Ignite Creation Date:
2025-12-24 @ 9:16 PM
Ignite Modification Date:
2026-01-07 @ 10:06 AM
Study NCT ID:
NCT01909804
Status:
COMPLETED
Last Update Posted:
2018-11-15
First Post:
2013-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of Sofosbuvir Plus Velpatasvir With or Without Ribavirin in Treatment-experienced Subjects With Chronic HCV Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006526', 'term': 'Hepatitis C'}, {'id': 'D006505', 'term': 'Hepatitis'}], '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': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069474', 'term': 'Sofosbuvir'}, {'id': 'C000604171', 'term': 'velpatasvir'}, {'id': 'D012254', 'term': 'Ribavirin'}], 'ancestors': [{'id': 'D014542', 'term': 'Uridine Monophosphate'}, {'id': 'D014500', 'term': 'Uracil Nucleotides'}, {'id': 'D011742', 'term': 'Pyrimidine Nucleotides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009711', 'term': 'Nucleotides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012265', 'term': 'Ribonucleotides'}, {'id': 'D012263', 'term': 'Ribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialDisclosures@gilead.com', 'title': 'Clinical Trial Disclosures', 'organization': 'Gilead Sciences'}, 'certainAgreement': {'otherDetails': 'After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:\n\n* The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or\n* The study has been completed at all study sites for at least 2 years', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 12 weeks plus 30 days', 'description': 'Safety Analysis Set', 'eventGroups': [{'id': 'EG000', 'title': 'SOF+VEL 25 mg', 'description': 'SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotypes 1 and 3)', 'otherNumAtRisk': 79, 'otherNumAffected': 54, 'seriousNumAtRisk': 79, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'SOF+VEL 25 mg + RBV', 'description': 'SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotypes 1 and 3)', 'otherNumAtRisk': 82, 'otherNumAffected': 61, 'seriousNumAtRisk': 82, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'SOF+VEL 100 mg', 'description': 'SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotypes 1 and 3)', 'otherNumAtRisk': 80, 'otherNumAffected': 54, 'seriousNumAtRisk': 80, 'seriousNumAffected': 4}, {'id': 'EG003', 'title': 'SOF+VEL 100 mg + RBV', 'description': 'SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotypes 1 and 3)', 'otherNumAtRisk': 80, 'otherNumAffected': 62, 'seriousNumAtRisk': 80, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 19}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 27}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 24}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 16}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 12}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Dyspnoea exertional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 12}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 9}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}], 'seriousEvents': [{'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Drug withdrawal syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Thrombosis in device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Hypersensitivity vasculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'May-Thurner syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 80, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 80, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}, {'value': '25', 'groupId': 'OG005'}, {'value': '26', 'groupId': 'OG006'}, {'value': '26', 'groupId': 'OG007'}, {'value': '27', 'groupId': 'OG008'}, {'value': '29', 'groupId': 'OG009'}, {'value': '27', 'groupId': 'OG010'}, {'value': '28', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'SOF+VEL 25 mg (GT3 Non-Cirrhotic)', 'description': 'SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype (GT) 3 non-cirrhotic)'}, {'id': 'OG001', 'title': 'SOF+VEL 25 mg + RBV (GT3 Non-Cirrhotic)', 'description': 'SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 non-cirrhotic)'}, {'id': 'OG002', 'title': 'SOF+VEL 100 mg (GT3 Non-Cirrhotic)', 'description': 'SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3 non-cirrhotic)'}, {'id': 'OG003', 'title': 'SOF+VEL 100 mg + RBV (GT3 Non-Cirrhotic)', 'description': 'SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 non-cirrhotic)'}, {'id': 'OG004', 'title': 'SOF+VEL 25 mg (GT3 Cirrhotic)', 'description': 'SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 3 cirrhotic)'}, {'id': 'OG005', 'title': 'SOF+VEL 25 mg + RBV (GT3 Cirrhotic)', 'description': 'SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 cirrhotic)'}, {'id': 'OG006', 'title': 'SOF+VEL 100 mg (GT3 Cirrhotic)', 'description': 'SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3 