Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2026-04-19 @ 2:10 AM
Study NCT ID:
NCT02175758
Status:
COMPLETED
Last Update Posted:
2019-04-30
First Post:
2014-06-24
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of Sofosbuvir + Ribavirin in Adolescents and Children With Genotype 2 or 3 Chronic HCV Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['India']}, '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'}, {'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': 'GileadClinicalTrials@gilead.com', 'phone': '1-833-445-3230 (GILEAD-0)', 'title': 'Gilead Clinical Study Information Center', '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': 'Adverse Events (AEs): First dose date up to Week 12 or 24 (depending on group) plus 30 days (includes AEs occurring during the PK Lead-in Phase); All-Cause Mortality: Up to Posttreatment Week 24', 'description': 'Safety Analysis Set included all participants who took at least 1 dose of study drug.', 'eventGroups': [{'id': 'EG000', 'title': '12 to < 18 Years Old - SOF+RBV 12 Weeks', 'description': 'Participants 12 to \\< 18 years of age with HCV genotype 2 received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 12, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '12 to < 18 Years Old - SOF+RBV 24 Weeks', 'description': 'Participants 12 to \\< 18 years of age with HCV genotype 3 received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.', 'otherNumAtRisk': 39, 'deathsNumAtRisk': 39, 'otherNumAffected': 27, 'seriousNumAtRisk': 39, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': '6 to < 12 Years Old - SOF+RBV 12 Weeks', 'description': 'Participants 6 to \\< 12 years of age with HCV genotype 2 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 9, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': '6 to < 12 Years Old - SOF+RBV 24 Weeks', 'description': 'Participants 6 to \\< 12 years of age with HCV genotype 3 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.', 'otherNumAtRisk': 28, 'deathsNumAtRisk': 28, 'otherNumAffected': 24, 'seriousNumAtRisk': 28, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': '3 to < 6 Years Old - SOF+RBV 12 Weeks', 'description': 'Participants 3 to \\< 6 years of age with HCV genotype 2 received SOF (weight ≥ 17 kg: 200 mg granules; weight \\< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 5, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': '3 to < 6 Years Old - SOF+RBV 24 Weeks', 'description': 'Participants 3 to \\< 6 years of age with HCV genotype 3 received SOF (weight ≥ 17 kg: 200 mg granules; weight \\< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 8, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Motion sickness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Anal pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Epigastric discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Mouth ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Oral contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Tooth loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 11}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Seasonal allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Conjunctivitis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Ear infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Folliculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Fungal skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Impetigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Respiratory tract infection viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Tinea infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 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disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Rash papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Skin exfoliation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Tooth extraction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}], 'seriousEvents': [{'term': 'Accidental overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'For Participants in the PK Lead-in Phase, Pharmacokinetic (PK) Parameter: AUCtau of GS-331007 (Metabolite of SOF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks', 'description': 'Participants 12 to \\< 18 years of age received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.'}, {'id': 'OG001', 'title': 'PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks', 'description': 'Participants 6 to \\< 12 years of age received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.'}, {'id': 'OG002', 'title': 'PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks', 'description': 'Participants 3 to \\< 6 years of age received SOF (weight ≥ 17 kg: 200 mg granules; weight \\< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '9106.0', 'spread': '2601.96', 'groupId': 'OG000'}, {'value': '7651.2', 'spread': '1723.32', 'groupId': 'OG001'}, {'value': '10293.7', 'spread': '1860.57', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Percentage Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '129.48', 'ciLowerLimit': '109.96', 'ciUpperLimit': '152.48', 'groupDescription': 'AUCtau of GS-331007 for the 12 to \\< 18 Years old group in the PK Lead-in Phase was compared against historical data collected in adult Phase 2/3 studies.', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Equivalence was determined if the 90% confidence intervals (CI) were within the predefined equivalence boundaries of 50% to 200% for all age groups.'}, {'groupIds': ['OG001'], 'paramType': 'Percentage Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '109.80', 'ciLowerLimit': '93.25', 'ciUpperLimit': '129.29', 'groupDescription': 'AUCtau of GS-331007 for the 6 to \\< 12 Years Old group in the PK Lead-in Phase was compared against historical data collected in adult Phase 2/3 studies.', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Equivalence was determined if the 90% CIs were within the predefined equivalence boundaries of 50% to 200% for all age groups.'}, {'groupIds': ['OG002'], 'paramType': 'Percentage Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '149.67', 'ciLowerLimit': '127.12', 'ciUpperLimit': '176.21', 'groupDescription': 'AUCtau of GS-331007 for the 3 to \\< 6 Years Old group in the PK Lead-in Phase was compared against historical data collected in adult Phase 2/3 studies.', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Equivalence was determined if the 90% CIs were within the predefined equivalence boundaries of 50% to 200% for all age groups.'}], 'paramType': 'MEAN', 'timeFrame': '6 to < 18 years of age: predose, 0.5, 1, 2, 3, 4, 8, and 12 hours postdose on Day 7; 3 to < 6 years of age: predose, 2, 4, 8, and 12 hours postdose on Day 7', 'description': 'AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).', 'unitOfMeasure': 'h*ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intensive PK Analysis Set included all participants in the PK lead-in phase who received at least 1 dose of study drug and for whom at least 1 nonmissing PK concentration value, during the intensive sampling period, was reported by the PK laboratory.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event During the PK Lead-in Phase or the Treatment Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': '12 to < 18 Years Old - SOF+RBV 12 Weeks', 'description': 'Participants 12 to \\< 18 years of age with HCV genotype 2 received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.'}, {'id': 'OG001', 'title': '12 to < 18 Years Old - SOF+RBV 24 Weeks', 'description': 'Participants 12 to \\< 18 years of age with HCV genotype 3 received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.'}, {'id': 'OG002', 'title': '6 to < 12 Years Old - SOF+RBV 12 Weeks', 'description': 'Participants 6 to \\< 12 years of age with HCV genotype 2 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.'}, {'id': 'OG003', 'title': '6 to < 12 Years Old - SOF+RBV 24 Weeks', 'description': 'Participants 6 to \\< 12 years of age with HCV genotype 3 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.'}, {'id': 'OG004', 'title': '3 to < 6 Years Old - SOF+RBV 12 Weeks', 'description': 'Participants 3 to \\< 6 years of age with HCV genotype 2 received SOF (weight ≥ 17 kg: 200 mg granules; weight \\< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.'}, {'id': 'OG005', 'title': '3 to < 6 Years Old - SOF+RBV 24 Weeks', 'description': 'Participants 3 to \\< 6 years of age with HCV genotype 3 received SOF (weight ≥ 17 kg: 200 mg granules; weight \\< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '20.0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 24 weeks', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set included all participants who took at least 1 dose of study drug.'}, {'type': 'PRIMARY', 'title': 'For the Treatment Phase, Percentage of Participants With SVR at 12 Weeks After Discontinuation of Therapy (SVR12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '28', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '8', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': '12 to < 18 Years Old (Total) - SOF+RBV 12 or 24 Weeks', 'description': 'Participants 12 to \\< 18 years of age received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.'}, {'id': 'OG001', 'title': '3 to < 12 Years Old (Total) - SOF+RBV 12 or 24 Weeks', 'description': 'Participants 6 to \\< 12 years of age received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.\n\nParticipants 3 to \\< 6 years of age received SOF (weight ≥ 17 kg: 200 mg granules; weight \\< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.'}, {'id': 'OG002', 'title': '12 to < 18 Years Old - SOF+RBV 12 Weeks', 'description': 'Participants 12 to \\< 18 years of age with HCV genotype 2 received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.'}, {'id': 'OG003', 'title': '12 to < 18 Years Old - SOF+RBV 24 Weeks', 'description': 'Participants 12 to \\< 18 years of age with HCV genotype 3 received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.'}, {'id': 'OG004', 'title': '6 to < 12 Years Old - SOF+RBV 12 Weeks', 'description': 'Participants 6 to \\< 12 years of age with HCV genotype 2 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.'}, {'id': 'OG005', 'title': '6 to < 12 Years Old - SOF+RBV 24 Weeks', 'description': 'Participants 6 to \\< 12 years of age with HCV genotype 3 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.'