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks.'}, {'id': 'OG001', 'title': 'Daclatasvir, 60 mg, 16-Week Cohort', 'description': 'Participants received daclatasvir tablets 60 mg orally, once daily, along with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received placebo matching with daclatasvir tablets orally, once daily, along with pegIFNα-2a solution for injection 180 mcg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks.'}], 'classes': [{'title': 'Virologic breakthrough (n=24,23,24)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': '<1 log10 decrease in HCV RNA at Week4 (n=24,23,24)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'HCV RNA ≥LLOQ or <LLOQ, TD at EOT (n=24,23,24)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Relapse (n=23,21,22)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Week 48', 'description': 'Virologic failure was defined as:\n\n1. Virologic breakthrough: confirmed \\>1 log10 increase in HCV RNA over nadir or confirmed RNA ≥lower limit of quantitation (LLOQ) after confirmed HCV RNA \\<LLOQ, target not detected (TND) while on treatment\n2. \\<1 log10 decrease in HCV RNA from baseline at Week 4 of treatment\n3. Failure to achieve early virologic response: \\<2 log10 decrease in HCV RNA from baseline and HCV RNA ≥LLOQ at Week 12 of treatment\n4. HCV RNA ≥LLOQ or \\<LLOQ, target detected (TD) at the end of treatment (EOT) (including early discontinuation)\n5. Relapse, defined as HCV RNA ≥LLOQ or \\<LLOQ, TD during follow-up, after HCV RNA \\<LLOQ, TND at EOT.\n\nThe LLOQ was 25 IU/mL, and \\<LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants with HCV genotype 2. Here, "n" signifies the number of participants evaluable for the respective category.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Virologic Failure for Hepatitis C Virus (HCV) Genotype 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Daclatasvir, 60 mg, 12-Week Cohort', 'description': 'Participants received daclatasvir tablets 60 mg orally, once daily, with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks.'}, {'id': 'OG001', 'title': 'Daclatasvir, 60 mg, 16-Week Cohort', 'description': 'Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received placebo matching with daclatasvir tablets orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks.'}], 'classes': [{'title': 'Virologic breakthrough (n=26,27,27)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': '<1 log10 decrease in HCV RNA at Week4 (n=26,27,27)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'HCV RNA ≥LLOQ or <LLOQ, TD at EOT (n=26,27,27)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Relapse (n=25,24,21)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Week 48', 'description': 'Virologic failure was defined as:\n\n1. Virologic breakthrough: confirmed \\>1 log10 increase in HCV RNA over nadir or confirmed RNA ≥lower limit of quantitation (LLOQ) after confirmed HCV RNA \\<LLOQ, target not detected (TND) while on treatment\n2. \\<1 log10 decrease in HCV RNA from baseline at Week 4 of treatment\n3. Failure to achieve early virologic response: \\<2 log10 decrease in HCV RNA from baseline and HCV RNA ≥LLOQ at Week 12 of treatment\n4. HCV RNA ≥LLOQ or \\<LLOQ, target detected (TD) at the end of treatment (EOT) (including early discontinuation)\n5. Relapse, defined as HCV RNA ≥LLOQ or \\<LLOQ, TD during follow-up, after HCV RNA \\<LLOQ, TND at EOT.\n\nThe LLOQ was 25 IU/mL, and \\<LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants with HCV genotype 3. Here, "n" signifies the number of participants evaluable for the respective category.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Achieving Sustained Virologic Response at Follow-up Week 24 (SVR24) for Hepatitis C Virus (HCV) Genotype 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Daclatasvir, 60 mg, 12-Week Cohort', 'description': 'Participants received daclatasvir tablets 60 mg orally, once daily, along with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks.'}, {'id': 'OG001', 'title': 'Daclatasvir, 60 mg, 16-Week Cohort', 'description': 'Participants received daclatasvir tablets 60 mg orally, once daily, along with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received placebo matching with daclatasvir tablets orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '69.2', 'groupId': 'OG000', 'lowerLimit': '57.6', 'upperLimit': '80.8'}, {'value': '66.7', 'groupId': 'OG001', 'lowerLimit': '55.0', 'upperLimit': '78.3'}, {'value': '59.3', 'groupId': 'OG002', 'lowerLimit': '47.1', 'upperLimit': '71.4'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '10.0', 'ciLowerLimit': '-6.8', 'ciUpperLimit': '26.7', 'estimateComment': 'The difference in the percentage of participants with antiviral response between daclatasvir and placebo was presented with a difference estimate (daclatasvir - placebo) and 80% confidence Interval.