cirrhotic)'}, {'id': 'OG007', 'title': 'SOF+VEL 100 mg + RBV (GT3 Cirrhotic)', 'description': 'SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 cirrhotic)'}, {'id': 'OG008', 'title': 'SOF+VEL 25 mg (GT1)', 'description': 'SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 1)'}, {'id': 'OG009', 'title': 'SOF+VEL 25 mg + RBV (GT1)', 'description': 'SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 1)'}, {'id': 'OG010', 'title': 'SOF+VEL 100 mg (GT1)', 'description': 'SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 1)'}, {'id': 'OG011', 'title': 'SOF+VEL 100 mg + RBV (GT1)', 'description': 'SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 1)'}], 'classes': [{'categories': [{'measurements': [{'value': '84.6', 'groupId': 'OG000', 'lowerLimit': '65.1', 'upperLimit': '95.6'}, {'value': '96.4', 'groupId': 'OG001', 'lowerLimit': '81.7', 'upperLimit': '99.9'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '87.2', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG003', 'lowerLimit': '86.8', 'upperLimit': '100.0'}, {'value': '57.7', 'groupId': 'OG004', 'lowerLimit': '36.9', 'upperLimit': '76.6'}, {'value': '84.0', 'groupId': 'OG005', 'lowerLimit': '63.9', 'upperLimit': '95.5'}, {'value': '88.5', 'groupId': 'OG006', 'lowerLimit': '69.8', 'upperLimit': '97.6'}, {'value': '96.2', 'groupId': 'OG007', 'lowerLimit': '80.4', 'upperLimit': '99.9'}, {'value': '100.0', 'groupId': 'OG008', 'lowerLimit': '87.2', 'upperLimit': '100.0'}, {'value': '96.6', 'groupId': 'OG009', 'lowerLimit': '82.2', 'upperLimit': '99.9'}, {'value': '100.0', 'groupId': 'OG010', 'lowerLimit': '87.2', 'upperLimit': '100.0'}, {'value': '96.4', 'groupId': 'OG011', 'lowerLimit': '81.7', 'upperLimit': '99.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Posttreatment Week 12', 'description': 'SVR12 was defined as HCV RNA \\< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: participants randomized into the study and received at least 1 dose of study drug.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}, {'value': '80', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'SOF+VEL 25 mg', 'description': 'SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotypes 1 and 3)'}, {'id': 'OG001', 'title': 'SOF+VEL 25 mg + RBV', 'description': 'SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotypes 1 and 3)'}, {'id': 'OG002', 'title': 'SOF+VEL 100 mg', 'description': 'SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotypes 1 and 3)'}, {'id': 'OG003', 'title': 'SOF+VEL 100 mg + RBV', 'description': 'SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotypes 1 and 3)'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1.2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 12 weeks', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}, {'value': '25', 'groupId': 'OG005'}, {'value': '26', 'groupId': 'OG006'}, {'value': '26', 'groupId': 'OG007'}, {'value': '27', 'groupId': 'OG008'}, {'value': '29', 'groupId': 'OG009'}, {'value': '27', 'groupId': 'OG010'}, {'value': '28', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'SOF+VEL 25 mg (GT3 Non-Cirrhotic)', 'description': 'SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype (GT) 3 non-cirrhotic)'}, {'id': 'OG001', 'title': 'SOF+VEL 25 mg + RBV (GT3 Non-Cirrhotic)', 'description': 'SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 non-cirrhotic)'}, {'id': 'OG002', 'title': 'SOF+VEL 100 mg (GT3 Non-Cirrhotic)', 'description': 'SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3 non-cirrhotic)'}, {'id': 'OG003', 'title': 'SOF+VEL 100 mg + RBV (GT3 Non-Cirrhotic)', 'description': 'SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 non-cirrhotic)'}, {'id': 'OG004', 'title': 'SOF+VEL 25 mg (GT3 Cirrhotic)', 'description': 'SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 3 cirrhotic)'}, {'id': 'OG005', 'title': 'SOF+VEL 25 mg + RBV (GT3 Cirrhotic)', 'description': 'SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 cirrhotic)'}, {'id': 'OG006', 'title': 'SOF+VEL 100 mg (GT3 Cirrhotic)', 'description': 'SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3 cirrhotic)'}, {'id': 'OG007', 'title': 'SOF+VEL 100 mg + RBV (GT3 Cirrhotic)', 'description': 'SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 cirrhotic)'}, {'id': 'OG008', 'title': 'SOF+VEL 25 mg (GT1)', 'description': 'SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 1)'}, {'id': 'OG009', 'title': 'SOF+VEL 25 mg + RBV (GT1)', 'description': 'SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 1)'}, {'id': 'OG010', 'title': 'SOF+VEL 100 mg (GT1)', 'description': 'SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 1)'}, {'id': 'OG011', 'title': 'SOF+VEL 100 mg + RBV (GT1)', 'description': 'SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 1)'}], 'classes': [{'title': 