}, {'id': 'OG006', 'title': '3 to < 6 Years Old - SOF+RBV 12 Weeks', 'description': 'Participants 3 to \\< 6 years of age with HCV genotype 2 received SOF (weight ≥ 17 kg: 200 mg granules; weight \\< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.'}, {'id': 'OG007', 'title': '3 to < 6 Years Old - SOF+RBV 24 Weeks', 'description': 'Participants 3 to \\< 6 years of age with HCV genotype 3 received SOF (weight ≥ 17 kg: 200 mg granules; weight \\< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '98.1', 'groupId': 'OG000', 'lowerLimit': '89.7', 'upperLimit': '100.0'}, {'value': '98.1', 'groupId': 'OG001', 'lowerLimit': '90.1', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '75.3', 'upperLimit': '100.0'}, {'value': '97.4', 'groupId': 'OG003', 'lowerLimit': '86.5', 'upperLimit': '99.9'}, {'value': '100.0', 'groupId': 'OG004', 'lowerLimit': '75.3', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG005', 'lowerLimit': '87.7', 'upperLimit': '100.0'}, {'value': '80.0', 'groupId': 'OG006', 'lowerLimit': '28.4', 'upperLimit': '99.5'}, {'value': '100.0', 'groupId': 'OG007', 'lowerLimit': '63.1', 'upperLimit': '100.0'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'groupDescription': 'The SVR12 rate for the 12 to \\< 18 Years Old group was compared with the historical SVR12 rate of 80% using a 2-sided exact 1-sample binomial test at the 0.05 significance level. If superiority was demonstrated in the 12 to \\< 18 Years Old group, then the SVR12 rate for participants aged 3 to \\< 12 years would be compared with 80% at the 0.05 significance level.', 'statisticalMethod': '2-sided exact 1-sample binomial test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG001'], 'groupDescription': 'The SVR12 rate for the 3 to \\< 12 Years Old group was compared with the historical SVR12 rate of 80% using a 2-sided exact 1-sample binomial test at the 0.05 significance level.', 'statisticalMethod': '2-sided exact 1-sample binomial test', 'nonInferiorityType': 'SUPERIORITY'}], '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 included all participants who were enrolled into the study and received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'For Participants in the PK Lead-in Phase, Change From Baseline in HCV RNA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 Weeks', 'description': 'Participants 12 to \\< 18 years of age with HCV genotype 2 received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.'}, {'id': 'OG001', 'title': 'PK Lead-in: 12 to < 18 Years Old - SOF+RBV 24 Weeks', 'description': 'Participants 12 to \\< 18 years of age with HCV genotype 3 received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.'}, {'id': 'OG002', 'title': 'PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 Weeks', 'description': 'Participants 6 to \\< 12 years of age with HCV genotype 2 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.'}, {'id': 'OG003', 'title': 'PK Lead-in: 6 to < 12 Years Old - SOF+RBV 24 Weeks', 'description': 'Participants 6 to \\< 12 years of age with HCV genotype 3 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.'}, {'id': 'OG004', 'title': 'PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 Weeks', 'description': 'Participants 3 to \\< 6 years of age with HCV genotype 2 received SOF (weight ≥ 17 kg: 200 mg granules; weight \\< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.'}, {'id': 'OG005', 'title': 'PK Lead-in: 3 to < 6 Years Old - SOF+RBV 24 Weeks', 'description': 'Participants 3 to \\< 6 years of age with HCV genotype 3 received SOF (weight ≥ 17 kg: 200 mg granules; weight \\< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.'}], 'classes': [{'title': 'Change at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-3.98', 'spread': '1.056', 'groupId': 'OG000'}, {'value': '-4.23', 'spread': '0.765', 'groupId': 'OG001'}, {'value': '-3.82', 'spread': '0.447', 'groupId': 'OG002'}, {'value': '-3.78', 'spread': '1.234', 'groupId': 'OG003'}, {'value': '-4.12', 'spread': '0.632', 'groupId': 'OG004'}, {'value': '-3.53', 'spread': '0.347', 'groupId': 'OG005'}]}]}, {'title': 'Change at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-4.84', 'spread': '0.743', 'groupId': 'OG000'}, {'value': '-4.34', 'spread': '0.758', 'groupId': 'OG001'}, {'value': '-4.92', 'spread': '0.674', 'groupId': 'OG002'}, {'value': '-4.56', 'spread': '1.553', 'groupId': 'OG003'}, {'value': '-4.31', 'spread': '0.846', 'groupId': 'OG004'}, {'value': '-3.94', 'spread': '0.422', 'groupId': 'OG005'}]}]}, {'title': 'Change at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-4.84', 'spread': '0.743', 'groupId': 'OG000'}, {'value': '-4.34', 'spread': '0.758', 'groupId': 'OG001'}, {'value': '-4.92', 'spread': '0.674', 'groupId': 'OG002'}, {'value': '-4.60', 'spread': '1.686', 'groupId': 'OG003'}, {'value': '-4.42', 'spread': '1.006', 'groupId': 'OG004'}, {'value': '-3.97', 'spread': '0.453', 'groupId': 'OG005'}]}]}, {'title': 'Change at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-4.84', 'spread': '0.743', 'groupId': 'OG000'}, {'value': '-4.34', 'spread': '0.758', 'groupId': 'OG001'}, {'value': '-4.92', 'spread': '0.674', 'groupId': 'OG002'}, {'value': '-4.61', 'spread': '1.700', 'groupId': 'OG003'}, {'value': '-4.52', 'spread': '1.177', 'groupId': 'OG004'}, {'value': '-3.97', 'spread': '0.453', 'groupId': 'OG005'}]}]}, {'title': 'Change at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-4.84', 'spread': '0.743', 'groupId': 'OG000'}, {'value': '-4.34', 'spread': '0.758', 'groupId': 'OG001'}, {'value': '-4.92', 'spread': '0.674', 'groupId': 'OG002'}, {'value': '-4.61', 'spread': '1.700', 'groupId': 'OG003'}, {'value': '-4.52', 'spread': '1.177', 'groupId': 'OG004'}, {'value': '-3.97', 'spread': '0.453', 'groupId': 'OG005'}]}]}, {'title': 'Change at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-4.34', 'spread': '0.758', 'groupId': 'OG001'}, {'value': '-4.61', 'spread': '1.700', 'groupId': 'OG003'}, {'value': '-3.97', 'spread': '0.453', 'groupId': 'OG005'}]}]}, {'title': 'Change at Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-4.34', 'spread': '0.758', 'groupId': 'OG001'}, {'value': '-4.61', 'spread': '1.700', 'groupId': 'OG003'}, {'value': '-3.97', 'spread': '0.453', 'groupId': 'OG005'}]}]}, {'title': 'Change at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-4.34', 'spread': '0.758', 'groupId': 'OG001'}, {'value': '-4.61', 'spread': '1.700', 'groupId': 'OG003'}, {'value': '-3.97', 'spread': '0.453', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Weeks 1, 2, 4, 8, and 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only)', 'unitOfMeasure': 'log10 IU/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who were enrolled in the PK lead-in phase with available data were analyzed. Participants from the 12 Weeks groups were not analyzed for Change at Weeks 16, 20, and 24 because they were only treated for 12 weeks.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event During the PK Lead-in Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PK Lead-in: 12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks', 'description': 'Participants 12 to \\< 18 years of age received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.'}, {'id': 'OG001', 'title': 'PK Lead-in: 6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks', 'description': 'Participants 6 to \\< 12 years of age received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.'}, {'id': 'OG002', 'title': 'PK Lead-in: 3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks', 'description': 'Participants 3 to \\< 6 years of age received SOF (weight ≥ 17 kg: 200 mg granules; weight \\< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Day 7', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who were enrolled in the PK lead-in phase were analyzed.'}, {'type': 'SECONDARY', 'title': 'For the Treatment Phase, Percentage of Participants With Sustained Virologic Response (SVR) at 4 Weeks After Discontinuation of Therapy (SVR4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': '12 to < 18 Years Old - SOF+RBV 12 Weeks', 'description': 'Participants 12 to \\< 18 years of age with HCV genotype 2 received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.'}, {'id': 'OG001', 'title': '12 to < 18 Years Old - SOF+RBV 24 Weeks', 'description': 'Participants 12 to \\< 18 years of age with HCV genotype 3 received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.'}, {'id': 'OG002', 'title': '6 to < 12 Years Old - SOF+RBV 12 Weeks', 'description': 'Participants 6 to \\< 12 years of age with HCV genotype 2 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.'}, {'id': 'OG003', 'title': '6 to < 12 Years Old - SOF+RBV 24 Weeks', 'description': 'Participants 6 to \\< 12 years of age with HCV genotype 3 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.'}, {'id': 'OG004', 'title': '3 to < 6 Years Old - SOF+RBV 12 Weeks', 'description': 'Participants 3 to \\< 6 years of age with HCV genotype 2 received SOF (weight ≥ 17 kg: 200 mg granules; weight \\< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.'}, {'id': 'OG005', 'title': '3 to < 6 Years Old - SOF+RBV 24 Weeks', 'description': 'Participants 3 to \\< 6 years of age with HCV genotype 3 received SOF (weight ≥ 17 kg: 200 mg granules; weight \\< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '75.3', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '91.0', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '75.3', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG003', 'lowerLimit': '87.7', 'upperLimit': '100.0'}, {'value': '80.0', 'groupId': 'OG004', 'lowerLimit': '28.4', 'upperLimit': '99.5'}, {'value': '100.0', 'groupId': 'OG005', 'lowerLimit': '63.1', 'upperLimit': '100.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Posttreatment Week 4', 'description': 'SVR4 was defined as HCV RNA \\< LLOQ at 4 weeks after stopping study treatment.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set were analyzed.'}, {'type': 'SECONDARY', 'title': 'For the Treatment Phase, Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': '12 to < 18 Years Old - SOF+RBV 12 Weeks', 'description': 'Participants 12 to \\< 18 years of age with HCV genotype 2 received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.'