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '7.4', 'ciLowerLimit': '-9.4', 'ciUpperLimit': '24.2', 'estimateComment': 'The difference in the percentage of participants with antiviral response between daclatasvir and placebo was presented with a difference estimate (daclatasvir - placebo) and 80% confidence Interval.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Follow-up Week 24', 'description': 'SVR24 was defined as undetectable HCV RNA (HCV RNA \\<lower limit of quantitation \\[LLOQ\\], target not detected \\[TND\\]) at follow-up Week 24. The LLOQ was 25 IU/mL, and \\<LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '80% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants with HCV genotype 3.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Treatment-related AEs and Who Died During Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Daclatasvir, 60 mg, 12-Week Cohort', 'description': 'Participants received daclatasvir tablets 60 mg orally, once daily, along with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks.'}, {'id': 'OG001', 'title': 'Daclatasvir, 60 mg, 16-Week Cohort', 'description': 'Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received placebo matching with daclatasvir tablets orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks.'}], 'classes': [{'title': 'AEs', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Discontinuations due to AEs', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Grade 2-4 Treatment-related AEs', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}]}, {'title': 'Deaths', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Day 1) up to 24 weeks (treatment period)', 'description': 'AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not has a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. Treatment-related AE was defined as an AE that had certain, probable, possible, or unknown relationship to study drug. Mild (Grade 1): awareness of event but easily tolerated; Moderate (Grade 2): discomfort enough to cause some interference with usual activity; Severe (Grade 3): inability to carry out usual activity; Very severe (Grade 4): debilitating, significantly incapacitates participant despite symptomatic therapy. Only Grade 2-4 treatment-related AEs were reported.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Who Died During Follow-up Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Daclatasvir, 60 mg, 12-Week Cohort: Follow-up', 'description': 'Participants received daclatasvir tablets 60 mg orally, once daily, along with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks during treatment period and entered into the follow-up period.'}, {'id': 'OG001', 'title': 'Daclatasvir, 60 mg, 16-Week Cohort: Follow-up', 'description': 'Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks during treatment period and entered into the follow-up period.'}, {'id': 'OG002', 'title': 'Placebo: Follow-up', 'description': 'Participants received placebo matching with daclatasvir tablets orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks during treatment period and entered into the follow-up period.'}], 'classes': [{'title': 'AEs', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Deaths', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From end of treatment period up to Week 48 (follow-up period)', 'description': 'AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not has a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All follow-up participants.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Daclatasvir, 60 mg, 12-Week Cohort', 'description': 'Participants received daclatasvir tablets 60 mg orally, once daily, with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, for up to 12 weeks.'}, {'id': 'FG001', 'title': 'Daclatasvir, 60 mg, 16-Week Cohort', 'description': 'Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, for up to 16 weeks.'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Participants received placebo matched with daclatasvir tablets orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, for up to 24 weeks.'