'SVR4', 'categories': [{'measurements': [{'value': '88.5', 'groupId': 'OG000', 'lowerLimit': '69.8', 'upperLimit': '97.6'}, {'value': '96.4', 'groupId': 'OG001', 'lowerLimit': '81.7', 'upperLimit': '99.9'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '87.2', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG003', 'lowerLimit': '86.8', 'upperLimit': '100.0'}, {'value': '61.5', 'groupId': 'OG004', 'lowerLimit': '40.6', 'upperLimit': '79.8'}, {'value': '84.0', 'groupId': 'OG005', 'lowerLimit': '63.9', 'upperLimit': '95.5'}, {'value': '88.5', 'groupId': 'OG006', 'lowerLimit': '69.8', 'upperLimit': '97.6'}, {'value': '96.2', 'groupId': 'OG007', 'lowerLimit': '80.4', 'upperLimit': '99.9'}, {'value': '100.0', 'groupId': 'OG008', 'lowerLimit': '87.2', 'upperLimit': '100.0'}, {'value': '96.6', 'groupId': 'OG009', 'lowerLimit': '82.2', 'upperLimit': '99.9'}, {'value': '100.0', 'groupId': 'OG010', 'lowerLimit': '87.2', 'upperLimit': '100.0'}, {'value': '96.4', 'groupId': 'OG011', 'lowerLimit': '81.7', 'upperLimit': '99.9'}]}]}, {'title': 'SVR24', 'categories': [{'measurements': [{'value': '84.6', 'groupId': 'OG000', 'lowerLimit': '65.1', 'upperLimit': '95.6'}, {'value': '96.4', 'groupId': 'OG001', 'lowerLimit': '81.7', 'upperLimit': '99.9'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '87.2', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG003', 'lowerLimit': '86.8', 'upperLimit': '100.0'}, {'value': '57.7', 'groupId': 'OG004', 'lowerLimit': '36.9', 'upperLimit': '76.6'}, {'value': '84.0', 'groupId': 'OG005', 'lowerLimit': '63.9', 'upperLimit': '95.5'}, {'value': '92.3', 'groupId': 'OG006', 'lowerLimit': '74.9', 'upperLimit': '99.1'}, {'value': '96.2', 'groupId': 'OG007', 'lowerLimit': '80.4', 'upperLimit': '99.9'}, {'value': '100.0', 'groupId': 'OG008', 'lowerLimit': '87.2', 'upperLimit': '100.0'}, {'value': '96.6', 'groupId': 'OG009', 'lowerLimit': '82.2', 'upperLimit': '99.9'}, {'value': '100.0', 'groupId': 'OG010', 'lowerLimit': '87.2', 'upperLimit': '100.0'}, {'value': '96.4', 'groupId': 'OG011', 'lowerLimit': '81.7', 'upperLimit': '99.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Posttreatment Weeks 4 and 24', 'description': 'SVR4 and SVR 24 were defined as HCV RNA \\< LLOQ at 4 and 24 weeks after stopping study treatment, respectively.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Virologic Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}, {'value': '25', 'groupId': 'OG005'}, {'value': '26', 'groupId': 'OG006'}, {'value': '26', 'groupId': 'OG007'}, {'value': '27', 'groupId': 'OG008'}, {'value': '29', 'groupId': 'OG009'}, {'value': '27', 'groupId': 'OG010'}, {'value': '28', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'SOF+VEL 25 mg (GT3 Non-Cirrhotic)', 'description': 'SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype (GT) 3 non-cirrhotic)'}, {'id': 'OG001', 'title': 'SOF+VEL 25 mg + RBV (GT3 Non-Cirrhotic)', 'description': 'SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 non-cirrhotic)'}, {'id': 'OG002', 'title': 'SOF+VEL 100 mg (GT3 Non-Cirrhotic)', 'description': 'SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3 non-cirrhotic)'}, {'id': 'OG003', 'title': 'SOF+VEL 100 mg + RBV (GT3 Non-Cirrhotic)', 'description': 'SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 non-cirrhotic)'}, {'id': 'OG004', 'title': 'SOF+VEL 25 mg (GT3 Cirrhotic)', 'description': 'SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 3 cirrhotic)'}, {'id': 'OG005', 'title': 'SOF+VEL 25 mg + RBV (GT3 Cirrhotic)', 'description': 'SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 cirrhotic)'}, {'id': 'OG006', 'title': 'SOF+VEL 100 mg (GT3 Cirrhotic)', 'description': 'SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3 cirrhotic)'}, {'id': 'OG007', 'title': 'SOF+VEL 100 mg + RBV (GT3 Cirrhotic)', 'description': 'SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 cirrhotic)'}, {'id': 'OG008', 'title': 'SOF+VEL 25 mg (GT1)', 'description': 'SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 1)'}, {'id': 'OG009', 'title': 'SOF+VEL 25 mg + RBV (GT1)', 'description': 'SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 1)'}, {'id': 'OG010', 'title': 'SOF+VEL 100 mg (GT1)', 'description': 'SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 1)'}, {'id': 'OG011', 'title': 'SOF+VEL 100 mg + RBV (GT1)', 'description': 'SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 1)'}], 'classes': [{'categories': [{'measurements': [{'value': '15.4', 'groupId': 'OG000'}, {'value': '3.6', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '42.3', 'groupId': 'OG004'}, {'value': '12.0', 'groupId': 'OG005'}, {'value': '11.5', 'groupId': 'OG006'}, {'value': '3.8', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '3.4', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '3.6', 'groupId': 'OG011'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Posttreatment Week 24', 'description': 'Virologic failure was defined as:\n\n* On-treatment virologic failure:\n\n * Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA \\< LLOQ while on treatment), or\n * Rebound (confirmed \\> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or\n * Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)\n* Virologic relapse:\n\n * Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA \\< LLOQ at last on-treatment visit.