}, {'id': 'OG001', 'title': '12 to < 18 Years Old - SOF+RBV 24 Weeks', 'description': 'Participants 12 to \\< 18 years of age with HCV genotype 3 received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.'}, {'id': 'OG002', 'title': '6 to < 12 Years Old - SOF+RBV 12 Weeks', 'description': 'Participants 6 to \\< 12 years of age with HCV genotype 2 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.'}, {'id': 'OG003', 'title': '6 to < 12 Years Old - SOF+RBV 24 Weeks', 'description': 'Participants 6 to \\< 12 years of age with HCV genotype 3 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.'}, {'id': 'OG004', 'title': '3 to < 6 Years Old - SOF+RBV 12 Weeks', 'description': 'Participants 3 to \\< 6 years of age with HCV genotype 2 received SOF (weight ≥ 17 kg: 200 mg granules; weight \\< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.'}, {'id': 'OG005', 'title': '3 to < 6 Years Old - SOF+RBV 24 Weeks', 'description': 'Participants 3 to \\< 6 years of age with HCV genotype 3 received SOF (weight ≥ 17 kg: 200 mg granules; weight \\< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '75.3', 'upperLimit': '100.0'}, {'value': '97.4', 'groupId': 'OG001', 'lowerLimit': '86.5', 'upperLimit': '99.9'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '75.3', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG003', 'lowerLimit': '87.7', 'upperLimit': '100.0'}, {'value': '80.0', 'groupId': 'OG004', 'lowerLimit': '28.4', 'upperLimit': '99.5'}, {'value': '100.0', 'groupId': 'OG005', 'lowerLimit': '63.1', 'upperLimit': '100.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Posttreatment Week 24', 'description': 'SVR24 was defined as HCV RNA \\< LLOQ at 24 weeks after stopping study treatment.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set were analyzed.'}, {'type': 'SECONDARY', 'title': 'For the Treatment Phase, Percentage of Participants Experiencing Viral Breakthrough', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': '12 to < 18 Years Old - SOF+RBV 12 Weeks', 'description': 'Participants 12 to \\< 18 years of age with HCV genotype 2 received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.'}, {'id': 'OG001', 'title': '12 to < 18 Years Old - SOF+RBV 24 Weeks', 'description': 'Participants 12 to \\< 18 years of age with HCV genotype 3 received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.'}, {'id': 'OG002', 'title': '6 to < 12 Years Old - SOF+RBV 12 Weeks', 'description': 'Participants 6 to \\< 12 years of age with HCV genotype 2 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.'}, {'id': 'OG003', 'title': '6 to < 12 Years Old - SOF+RBV 24 Weeks', 'description': 'Participants 6 to \\< 12 years of age with HCV genotype 3 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.'}, {'id': 'OG004', 'title': '3 to < 6 Years Old - SOF+RBV 12 Weeks', 'description': 'Participants 3 to \\< 6 years of age with HCV genotype 2 received SOF (weight ≥ 17 kg: 200 mg granules; weight \\< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.'}, {'id': 'OG005', 'title': '3 to < 6 Years Old - SOF+RBV 24 Weeks', 'description': 'Participants 3 to \\< 6 years of age with HCV genotype 3 received SOF (weight ≥ 17 kg: 200 mg granules; weight \\< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 24 weeks', 'description': 'Viral breakthrough was defined as having confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA \\< LLOQ while on treatment.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set were analyzed.'}, {'type': 'SECONDARY', 'title': 'For the Treatment Phase, Percentage of Participants Experiencing Viral Relapse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': '12 to < 18 Years Old - SOF+RBV 12 Weeks', 'description': 'Participants 12 to \\< 18 years of age with HCV genotype 2 received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.'}, {'id': 'OG001', 'title': '12 to < 18 Years Old - SOF+RBV 24 Weeks', 'description': 'Participants 12 to \\< 18 years of age with HCV genotype 3 received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.'}, {'id': 'OG002', 'title': '6 to < 12 Years Old - SOF+RBV 12 Weeks', 'description': 'Participants 6 to \\< 12 years of age with HCV genotype 2 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.'}, {'id': 'OG003', 'title': '6 to < 12 Years Old - SOF+RBV 24 Weeks', 'description': 'Participants 6 to \\< 12 years of age with HCV genotype 3 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.'}, {'id': 'OG004', 'title': '3 to < 6 Years Old - SOF+RBV 12 Weeks', 'description': 'Participants 3 to \\< 6 years of age with HCV genotype 2 received SOF (weight ≥ 17 kg: 200 mg granules; weight \\< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.'}, {'id': 'OG005', 'title': '3 to < 6 Years Old - SOF+RBV 24 Weeks', 'description': 'Participants 3 to \\< 6 years of age with HCV genotype 3 received SOF (weight ≥ 17 kg: 200 mg granules; weight \\< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Posttreatment Week 24', 'description': 'Viral relapse was defined as having 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': 'Participants in the Full Analysis Set were analyzed.'}, {'type': 'SECONDARY', 'title': 'For the Treatment Phase, Change From Baseline in HCV RNA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': '12 to < 18 Years Old - SOF+RBV 12 Weeks', 'description': 'Participants 12 to \\< 18 years of age with HCV genotype 2 received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.'}, {'id': 'OG001', 'title': '12 to < 18 Years Old - SOF+RBV 24 Weeks', 'description': 'Participants 12 to \\< 18 years of age with HCV genotype 3 received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.'}, {'id': 'OG002', 'title': '6 to < 12 Years Old - SOF+RBV 12 Weeks', 'description': 'Participants 6 to \\< 12 years of age with HCV genotype 2 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.'}, {'id': 'OG003', 'title': '6 to < 12 Years Old - SOF+RBV 24 Weeks', 'description': 'Participants 6 to \\< 12 years of age with HCV genotype 3 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.'}, {'id': 'OG004', 'title': '3 to < 6 Years Old - SOF+RBV 12 Weeks', 'description': 'Participants 3 to \\< 6 years of age with HCV genotype 2 received SOF (weight ≥ 17 kg: 200 mg granules; weight \\< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.'}, {'id': 'OG005', 'title': '3 to < 6 Years Old - SOF+RBV 24 Weeks', 'description': 'Participants 3 to \\< 6 years of age with HCV genotype 3 received SOF (weight ≥ 17 kg: 200 mg granules; weight \\< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.'}], 'classes': [{'title': 'Change at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-4.25', 'spread': '0.986', 'groupId': 'OG000'}, {'value': '-4.12', 'spread': '0.733', 'groupId': 'OG001'}, {'value': '-4.12', 'spread': '0.692', 'groupId': 'OG002'}, {'value': '-3.88', 'spread': '0.928', 'groupId': 'OG003'}, {'value': '-4.12', 'spread': '0.632', 'groupId': 'OG004'}, {'value': '-3.53', 'spread': '0.347', 'groupId': 'OG005'}]}]}, {'title': 'Change at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-4.74', 'spread': '0.980', 'groupId': 'OG000'}, {'value': '-4.86', 'spread': '0.702', 'groupId': 'OG001'}, {'value': '-4.55', 'spread': '0.812', 'groupId': 'OG002'}, {'value': '-4.51', 'spread': '1.102', 'groupId': 'OG003'}, {'value': '-4.31', 'spread': '0.846', 'groupId': 'OG004'}, {'value': '-3.94', 'spread': '0.422', 'groupId': 'OG005'}]}]}, {'title': 'Change at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-4.74', 'spread': '0.980', 'groupId': 'OG000'}, {'value': '-5.01', 'spread': '0.760', 'groupId': 'OG001'}, {'value': '-4.68', 'spread': '0.843', 'groupId': 'OG002'}, {'value': '-4.56', 'spread': '1.171', 'groupId': 'OG003'}, {'value': '-4.42', 'spread': '1.006', 'groupId': 'OG004'}, {'value': '-3.97', 'spread': '0.453', 'groupId': 'OG005'}]}]}, {'title': 'Change at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-4.74', 'spread': '0.980', 'groupId': 'OG000'}, {'value': '-5.02', 'spread': '0.771', 'groupId': 'OG001'}, {'value': '-4.68', 'spread': '0.843', 'groupId': 'OG002'}, {'value': '-4.54', 'spread': '1.191', 'groupId': 'OG003'}, {'value': '-4.52', 'spread': '1.177', 'groupId': 'OG004'}, {'value': '-3.97', 'spread': '0.453', 'groupId': 'OG005'}]}]}, {'title': 'Change at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-4.74', 'spread': '0.980', 'groupId': 'OG000'}, {'value': '-5.02', 'spread': '0.771', 'groupId': 'OG001'}, {'value': '-4.68', 'spread': '0.843', 'groupId': 'OG002'}, {'value': '-4.57', 'spread': '1.178', 'groupId': 'OG003'}, {'value': '-4.52', 'spread': '1.177', 'groupId': 'OG004'}, {'value': '-3.97', 'spread': '0.453', 'groupId': 'OG005'}]}]}, {'title': 'Change at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-5.02', 'spread': '0.771', 'groupId': 'OG001'}, {'value': '-4.57', 'spread': '1.178', 'groupId': 'OG003'}, {'value': '-3.97', 'spread': '0.453', 'groupId': 'OG005'}]}]}, {'title': 'Change at Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-5.02', 'spread': '0.771', 'groupId': 'OG001'}, {'value': '-4.57', 'spread': '1.178', 'groupId': 'OG003'}, {'value': '-3.97', 'spread': '0.453', 'groupId': 'OG005'}]}]}, {'title': 'Change at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-5.02', 'spread': '0.771', 'groupId': 'OG001'}, {'value': '-4.57', 'spread': '1.178', 'groupId': 'OG003'}, {'value': '-3.97', 'spread': '0.453', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only)', 'unitOfMeasure': 'log10 IU/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set with available data were analyzed. Participants from the 12 Weeks groups were not analyzed for Change at Weeks 16, 20, and 24 because they were only treated for 12 weeks.'}, {'type': 'SECONDARY', 'title': 'For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': '12 to < 18 Years Old - SOF+RBV 12 Weeks', 'description': 'Participants 12 to \\< 18 years of age with HCV genotype 2 received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.'}, {'id': 'OG001', 'title': '12 to < 18 Years Old - SOF+RBV 24 Weeks', 'description': 'Participants 12 to \\< 18 years of age with HCV genotype 3 received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.'}, {'id': 'OG002', 'title': '6 to < 12 Years Old - SOF+RBV 12 Weeks', 'description': 'Participants 6 to \\< 12 years of age with HCV genotype 2 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.'