Ignite Creation Date:
2025-12-24 @ 3:19 PM
Ignite Modification Date:
2025-12-26 @ 3:22 AM
Study NCT ID:
NCT01628692
Status:
COMPLETED
Last Update Posted:
2017-02-23
First Post:
2012-06-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Daclatasvir (BMS-790052) and Simeprevir (TMC435) in Patients With Genotype 1 Chronic Hepatitis C Virus
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': 'D000069616', 'term': 'Simeprevir'}, {'id': 'D012254', 'term': 'Ribavirin'}], 'ancestors': [{'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'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': 'From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)', 'description': 'On-Treatment Period', 'eventGroups': [{'id': 'EG000', 'title': 'Genotype 1b: Daclatasvir + Simeprevir (Naive + Null)', 'description': 'Participants with and without prior treatment of hepatitis C virus genotype 1b and who never attained ≥2 log10 decline in hepatitis C virus RNA levels after at least 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal once daily (QD), for a period of 12 weeks or 24 weeks based on re-randomization and continued into a post-treatment follow-up period.', 'otherNumAtRisk': 76, 'otherNumAffected': 49, 'seriousNumAtRisk': 76, 'seriousNumAffected': 7}, {'id': 'EG001', 'title': 'Genotype1b: Daclatasvir +Simeprevir + Ribavirin (Naive + Null)', 'description': 'Participants with and without prior treatment of hepatitis C virus genotype 1b and who never attained ≥2 log10 decline in hepatitis C virus RNA levels after at least 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing \\<75/\\>= 75 kg, respectively) ribavirin twice daily (BID) for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.', 'otherNumAtRisk': 71, 'otherNumAffected': 63, 'seriousNumAtRisk': 71, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'Genotype1a: Daclatasvir +Simeprevir + Ribavirin (Naive + Null)', 'description': 'Participants with and without prior treatment of hepatitis C virus genotype 1a and who never attained ≥2 log10 decline in hepatitis C virus RNA levels after at least 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing \\<75/\\>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.', 'otherNumAtRisk': 21, 'otherNumAffected': 21, 'seriousNumAtRisk': 21, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Sleep disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Depressed mood', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Hyperbilirubinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 3}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Gastric disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Disturbance in attention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Jaundice', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Photosensitivity reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Visual acuity reduced', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}], 'seriousEvents': [{'term': 'Intracranial haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Thrombophlebitis superficial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Liver disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Neurotoxicity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Hepatic cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Post lumbar puncture syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Percentage of Participants With Rapid Virologic Response (RVR) at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Genotype 1b: Daclatasvir + Simeprevir (Naive)', 'description': 'Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal once daily (QD), for a period of 12 weeks or 24 weeks based on re-randomization and continued into a post-treatment follow-up period.'}, {'id': 'OG001', 'title': 'Genotype 1b: Daclatasvir + Simeprevir (Null)', 'description': 'Participants with hepatitis C virus genotype 1b, and who never attained ≥2 log10 decline in hepatitis C virus RNA levels after at least 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal QD, for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.'}, {'id': 'OG002', 'title': 'Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Naive)', 'description': 'Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing \\<75/\\>= 75 kg, respectively) ribavirin twice daily (BID) for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.'}, {'id': 'OG003', 'title': 'Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Null)', 'description': 'Participants with hepatitis C virus genotype 1b, who never attained ≥2 log10 decline in hepatitis C virus RNA level after 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing \\<75/\\>=75 kg, respectively) ribavirin BID were continued to receive treatment for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up period.'}, {'id': 'OG004', 'title': 'Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Naive)', 'description': 'Participants with no prior treatment of hepatitis C virus genotype 1a. