Ignite Creation Date:
2025-12-25 @ 4:19 AM
Ignite Modification Date:
2026-03-02 @ 7:01 PM
Study NCT ID:
NCT01682720
Status:
COMPLETED
Last Update Posted:
2014-10-09
First Post:
2012-09-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Sofosbuvir and Ribavirin in Treatment-Naive and Treatment-Experienced Subjects With Chronic Genotype 2 or 3 HCV Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006526', 'term': 'Hepatitis C'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069474', 'term': 'Sofosbuvir'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialDisclosures@gilead.com', 'title': 'Clinical Trial Disclosures', 'organization': 'Gilead Sciences, Inc.'}, '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': 'Baseline up to Week 24 plus 30 days', 'description': 'Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo 12 Weeks (GT2/3)', 'description': 'Placebo to match SOF + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection.', 'otherNumAtRisk': 85, 'otherNumAffected': 60, 'seriousNumAtRisk': 85, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'SOF 12 Weeks (GT2/3)', 'description': 'SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection.', 'otherNumAtRisk': 84, 'otherNumAffected': 72, 'seriousNumAtRisk': 84, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'SOF 24 Weeks (GT3)', 'description': 'SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 24 weeks in participants with genotype 3 HCV infection.', 'otherNumAtRisk': 250, 'otherNumAffected': 229, 'seriousNumAtRisk': 250, 'seriousNumAffected': 10}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 250, 'numAffected': 17}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 250, 'numAffected': 33}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 250, 'numAffected': 30}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 250, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numAffected': 21}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 250, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 250, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 250, 'numAffected': 75}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 250, 'numAffected': 53}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 250, 'numAffected': 26}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numAffected': 16}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 250, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 250, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 250, 'numAffected': 36}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 250, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 250, 'numAffected': 16}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 250, 'numAffected': 25}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 250, 'numAffected': 22}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 250, 'numAffected': 15}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numAffected': 13}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 250, 'numAffected': 74}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 250, 'numAffected': 19}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Disturbance in attention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numAffected': 15}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 250, 'numAffected': 41}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Sleep disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 250, 'numAffected': 23}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numAffected': 13}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Depressed mood', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numAffected': 13}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 250, 'numAffected': 27}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 250, 'numAffected': 27}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Dyspnoea exertional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 250, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 250, 'numAffected': 67}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 250, 'numAffected': 31}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 250, 'numAffected': 24}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 250, 'numAffected': 14}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}], 'seriousEvents': [{'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Adenocarcinoma of colon', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Haemorrhoidal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Biliary colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Amylase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Lipase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Hepatocellular carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Invasive ductal breast carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Complex regional pain syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 250, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '250', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'SOF 12 Weeks (GT2)', 'description': 'SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 HCV infection.'}, {'id': 'OG001', 'title': 'SOF 12 Weeks (GT3)', 'description': 'SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 3 HCV infection.'}, {'id': 'OG002', 'title': 'SOF 24 Weeks (GT3)', 'description': 'SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 24 weeks in participants with genotype 3 HCV infection.'}], 'classes': [{'categories': [{'measurements': [{'value': '93.2', 'groupId': 'OG000'}, {'value': '27.3', 'groupId': 'OG001'}, {'value': '85.2', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Posttreatment Week 12', 'description': 'SVR12 was defined as HCV RNA \\< the lower limit of quantitation (LLOQ, ie, \\< 25 IU/mL) 12 weeks following the last dose of study drug. Data for this outcome measure was not collected for the Placebo 12 Weeks (GT2/3) group.