}, {'id': 'OG003', 'title': '6 to < 12 Years Old - SOF+RBV 24 Weeks', 'description': 'Participants 6 to \\< 12 years of age with HCV genotype 3 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.'}, {'id': 'OG004', 'title': '3 to < 6 Years Old - SOF+RBV 12 Weeks', 'description': 'Participants 3 to \\< 6 years of age with HCV genotype 2 received SOF (weight ≥ 17 kg: 200 mg granules; weight \\< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.'}, {'id': 'OG005', 'title': '3 to < 6 Years Old - SOF+RBV 24 Weeks', 'description': 'Participants 3 to \\< 6 years of age with HCV genotype 3 received SOF (weight ≥ 17 kg: 200 mg granules; weight \\< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.'}], 'classes': [{'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '30.8', 'groupId': 'OG000', 'lowerLimit': '9.1', 'upperLimit': '61.4'}, {'value': '30.8', 'groupId': 'OG001', 'lowerLimit': '17.0', 'upperLimit': '47.6'}, {'value': '46.2', 'groupId': 'OG002', 'lowerLimit': '19.2', 'upperLimit': '74.9'}, {'value': '39.3', 'groupId': 'OG003', 'lowerLimit': '21.5', 'upperLimit': '59.4'}, {'value': '50.0', 'groupId': 'OG004', 'lowerLimit': '6.8', 'upperLimit': '93.2'}, {'value': '37.5', 'groupId': 'OG005', 'lowerLimit': '8.5', 'upperLimit': '75.5'}]}]}, {'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '75.3', 'upperLimit': '100.0'}, {'value': '74.4', 'groupId': 'OG001', 'lowerLimit': '57.9', 'upperLimit': '87.0'}, {'value': '76.9', 'groupId': 'OG002', 'lowerLimit': '46.2', 'upperLimit': '95.0'}, {'value': '78.6', 'groupId': 'OG003', 'lowerLimit': '59.0', 'upperLimit': '91.7'}, {'value': '75.0', 'groupId': 'OG004', 'lowerLimit': '19.4', 'upperLimit': '99.4'}, {'value': '87.5', 'groupId': 'OG005', 'lowerLimit': '47.3', 'upperLimit': '99.7'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '75.3', 'upperLimit': '100.0'}, {'value': '92.3', 'groupId': 'OG001', 'lowerLimit': '79.1', 'upperLimit': '98.4'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '75.3', 'upperLimit': '100.0'}, {'value': '96.4', 'groupId': 'OG003', 'lowerLimit': '81.7', 'upperLimit': '99.9'}, {'value': '75.0', 'groupId': 'OG004', 'lowerLimit': '19.4', 'upperLimit': '99.4'}, {'value': '100.0', 'groupId': 'OG005', 'lowerLimit': '63.1', 'upperLimit': '100.0'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '75.3', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '91.0', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '75.3', 'upperLimit': '100.0'}, {'value': '96.4', 'groupId': 'OG003', 'lowerLimit': '81.7', 'upperLimit': '99.9'}, {'value': '100.0', 'groupId': 'OG004', 'lowerLimit': '39.8', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG005', 'lowerLimit': '63.1', 'upperLimit': '100.0'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '75.3', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '91.0', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '75.3', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG003', 'lowerLimit': '87.7', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG004', 'lowerLimit': '39.8', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG005', 'lowerLimit': '63.1', 'upperLimit': '100.0'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '91.0', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG003', 'lowerLimit': '87.7', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG005', 'lowerLimit': '63.1', 'upperLimit': '100.0'}]}]}, {'title': 'Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '91.0', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG003', 'lowerLimit': '87.7', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG005', 'lowerLimit': '63.1', 'upperLimit': '100.0'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '91.0', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG003', 'lowerLimit': '87.7', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG005', 'lowerLimit': '63.1', 'upperLimit': '100.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only)', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set with available data were analyzed. Participants from the 12 Weeks groups were not analyzed for Weeks 16, 20, and 24 because they were only treated for 12 weeks.'}, {'type': 'SECONDARY', 'title': 'For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': '12 to < 18 Years Old - SOF+RBV 12 Weeks', 'description': 'Participants 12 to \\< 18 years of age with HCV genotype 2 received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.'}, {'id': 'OG001', 'title': '12 to < 18 Years Old - SOF+RBV 24 Weeks', 'description': 'Participants 12 to \\< 18 years of age with HCV genotype 3 received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.'}, {'id': 'OG002', 'title': '6 to < 12 Years Old - SOF+RBV 12 Weeks', 'description': 'Participants 6 to \\< 12 years of age with HCV genotype 2 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.'}, {'id': 'OG003', 'title': '6 to < 12 Years Old - SOF+RBV 24 Weeks', 'description': 'Participants 6 to \\< 12 years of age with HCV genotype 3 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.'}, {'id': 'OG004', 'title': '3 to < 6 Years Old - SOF+RBV 12 Weeks', 'description': 'Participants 3 to \\< 6 years of age with HCV genotype 2 received SOF (weight ≥ 17 kg: 200 mg granules; weight \\< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.'}, {'id': 'OG005', 'title': '3 to < 6 Years Old - SOF+RBV 24 Weeks', 'description': 'Participants 3 to \\< 6 years of age with HCV genotype 3 received SOF (weight ≥ 17 kg: 200 mg granules; weight \\< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.'}], 'classes': [{'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}, {'value': '63.6', 'groupId': 'OG001'}, {'value': '25.0', 'groupId': 'OG002'}, {'value': '75.0', 'groupId': 'OG003'}, {'value': '100.0', 'groupId': 'OG005'}]}]}, {'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '90.9', 'groupId': 'OG001'}, {'value': '100.0', 'groupId': 'OG002'}, {'value': '93.3', 'groupId': 'OG003'}, {'value': '100.0', 'groupId': 'OG005'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '95.5', 'groupId': 'OG001'}, {'value': '100.0', 'groupId': 'OG002'}, {'value': '100.0', 'groupId': 'OG003'}, {'value': '100.0', 'groupId': 'OG005'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '95.5', 'groupId': 'OG001'}, {'value': '100.0', 'groupId': 'OG002'}, {'value': '100.0', 'groupId': 'OG003'}, {'value': '100.0', 'groupId': 'OG005'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}, {'value': '100.0', 'groupId': 'OG002'}, {'value': '100.0', 'groupId': 'OG003'}, {'value': '100.0', 'groupId': 'OG005'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG001'}, {'value': '100.0', 'groupId': 'OG003'}, {'value': '100.0', 'groupId': 'OG005'}]}]}, {'title': 'Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG001'}, {'value': '100.0', 'groupId': 'OG003'}, {'value': '100.0', 'groupId': 'OG005'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG001'}, {'value': '100.0', 'groupId': 'OG003'}, {'value': '100.0', 'groupId': 'OG005'}]}]}, {'title': 'Posttreatment Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}, {'value': '100.0', 'groupId': 'OG002'}, {'value': '100.0', 'groupId': 'OG003'}, {'value': '100.0', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only), and Posttreatment Week 4', 'description': 'ALT normalization was defined as ALT \\> the upper limit of normal (ULN) at baseline and ALT ≤ ULN at each visit. One participant in the 3 to \\< 6 Years Old 12 Weeks group had ALT \\> ULN at Baseline, but had no other available data.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set with ALT \\> ULN at Baseline with available data were analyzed. Participants from the 12 Weeks groups were not analyzed for Weeks 16, 20, and 24 because they were only treated for 12 weeks. One participant in the 3 to \\< 6 Years Old 12 Weeks group had ALT \\> ULN at Baseline, but had no other available data.'}, {'type': 'SECONDARY', 'title': 'For the Treatment Phase, Change From Baseline in Height', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': '12 to < 18 Years Old - SOF+RBV 12 Weeks', 'description': 'Participants 12 to \\< 18 years of age with HCV genotype 2 received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.'}, {'id': 'OG001', 'title': '12 to < 18 Years Old - SOF+RBV 24 Weeks', 'description': 'Participants 12 to \\< 18 years of age with HCV genotype 3 received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.'}, {'id': 'OG002', 'title': '6 to < 12 Years Old - SOF+RBV 12 Weeks', 'description': 'Participants 6 to \\< 12 years of age with HCV genotype 2 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.'}, {'id': 'OG003', 'title': '6 to < 12 Years Old - SOF+RBV 24 Weeks', 'description': 'Participants 6 to \\< 12 years of age with HCV genotype 3 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.'}, {'id': 'OG004', 'title': '3 to < 6 Years Old - SOF+RBV 12 Weeks', 'description': 'Participants 3 to \\< 6 years of age with HCV genotype 2 received SOF (weight ≥ 17 kg: 200 mg granules; weight \\< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.'}, {'id': 'OG005', 'title': '3 to < 6 Years Old - SOF+RBV 24 Weeks', 'description': 'Participants 3 to \\< 6 years of age with HCV genotype 3 received SOF (weight ≥ 17 kg: 200 mg granules; weight \\< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.'