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing \\<75/\\>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.'}, {'id': 'OG005', 'title': 'Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Null)', 'description': 'Participants with hepatitis C virus genotype 1a, who never attained ≥2 log10 decline in hepatitis C virus genotype RNA level after 12 weeks of prior therapy. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing \\<75/\\>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '79.2', 'groupId': 'OG000', 'lowerLimit': '72.1', 'upperLimit': '86.4'}, {'value': '69.6', 'groupId': 'OG001', 'lowerLimit': '57.3', 'upperLimit': '81.9'}, {'value': '68.6', 'groupId': 'OG002', 'lowerLimit': '60.3', 'upperLimit': '77.0'}, {'value': '85', 'groupId': 'OG003', 'lowerLimit': '74.8', 'upperLimit': '95.2'}, {'value': '75', 'groupId': 'OG004', 'lowerLimit': '59.0', 'upperLimit': '91.0'}, {'value': '33.3', 'groupId': 'OG005', 'lowerLimit': '13.2', 'upperLimit': '53.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 4', 'description': 'RVR was defined as hepatitis C virus (HCV) RNA levels to be \\<lower limit of quantitation, target not detected at Week 4. 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.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Complete Early Virologic Response (cEVR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Genotype 1b: Daclatasvir + Simeprevir (Naive)', 'description': 'Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal once daily (QD), for a period of 12 weeks or 24 weeks based on re-randomization and continued into a post-treatment follow-up period.'}, {'id': 'OG001', 'title': 'Genotype 1b: Daclatasvir + Simeprevir (Null)', 'description': 'Participants with hepatitis C virus genotype 1b, and who never attained ≥2 log10 decline in hepatitis C virus RNA levels after at least 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal QD, for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.'}, {'id': 'OG002', 'title': 'Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Naive)', 'description': 'Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing \\<75/\\>= 75 kg, respectively) ribavirin twice daily (BID) for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.'}, {'id': 'OG003', 'title': 'Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Null)', 'description': 'Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing \\<75/\\>= 75 kg, respectively) ribavirin twice daily (BID) for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.'}, {'id': 'OG004', 'title': 'Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Naive)', 'description': 'Participants with no prior treatment of hepatitis C virus genotype 1a. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing \\<75/\\>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.'}, {'id': 'OG005', 'title': 'Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Null)', 'description': 'Participants with hepatitis C virus genotype 1a, who never attained ≥2 log10 decline in hepatitis C virus genotype RNA level after 12 weeks of prior therapy. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing \\<75/\\>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '84.9', 'groupId': 'OG000', 'lowerLimit': '78.6', 'upperLimit': '91.2'}, {'value': '73.9', 'groupId': 'OG001', 'lowerLimit': '62.2', 'upperLimit': '85.6'}, {'value': '82.4', 'groupId': 'OG002', 'lowerLimit': '75.5', 'upperLimit': '89.2'}, {'value': '90', 'groupId': 'OG003', 'lowerLimit': '81.4', 'upperLimit': '98.6'}, {'value': '66.7', 'groupId': 'OG004', 'lowerLimit': '49.2', 'upperLimit': '84.1'}, {'value': '11.1', 'groupId': 'OG005', 'lowerLimit': '0', 'upperLimit': '24.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'cEVR was defined as hepatitis C virus (HCV) RNA levels to be \\<lower limit of quantitation, target not detected at Week 12. 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.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Sustained Virologic Response Rate at Post-treatment Week 12 (SVR12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Genotype 1b: Daclatasvir + Simeprevir (Naive)', 'description': 'Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal once daily (QD), for a period of 12 weeks or 24 weeks based on re-randomization and continued into a post-treatment follow-up period.'}, {'id': 'OG001', 'title': 'Genotype 1b: Daclatasvir + Simeprevir (Null)', 'description': 'Participants with hepatitis C virus genotype 1b, and who never attained ≥2 log10 decline in hepatitis C virus RNA levels after at least 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal QD, for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up'}, {'id': 'OG002', 'title': 'Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Naive)', 'description': 'Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing \\<75/\\>= 75 kg, respectively) ribavirin twice daily (BID) for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.'