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SOF+VEL 25 mg (GT3 Non-Cirrhotic)', 'description': 'Sofosbuvir (SOF) 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype (GT) 3 non-cirrhotic)'}, {'id': 'FG001', 'title': 'SOF+VEL 25 mg + RBV (GT3 Non-Cirrhotic)', 'description': 'SOF 400 mg tablet + velpatasvir (VEL) 25 mg tablet administered orally once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 non-cirrhotic)'}, {'id': 'FG002', 'title': 'SOF+VEL 100 mg (GT3 Non-Cirrhotic)', 'description': 'SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3 non-cirrhotic)'}, {'id': 'FG003', 'title': 'SOF+VEL 100 mg + RBV (GT3 Non-Cirrhotic)', 'description': 'SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 non-cirrhotic)'}, {'id': 'FG004', 'title': 'SOF+VEL 25 mg (GT3 Cirrhotic)', 'description': 'SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 3 cirrhotic)'}, {'id': 'FG005', 'title': 'SOF+VEL 25 mg + RBV (GT3 Cirrhotic)', 'description': 'SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 cirrhotic)'}, {'id': 'FG006', 'title': 'SOF+VEL 100 mg (GT3 Cirrhotic)', 'description': 'SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3 cirrhotic)'}, {'id': 'FG007', 'title': 'SOF+VEL 100 mg + RBV (GT3 Cirrhotic)', 'description': 'SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 cirrhotic)'}, {'id': 'FG008', 'title': 'SOF+VEL 25 mg (GT1)', 'description': 'SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 1)'}, {'id': 'FG009', 'title': 'SOF+VEL 25 mg + RBV (GT1)', 'description': 'SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 1)'}, {'id': 'FG010', 'title': 'SOF+VEL 100 mg (GT1)', 'description': 'SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 1)'}, {'id': 'FG011', 'title': 'SOF+VEL 100 mg + RBV (GT1)', 'description': 'SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 1)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '28'}, {'groupId': 'FG002', 'numSubjects': '27'}, {'groupId': 'FG003', 'numSubjects': '26'}, {'groupId': 'FG004', 'numSubjects': '26'}, {'groupId': 'FG005', 'numSubjects': '25'}, {'groupId': 'FG006', 'numSubjects': '27'}, {'groupId': 'FG007', 'numSubjects': '26'}, {'groupId': 'FG008', 'numSubjects': '27'}, {'groupId': 'FG009', 'numSubjects': '29'}, {'groupId': 'FG010', 'numSubjects': '27'}, {'groupId': 'FG011', 'numSubjects': '29'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '27'}, {'groupId': 'FG002', 'numSubjects': '27'}, {'groupId': 'FG003', 'numSubjects': '26'}, {'groupId': 'FG004', 'numSubjects': '18'}, {'groupId': 'FG005', 'numSubjects': '21'}, {'groupId': 'FG006', 'numSubjects': '25'}, {'groupId': 'FG007', 'numSubjects': '25'}, {'groupId': 'FG008', 'numSubjects': '27'}, {'groupId': 'FG009', 'numSubjects': '28'}, {'groupId': 'FG010', 'numSubjects': '26'}, {'groupId': 'FG011', 'numSubjects': '26'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '8'}, {'groupId': 'FG005', 'numSubjects': '4'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '1'}, {'groupId': 'FG010', 'numSubjects': '1'}, {'groupId': 'FG011', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Randomized but Never Treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '1'}, {'groupId': 'FG011', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '7'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '1'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '1'}]}, {'type': 'Withdrew Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants were enrolled at study sites in Australia, New Zealand, and the United States. The first participant was screened on 17 June 2013. The last study visit occurred on 22 August 2014.', 'preAssignmentDetails': '416 participants were screened.