}], 'periods': [{'title': 'Treatment Period (up to Week 24)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '50'}, {'groupId': 'FG002', 'numSubjects': '51'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}, {'groupId': 'FG001', 'numSubjects': '44'}, {'groupId': 'FG002', 'numSubjects': '42'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Poor compliance/noncompliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': "Participant's request to discontinue", 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}, {'title': 'Follow-up Period (up to Week 48)', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Those who completed period 1 or with detectable hepatitis C virus RNA, despite length of treatment.', 'groupId': 'FG000', 'numSubjects': '49'}, {'comment': 'Those who completed period 1 or with detectable hepatitis C virus RNA, despite length of treatment.', 'groupId': 'FG001', 'numSubjects': '47'}, {'comment': 'Those who completed period 1 or with detectable hepatitis C virus RNA, despite length of treatment.', 'groupId': 'FG002', 'numSubjects': '49'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '48'}, {'groupId': 'FG001', 'numSubjects': '41'}, {'groupId': 'FG002', 'numSubjects': '39'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '10'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '5'}]}]}], 'preAssignmentDetails': 'A total of 196 participants were enrolled, of which 152 participants were randomized; remaining 44 participants did not meet study criteria. Of randomized participants:151 were treated; 1 participant withdrew consent.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '151', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Dacalatasvir, 60 mg, 12-Week Cohort', 'description': 'Participants received daclatasvir tablets 60 mg orally, once daily, with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks.'}, {'id': 'BG001', 'title': 'Daclatasvir, 60 mg, 16-Week Cohort', 'description': 'Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks.'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Participants received placebo matching with daclatasvir tablets orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '47.5', 'spread': '8.42', 'groupId': 'BG000'}, {'value': '47.5', 'spread': '9.20', 'groupId': 'BG001'}, {'value': '48.8', 'spread': '9.73', 'groupId': 'BG002'}, {'value': '47.9', 'spread': '9.09', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '55', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '96', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Hepatitis C Virus (HCV) RNA (IU/mL)', 'classes': [{'categories': [{'measurements': [{'value': '6.4', 'spread': '0.82', 'groupId': 'BG000'}, {'value': '6.6', 'spread': '0.62', 'groupId': 'BG001'}, {'value': '6.6', 'spread': '0.59', 'groupId': 'BG002'}, {'value': '6.5', 'spread': '0.69', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Log10 IU/mL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'HCV RNA Distribution', 'classes': [{'title': '<800,000 IU/mL', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}]}]}, {'title': '≥800,000 IU/mL', 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}, {'value': '126', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Randomization Stratum', 'classes': [{'title': 'HCV Genotype 2', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '71', 'groupId': 'BG003'}]}]}, {'title': 'HCV Genotype 3', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '80', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Cirrhosis Status', 'classes': [{'title': 'Absent', 'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '127', 'groupId': 'BG003'}]}]}, {'title': 'Present', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}]}]}, {'title': 'Not Reported', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'All participants who received at least 1 dose of study drug.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 196}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-10', 'studyFirstSubmitDate': '2010-12-01', 'resultsFirstSubmitDate': '2015-08-05', 'studyFirstSubmitQcDate': '2010-12-08', 'lastUpdatePostDateStruct': {'date': '2015-12-14', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-11-10', 'studyFirstPostDateStruct': {'date': '2010-12-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-12-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Achieving Sustained Virologic Response at Follow-up Week 24 (SVR24) for Hepatitis C Virus (HCV) Genotype 2', 'timeFrame': 'Follow-up Week 24', 'description': 'SVR24 was defined as undetectable HCV RNA (HCV RNA \\<lower limit of quantitation \\[LLOQ\\], target not detected \\[TND\\]) at follow-up Week 24. The LLOQ was 25 IU/mL, and \\<LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.'