}, {'id': 'OG003', 'title': 'Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Null)', 'description': 'Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing \\<75/\\>= 75 kg, respectively) ribavirin twice daily (BID) for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.'}, {'id': 'OG004', 'title': 'Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Naive)', 'description': 'Participants with no prior treatment of hepatitis C virus genotype 1a. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing \\<75/\\>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.'}, {'id': 'OG005', 'title': 'Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Null)', 'description': 'Participants with hepatitis C virus genotype 1a, who never attained ≥2 log10 decline in hepatitis C virus genotype RNA level after 12 weeks of prior therapy. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing \\<75/\\>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '84.9', 'groupId': 'OG000', 'lowerLimit': '78.6', 'upperLimit': '91.2'}, {'value': '69.6', 'groupId': 'OG001', 'lowerLimit': '57.3', 'upperLimit': '81.9'}, {'value': '74.5', 'groupId': 'OG002', 'lowerLimit': '66.7', 'upperLimit': '82.3'}, {'value': '95', 'groupId': 'OG003', 'lowerLimit': '88.8', 'upperLimit': '100'}, {'value': '66.7', 'groupId': 'OG004', 'lowerLimit': '49.2', 'upperLimit': '84.1'}, {'value': '0', 'comment': 'As none of the participants responded to SVR12, 80% confidence interval value is not available.', 'groupId': 'OG005', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Post Treatment Week 12 (Follow-up period)', 'description': 'SVR12 rate was defined as hepatitis C virus (HCV) RNA levels to be \\<lower limit of quantitation, target detected or target not detected, at post-treatment Week 12. 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 participants who were randomized and received at least 1 dose of active study therapy (daclatasvir, simeprevir, ribavirin).'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Extended Rapid Virologic Response (eRVR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Genotype 1b: Daclatasvir + Simeprevir (Naive)', 'description': 'Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal once daily (QD), for a period of 12 weeks or 24 weeks based on re-randomization and continued into a post-treatment follow-up period.'}, {'id': 'OG001', 'title': 'Genotype 1b: Daclatasvir + Simeprevir (Null)', 'description': 'Participants with hepatitis C virus genotype 1b, and who never attained ≥2 log10 decline in hepatitis C virus RNA levels after at least 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal QD, for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.'}, {'id': 'OG002', 'title': 'Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Naive)', 'description': 'Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing \\<75/\\>= 75 kg, respectively) ribavirin twice daily (BID) for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.'}, {'id': 'OG003', 'title': 'Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Null)', 'description': 'Participants with hepatitis C virus genotype 1b, who never attained ≥2 log10 decline in hepatitis C virus RNA level after 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing \\<75/\\>=75 kg, respectively) ribavirin BID were continued to receive treatment for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up period.'}, {'id': 'OG004', 'title': 'Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Naive)', 'description': 'Participants with no prior treatment of hepatitis C virus genotype 1a. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing \\<75/\\>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.'}, {'id': 'OG005', 'title': 'Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Null)', 'description': 'Participants with hepatitis C virus genotype 1a, who never attained ≥2 log10 decline in hepatitis C virus genotype RNA level after 12 weeks of prior therapy. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing \\<75/\\>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '71.7', 'groupId': 'OG000', 'lowerLimit': '63.8', 'upperLimit': '79.6'}, {'value': '60.9', 'groupId': 'OG001', 'lowerLimit': '47.8', 'upperLimit': '73.9'}, {'value': '62.7', 'groupId': 'OG002', 'lowerLimit': '54.1', 'upperLimit': '71.4'}, {'value': '75', 'groupId': 'OG003', 'lowerLimit': '62.6', 'upperLimit': '87.4'}, {'value': '58.3', 'groupId': 'OG004', 'lowerLimit': '40.1', 'upperLimit': '76.6'}, {'value': '11.1', 'groupId': 'OG005', 'lowerLimit': '0', 'upperLimit': '24.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 4 and Week 12', 'description': 'eRVR were defined as hepatitis C virus (HCV) RNA levels to be \\<lower limit of quantitation, target not detected at both Week 4 and Week 12. 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.