}], 'classes': [{'title': 'Change at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '1.10', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.57', 'groupId': 'OG001'}, {'value': '0.0', 'spread': '0.57', 'groupId': 'OG002'}, {'value': '0.0', 'spread': '0.73', 'groupId': 'OG003'}, {'value': '0.3', 'spread': '1.12', 'groupId': 'OG004'}, {'value': '0.3', 'spread': '0.75', 'groupId': 'OG005'}]}]}, {'title': 'Change at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '1.07', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '0.59', 'groupId': 'OG001'}, {'value': '0.1', 'spread': '0.66', 'groupId': 'OG002'}, {'value': '0.0', 'spread': '0.54', 'groupId': 'OG003'}, {'value': '0.7', 'spread': '1.09', 'groupId': 'OG004'}, {'value': '0.3', 'spread': '0.50', 'groupId': 'OG005'}]}]}, {'title': 'Change at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '1.20', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '0.78', 'groupId': 'OG001'}, {'value': '0.3', 'spread': '0.67', 'groupId': 'OG002'}, {'value': '0.4', 'spread': '0.74', 'groupId': 'OG003'}, {'value': '0.9', 'spread': '0.87', 'groupId': 'OG004'}, {'value': '0.5', 'spread': '0.67', 'groupId': 'OG005'}]}]}, {'title': 'Change at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '1.27', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '0.85', 'groupId': 'OG001'}, {'value': '1.0', 'spread': '1.00', 'groupId': 'OG002'}, {'value': '0.4', 'spread': '0.62', 'groupId': 'OG003'}, {'value': '0.9', 'spread': '0.72', 'groupId': 'OG004'}, {'value': '0.8', 'spread': '0.51', 'groupId': 'OG005'}]}]}, {'title': 'Change at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.5', 'spread': '1.68', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.95', 'groupId': 'OG001'}, {'value': '0.8', 'spread': '0.81', 'groupId': 'OG002'}, {'value': '0.7', 'spread': '0.68', 'groupId': 'OG003'}, {'value': '1.5', 'spread': '0.45', 'groupId': 'OG004'}, {'value': '1.7', 'spread': '1.84', 'groupId': 'OG005'}]}]}, {'title': 'Change at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.91', 'groupId': 'OG001'}, {'value': '1.1', 'spread': '0.93', 'groupId': 'OG003'}, {'value': '1.8', 'spread': '0.79', 'groupId': 'OG005'}]}]}, {'title': 'Change at Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.5', 'spread': '1.10', 'groupId': 'OG001'}, {'value': '1.6', 'spread': '1.15', 'groupId': 'OG003'}, {'value': '2.5', 'spread': '1.01', 'groupId': 'OG005'}]}]}, {'title': 'Change at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.8', 'spread': '1.54', 'groupId': 'OG001'}, {'value': '2.1', 'spread': '0.88', 'groupId': 'OG003'}, {'value': '2.7', 'spread': '1.05', 'groupId': 'OG005'}]}]}, {'title': 'Change at Posttreatment Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.5', 'spread': '1.79', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '1.70', 'groupId': 'OG001'}, {'value': '1.4', 'spread': '0.80', 'groupId': 'OG002'}, {'value': '2.6', 'spread': '1.17', 'groupId': 'OG003'}, {'value': '1.6', 'spread': '0.91', 'groupId': 'OG004'}, {'value': '3.5', 'spread': '0.85', 'groupId': 'OG005'}]}]}, {'title': 'Change at Posttreatment Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1.4', 'spread': '1.65', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '1.90', 'groupId': 'OG001'}, {'value': '2.4', 'spread': '1.02', 'groupId': 'OG002'}, {'value': '3.8', 'spread': '1.30', 'groupId': 'OG003'}, {'value': '2.8', 'spread': '1.81', 'groupId': 'OG004'}, {'value': '4.0', 'spread': '0.95', 'groupId': 'OG005'}]}]}, {'title': 'Change at Posttreatment Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1.6', 'spread': '1.89', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '2.83', 'groupId': 'OG001'}, {'value': '4.2', 'spread': '1.11', 'groupId': 'OG002'}, {'value': '5.1', 'spread': '1.59', 'groupId': 'OG003'}, {'value': '5.0', 'spread': '1.61', 'groupId': 'OG004'}, {'value': '5.7', 'spread': '1.27', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only), and Posttreatment Weeks 4, 12, and 24', 'unitOfMeasure': 'centimeters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Safety Analysis Set with available data were analyzed. Participants from the 12 Weeks groups were not analyzed for Change at Weeks 16, 20, and 24 because they were only treated for 12 weeks.'}, {'type': 'SECONDARY', 'title': 'For the Treatment Phase, Change From Baseline in Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': '12 to < 18 Years Old - SOF+RBV 12 Weeks', 'description': 'Participants 12 to \\< 18 years of age with HCV genotype 2 received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.'}, {'id': 'OG001', 'title': '12 to < 18 Years Old - SOF+RBV 24 Weeks', 'description': 'Participants 12 to \\< 18 years of age with HCV genotype 3 received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.'}, {'id': 'OG002', 'title': '6 to < 12 Years Old - SOF+RBV 12 Weeks', 'description': 'Participants 6 to \\< 12 years of age with HCV genotype 2 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.'}, {'id': 'OG003', 'title': '6 to < 12 Years Old - SOF+RBV 24 Weeks', 'description': 'Participants 6 to \\< 12 years of age with HCV genotype 3 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.'}, {'id': 'OG004', 'title': '3 to < 6 Years Old - SOF+RBV 12 Weeks', 'description': 'Participants 3 to \\< 6 years of age with HCV genotype 2 received SOF (weight ≥ 17 kg: 200 mg granules; weight \\< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.'}, {'id': 'OG005', 'title': '3 to < 6 Years Old - SOF+RBV 24 Weeks', 'description': 'Participants 3 to \\< 6 years of age with HCV genotype 3 received SOF (weight ≥ 17 kg: 200 mg granules; weight \\< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.'}], 'classes': [{'title': 'Change at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-0.7', 'spread': '1.28', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '1.36', 'groupId': 'OG001'}, {'value': '0.2', 'spread': '0.82', 'groupId': 'OG002'}, {'value': '0.0', 'spread': '0.55', 'groupId': 'OG003'}, {'value': '0.2', 'spread': '0.10', 'groupId': 'OG004'}, {'value': '-0.2', 'spread': '0.51', 'groupId': 'OG005'}]}]}, {'title': 'Change at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'spread': '0.87', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '0.99', 'groupId': 'OG001'}, {'value': '0.3', 'spread': '1.08', 'groupId': 'OG002'}, {'value': '0.0', 'spread': '0.64', 'groupId': 'OG003'}, {'value': '0.5', 'spread': '0.21', 'groupId': 'OG004'}, {'value': '-0.1', 'spread': '0.50', 'groupId': 'OG005'}]}]}, {'title': 'Change at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'spread': '1.67', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '1.15', 'groupId': 'OG001'}, {'value': '0.4', 'spread': '0.90', 'groupId': 'OG002'}, {'value': '0.1', 'spread': '0.90', 'groupId': 'OG003'}, {'value': '0.0', 'spread': '0.22', 'groupId': 'OG004'}, {'value': '-0.1', 'spread': '0.49', 'groupId': 'OG005'}]}]}, {'title': 'Change at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'spread': '2.39', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '1.53', 'groupId': 'OG001'}, {'value': '0.6', 'spread': '1.57', 'groupId': 'OG002'}, {'value': '0.1', 'spread': '1.21', 'groupId': 'OG003'}, {'value': '0.3', 'spread': '0.14', 'groupId': 'OG004'}, {'value': '0.0', 'spread': '0.55', 'groupId': 'OG005'}]}]}, {'title': 'Change at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'spread': '2.62', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '2.01', 'groupId': 'OG001'}, {'value': '0.9', 'spread': '2.15', 'groupId': 'OG002'}, {'value': '0.5', 'spread': '1.35', 'groupId': 'OG003'}, {'value': '0.3', 'spread': '0.22', 'groupId': 'OG004'}, {'value': '0.1', 'spread': '0.85', 'groupId': 'OG005'}]}]}, {'title': 'Change at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '2.35', 'groupId': 'OG001'}, {'value': '0.6', 'spread': '1.34', 'groupId': 'OG003'}, {'value': '0.1', 'spread': '0.76', 'groupId': 'OG005'}]}]}, {'title': 'Change at Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '2.65', 'groupId': 'OG001'}, {'value': '0.9', 'spread': '1.59', 'groupId': 'OG003'}, {'value': '0.4', 'spread': '0.86', 'groupId': 'OG005'}]}]}, {'title': 'Change at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.5', 'spread': '3.13', 'groupId': 'OG001'}, {'value': '1.2', 'spread': '1.91', 'groupId': 'OG003'}, {'value': '0.4', 'spread': '1.03', 'groupId': 'OG005'}]}]}, {'title': 'Change at Posttreatment Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'spread': '3.19', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '3.24', 'groupId': 'OG001'}, {'value': '1.2', 'spread': '2.20', 'groupId': 'OG002'}, {'value': '1.3', 'spread': '2.19', 'groupId': 'OG003'}, {'value': '0.5', 'spread': '0.27', 'groupId': 'OG004'}, {'value': '0.7', 'spread': '1.05', 'groupId': 'OG005'}]}]}, {'title': 'Change at Posttreatment Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.9', 'spread': '2.69', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '3.73', 'groupId': 'OG001'}, {'value': '2.1', 'spread': '3.28', 'groupId': 'OG002'}, {'value': '2.2', 'spread': '2.21', 'groupId': 'OG003'}, {'value': '1.0', 'spread': '0.88', 'groupId': 'OG004'}, {'value': '0.9', 'spread': '1.12', 'groupId': 'OG005'}]}]}, {'title': 'Change at Posttreatment Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '2.5', 'spread': '4.98', 'groupId': 'OG000'}, {'value': '3.0', 'spread': '4.62', 'groupId': 'OG001'}, {'value': '3.8', 'spread': '3.67', 'groupId': 'OG002'}, {'value': '3.5', 'spread': '2.42', 'groupId': 'OG003'}, {'value': '1.3', 'spread': '1.10', 'groupId': 'OG004'}, {'value': '1.7', 'spread': '1.28', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only), and Posttreatment Weeks 4, 12, and 24', 'unitOfMeasure': 'kilograms', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Safety Analysis Set with available data were analyzed. Participants from the 12 Weeks groups were not analyzed for Change at Weeks 16, 20, and 24 because they were only treated for 12 weeks.'}, {'type': 'SECONDARY', 'title': 'For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Pubic Hair', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks', 'description': 'Male participants 12 to \\< 18 years of age received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.'}, {'id': 'OG001', 'title': '6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks', 'description': 'Male participants 6 to \\< 12 years of age received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.'}, {'id': 'OG002', 'title': '3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks', 'description': 'Male participants 3 to \\< 6 years of age received SOF (weight ≥ 17 kg: 200 mg granules; weight \\< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.'}], 'classes': [{'title': 'End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'title': 'No Change', 'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}, {'title': 'Increase', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Decrease', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Posttreatment Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'title': 'No Change', 'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}, {'title': 'Increase', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Decrease', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Posttreatment Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'title': 'No Change', 'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}, {'title': 'Increase', 'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Decrease', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline; End of Treatment (either Week 12 or 24), Posttreatment Week 12, and Posttreatment Week 24', 'description': 'Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). Any shifts (increase or decrease) in Tanner Stage from Baseline were analyzed and presented.