}, {'measure': 'Percentage of Participants Achieving Sustained Virologic Response at Follow-up Week 24 (SVR24) for Hepatitis C Virus (HCV) Genotype 3', 'timeFrame': 'Follow-up Week 24', 'description': 'SVR24 was defined as undetectable HCV RNA (HCV RNA \\<lower limit of quantitation \\[LLOQ\\], target not detected \\[TND\\]) at follow-up Week 24. The LLOQ was 25 IU/mL, and \\<LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Achieving Rapid Virologic Response (RVR) at Week 4 for Hepatitis C Virus (HCV) Genotype 2', 'timeFrame': 'Week 4', 'description': 'RVR was defined as undetectable HCV RNA (HCV RNA \\<lower limit of quantitation \\[LLOQ\\], target not detected \\[TND\\]) at Week 4. The LLOQ was 25 IU/mL, and \\<LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.'}, {'measure': 'Percentage of Participants Achieving Rapid Virologic Response (RVR) at Week 4 for Hepatitis C Virus (HCV) Genotype 3', 'timeFrame': 'Week 4', 'description': 'RVR was defined as undetectable HCV RNA (HCV RNA \\<lower limit of quantitation \\[LLOQ\\], target not detected \\[TND\\]) at Week 4. The LLOQ was 25 IU/mL, and \\<LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.'}, {'measure': 'Percentage of Participants Achieving Complete Early Virologic Response (cEVR) at Week 12 for Hepatitis C Virus (HCV) Genotype 2', 'timeFrame': 'Week 12', 'description': 'cEVR was defined as undetectable HCV RNA (HCV RNA \\<lower limit of quantitation \\[LLOQ\\], target not detected \\[TND\\]) at Week 12. The LLOQ was 25 IU/mL, and \\<LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.'}, {'measure': 'Percentage of Participants Achieving Complete Early Virologic Response (cEVR) at Week 12 for Hepatitis C Virus (HCV) Genotype 3', 'timeFrame': 'Week 12', 'description': 'cEVR was defined as undetectable HCV RNA (HCV RNA \\<lower limit of quantitation \\[LLOQ\\], target not detected \\[TND\\]) at Week 12. The LLOQ was 25 IU/mL, and \\<LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.'}, {'measure': 'Percentage of Participants Achieving Sustained Virologic Response at Follow-up Week 12 (SVR12) for Hepatitis C Virus (HCV) Genotype 2', 'timeFrame': 'Follow-up Week 12', 'description': 'SVR12 was defined as undetectable HCV RNA (HCV RNA \\<lower limit of quantitation \\[LLOQ\\], target not detected \\[TND\\]) at follow-up Week 12. The LLOQ was 25 IU/mL, and \\<LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.'}, {'measure': 'Percentage of Participants Achieving Sustained Virologic Response at Follow-up Week 12 (SVR12) for Hepatitis C Virus (HCV) Genotype 3', 'timeFrame': 'Follow-up Week 12', 'description': 'SVR12 was defined as undetectable HCV RNA (HCV RNA \\<lower limit of quantitation \\[LLOQ\\], target not detected \\[TND\\]) at follow-up Week 12. The LLOQ was 25 IU/mL, and \\<LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.'}, {'measure': 'Number of Participants With Virologic Failure for Hepatitis C Virus (HCV) Genotype 2', 'timeFrame': 'Baseline up to Week 48', 'description': 'Virologic failure was defined as:\n\n1. Virologic breakthrough: confirmed \\>1 log10 increase in HCV RNA over nadir or confirmed RNA ≥lower limit of quantitation (LLOQ) after confirmed HCV RNA \\<LLOQ, target not detected (TND) while on treatment\n2. \\<1 log10 decrease in HCV RNA from baseline at Week 4 of treatment\n3. Failure to achieve early virologic response: \\<2 log10 decrease in HCV RNA from baseline and HCV RNA ≥LLOQ at Week 12 of treatment\n4. HCV RNA ≥LLOQ or \\<LLOQ, target detected (TD) at the end of treatment (EOT) (including early discontinuation)\n5. Relapse, defined as HCV RNA ≥LLOQ or \\<LLOQ, TD during follow-up, after HCV RNA \\<LLOQ, TND at EOT.\n\nThe LLOQ was 25 IU/mL, and \\<LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.'}, {'measure': 'Number of Participants With Virologic Failure for Hepatitis C Virus (HCV) Genotype 3', 'timeFrame': 'Baseline up to Week 48', 'description': 'Virologic failure was defined as:\n\n1. Virologic breakthrough: confirmed \\>1 log10 increase in HCV RNA over nadir or confirmed RNA ≥lower limit of quantitation (LLOQ) after confirmed HCV RNA \\<LLOQ, target not detected (TND) while on treatment\n2. \\<1 log10 decrease in HCV RNA from baseline at Week 4 of treatment\n3. Failure to achieve early virologic response: \\<2 log10 decrease in HCV RNA from baseline and HCV RNA ≥LLOQ at Week 12 of treatment\n4. HCV RNA ≥LLOQ or \\<LLOQ, target detected (TD) at the end of treatment (EOT) (including early discontinuation)\n5. Relapse, defined as HCV RNA ≥LLOQ or \\<LLOQ, TD during follow-up, after HCV RNA \\<LLOQ, TND at EOT.\n\nThe LLOQ was 25 IU/mL, and \\<LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.'