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With End of Treatment Response (EOTR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Genotype 1b: Daclatasvir + Simeprevir (Naive)', 'description': 'Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal once daily (QD), for a period of 12 weeks or 24 weeks based on re-randomization and continued into a post-treatment follow-up period.'}, {'id': 'OG001', 'title': 'Genotype 1b: Daclatasvir + Simeprevir (Null)', 'description': 'Participants with hepatitis C virus genotype 1b, and who never attained ≥2 log10 decline in hepatitis C virus RNA levels after at least 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal QD, for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.'}, {'id': 'OG002', 'title': 'Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Naive)', 'description': 'Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing \\<75/\\>= 75 kg, respectively) ribavirin twice daily (BID) for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.'}, {'id': 'OG003', 'title': 'Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Null)', 'description': 'Participants with hepatitis C virus genotype 1b, who never attained ≥2 log10 decline in hepatitis C virus RNA level after 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing \\<75/\\>=75 kg, respectively) ribavirin BID were continued to receive treatment for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up period.'}, {'id': 'OG004', 'title': 'Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Naive)', 'description': 'Participants with no prior treatment of hepatitis C virus genotype 1a. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing \\<75/\\>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.'}, {'id': 'OG005', 'title': 'Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Null)', 'description': 'Participants with hepatitis C virus genotype 1a, who never attained ≥2 log10 decline in hepatitis C virus genotype RNA level after 12 weeks of prior therapy. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing \\<75/\\>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '88.7', 'groupId': 'OG000', 'lowerLimit': '83.1', 'upperLimit': '94.3'}, {'value': '78.3', 'groupId': 'OG001', 'lowerLimit': '67.2', 'upperLimit': '89.3'}, {'value': '78.4', 'groupId': 'OG002', 'lowerLimit': '71.1', 'upperLimit': '85.8'}, {'value': '95', 'groupId': 'OG003', 'lowerLimit': '88.8', 'upperLimit': '100'}, {'value': '66.7', 'groupId': 'OG004', 'lowerLimit': '49.2', 'upperLimit': '84.1'}, {'value': '0', 'comment': 'As none of the participants responded at EOT, hence 80% confidence interval value is not available.', 'groupId': 'OG005', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'End of treatment (Week 24)', 'description': 'EOTR were defined as hepatitis C virus (HCV) RNA levels \\<lower limit of quantitation, target not detected at end of treatment. 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.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Sustained Virologic Response at Week 12 (SVR12) by rs12979860 Single Nucleotide Polymorphisms in the IL-28B Gene Categories', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Genotype 1b: Daclatasvir + Simeprevir (Naive)', 'description': 'Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal once daily (QD), for a period of 12 weeks or 24 weeks based on re-randomization and continued into a post-treatment follow-up period.'}, {'id': 'OG001', 'title': 'Genotype 1b: Daclatasvir + Simeprevir (Null)', 'description': 'Participants with hepatitis C virus genotype 1b, and who never attained ≥2 log10 decline in hepatitis C virus RNA levels after at least 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal QD, for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.'}, {'id': 'OG002', 'title': 'Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Naive)', 'description': 'Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing \\<75/\\>= 75 kg, respectively) ribavirin twice daily (BID) for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.'}, {'id': 'OG003', 'title': 'Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Null)', 'description': 'Participants with hepatitis C virus genotype 1b, who never attained ≥2 log10 decline in hepatitis C virus RNA level after 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing \\<75/\\>=75 kg, respectively) ribavirin BID were continued to receive treatment for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up period.'}, {'id': 'OG004', 'title': 'Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Naive)', 'description': 'Participants with no prior treatment of hepatitis C virus genotype 1a. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing \\<75/\\>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.'