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Male participants in the Safety Analysis Set with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Genitalia Development', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks', 'description': 'Male participants 12 to \\< 18 years of age received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.'}, {'id': 'OG001', 'title': '6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks', 'description': 'Male participants 6 to \\< 12 years of age received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.'}, {'id': 'OG002', 'title': '3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks', 'description': 'Male participants 3 to \\< 6 years of age received SOF (weight ≥ 17 kg: 200 mg granules; weight \\< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.'}], 'classes': [{'title': 'End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'title': 'No Change', 'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}, {'title': 'Increase', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Decrease', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Posttreatment Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'title': 'No Change', 'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}, {'title': 'Increase', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Decrease', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Posttreatment Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'title': 'No Change', 'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}, {'title': 'Increase', 'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Decrease', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline; End of Treatment (either Week 12 or 24), Posttreatment Week 12, and Posttreatment Week 24', 'description': 'Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). Any shifts (increase or decrease) in Tanner Stage from Baseline were analyzed and presented.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Male participants in the Safety Analysis Set with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Pubic Hair', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks', 'description': 'Female participants 12 to \\< 18 years of age received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.'}, {'id': 'OG001', 'title': '6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks', 'description': 'Female participants 6 to \\< 12 years of age received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.'}, {'id': 'OG002', 'title': '3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks', 'description': 'Female participants 3 to \\< 6 years of age received SOF (weight ≥ 17 kg: 200 mg granules; weight \\< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.'}], 'classes': [{'title': 'End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'title': 'No Change', 'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}, {'title': 'Increase', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Decrease', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Posttreatment Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'title': 'No Change', 'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}, {'title': 'Increase', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Decrease', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Posttreatment Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'title': 'No Change', 'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}, {'title': 'Increase', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Decrease', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline; End of Treatment (either Week 12 or 24), Posttreatment Week 12, and Posttreatment Week 24', 'description': 'Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). Any shifts (increase or decrease) in Tanner Stage from Baseline were analyzed and presented.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Female participants in the Safety Analysis Set with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Breast Development', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks', 'description': 'Female participants 12 to \\< 18 years of age received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.'}, {'id': 'OG001', 'title': '6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks', 'description': 'Female participants 6 to \\< 12 years of age received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.'}, {'id': 'OG002', 'title': '3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks', 'description': 'Female participants 3 to \\< 6 years of age received SOF (weight ≥ 17 kg: 200 mg granules; weight \\< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.'}], 'classes': [{'title': 'End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'title': 'No Change', 'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}, {'title': 'Increase', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Decrease', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Posttreatment Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'title': 'No Change', 'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}, {'title': 'Increase', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Decrease', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Posttreatment Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'title': 'No Change', 'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}, {'title': 'Increase', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Decrease', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline; End of Treatment (either Week 12 or 24), Posttreatment Week 12, and Posttreatment Week 24', 'description': 'Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). Any shifts (increase or decrease) in Tanner Stage from Baseline were analyzed and presented.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Female participants in the Safety Analysis Set with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'For the Treatment Phase, Palatability of SOF Granules at Day 1 as Assessed by the Percentage of Participants Able/Unable to Taste the SOF Oral Granules', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '12 to < 18 Years Old - SOF+RBV 12 or 24 Weeks', 'description': 'Participants 12 to \\< 18 years of age received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.'}, {'id': 'OG001', 'title': '6 to < 12 Years Old - SOF+RBV 12 or 24 Weeks', 'description': 'Participants 6 to \\< 12 years of age received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.'}, {'id': 'OG002', 'title': '3 to < 6 Years Old - SOF+RBV 12 or 24 Weeks', 'description': 'Participants 3 to \\< 6 years of age received SOF (weight ≥ 17 kg: 200 mg granules; weight \\< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 or 24 weeks.'}], 'classes': [{'title': 'Able to Taste SOF Granules: Yes', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '42.9', 'groupId': 'OG001'}, {'value': '75.0', 'groupId': 'OG002'}]}]}, {'title': 'Able to Taste SOF Granules: No', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '57.1', 'groupId': 'OG001'}, {'value': '25.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1', 'description': 'Participants were asked if they were able to taste the SOF oral granules.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Safety Analysis Set who performed the palatability assessment were analyzed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '12 to < 18 Years Old - SOF+RBV 12 Weeks', 'description': 'Participants 12 to \\< 18 years of age with hepatitis C virus (HCV) genotype 2 received sofosbuvir (SOF) 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + ribavirin (RBV) capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks. Participants participating in the Pharmacokinetic (PK) Lead-in Phase immediately rolled over into the Treatment Phase without interruption to study drug administration.'}, {'id': 'FG001', 'title': '12 to < 18 Years Old - SOF+RBV 24 Weeks', 'description': 'Participants 12 to \\< 18 years of age with HCV genotype 3 received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks. Participants participating in the PK Lead-in Phase immediately rolled over into the Treatment Phase without interruption to study drug administration.'}, {'id': 'FG002', 'title': '6 to < 12 Years Old - SOF+RBV 12 Weeks', 'description': 'Participants 6 to \\< 12 years of age with HCV genotype 2 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks. Participants participating in the PK Lead-in Phase immediately rolled over into the Treatment Phase without interruption to study drug administration.'}, {'id': 'FG003', 'title': '6 to < 12 Years Old - SOF+RBV 24 Weeks', 'description': 'Participants 6 to \\< 12 years of age with HCV genotype 3 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks. Participants participating in the PK Lead-in Phase immediately rolled over into the Treatment Phase without interruption to study drug administration.'}, {'id': 'FG004', 'title': '3 to < 6 Years Old - SOF+RBV 12 Weeks', 'description': 'Participants 3 to \\< 6 years of age with HCV genotype 2 received SOF (weight ≥ 17 kg: 200 mg granules; weight \\< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks. Participants participating in the PK Lead-in Phase immediately rolled over into the Treatment Phase without interruption to study drug administration.'}, {'id': 'FG005', 'title': '3 to < 6 Years Old - SOF+RBV 24 Weeks', 'description': 'Participants 3 to \\< 6 years of age with HCV genotype 3 received SOF (weight ≥ 17 kg: 200 mg granules; weight \\< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks. Participants participating in the PK Lead-in Phase immediately rolled over into the Treatment Phase without interruption to study drug administration.'