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: participants with genotype 2 or 3 HCV infection were randomized and received at least 1 dose of SOF.'}, {'type': 'PRIMARY', 'title': 'Adverse Events Leading to Permanent Discontinuation of Study Drug(s)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '250', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo 12 Weeks (GT2/3)', 'description': 'Placebo to match SOF + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection.'}, {'id': 'OG001', 'title': 'SOF 12 Weeks (GT2/3)', 'description': 'SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection.'}, {'id': 'OG002', 'title': 'SOF 24 Weeks (GT3)', 'description': 'SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 24 weeks in participants with genotype 3 HCV infection.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000'}, {'value': '1.2', 'groupId': 'OG001'}, {'value': '0.4', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 24 weeks', 'description': 'The percentage of participants experiencing an adverse event leading to permanent discontinuation of study drug(s) was analyzed.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '250', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'SOF 12 Weeks (GT2)', 'description': 'SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 HCV infection.'}, {'id': 'OG001', 'title': 'SOF 12 Weeks (GT3)', 'description': 'SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 3 HCV infection.'}, {'id': 'OG002', 'title': 'SOF 24 Weeks (GT3)', 'description': 'SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 24 weeks in participants with genotype 3 HCV infection.'}], 'classes': [{'title': 'SVR4', 'categories': [{'measurements': [{'value': '93.2', 'groupId': 'OG000'}, {'value': '45.5', 'groupId': 'OG001'}, {'value': '87.2', 'groupId': 'OG002'}]}]}, {'title': 'SVR24', 'categories': [{'measurements': [{'value': '93.2', 'groupId': 'OG000'}, {'value': '27.3', 'groupId': 'OG001'}, {'value': '84.4', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Posttreatment Weeks 4 and 24', 'description': 'SVR4 and SVR24 was defined as HCV RNA \\< LLOQ at 4 and 24 weeks following the last dose of study drug, respectively. Data for this outcome measure was not collected for the Placebo 12 Weeks (GT2/3) group.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: participants with genotype 2 or 3 HCV infection were randomized and received at least 1 dose of SOF.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Experiencing Viral Breakthrough or Viral Relapse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '250', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'SOF 12 Weeks (GT2)', 'description': 'SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 HCV infection.'}, {'id': 'OG001', 'title': 'SOF 12 Weeks (GT3)', 'description': 'SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 3 HCV infection.'}, {'id': 'OG002', 'title': 'SOF 24 Weeks (GT3)', 'description': 'SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 24 weeks in participants with genotype 3 HCV infection.'}], 'classes': [{'title': 'Viral breakthrough', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0.4', 'groupId': 'OG002'}]}]}, {'title': 'Viral relapse', 'categories': [{'measurements': [{'value': '6.8', 'groupId': 'OG000'}, {'value': '54.5', 'groupId': 'OG001'}, {'value': '14.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Posttreatment Week 24', 'description': 'Viral breakthrough was defined as having confirmed detectable HCV RNA levels (HCV RNA \\> LLOQ) after having previously had undetectable HCV RNA levels (HCV RNA \\< LLOQ) while on treatment.\n\nViral relapse was defined as having achieved undetectable HCV RNA levels (HCV RNA \\< LLOQ) at end of treatment, but did not achieve an SVR.\n\nData for this outcome measure was not collected for the Placebo 12 Weeks (GT2/3) group.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: participants with genotype 2 or 3 HCV infection were randomized and received at least 1 dose of SOF.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo 12 Weeks (GT2/3)', 'description': 'Placebo to match sofosbuvir (SOF) + placebo to match ribavirin (RBV) for 12 weeks in participants with genotype (GT)2 or 3 HCV infection.'}, {'id': 'FG001', 'title': 'SOF 12 Weeks (GT2)', 'description': 'SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 HCV infection.'}, {'id': 'FG002', 'title': 'SOF 12 Weeks (GT3)', 'description': 'SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 3 HCV infection.'}, {'id': 'FG003', 'title': 'SOF 24 Weeks (GT3)', 'description': 'SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 24 weeks in participants with genotype 3 HCV infection.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '85'}, {'groupId': 'FG001', 'numSubjects': '74'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '250'}]}, {'type': 'Included in Full Analysis Set', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '73'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '250'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '69'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '211'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '85'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '39'}]}], 'dropWithdraws': [{'type': 'Randomized but Not Treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Terminated by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '83'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Efficacy Failure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '30'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '6'}]}, {'type': 'Subject Withdrew Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants were enrolled at a total of 77 study sites in Europe. The first participant was screened on 19 September 2012. The last participant observation occurred on 08 January 2014.', 'preAssignmentDetails': '* 475 participants were screened and 421 were randomized.