}, {'measure': 'Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Treatment-related AEs and Who Died During Treatment Period', 'timeFrame': 'Baseline (Day 1) up to 24 weeks (treatment period)', 'description': 'AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not has a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. Treatment-related AE was defined as an AE that had certain, probable, possible, or unknown relationship to study drug. Mild (Grade 1): awareness of event but easily tolerated; Moderate (Grade 2): discomfort enough to cause some interference with usual activity; Severe (Grade 3): inability to carry out usual activity; Very severe (Grade 4): debilitating, significantly incapacitates participant despite symptomatic therapy. Only Grade 2-4 treatment-related AEs were reported.'}, {'measure': 'Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Who Died During Follow-up Period', 'timeFrame': 'From end of treatment period up to Week 48 (follow-up period)', 'description': 'AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not has a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hepatitis C Virus']}, 'referencesModule': {'references': [{'pmid': '25311593', 'type': 'DERIVED', 'citation': 'Dore GJ, Lawitz E, Hezode C, Shafran SD, Ramji A, Tatum HA, Taliani G, Tran A, Brunetto MR, Zaltron S, Strasser SI, Weis N, Ghesquiere W, Lee SS, Larrey D, Pol S, Harley H, George J, Fung SK, de Ledinghen V, Hagens P, McPhee F, Hernandez D, Cohen D, Cooney E, Noviello S, Hughes EA. Daclatasvir plus peginterferon and ribavirin is noninferior to peginterferon and ribavirin alone, and reduces the duration of treatment for HCV genotype 2 or 3 infection. Gastroenterology. 2015 Feb;148(2):355-366.e1. doi: 10.1053/j.gastro.2014.10.007. Epub 2014 Oct 13.'}], 'seeAlsoLinks': [{'url': 'http://www.bms.com/studyconnect/Pages/home.aspx', 'label': 'BMS clinical trial educational resource'}, {'url': 'http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx', 'label': 'Investigator Inquiry form'}]}, 'descriptionModule': {'briefSummary': 'To identify a shorter duration of antiviral therapy (12 or 16 weeks) for the combination of daclatasvir with pegylated interferon alfa-2a and ribavirin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Participants chronically infected with hepatitis C virus (HCV) genotype 2 or 3\n* No previous exposure to an interferon formulation (ie, interferon alfa, pegylated interferon alfa-2a ) or ribavirin\n* Body mass index (BMI) of 18 to 35 kg/m\\^2, inclusive. BMI=weight (kg)/height (m)\\^2\n* Males and females, 18 - 70 years of age\n\nKey Exclusion Criteria:\n\n* Liver transplant recipients\n* Documented or suspected hepatocellular carcinoma\n* Evidence of decompensated cirrhosis\n* History of chronic hepatitis B virus (HBV). Patients with resolved HBV infection may participate\n* Current or known history of cancer\n* Any gastrointestinal disease or surgical procedure that may impact the absorption of study drug\n* Inability to tolerate oral medication\n* Poor venous access\n* Severe psychiatric disease\n* History of chronic pulmonary disease\n* History of cardiomyopathy, coronary artery disease (including angina), interventive procedure for coronary artery disease (including angioplasty, stent procedure, or cardiac bypass surgery), ventricular arrhythmia,, or other clinically significant cardiac disease\n* History of or current electrocardiogram findings indicative of cardiovascular instability\n* Preexisting ophthalmologic disorders considered clinically significant on eye\n* History of uncontrolled diabetes mellitus\n* Any known contraindication to pegylated interferon alfa-2a or ribavirin not otherwise specified.\n* Positive hepatitis B virus surface antigen, HIV-1 or HIV-2 Ab\n* Prior exposure to any HCV direct antiviral agent (eg, HCV protease, polymerase, previous nonstructural protein 5A inhibitors)\n* Exposure to any investigational drug or placebo'}, 'identificationModule': {'nctId': 'NCT01257204', 'briefTitle': 'Study in Genotype 2 or 3 Patients With Chronic Hepatitis Virus Infection', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Phase 2B Pilot Study of Short-Term Treatment of BMS-790052 in Combination With Peg-Interferon Alfa-2a and Ribavirin in Treatment Naive Subjects With Chronic Hepatitis C Genotype 2 or 3 Infection', 'orgStudyIdInfo': {'id': 'AI444-031'}, 'secondaryIdInfos': [{'id': '2010-022408-28', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Placebo + Pegylated interferon alfa-2a + Ribavirin', 'interventionNames': ['Drug: Placebo', 'Drug: Pegylated interferon alfa-2a', 'Drug: Ribavirin']}, {'type': 'EXPERIMENTAL', 'label': '12 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