}], 'periods': [{'title': 'PK Lead-in Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '10'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '10'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Treatment Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '9 participants enrolled directly into the Treatment Phase, without entering the PK Lead-In Phase.', 'groupId': 'FG000', 'numSubjects': '13'}, {'comment': '33 participants enrolled directly into the Treatment Phase, without entering the PK Lead-In Phase.', 'groupId': 'FG001', 'numSubjects': '39'}, {'comment': '11 participants enrolled directly into the Treatment Phase, without entering the PK Lead-In Phase.', 'groupId': 'FG002', 'numSubjects': '13'}, {'comment': '18 participants enrolled directly into the Treatment Phase, without entering the PK Lead-In Phase.', 'groupId': 'FG003', 'numSubjects': '28'}, {'comment': '1 participant enrolled directly into the Treatment Phase, without entering the PK Lead-In Phase.', 'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '38'}, {'groupId': 'FG002', 'numSubjects': '13'}, {'groupId': 'FG003', 'numSubjects': '28'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were enrolled at study sites in Australia, Europe, Russia, New Zealand, and the United States. The first participant was screened on 07 July 2014. The last study visit occurred on 13 September 2018.', 'preAssignmentDetails': '135 participants were screened.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}, {'value': '106', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': '12 to < 18 Years Old - SOF+RBV 12 Weeks', 'description': 'Participants 12 to \\< 18 years of age with HCV genotype 2 received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.'}, {'id': 'BG001', 'title': '12 to < 18 Years Old - SOF+RBV 24 Weeks', 'description': 'Participants 12 to \\< 18 years of age with HCV genotype 3 received SOF 400 mg (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.'}, {'id': 'BG002', 'title': '6 to < 12 Years Old - SOF+RBV 12 Weeks', 'description': 'Participants 6 to \\< 12 years of age with HCV genotype 2 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.'}, {'id': 'BG003', 'title': '6 to < 12 Years Old - SOF+RBV 24 Weeks', 'description': 'Participants 6 to \\< 12 years of age with HCV genotype 3 received SOF 200 mg (2 x 100 mg tablets or 4 x 50 mg oral granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.'}, {'id': 'BG004', 'title': '3 to < 6 Years Old - SOF+RBV 12 Weeks', 'description': 'Participants 3 to \\< 6 years of age with HCV genotype 2 received SOF (weight ≥ 17 kg: 200 mg granules; weight \\< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 12 weeks.'}, {'id': 'BG005', 'title': '3 to < 6 Years Old - SOF+RBV 24 Weeks', 'description': 'Participants 3 to \\< 6 years of age with HCV genotype 3 received SOF (weight ≥ 17 kg: 200 mg granules; weight \\< 17 kg: 150 mg granules) once daily + RBV capsules or oral solution (up to 1400 mg, dose depending on weight) for 24 weeks.'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '15', 'spread': '1.9', 'groupId': 'BG000'}, {'value': '15', 'spread': '1.9', 'groupId': 'BG001'}, {'value': '8', 'spread': '2.1', 'groupId': 'BG002'}, {'value': '9', 'spread': '1.7', 'groupId': 'BG003'}, {'value': '4', 'spread': '0.8', 'groupId': 'BG004'}, {'value': '5', 'spread': '0.8', 'groupId': 'BG005'}, {'value': '11', 'spread': '4.2', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '61', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '45', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '9', 'groupId': 'BG006'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}, {'value': '95', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', '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': '2', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race', 'categories': [{'title': 'White', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '85', 'groupId': 'BG006'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '10', 'groupId': 'BG006'}]}, {'title': 'Other', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '7', 'groupId': 'BG006'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}]}, {'title': 'Native Hawaiian or Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'New Zealand', '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': '2', 'groupId': 'BG006'}]}]}, {'title': 'Belgium', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': 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'groupId': 'BG005'}, {'value': '17', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'HCV RNA Category', 'classes': [{'categories': [{'title': '< 800,000 IU/mL', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}, {'value': '50', 'groupId': 'BG006'}]}, {'title': '≥ 800,000 IU/mL', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '56', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety Analysis Set included all participants who took at least 1 dose of study drug.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2013-12-20', 'size': 2610225, 'label': 'Study Protocol: Original', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-02-01T12:42', 'hasProtocol': True}, {'date': '2014-02-10', 'size': 2636989, 'label': 'Study Protocol: Amendment 1', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-02-01T12:43', 'hasProtocol': True}, {'date': '2014-03-14', 'size': 3064471, 'label': 'Study Protocol: Amendment 2', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-02-01T12:44', 'hasProtocol': True}, {'date': '2014-10-10', 'size': 1646134, 'label': 'Study Protocol: Amendment 3', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_003.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-02-01T12:45', 'hasProtocol': True}, {'date': '2014-11-12', 'size': 3140617, 'label': 'Study Protocol: Amendment 4', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_004.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-02-01T12:46', 'hasProtocol': True}, {'date': '2015-05-29', 'size': 3492896, 'label': 'Study Protocol: Amendment 5', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_005.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-02-01T12:46', 'hasProtocol': True}, {'date': '2016-02-26', 'size': 3595448, 'label': 'Study Protocol: Amendment 6', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_006.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-02-01T12:47', 'hasProtocol': True}, {'date': '2018-05-24', 'size': 365188, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_007.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-02-01T12:48', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 106}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2018-09-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-05', 'studyFirstSubmitDate': '2014-06-24', 'resultsFirstSubmitDate': '2019-02-28', 'studyFirstSubmitQcDate': '2014-06-24', 'lastUpdatePostDateStruct': {'date': '2019-04-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-04-05', 'studyFirstPostDateStruct': {'date': '2014-06-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-04-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'For Participants in the PK Lead-in Phase, Pharmacokinetic (PK) Parameter: AUCtau of GS-331007 (Metabolite of SOF)', 'timeFrame': '6 to < 18 years of age: predose, 0.5, 1, 2, 3, 4, 8, and 12 hours postdose on Day 7; 3 to < 6 years of age: predose, 2, 4, 8, and 12 hours postdose on Day 7', 'description': 'AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).'}, {'measure': 'Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event During the PK Lead-in Phase or the Treatment Phase', 'timeFrame': 'Up to 24 weeks'}, {'measure': 'For the Treatment Phase, Percentage of Participants With SVR at 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.'}], 'secondaryOutcomes': [{'measure': 'For Participants in the PK Lead-in Phase, Change From Baseline in HCV RNA', 'timeFrame': 'Baseline; Weeks 1, 2, 4, 8, and 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only)'}, {'measure': 'Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event During the PK Lead-in Phase', 'timeFrame': 'Up to Day 7'}, {'measure': 'For the Treatment Phase, Percentage of Participants With Sustained Virologic Response (SVR) at 4 Weeks After Discontinuation of Therapy (SVR4)', 'timeFrame': 'Posttreatment Week 4', 'description': 'SVR4 was defined as HCV RNA \\< LLOQ at 4 weeks after stopping study treatment.'}, {'measure': 'For the Treatment Phase, Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)', 'timeFrame': 'Posttreatment Week 24', 'description': 'SVR24 was defined as HCV RNA \\< LLOQ at 24 weeks after stopping study treatment.'}, {'measure': 'For the Treatment Phase, Percentage of Participants Experiencing Viral Breakthrough', 'timeFrame': 'Up to 24 weeks', 'description': 'Viral breakthrough was defined as having confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA \\< LLOQ while on treatment.'}, {'measure': 'For the Treatment Phase, Percentage of Participants Experiencing Viral Relapse', 'timeFrame': 'Up to Posttreatment Week 24', 'description': 'Viral relapse was defined as having confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA \\< LLOQ at last on-treatment visit.'}, {'measure': 'For the Treatment Phase, Change From Baseline in HCV RNA', 'timeFrame': 'Baseline; Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only)'}, {'measure': 'For the Treatment Phase, Percentage of Participants With HCV RNA < LLOQ While On Treatment', 'timeFrame': 'Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only)'}, {'measure': 'For the Treatment Phase, Percentage of Participants With Alanine Aminotransferase (ALT) Normalization', 'timeFrame': 'Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only), and Posttreatment Week 4', 'description': 'ALT normalization was defined as ALT \\> the upper limit of normal (ULN) at baseline and ALT ≤ ULN at each visit. One participant in the 3 to \\< 6 Years Old 12 Weeks group had ALT \\> ULN at Baseline, but had no other available data.'}, {'measure': 'For the Treatment Phase, Change From Baseline in Height', 'timeFrame': 'Baseline; Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only), and Posttreatment Weeks 4, 12, and 24'}, {'measure': 'For the Treatment Phase, Change From Baseline in Weight', 'timeFrame': 'Baseline; Weeks 1, 2, 4, 8, 12, 16 (24 Week groups only), 20 (24 Week groups only), and 24 (24 Week groups only), and Posttreatment Weeks 4, 12, and 24'}, {'measure': 'For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Pubic Hair', 'timeFrame': 'Baseline; End of Treatment (either Week 12 or 24), Posttreatment Week 12, and Posttreatment Week 24', 'description': 'Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). Any shifts (increase or decrease) in Tanner Stage from Baseline were analyzed and presented.'