\n* 419 participants were randomized and received at least 1 dose of study drug (Safety Analysis Set).\n* 334 participants with genotype 2 or 3 hepatitis C virus (HCV) infection were randomized and received at least 1 dose of sofosbuvir (Full Analysis Set).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '250', 'groupId': 'BG003'}, {'value': '419', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo 12 Weeks (GT2/3)', 'description': 'Placebo to match SOF + placebo to match RBV for 12 weeks in participants with genotype 2 or 3 HCV infection.'}, {'id': 'BG001', 'title': 'SOF 12 Weeks (GT2)', 'description': 'SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 HCV infection.'}, {'id': 'BG002', 'title': 'SOF 12 Weeks (GT3)', 'description': 'SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 3 HCV infection.'}, {'id': 'BG003', 'title': 'SOF 24 Weeks (GT3)', 'description': 'SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 24 weeks in participants with genotype 3 HCV infection.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '49', 'spread': '10.5', 'groupId': 'BG000'}, {'value': '58', 'spread': '10.1', 'groupId': 'BG001'}, {'value': '46', 'spread': '8.8', 'groupId': 'BG002'}, {'value': '48', 'spread': '10.1', 'groupId': 'BG003'}, {'value': '50', 'spread': '10.8', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '95', 'groupId': 'BG003'}, {'value': '169', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '155', 'groupId': 'BG003'}, {'value': '250', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}, {'value': '53', 'groupId': 'BG004'}]}]}, {'title': 'Not Hispanic or Latino', 'categories': [{'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '203', 'groupId': 'BG003'}, {'value': '349', 'groupId': 'BG004'}]}]}, {'title': 'Not Permitted', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Black or African American', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '236', 'groupId': 'BG003'}, {'value': '393', 'groupId': 'BG004'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}]}]}, {'title': 'Not permitted', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'France', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '53', 'groupId': 'BG003'}, {'value': '81', 'groupId': 'BG004'}]}]}, {'title': 'Estonia', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '15', 'groupId': 'BG004'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}, {'value': '48', 'groupId': 'BG004'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}, {'value': '22', 'groupId': 'BG004'}]}]}, {'title': 'Austria', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '18', 'groupId': 'BG004'}]}]}, {'title': 'Netherlands', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '25', 'groupId': 'BG004'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '46', 'groupId': 'BG003'}, {'value': '69', 'groupId': 'BG004'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}, {'value': '55', 'groupId': 'BG004'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}, {'value': '62', 'groupId': 'BG004'}]}]}, {'title': 'Sweden', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'HCV Genotype', 'classes': [{'title': 'Genotype 2', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '91', 'groupId': 'BG004'}]}]}, {'title': 'Genotype 3', 'categories': [{'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '250', 'groupId': 'BG003'}, {'value': '328', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Liver Cirrhosis', 'classes': [{'title': 'No', 'categories': [{'measurements': [{'value': '68', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '190', 'groupId': 'BG003'}, {'value': '329', 'groupId': 'BG004'}]}]}, {'title': 'Yes', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '60', 'groupId': 'BG003'}, {'value': '90', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'IL28b Status', 'classes': [{'title': 'CC', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '86', 'groupId': 'BG003'}, {'value': '136', 'groupId': 'BG004'}]}]}, {'title': 'CT', 'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '131', 'groupId': 'BG003'}, {'value': '225', 'groupId': 'BG004'}]}]}, {'title': 'TT', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}, {'value': '58', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'description': 'CC, CT, and TT alleles are different forms of the IL28b gene.', 'unitOfMeasure': 'participants'}, {'title': 'HCV RNA', 'classes': [{'categories': [{'measurements': [{'value': '6.5', 'spread': '0.69', 'groupId': 'BG000'}, {'value': '6.5', 'spread': '0.70', 'groupId': 'BG001'}, {'value': '6.2', 'spread': '0.77', 'groupId': 'BG002'}, {'value': '6.3', 'spread': '0.74', 'groupId': 'BG003'}, {'value': '6.4', 'spread': '0.72', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'log10 IU/mL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'HCV RNA Category', 'classes': [{'title': '< 6 log10 IU/mL', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '72', 'groupId': 'BG003'}, {'value': '113', 'groupId': 'BG004'}]}]}, {'title': '≥ 6 log10 IU/mL', 'categories': [{'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '178', 'groupId': 'BG003'}, {'value': '306', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Prior HCV Treatment Experience', 'classes': [{'title': 'Experienced', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '145', 'groupId': 'BG003'}, {'value': '245', 'groupId': 'BG004'}]}]}, {'title': 