}, {'id': 'OG005', 'title': 'Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Null)', 'description': 'Participants with hepatitis C virus genotype 1a, who never attained ≥2 log10 decline in hepatitis C virus genotype RNA level after 12 weeks of prior therapy. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing \\<75/\\>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.'}], 'classes': [{'title': 'IL28B Genotype CC type (n= 16,1,13,1,3,0)', 'categories': [{'measurements': [{'value': '87.5', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '84.6', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}, {'value': '66.7', 'groupId': 'OG004'}, {'value': 'NA', 'comment': 'As no participant was evaluable for assessment, hence value is not available.', 'groupId': 'OG005'}]}]}, {'title': 'IL28B Genotype CT type (n= 22,15, 28,10,9,8)', 'categories': [{'measurements': [{'value': '95.5', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '82.1', 'groupId': 'OG002'}, {'value': '90', 'groupId': 'OG003'}, {'value': '66.7', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'IL28B Genotype TT type (n= 12,6,10,7,0,1)', 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}, {'value': '83.3', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}, {'value': 'NA', 'comment': 'No participants were available for assessment', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, post-treatment Week 12 (Follow-up period)', 'description': 'Participants were categorized into 3 genotypes based on single nucleotide polymorphisms in the IL28B gene. SVR12 was defined as hepatitis C virus (HCV) RNA levels below lower limit of quantitation, target detected or target not detected at follow-up Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "All treated participants. Here 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Serious Adverse Events (SAEs) and Discontinuations Due to Adverse Events (AEs) and Who Died', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Genotype 1b: Daclatasvir + Simeprevir (Naive + Null)', 'description': 'Participants with and without prior treatment of hepatitis C virus genotype 1b and who never attained ≥2 log10 decline in hepatitis C virus RNA levels after at least 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal once daily (QD), for a period of 12 weeks or 24 weeks based on re-randomization and continued into a post-treatment follow-up period.'}, {'id': 'OG001', 'title': 'Genotype1b: Daclatasvir +Simeprevir + Ribavirin (Naive + Null)', 'description': 'Participants with and without prior treatment of hepatitis C virus genotype 1b and who never attained ≥2 log10 decline in hepatitis C virus RNA levels after at least 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing \\<75/\\>= 75 kg, respectively) ribavirin twice daily (BID) for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.'}, {'id': 'OG002', 'title': 'Genotype1a: Daclatasvir +Simeprevir + Ribavirin(Naive + Null)', 'description': 'Participants with and without prior treatment of hepatitis C virus genotype 1a and who never attained ≥2 log10 decline in hepatitis C virus RNA levels after at least 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing \\<75/\\>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.'}], 'classes': [{'title': 'SAEs', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'AEs Leading to Discontinuation', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Death', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)', 'description': 'AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have 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. Based on the severity, AEs were categorized as Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Genotype 1b: Daclatasvir + Simeprevir (Naive)', 'description': 'Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal once daily (QD), for a period of 12 weeks or 24 weeks based on re-randomization and continued into a post-treatment follow-up period.'}, {'id': 'FG001', 'title': 'Genotype 1b: Daclatasvir + Simeprevir (Null)', 'description': 'Participants with hepatitis C virus genotype 1b, and who never attained ≥2 log10 decline in hepatitis C virus RNA levels after at least 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal QD, for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.'}, {'id': 'FG002', 'title': 'Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Naive)', 'description': 'Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing \\<75/\\>= 75 kg, respectively) ribavirin twice daily (BID) for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.'}, {'id': 'FG003', 'title': 'Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Null)', 'description': 'Participants with hepatitis C virus genotype 1b, who never attained ≥2 log10 decline in hepatitis C virus RNA level after 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing \\<75/\\>=75 kg, respectively) ribavirin BID were continued to receive treatment for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up period.'