}, {'measure': 'For the Treatment Phase, Number of Male Participants With a Change From Baseline in Tanner Stage for Genitalia Development', 'timeFrame': 'Baseline; End of Treatment (either Week 12 or 24), Posttreatment Week 12, and Posttreatment Week 24', 'description': 'Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). Any shifts (increase or decrease) in Tanner Stage from Baseline were analyzed and presented.'}, {'measure': 'For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Pubic Hair', 'timeFrame': 'Baseline; End of Treatment (either Week 12 or 24), Posttreatment Week 12, and Posttreatment Week 24', 'description': 'Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). Any shifts (increase or decrease) in Tanner Stage from Baseline were analyzed and presented.'}, {'measure': 'For the Treatment Phase, Number of Female Participants With a Change From Baseline in Tanner Stage for Breast Development', 'timeFrame': 'Baseline; End of Treatment (either Week 12 or 24), Posttreatment Week 12, and Posttreatment Week 24', 'description': 'Tanner Stages is a scale that defines physical measurements of development based on external primary and secondary sex characteristics. It was used in this study to assess pubertal development with values ranging from Stage 1 (pre-pubertal characteristics) to Stage 5 (adult or mature characteristics). Any shifts (increase or decrease) in Tanner Stage from Baseline were analyzed and presented.'}, {'measure': 'For the Treatment Phase, Palatability of SOF Granules at Day 1 as Assessed by the Percentage of Participants Able/Unable to Taste the SOF Oral Granules', 'timeFrame': 'Day 1', 'description': 'Participants were asked if they were able to taste the SOF oral granules.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hepatitis C Virus Infection']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'Kirby B, German P, Kanwar B, Ni L, Lakatos I, Ling J, Mathias A. Pharmacokinetics of Once-Daily Sofosbuvir and Ledipasvir/Sofosbuvir in HCV-Infected Adolescents [Poster 1707]. American Association for the Study of Liver Diseases (AASLD); 2015 November 13-17, San Francisco, USA. Hepatology 2015;62 (S1): 1040A-1041A'}, {'type': 'RESULT', 'citation': 'Garrison KL, Mathias A, Kersey K, Kanwar B, Ni L, Jain A, et al. Pharmacokinetics of Once-Daily Sofosbuvir and Ledipasvir/Sofosbuvir in HCV-Infected Pediatrics Aged 6 to <12 Years Old [Poster 878]. American Association for the Study of Liver Diseases (AASLD); 2016 11-15 November; Boston, MA. Hepatology 2016;64 (S1): 436A'}, {'type': 'RESULT', 'citation': 'Schwarz KB, Rosenthal P, Gonzales-Peralta RP, Jonas MM, Balistreri WF, Lin CH, et al. Sofosbuvir + Ribavirin for 12 or 24 Weeks Is Safe and Effective in Adolescents with Genotype 2 or Genotype 3 Chronic Hepatitis C Infection. Hepatology 2016; 63 (Suppl 1): abstract 706.'}, {'pmid': '28543053', 'type': 'RESULT', 'citation': 'Wirth S, Rosenthal P, Gonzalez-Peralta RP, Jonas MM, Balistreri WF, Lin CH, Hardikar W, Kersey K, Massetto B, Kanwar B, Brainard DM, Shao J, Svarovskaia E, Kirby B, Arnon R, Murray KF, Schwarz KB. Sofosbuvir and ribavirin in adolescents 12-17 years old with hepatitis C virus genotype 2 or 3 infection. Hepatology. 2017 Oct;66(4):1102-1110. doi: 10.1002/hep.29278. Epub 2017 Aug 26.'}, {'pmid': '29193603', 'type': 'RESULT', 'citation': 'Younossi ZM, Stepanova M, Schwarz KB, Wirth S, Rosenthal P, Gonzalez-Peralta R, Murray K, Henry L, Hunt S. Quality of life in adolescents with hepatitis C treated with sofosbuvir and ribavirin. J Viral Hepat. 2018 Apr;25(4):354-362. doi: 10.1111/jvh.12830. Epub 2017 Dec 26.'}, {'type': 'RESULT', 'citation': 'Rosenthal P, Schwarz KB, Gonzales-Peralta RP, Lin CH, Kelly DA, Nightingale S, et al. Sofosbuvir + Ribavirin for 12 or 24 Weeks Is Safe and Effective in Children 3 to <12 Years Old with Genotype 2 or Genotype 3 Chronic Hepatitis C Infection. Hepatology 2018; 68 (Suppl 1): abstract 1844.'}, {'pmid': '31222783', 'type': 'DERIVED', 'citation': 'Rosenthal P, Schwarz KB, Gonzalez-Peralta RP, Lin CH, Kelly DA, Nightingale S, Balistreri WF, Bansal S, Jonas MM, Massetto B, Brainard DM, Hsueh CH, Shao J, Parhy B, Davison S, Feiterna-Sperling C, Gillis LA, Indolfi G, Sokal EM, Murray KF, Wirth S. Sofosbuvir and Ribavirin Therapy for Children Aged 3 to <12 Years With Hepatitis C Virus Genotype 2 or 3 Infection. Hepatology. 2020 Jan;71(1):31-43. doi: 10.1002/hep.30821. Epub 2019 Aug 13.'}]}, 'descriptionModule': {'briefSummary': 'This study will have two parts as follows:\n\nThe PK Lead-in Phase of the study will evaluate the steady state pharmacokinetics (PK) and confirm the dose of sofosbuvir (SOF) in hepatitis C virus (HCV)-infected pediatric participants. The PK Lead-in Phase will also evaluate the safety and tolerability of 7 days of dosing of SOF+ribavirin (RBV) in HCV-infected pediatric participants.\n\nThe Treatment Phase will be initiated by age cohort after confirmation of age-appropriate SOF dosage levels. Participants from the PK Lead-in Phase will immediately rollover into the Treatment Phase with no interruption of study drug administration. The Treatment Phase will evaluate the antiviral efficacy, safety, and tolerability of SOF+RBV for 12 or 24 weeks in pediatric participants with genotype 2 or 3 HCV infection, respectively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Consent of parent or legal guardian required\n* Chronic HCV infection genotype 2 or 3\n* Screening laboratory values within defined thresholds\n* PK Lead-in only: all individuals must be treatment naive\n\nKey Exclusion Criteria:\n\n* History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol\n* Co-infection with HIV, acute hepatitis A virus, or hepatitis B virus\n* Clinical hepatic decompensation (ie, ascites, encephalopathy or variceal hemorrhage)\n* Pregnant or nursing females\n* Known hypersensitivity to study medication\n* Use of any prohibited concomitant medications as within 28 days of the Day 1 visit\n\nNote: Other protocol defined Inclusion/Exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT02175758', 'briefTitle': 'Safety and Efficacy of Sofosbuvir + Ribavirin in Adolescents and Children With Genotype 2 or 3 Chronic HCV Infection', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gilead Sciences'}, 'officialTitle': 'A Phase 2, Open-Label, Multicenter, Multi-cohort, Single-Arm Study to Investigate the Safety and Efficacy of Sofosbuvir + Ribavirin in Adolescents and Children With Genotype 2 or 3 Chronic HCV Infection', 'orgStudyIdInfo': {'id': 'GS-US-334-1112'}, 'secondaryIdInfos': [{'id': '2014-002283-32', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '12 to < 18 Years Old, SOF+RBV 12 Weeks (GT 2)', 'description': 'Participants between 12 to \\< 18 years of age with genotype (GT) 2 HCV infection weighing ≥ 45 kg will receive SOF (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules based on swallowability assessment during screening) plus RBV (up to 1400 mg) for 12 weeks.', 'interventionNames': ['Drug: SOF', 'Drug: RBV']}, {'type': 'EXPERIMENTAL', 'label': '12 to < 18 Years Old, SOF+RBV 24 Weeks (GT 3)', 'description': 'Participants between 12 to \\< 18 years of age with genotype 3 HCV infection weighing ≥ 45 kg will receive SOF (1 x 400 mg tablet, 4 x 100 mg tablets, or 8 x 50 mg oral granules based on swallowability assessment during screening) plus RBV (up to 1400 mg) for 24 weeks.', 'interventionNames': ['Drug: SOF', 'Drug: RBV']}, {'type': 'EXPERIMENTAL', 'label': '6 to < 12 Years Old, SOF+RBV 12 Weeks (GT 2)', 'description': 'Participants between 6 to \\< 12 years of age with genotype 2 HCV infection weighing ≥ 17 kg and \\< 45 kg will receive SOF (2 x 100 mg tablets or 4 x 50 mg oral granules based on swallowability assessment during screening) plus RBV (up to 1400 mg) for 12 weeks.', 'interventionNames': ['Drug: SOF', 'Drug: RBV']}, {'type': 'EXPERIMENTAL', 'label': '6 to <12 Years Old, SOF+RBV 24 Weeks (GT 3)', 'description': 'Participants between 6 to \\< 12 years of age with genotype 3 HCV infection weighing ≥ 17 kg and \\< 45 kg will receive SOF (2 x 100 mg tablets or 4 x 50 mg oral granules based on swallowability assessment during screening) plus RBV (up to 1400 mg) for 24 weeks.', 'interventionNames': ['Drug: SOF', 'Drug: RBV']}, {'type': 'EXPERIMENTAL', 'label': '3 to < 6 Years Old, SOF+RBV 12 Weeks (GT 2)', 'description': 'Participants between 3 to \\< 6 years of age with genotype 2 HCV infection weighing ≥ 17kg will receive SOF (4 x 50 mg oral granules) plus RBV (up to 1400 mg) for 12 weeks and those weighing \\< 17 kg will receive SOF (3 x 50 mg oral granules) + RBV (up to 1400 mg) for 12 weeks.', 'interventionNames': ['Drug: SOF', 'Drug: RBV']}, {'type': 'EXPERIMENTAL', 'label': '3 to < 6 Years Old, SOF+RBV 24 Weeks (GT 3)', 'description': 'Participants between 3 to \\< 6 years of age with genotype 2 HCV infection weighing ≥ 17kg will receive SOF (4 x 50 mg oral granules) plus RBV (up to 1400 mg) for 24 weeks and those weighing \\< 17 kg will receive SOF (3 x 50 mg oral granules) + RBV (up to 1400 mg) for 24 weeks.', 'interventionNames': ['Drug: SOF', 'Drug: RBV']}], 'interventions': [{'name': 'SOF', 'type': 'DRUG', 'otherNames': ['Sovaldi®', 'GS-7977'], 'description': 'SOF administered orally once daily', 'armGroupLabels': ['12 to < 18 Years Old, SOF+RBV 12 Weeks (GT 2)', '12 to < 18 Years Old, SOF+RBV 24 Weeks (GT 3)', '3 to < 6 Years Old, SOF+RBV 12 Weeks (GT 2)', '3 to < 6 Years Old, SOF+RBV 24 Weeks (GT 3)', '6 to < 12 Years Old, SOF+RBV 12 Weeks (GT 2)', '6 to <12 Years Old, SOF+RBV 24 Weeks (GT 3)']}, {'name': 'RBV', 'type': 'DRUG', 'otherNames': ['REBETOL®'], 'description': 'RBV oral solution or capsules will be administered orally in a divided daily dose based on weight', 'armGroupLabels': ['12 to < 18 Years Old, SOF+RBV 12 Weeks (GT 2)', '12 to < 18 Years Old, SOF+RBV 24 Weeks (GT 3)', '3 to < 6 Years Old, SOF+RBV 12 Weeks (GT 2)', '3 to < 6 Years Old, SOF+RBV 24 Weeks (GT 3)', '6 to < 12 Years Old, SOF+RBV 12 Weeks (GT 2)', '6 to <12 Years Old, SOF+RBV 24 Weeks (GT 3)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'city': 'Indianapolis', 'state': 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