'Naive', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '105', 'groupId': 'BG003'}, {'value': '174', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Response to prior HCV treatment', 'classes': [{'title': 'Interferon intolerant', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}]}]}, {'title': 'Nonresponse', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '41', 'groupId': 'BG003'}, {'value': '73', 'groupId': 'BG004'}]}]}, {'title': 'Relapse/Breakthrough', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '94', 'groupId': 'BG003'}, {'value': '159', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'description': 'Only participants who were treatment-experienced at baseline were analyzed.', 'unitOfMeasure': 'participants'}, {'title': 'Interferon Eligibility', 'classes': [{'title': 'Interferon eligible', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '94', 'groupId': 'BG003'}, {'value': '153', 'groupId': 'BG004'}]}]}, {'title': 'Interferon ineligible', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '21', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'description': 'Only participants who were treatment-naive at baseline were analyzed.', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 421}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-08', 'studyFirstSubmitDate': '2012-09-05', 'resultsFirstSubmitDate': '2014-10-02', 'studyFirstSubmitQcDate': '2012-09-06', 'lastUpdatePostDateStruct': {'date': '2014-10-09', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-10-08', 'studyFirstPostDateStruct': {'date': '2012-09-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-10-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Sustained Virologic Response 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, \\< 25 IU/mL) 12 weeks following the last dose of study drug. Data for this outcome measure was not collected for the Placebo 12 Weeks (GT2/3) group.'}, {'measure': 'Adverse Events Leading to Permanent Discontinuation of Study Drug(s)', 'timeFrame': 'Up to 24 weeks', 'description': 'The percentage of participants experiencing an adverse event leading to permanent discontinuation of study drug(s) was analyzed.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)', 'timeFrame': 'Posttreatment Weeks 4 and 24', 'description': 'SVR4 and SVR24 was defined as HCV RNA \\< LLOQ at 4 and 24 weeks following the last dose of study drug, respectively. Data for this outcome measure was not collected for the Placebo 12 Weeks (GT2/3) group.'}, {'measure': 'Percentage of Participants Experiencing Viral Breakthrough or Viral Relapse', 'timeFrame': 'Up to Posttreatment Week 24', 'description': 'Viral breakthrough was defined as having confirmed detectable HCV RNA levels (HCV RNA \\> LLOQ) after having previously had undetectable HCV RNA levels (HCV RNA \\< LLOQ) while on treatment.\n\nViral relapse was defined as having achieved undetectable HCV RNA levels (HCV RNA \\< LLOQ) at end of treatment, but did not achieve an SVR.\n\nData for this outcome measure was not collected for the Placebo 12 Weeks (GT2/3) group.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['HCV', 'Genotype 2', 'Genotype 3'], 'conditions': ['Hepatitis C']}, 'referencesModule': {'references': [{'pmid': '24795201', 'type': 'RESULT', 'citation': 'Zeuzem S, Dusheiko GM, Salupere R, Mangia A, Flisiak R, Hyland RH, Illeperuma A, Svarovskaia E, Brainard DM, Symonds WT, Subramanian GM, McHutchison JG, Weiland O, Reesink HW, Ferenci P, Hezode C, Esteban R; VALENCE Investigators. Sofosbuvir and ribavirin in HCV genotypes 2 and 3. N Engl J Med. 2014 May 22;370(21):1993-2001. doi: 10.1056/NEJMoa1316145. Epub 2014 May 4.'}, {'pmid': '25583164', 'type': 'DERIVED', 'citation': 'Younossi ZM, Stepanova M, Sulkowski M, Naggie S, Puoti M, Orkin C, Hunt SL. Sofosbuvir and Ribavirin for Treatment of Chronic Hepatitis C in Patients Coinfected With Hepatitis C Virus and HIV: The Impact on Patient-Reported Outcomes. J Infect Dis. 2015 Aug 1;212(3):367-77. doi: 10.1093/infdis/jiv005. Epub 2015 Jan 12.'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the safety, tolerability, and antiviral efficacy of GS-7977 with ribavirin (RBV) in participants with genotype 2 or 3 hepatitis C virus (HCV) infection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age \\> 18 with chronic genotype 2 or 3 HCV infection\n* HCV RNA \\> 10,000 IU/mL at screening\n* Subjects must be treatment naive or treatment experienced\n* Presence or absence of cirrhosis; a liver biopsy may be required\n* Healthy according to medical history and physical examination with the exception of HCV diagnosis\n* Agree to use two forms of highly effective contraception for the duration of the study and 6 months after the last dose of study medication\n\nExclusion Criteria:\n\n* Prior use of any other inhibitor of the HCV NS5B Polymerase\n* History of any other clinically significant chronic liver disease\n* Evidence of or history of decompensated liver disease\n* HIV or chronic hepatitis B virus (HBV) infection\n* Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain resolved skin cancers)\n* Chronic use of immunosuppressive agents or immunomodulatory agents\n* History or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the subject's participation for the full duration of the study or not be in the best interest of the subject in the opinion of the investigator"}, 'identificationModule': {'nctId': 'NCT01682720', 'briefTitle': 'Sofosbuvir and Ribavirin in Treatment-Naive and Treatment-Experienced Subjects With Chronic Genotype 2 or 3 HCV Infection', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gilead Sciences'}, 'officialTitle': 'A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to 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