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}, {'value': '26', 'groupId': 'BG004'}, {'value': '25', 'groupId': 'BG005'}, {'value': '26', 'groupId': 'BG006'}, {'value': '26', 'groupId': 'BG007'}, {'value': '27', 'groupId': 'BG008'}, {'value': '29', 'groupId': 'BG009'}, {'value': '27', 'groupId': 'BG010'}, {'value': '28', 'groupId': 'BG011'}, {'value': '321', 'groupId': 'BG012'}]}], 'groups': [{'id': 'BG000', 'title': 'SOF+VEL 25 mg (GT3 Non-Cirrhotic)', 'description': 'SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype (GT) 3 non-cirrhotic)'}, {'id': 'BG001', 'title': 'SOF+VEL 25 mg + RBV (GT3 Non-Cirrhotic)', 'description': 'SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 non-cirrhotic)'}, {'id': 'BG002', 'title': 'SOF+VEL 100 mg (GT3 Non-Cirrhotic)', 'description': 'SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3 non-cirrhotic)'}, {'id': 'BG003', 'title': 'SOF+VEL 100 mg + RBV (GT3 Non-Cirrhotic)', 'description': 'SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 non-cirrhotic)'}, {'id': 'BG004', 'title': 'SOF+VEL 25 mg (GT3 Cirrhotic)', 'description': 'SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 3 cirrhotic)'}, {'id': 'BG005', 'title': 'SOF+VEL 25 mg + RBV (GT3 Cirrhotic)', 'description': 'SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 cirrhotic)'}, {'id': 'BG006', 'title': 'SOF+VEL 100 mg (GT3 Cirrhotic)', 'description': 'SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3 cirrhotic)'}, {'id': 'BG007', 'title': 'SOF+VEL 100 mg + RBV (GT3 Cirrhotic)', 'description': 'SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 cirrhotic)'}, {'id': 'BG008', 'title': 'SOF+VEL 25 mg (GT1)', 'description': 'SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 1)'}, {'id': 'BG009', 'title': 'SOF+VEL 25 mg + RBV (GT1)', 'description': 'SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 1)'}, {'id': 'BG010', 'title': 'SOF+VEL 100 mg (GT1)', 'description': 'SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 1)'}, {'id': 'BG011', 'title': 'SOF+VEL 100 mg + RBV (GT1)', 'description': 'SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 1)'}, {'id': 'BG012', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54', 'spread': '11.8', 'groupId': 'BG000'}, {'value': '51', 'spread': '10.4', 'groupId': 'BG001'}, {'value': '55', 'spread': '6.9', 'groupId': 'BG002'}, {'value': '56', 'spread': '6.4', 'groupId': 'BG003'}, {'value': '57', 'spread': '7.0', 'groupId': 'BG004'}, {'value': '56', 'spread': '5.6', 'groupId': 'BG005'}, {'value': '56', 'spread': '5.7', 'groupId': 'BG006'}, {'value': '54', 'spread': '4.7', 'groupId': 'BG007'}, {'value': '55', 'spread': '8.1', 'groupId': 'BG008'}, {'value': '57', 'spread': '5.8', 'groupId': 'BG009'}, {'value': '57', 'spread': '6.4', 'groupId': 'BG010'}, {'value': '56', 'spread': '6.0', 'groupId': 'BG011'}, {'value': '55', 'spread': '7.4', 'groupId': 'BG012'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '6', 'groupId': 'BG007'}, {'value': '12', 'groupId': 'BG008'}, {'value': '7', 'groupId': 'BG009'}, {'value': '12', 'groupId': 'BG010'}, {'value': '10', 'groupId': 'BG011'}, {'value': '100', 'groupId': 'BG012'}]}, {'title': 'Male', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '21', 'groupId': 'BG004'}, {'value': '15', 'groupId': 'BG005'}, {'value': '20', 'groupId': 'BG006'}, {'value': '20', 'groupId': 'BG007'}, {'value': '15', 'groupId': 'BG008'}, {'value': '22', 'groupId': 'BG009'}, {'value': '15', 'groupId': 'BG010'}, {'value': '18', 'groupId': 'BG011'}, {'value': '221', 'groupId': 'BG012'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '4', 'groupId': 'BG010'}, {'value': '3', 'groupId': 'BG011'}, {'value': '20', 'groupId': 'BG012'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '25', 'groupId': 'BG004'}, {'value': '24', 'groupId': 'BG005'}, {'value': '24', 'groupId': 'BG006'}, {'value': '26', 'groupId': 'BG007'}, {'value': '25', 'groupId': 'BG008'}, {'value': '28', 'groupId': 'BG009'}, {'value': '23', 'groupId': 'BG010'}, {'value': '25', 'groupId': 'BG011'}, {'value': '301', 'groupId': 'BG012'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '1', 'groupId': 'BG011'}, {'value': '4', 'groupId': 'BG012'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '2', 'groupId': 'BG011'}, {'value': '9', 'groupId': 'BG012'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '7', 'groupId': 'BG008'}, {'value': '2', 'groupId': 'BG009'}, {'value': '4', 'groupId': 'BG010'}, {'value': '4', 'groupId': 'BG011'}, {'value': '19', 'groupId': 'BG012'}]}]}, {'title': 'Native Hawaiian or Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '1', 'groupId': 'BG012'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '25', 'groupId': 'BG004'}, {'value': '23', 'groupId': 'BG005'}, {'value': '25', 'groupId': 'BG006'}, {'value': '24', 'groupId': 'BG007'}, {'value': '20', 'groupId': 'BG008'}, {'value': '27', 'groupId': 'BG009'}, {'value': '23', 'groupId': 'BG010'}, {'value': '21', 'groupId': 'BG011'}, {'value': '288', 'groupId': 'BG012'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'HCV Genotype', 'classes': [{'title': 'Genotype 1a', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '19', 'groupId': 'BG008'}, {'value': '22', 'groupId': 'BG009'}, {'value': '21', 'groupId': 'BG010'}, {'value': '22', 'groupId': 'BG011'}, {'value': '84', 'groupId': 'BG012'}]}]}, {'title': 'Genotype 