}, {'id': 'FG004', 'title': 'Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Naive)', 'description': 'Participants with no prior treatment of hepatitis C virus genotype 1a. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing \\<75/\\>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.'}, {'id': 'FG005', 'title': 'Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Null)', 'description': 'Participants with hepatitis C virus genotype 1a, who never attained ≥2 log10 decline in hepatitis C virus genotype RNA level after 12 weeks of prior therapy. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing \\<75/\\>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}, {'groupId': 'FG001', 'numSubjects': '23'}, {'groupId': 'FG002', 'numSubjects': '51'}, {'groupId': 'FG003', 'numSubjects': '20'}, {'groupId': 'FG004', 'numSubjects': '12'}, {'groupId': 'FG005', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '43'}, {'groupId': 'FG003', 'numSubjects': '19'}, {'groupId': 'FG004', 'numSubjects': '8'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '7'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Poor compliance/noncompliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Administrative reason by sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Completed 12 Week only', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'The study was conducted at 25 centers in 6 countries.', 'preAssignmentDetails': 'Of the 230 participants enrolled, 168 received treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '168', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Genotype 1b: Daclatasvir + Simeprevir (Naive)', 'description': 'Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal once daily (QD), for a period of 12 weeks or 24 weeks based on re-randomization and continued into a post-treatment follow-up period.'}, {'id': 'BG001', 'title': 'Genotype 1b: Daclatasvir + Simeprevir (Null)', 'description': 'Participants with hepatitis C virus genotype 1b, and who never attained ≥2 log10 decline in hepatitis C virus RNA levels after at least 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal QD, for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.'}, {'id': 'BG002', 'title': 'Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Naive)', 'description': 'Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing \\<75/\\>= 75 kg, respectively) ribavirin twice daily (BID) for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.'}, {'id': 'BG003', 'title': 'Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Null)', 'description': 'Participants with hepatitis C virus genotype 1b, who never attained ≥2 log10 decline in hepatitis C virus RNA level after 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing \\<75/\\>=75 kg, respectively) ribavirin BID were continued to receive treatment for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up period.'}, {'id': 'BG004', 'title': 'Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Naive)', 'description': 'Participants with no prior treatment of hepatitis C virus genotype 1a. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing \\<75/\\>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.'}, {'id': 'BG005', 'title': 'Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Null)', 'description': 'Participants with hepatitis C virus genotype 1a, who never attained ≥2 log10 decline in hepatitis C virus genotype RNA level after 12 weeks of prior therapy. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing \\<75/\\>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '<21 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}]}]}, {'title': '21-<65 years', 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '133', 'groupId': 'BG006'}]}]}, {'title': '>=65 years', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '33', 'groupId': 'BG006'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '86', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '7', 'groupId': 'BG005'}, {'value': '82', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Hepatitis C Virus RNA Distribution', 'classes': [{'title': '<800,000 IU/mL', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '35', 'groupId': 'BG006'}]}]}, {'title': '≥800,000 IU/mL', 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '133', 'groupId': 'BG006'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Randomization Stratum', 'classes': [{'title': 'Hepatitis C Virus Genotype 1b', 'categories': [{'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '147', 'groupId': 'BG006'}]}]}, {'title': 'Hepatitis C Virus Genotype 1a', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '21', 'groupId': 'BG006'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'The analysis was performed on the treated participants defined as all randomized participants who received at least 1 dose of active study therapy.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 230}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-10', 'studyFirstSubmitDate': '2012-06-25', 'resultsFirstSubmitDate': '2015-08-13', 'studyFirstSubmitQcDate': '2012-06-26', 'lastUpdatePostDateStruct': {'date': '2017-02-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-10-29', 'studyFirstPostDateStruct': {'date': '2012-06-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-11-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Sustained Virologic Response Rate at Post-treatment Week 12 (SVR12)', 'timeFrame': 'Post Treatment Week 12 (Follow-up period)', 'description': 'SVR12 rate was defined as hepatitis C virus (HCV) RNA levels to be \\<lower limit of quantitation, target detected or target not detected, at post-treatment Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Rapid Virologic Response (RVR) at Week 4', 'timeFrame': 'Week 4', 'description': 'RVR was defined as hepatitis C virus (HCV) RNA levels to be \\<lower limit of quantitation, target not detected at Week 4. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.'}, {'measure': 'Percentage of Participants With Complete Early Virologic Response (cEVR)', 'timeFrame': 'Week 12', 'description': 'cEVR was defined as hepatitis C virus (HCV) RNA levels to be \\<lower limit of quantitation, target not detected at Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.'}, {'measure': 'Percentage of Participants With Extended Rapid Virologic Response (eRVR)', 'timeFrame': 'Week 4 and Week 12', 'description': 'eRVR were defined as hepatitis C virus (HCV) RNA levels to be \\<lower limit of quantitation, target not detected at both Week 4 and Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.'}, {'measure': 'Percentage of Participants With End of Treatment Response (EOTR)', 'timeFrame': 'End of treatment (Week 24)', 'description': 'EOTR were defined as hepatitis C virus (HCV) RNA levels \\<lower limit of quantitation, target not detected at end of treatment. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.'}, {'measure': 'Percentage of Participants With Sustained Virologic Response at Week 12 (SVR12) by rs12979860 Single Nucleotide Polymorphisms in the IL-28B Gene Categories', 'timeFrame': 'Baseline, post-treatment Week 12 (Follow-up period)', 'description': 'Participants were categorized into 3 genotypes based on single nucleotide polymorphisms in the IL28B gene. SVR12 was defined as hepatitis C virus (HCV) RNA levels below lower limit of quantitation, target detected or target not detected at follow-up Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.'}, {'measure': 'Number of Participants With Serious Adverse Events (SAEs) and Discontinuations Due to Adverse Events (AEs) and Who Died', 'timeFrame': 'From start of treatment (Day 1) up to 7 days post last dose of study treatment (Week 24)', 'description': 'AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have 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. Based on the severity, AEs were categorized as Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Hepatitis C Virus']}, 'referencesModule': {'references': [{'pmid': '26453968', 'type': 'DERIVED', 'citation': 'Zeuzem S, Hezode C, Bronowicki JP, Loustaud-Ratti V, Gea F, Buti M, Olveira A, Banyai T, Al-Assi MT, Petersen J, Thabut D, Gadano A, Pruitt R, Makara M, Bourliere M, Pol S, Beumont-Mauviel M, Ouwerkerk-Mahadevan S, Picchio G, Bifano M, McPhee F, Boparai N, Cheung K, Hughes EA, Noviello S; LEAGUE-1 Study Team. Daclatasvir plus simeprevir with or without ribavirin for the treatment of chronic hepatitis C virus genotype 1 infection. J Hepatol. 2016 Feb;64(2):292-300. doi: 10.1016/j.jhep.2015.09.024. Epub 2015 Oct 8.'}], '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': 'The purpose of this study is to assess the safety and efficacy of daclatasvir and simeprevir with and without ribavirin for genotype 1 chronic hepatitis C virus infection in patients who are treatment-naive or null responders to previous pegylated interferon/ribavirin therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n* Hepatitis C virus (HCV) genotype 1a or 1b\n* Males and females, ≥18 years of age\n* HCV RNA ≥10,000 IU/mL\n* Participants with compensated cirrhosis are permitted\n\n * Advanced fibrosis (F3/F4) is capped at approximately 35% of the total treated population with a minimum of 20% F4 patients\n * If no cirrhosis, a liver biopsy within 3 years prior to enrollment\n * If cirrhosis is present, any prior liver biopsy\n\nKey Exclusion Criteria:\n\n* Liver or any other transplant (other than cornea and hair)\n* Evidence of a medical condition contributing to chronic liver disease other than HCV infection\n* Current or known history of cancer, (except in situ carcinoma of the cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to enrollment\n* Evidence of decompensated liver disease including, but not limited to, radiologic criteria, a history or presence of ascites, bleeding varices, or hepatic