1b', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '7', 'groupId': 'BG008'}, {'value': '7', 'groupId': 'BG009'}, {'value': '6', 'groupId': 'BG010'}, {'value': '6', 'groupId': 'BG011'}, {'value': '26', 'groupId': 'BG012'}]}]}, {'title': 'Genotype 1 (no confirmed subtype)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '1', 'groupId': 'BG012'}]}]}, {'title': 'Genotype 3', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}, {'value': '26', 'groupId': 'BG004'}, {'value': '25', 'groupId': 'BG005'}, {'value': '26', 'groupId': 'BG006'}, {'value': '26', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '210', 'groupId': 'BG012'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'IL28b Status', 'classes': [{'title': 'CC', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '12', 'groupId': 'BG006'}, {'value': '13', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '2', 'groupId': 'BG010'}, {'value': '3', 'groupId': 'BG011'}, {'value': '85', 'groupId': 'BG012'}]}]}, {'title': 'CT', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}, {'value': '14', 'groupId': 'BG005'}, {'value': '11', 'groupId': 'BG006'}, {'value': '10', 'groupId': 'BG007'}, {'value': '19', 'groupId': 'BG008'}, {'value': '21', 'groupId': 'BG009'}, {'value': '17', 'groupId': 'BG010'}, {'value': '19', 'groupId': 'BG011'}, {'value': '177', 'groupId': 'BG012'}]}]}, {'title': 'TT', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '8', 'groupId': 'BG008'}, {'value': '7', 'groupId': 'BG009'}, {'value': '8', 'groupId': 'BG010'}, {'value': '6', 'groupId': 'BG011'}, {'value': '59', 'groupId': 'BG012'}]}]}], 'paramType': 'NUMBER', 'description': 'CC, CT, and TT alleles are different forms of the IL28b gene.', 'unitOfMeasure': 'participants'}, {'title': 'Cirrhosis Status', 'classes': [{'title': 'Absent', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '17', 'groupId': 'BG008'}, {'value': '19', 'groupId': 'BG009'}, {'value': '18', 'groupId': 'BG010'}, {'value': '18', 'groupId': 'BG011'}, {'value': '175', 'groupId': 'BG012'}]}]}, {'title': 'Present', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '26', 'groupId': 'BG004'}, {'value': '25', 'groupId': 'BG005'}, {'value': '26', 'groupId': 'BG006'}, {'value': '26', 'groupId': 'BG007'}, {'value': '8', 'groupId': 'BG008'}, {'value': '10', 'groupId': 'BG009'}, {'value': '7', 'groupId': 'BG010'}, {'value': '10', 'groupId': 'BG011'}, {'value': '138', 'groupId': 'BG012'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '2', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '8', 'groupId': 'BG012'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'HCV RNA', 'classes': [{'categories': [{'measurements': [{'value': '6.7', 'spread': '0.76', 'groupId': 'BG000'}, {'value': '6.6', 'spread': '0.70', 'groupId': 'BG001'}, {'value': '6.6', 'spread': '0.59', 'groupId': 'BG002'}, {'value': '6.7', 'spread': '0.53', 'groupId': 'BG003'}, {'value': '6.6', 'spread': '0.46', 'groupId': 'BG004'}, {'value': '6.2', 'spread': '0.68', 'groupId': 'BG005'}, {'value': '6.4', 'spread': '0.76', 'groupId': 'BG006'}, {'value': '6.7', 'spread': '0.51', 'groupId': 'BG007'}, {'value': '6.5', 'spread': '0.59', 'groupId': 'BG008'}, {'value': '6.8', 'spread': '0.37', 'groupId': 'BG009'}, {'value': '6.4', 'spread': '0.53', 'groupId': 'BG010'}, {'value': '6.5', 'spread': '0.43', 'groupId': 'BG011'}, {'value': '6.6', 'spread': '0.60', 'groupId': 'BG012'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'log10 IU/mL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'HCV RNA Category', 'classes': [{'title': '< 800,000 IU/mL', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '7', 'groupId': 'BG005'}, {'value': '7', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '6', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '3', 'groupId': 'BG010'}, {'value': '3', 'groupId': 'BG011'}, {'value': '46', 'groupId': 'BG012'}]}]}, {'title': '≥ 800,000 IU/mL', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '23', 'groupId': 'BG004'}, {'value': '18', 'groupId': 'BG005'}, {'value': '19', 'groupId': 'BG006'}, {'value': '24', 'groupId': 'BG007'}, {'value': '21', 'groupId': 'BG008'}, {'value': '29', 'groupId': 'BG009'}, {'value': '24', 'groupId': 'BG010'}, {'value': '25', 'groupId': 'BG011'}, {'value': '275', 'groupId': 'BG012'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Prior HCV Treatment', 'classes': [{'title': 'Non-responder', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '10', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '6', 'groupId': 'BG008'}, {'value': '13', 'groupId': 'BG009'}, {'value': '7', 'groupId': 'BG010'}, {'value': '8', 'groupId': 'BG011'}, {'value': '91', 'groupId': 'BG012'}]}]}, {'title': 'Relapse / Breakthrough', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}, {'value': '16', 'groupId': 'BG005'}, {'value': '16', 