encephalopathy\n* Patients infected with HIV or hepatitis B virus\n* Gastrointestinal disease impacting absorption of study drug\n* Uncontrolled diabetes or hypertension\n* Prior exposure to an HCV direct-acting agent\n* Any criteria that would exclude the patient from receiving ribavirin\n* Absolute neutrophil count \\<1.5\\*1,000,000,000 cells/L (\\<1.2\\*1,000,000,000 cells/L for Black/African Americans)\n* Platelets \\<90\\*1,000,000,000 cells/L\n* Hemoglobin \\<12 g/dL for females, \\<13 g/dL for males\n* Alanine aminotransferase ≥5\\*upper limit of normal\n* In patients without cirrhosis, total bilirubin ≥2 mg/dL unless patient has a documented history of Gilbert's disease\n* In patients with cirrhosis, total bilirubin o ≥1.5 mg/dL\n* International normalized ratio ≥1.7\n* QTcF or QTcB \\>500 mSec\n* Creatinine clearance ≤50 mL/min\n* Alpha fetoprotein (AFP) \\>100 ng/mL OR\n* AFP ≥50 ng/mL and ≤100 ng/mL requiring liver ultrasound\n* Albumin \\<3.5 g/dL"}, 'identificationModule': {'nctId': 'NCT01628692', 'briefTitle': 'Study of Daclatasvir (BMS-790052) and Simeprevir (TMC435) in Patients With Genotype 1 Chronic Hepatitis C Virus', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Phase 2, Open-Label Study of Daclatasvir (BMS-790052) and TMC435 in Combination With or Without Ribavirin (RBV) For Treatment-Naive Subjects or Null Responders to Prior Peginterferon Alfa (PegIFN)/RBV Therapy With Genotype 1 Chronic Hepatitis C', 'orgStudyIdInfo': {'id': 'AI444-062'}, 'secondaryIdInfos': [{'id': '2012-000070-28', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1: (Genotype 1b) Daclatasvir + Simeprevir', 'description': 'Participants with hepatitis C virus genotype 1b received daclatasvir, 30 mg, once daily with or without food + simeprevir, 150 mg, once daily with a meal for 12 weeks', 'interventionNames': ['Drug: Daclatasvir', 'Drug: Simeprevir']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2: (Genotype 1b) Daclatasvir + Simeprevir + Ribavirin', 'description': 'Participants with hepatitis C virus genotype 1b received daclatasvir, 30 mg, once daily with or without food + simeprivir, 150 mg, once daily with a meal + ribavirin, twice daily with food (patients weighing \\<75 kg received a total ribavirin dose of 1000 mg per day; those weighing \\>=75 kg received 1200 mg per day) for 12 weeks.', 'interventionNames': ['Drug: Daclatasvir', 'Drug: Simeprevir']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 3: (Genotype 1a) Daclatasvir + Simeprevir + Ribavirin', 'description': 'Participants with hepatitis C virus genotype 1a received daclatasvir, 30 mg, once daily with or without food + simeprevir, 150 mg, once daily with a meal + ribavirin, twice daily with food (patients weighing \\<75 kg received a total ribavirin dose of 1000 mg per day; those weighing \\>=75 kg received 1200 mg per day) for 12 weeks.', 'interventionNames': ['Drug: Daclatasvir', 'Drug: Simeprevir', 'Drug: Ribavirin']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 4: (Genotype 1a) Daclatasvir + Simeprevir + Ribavirin', 'description': 'Participants with hepatitis C virus genotype 1a received daclatasvir, 30 mg, once daily with or without food + simeprivir, 150 mg, once daily with a meal + ribavirin, twice daily with food (patients weighing \\<75 kg received a total ribavirin dose of 1000 mg per day; those weighing \\>=75 kg received 1200 mg per day.', 'interventionNames': ['Drug: Daclatasvir', 'Drug: Simeprevir', 'Drug: Ribavirin']}], 'interventions': [{'name': 'Daclatasvir', 'type': 'DRUG', 'otherNames': ['BMS-790052'], 'description': 'Tablets, oral, 30 mg, once daily', 'armGroupLabels': ['Cohort 1: (Genotype 1b) Daclatasvir + Simeprevir', 'Cohort 2: (Genotype 1b) Daclatasvir + Simeprevir + Ribavirin', 'Cohort 3: (Genotype 1a) Daclatasvir + Simeprevir + Ribavirin', 'Cohort 4: (Genotype 1a) Daclatasvir + Simeprevir + Ribavirin']}, {'name': 'Simeprevir', 'type': 'DRUG', 'otherNames': ['TMC435'], 'description': 'Capsule, oral, 150 mg, once daily', 'armGroupLabels': ['Cohort 1: (Genotype 1b) Daclatasvir + Simeprevir', 'Cohort 2: (Genotype 1b) Daclatasvir + Simeprevir + Ribavirin', 'Cohort 3: (Genotype 1a) Daclatasvir + Simeprevir + Ribavirin', 'Cohort 4: (Genotype 1a) Daclatasvir + Simeprevir + Ribavirin']}, {'name': 'Ribavirin', 'type': 'DRUG', 'description': 'Tablets, oral, 500-600 mg, twice daily', 'armGroupLabels': ['Cohort 3: (Genotype 1a) Daclatasvir + Simeprevir + Ribavirin', 'Cohort 4: (Genotype 1a) Daclatasvir + Simeprevir + Ribavirin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94110', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'San Francisco General Hospital', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94118', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Med Ctr', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '21093', 'city': 'Lutherville', 'state': 'Maryland', 'country': 'United 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