'groupId': 'BG006'}, {'value': '23', 'groupId': 'BG007'}, {'value': '21', 'groupId': 'BG008'}, {'value': '16', 'groupId': 'BG009'}, {'value': '20', 'groupId': 'BG010'}, {'value': '20', 'groupId': 'BG011'}, {'value': '230', 'groupId': 'BG012'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 323}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'dispFirstSubmitDate': '2015-01-16', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-19', 'studyFirstSubmitDate': '2013-07-17', 'dispFirstSubmitQcDate': '2015-01-16', 'resultsFirstSubmitDate': '2016-07-27', 'studyFirstSubmitQcDate': '2013-07-26', 'dispFirstPostDateStruct': {'date': '2015-01-28', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2018-11-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-07-27', 'studyFirstPostDateStruct': {'date': '2013-07-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-09-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)', 'timeFrame': 'Posttreatment Week 12', 'description': 'SVR12 was defined as HCV RNA \\< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.'}, {'measure': 'Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event', 'timeFrame': 'Up to 12 weeks'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)', 'timeFrame': 'Posttreatment Weeks 4 and 24', 'description': 'SVR4 and SVR 24 were defined as HCV RNA \\< LLOQ at 4 and 24 weeks after stopping study treatment, respectively.'}, {'measure': 'Percentage of Participants With Virologic Failure', 'timeFrame': 'Up to Posttreatment Week 24', 'description': 'Virologic failure was defined as:\n\n* On-treatment virologic failure:\n\n * Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA \\< LLOQ while on treatment), or\n * Rebound (confirmed \\> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or\n * Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)\n* Virologic relapse:\n\n * Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA \\< LLOQ at last on-treatment visit.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hepatitis', 'Genotype 1', 'Genotype 3', 'Treatment experienced'], 'conditions': ['Hepatitis C']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'Pianko S, Flamm SL, Shiffman ML, Kumar S, Strasser SI, Dore GJ, et al. High Efficacy of Treatment with Sofosbuvir+GS-5816±Ribavirin for 12 Weeks in Treatment-Experienced Patients with Genotype 1 or 3 HCV Infection [Abstract 197]. American Association for the Study of Liver Diseases (AASLD); 2014 November 7-11; Boston MA United States.'}, {'pmid': '26551263', 'type': 'RESULT', 'citation': 'Pianko S, Flamm SL, Shiffman ML, Kumar S, Strasser SI, Dore GJ, McNally J, Brainard DM, Han L, Doehle B, Mogalian E, McHutchison JG, Rabinovitz M, Towner WJ, Gane EJ, Stedman CA, Reddy KR, Roberts SK. Sofosbuvir Plus Velpatasvir Combination Therapy for Treatment-Experienced Patients With Genotype 1 or 3 Hepatitis C Virus Infection: A Randomized Trial. Ann Intern Med. 2015 Dec 1;163(11):809-17. doi: 10.7326/M15-1014. Epub 2015 Nov 10.'}]}, 'descriptionModule': {'briefSummary': 'The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir (SOF) + velpatasvir (VEL; GS-5816) with or without ribavirin (RBV) in treatment-naive adults with chronic genotype (GT) 1 or 3 hepatitis C virus (HCV) infection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body mass index (BMI) ≥ 18 kg/m\\^2\n* HCV RNA ≥ 10000 IU/mL at screening\n* Prior treatment failure to a regimen including interferon with or without RBV\n* HCV genotype 1 or 3\n* Chronic HCV infection\n* Cirrhosis determination\n* Use of highly effective contraception methods if female of childbearing potential or sexually active male\n\nExclusion Criteria:\n\n* Current or prior history of clinically significant illness other than HCV\n* Screening ECG with clinically significant abnormalities\n* Prior exposure to HCV specific direct acting antiviral agent\n* Pregnant or nursing female or male with pregnant female partner\n* Chronic liver disease of non-HCV etiology\n* Hepatitis B\n* Active drug abuse\n* Use of any prohibited concomitant medications'}, 'identificationModule': {'nctId': 'NCT01909804', 'briefTitle': 'Safety and Efficacy of Sofosbuvir Plus Velpatasvir With or Without Ribavirin in Treatment-experienced Subjects With Chronic HCV Infection', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gilead Sciences'}, 'officialTitle': 'A Phase 2, Multicenter, Randomized, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir + GS-5816 for 12 Weeks in Treatment-Experienced Subjects With Chronic HCV Infection', 'orgStudyIdInfo': {'id': 'GS-US-342-0109'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SOF+VEL 25 mg (GT3) without cirrhosis', 'description': 'Participants with genotype 3 HCV infection without cirrhosis will receive SOF+VEL 25 mg for 12 weeks.', 'interventionNames': ['Drug: SOF']}, {'type': 'EXPERIMENTAL', 'label': 'SOF+VEL 25mg+RBV (GT3) without cirrhosis', 'description': 'Participants with genotype 3 HCV infection without cirrhosis will receive SOF+VEL 25 mg plus RBV for 12 weeks.', 'interventionNames': ['Drug: SOF', 'Drug: VEL', 'Drug: RBV']}, {'type': 'EXPERIMENTAL', 'label': 'SOF+VEL 100 mg (GT3) without cirrhosis', 'description': 'Participants with genotype 3 HCV infection without cirrhosis will receive SOF+VEL 100 mg for 12 weeks.', 'interventionNames': ['Drug: SOF', 'Drug: VEL']}, {'type': 'EXPERIMENTAL', 'label': 'SOF+VEL 100 mg+RBV (GT3) without cirrhosis', 'description': 'Participants with genotype 3 HCV infection without cirrhosis will receive SOF+VEL 100 mg plus RBV for 12 weeks.', 'interventionNames': ['Drug: SOF', 'Drug: VEL', 'Drug: RBV']}, {'type': 'EXPERIMENTAL', 'label': 'SOF+VEL 25 mg (GT3) with cirrhosis', 'description': 'Participants with genotype 3 HCV infection with cirrhosis will receive SOF+VEL 25 mg for 12 weeks.', 'interventionNames': ['Drug: SOF', 'Drug: VEL']}, {'type': 'EXPERIMENTAL', 'label': 'SOF+VEL 25 mg+RBV (GT3) with cirrhosis', 'description': 'Participants with genotype 3 HCV infection with cirrhosis will receive SOF+VEL 25 mg plus RBV for 12 weeks.', 'interventionNames': ['Drug: SOF', 'Drug: RBV']}, {'type': 'EXPERIMENTAL', 'label': 'SOF+VEL 100 mg (GT3) with cirrhosis', 'description': 'Participants with genotype 3 HCV infection with cirrhosis will receive SOF+VEL 100 mg for 12 weeks.', 'interventionNames': ['Drug: SOF', 'Drug: VEL']}, {'type': 'EXPERIMENTAL', 'label': 'SOF+VEL 100 mg+RBV (GT3) with cirrhosis', 'description': 'Participants with genotype 3 HCV infection with cirrhosis will receive SOF+VEL 100 mg plus RBV for 12 weeks.', 'interventionNames': ['Drug: SOF', 'Drug: VEL', 'Drug: RBV']}, {'type': 'EXPERIMENTAL', 'label': 'SOF+VEL 25 mg (GT1)', 'description': 'Participants with genotype 1 HCV infection will receive SOF+VEL 25 mg for 12 weeks.', 'interventionNames': ['Drug: SOF', 'Drug: VEL']}, {'type': 'EXPERIMENTAL', 'label': 'SOF+VEL 25 mg+RBV (GT1)', 'description': 'Participants with genotype 1 HCV infection will receive SOF+VEL 25 mg plus RBV for 12 weeks.', 'interventionNames': ['Drug: SOF', 'Drug: VEL', 'Drug: RBV']}, {'type': 'EXPERIMENTAL', 'label': 'SOF+VEL 100 mg (GT1)', 'description': 'Participants with genotype 1 HCV infection will receive SOF+VEL 100 mg for 12 weeks.', 'interventionNames': ['Drug: SOF', 'Drug: VEL']}, {'type': 'EXPERIMENTAL', 'label': 'SOF+VEL 100 mg+RBV (GT1)', 'description': 'Participants with genotype 1 HCV infection will receive SOF+VEL 100 mg plus RBV for 12 weeks.', 'interventionNames': ['Drug: SOF', 'Drug: VEL', 'Drug: RBV']}], 'interventions': [{'name': 'SOF', 'type': 'DRUG', 'otherNames': ['Sovaldi®', 'GS-7977', 'PSI-7977'], 'description': '400 mg tablet administered orally once daily', 'armGroupLabels': ['SOF+VEL 100 mg (GT1)', 'SOF+VEL 100 mg (GT3) with cirrhosis', 'SOF+VEL 100 mg (GT3) without cirrhosis', 'SOF+VEL 100 mg+RBV (GT1)', 'SOF+VEL 100 mg+RBV (GT3) with cirrhosis', 'SOF+VEL 100 mg+RBV (GT3) without cirrhosis', 'SOF+VEL 25 mg (GT1)', 'SOF+VEL 25 mg (GT3) with cirrhosis', 'SOF+VEL 25 mg (GT3) without cirrhosis', 'SOF+VEL 25 mg+RBV (GT1)', 'SOF+VEL 25 mg+RBV (GT3) with cirrhosis', 'SOF+VEL 25mg+RBV (GT3) without cirrhosis']}, {'name': 'VEL', 'type': 'DRUG', 'otherNames': ['GS-5816'], 'description': 'Tablet administered orally once daily', 'armGroupLabels': ['SOF+VEL 100 mg (GT1)', 'SOF+VEL 100 mg (GT3) with cirrhosis', 'SOF+VEL 100 mg (GT3) without cirrhosis', 'SOF+VEL 100 mg+RBV (GT1)', 'SOF+VEL 100 mg+RBV (GT3) with cirrhosis', 'SOF+VEL 100 mg+RBV (GT3) without cirrhosis', 'SOF+VEL 25 mg (GT1)', 'SOF+VEL 25 mg (GT3) with cirrhosis', 'SOF+VEL 25 mg+RBV (GT1)', 'SOF+VEL 25mg+RBV (GT3) without cirrhosis']}, {'name': 'RBV', 'type': 'DRUG', 'otherNames': ['Ribasphere®'], 'description': '200 mg tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)', 'armGroupLabels': ['SOF+VEL 100 mg+RBV (GT1)', 'SOF+VEL 100 mg+RBV (GT3) with cirrhosis', 'SOF+VEL 100 mg+RBV (GT3) without cirrhosis', 'SOF+VEL 25 mg+RBV (GT1)', 'SOF+VEL 25 mg+RBV (GT3) with cirrhosis', 'SOF+VEL 25mg+RBV (GT3) without cirrhosis']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'Pasadena', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.14778, 'lon': -118.14452}}, {'city': 'San Diego', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'city': 'Denver', 'state': 'Colorado', 'country': 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For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.', 'accessCriteria': 'A secured external environment with username, password, and RSA code.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gilead Sciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}