Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2025-12-26 @ 1:58 AM
Study NCT ID:
NCT00704405
Status:
COMPLETED
Last Update Posted:
2018-10-09
First Post:
2008-06-23
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of Vaniprevir (MK-7009) With Pegylated Interferon (Peg-IFN) and Ribavirin (RBV) in Treatment-Experienced Hepatitis C Virus (HCV) Participants (MK-7009-009)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Australia', 'Austria', 'Belgium', 'Canada', 'Chile', 'Czechia', 'France', 'Germany', 'Israel', 'Lithuania', 'New Zealand', 'Poland', 'Puerto Rico', 'South Korea', 'Sweden', 'Taiwan', 'Thailand', 'United Kingdom', 'United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D019698', 'term': 'Hepatitis C, Chronic'}, {'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': 'D006521', 'term': 'Hepatitis, Chronic'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C540393', 'term': 'vaniprevir'}, {'id': 'C100416', 'term': 'peginterferon alfa-2a'}, {'id': 'D012254', 'term': 'Ribavirin'}], 'ancestors': [{'id': 'D012263', 'term': 'Ribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp.'}, 'certainAgreement': {'otherDetails': 'The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'AEs were monitored for 50 weeks (48 weeks of active treatment and 2 weeks of follow-up) and serious AEs were monitored for 18 months.', 'description': 'AEs were monitored and presented for the combined NC and C participant populations.', 'eventGroups': [{'id': 'EG000', 'title': '24-wk Vaniprevir 600 mg + Peg-IFN/RBV', 'description': 'Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and peg-IFN 180 mcg injection once weekly for 24 weeks.', 'otherNumAtRisk': 56, 'otherNumAffected': 53, 'seriousNumAtRisk': 56, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': '24-wk Vaniprevir 600 mg, 24-wk PBO + Peg-IFN/RBV', 'description': 'Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for 24 weeks, followed by PBO and RBV (1000 mg or 1200 mg based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for an additional 24 weeks.', 'otherNumAtRisk': 56, 'otherNumAffected': 56, 'seriousNumAtRisk': 56, 'seriousNumAffected': 5}, {'id': 'EG002', 'title': '48-wk Vaniprevir 300 mg + Peg-IFN/RBV', 'description': 'Vaniprevir 300 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for 48 weeks.', 'otherNumAtRisk': 56, 'otherNumAffected': 55, 'seriousNumAtRisk': 56, 'seriousNumAffected': 6}, {'id': 'EG003', 'title': '48-wk Vaniprevir 600 mg + Peg-IFN/RBV', 'description': 'Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for 48 weeks.', 'otherNumAtRisk': 61, 'otherNumAffected': 61, 'seriousNumAtRisk': 61, 'seriousNumAffected': 9}, {'id': 'EG004', 'title': '48-wk PBO + Peg-IFN/RBV', 'description': 'PBO and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 48 weeks.', 'otherNumAtRisk': 56, 'otherNumAffected': 55, 'seriousNumAtRisk': 56, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 23, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 56, 'numEvents': 16, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 56, 'numEvents': 11, 'numAffected': 8}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v. 15.0)'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 56, 'numEvents': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v. 15.0)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 12, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 14, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 56, 'numEvents': 25, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 56, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v. 15.0)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 56, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 56, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v. 15.0)'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v. 15.0)'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 56, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v. 15.0)'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 56, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 56, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v. 15.0)'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 56, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v. 15.0)'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 56, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 56, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v. 15.0)'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 56, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 56, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v. 15.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 56, 'numEvents': 10, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 56, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v. 15.0)'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 56, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v. 15.0)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 56, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG004', 'numAtRisk': 56, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v. 15.0)'}, {'term': 'Aphthous stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 56, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v. 15.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 56, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v. 15.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 40, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 34, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 56, 'numEvents': 41, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 48, 'numAffected': 33}, {'groupId': 'EG004', 'numAtRisk': 56, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v. 15.0)'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 56, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v. 15.0)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 20, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 56, 'numEvents': 14, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 11, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 56, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v. 15.0)'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 56, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v. 15.0)'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 56, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 56, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v. 15.0)'}, {'term': 'Gingivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v. 15.0)'}, {'term': 'Haemorrhoidal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v. 15.0)'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 56, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 56, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v. 15.0)'}, {'term': 'Mouth ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 56, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v. 15.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 31, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 27, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 56, 'numEvents': 30, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 50, 'numAffected': 39}, {'groupId': 'EG004', 'numAtRisk': 56, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v. 15.0)'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 56, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 56, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v. 15.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 20, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 30, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 56, 'numEvents': 11, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 26, 'numAffected': 17}, {'groupId': 'EG004', 'numAtRisk': 56, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v. 15.0)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 56, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 14, 'numAffected': 13}, {'groupId': 'EG004', 'numAtRisk': 56, 'numEvents': 12, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v. 15.0)'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v. 15.0)'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 5, 'numAffected': 5}, {'groupId': 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56, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v. 15.0)'}, {'term': 'Completed suicide', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v. 15.0)'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v. 15.0)'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v. 15.0)'}, {'term': 'Dermatomyositis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v. 15.0)'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v. 15.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Achieving SVR24 Following Treatment With Vaniprevir 600 mg b.i.d.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '24- or 48-wk Vaniprevir 600 mg + Peg-IFN/RBV', 'description': 'Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 24 or 48 weeks.'}, {'id': 'OG001', 'title': '24-wk Vaniprevir 600 mg, 24-wk PBO + Peg-IFN/RBV', 'description': 'Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 24 weeks, followed by PBO and RBV (1000 mg or 1200 mg based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for an additional 24 weeks.'}, {'id': 'OG002', 'title': '48-wk Vaniprevir 600 mg + Peg-IFN/RBV', 'description': 'Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 48 weeks.'}, {'id': 'OG003', 'title': '48-wk PBO + Peg-IFN/RBV', 'description': 'PBO and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 48 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '71.1', 'groupId': 'OG000'}, {'value': '84.2', 'groupId': 'OG001'}, {'value': '78.0', 'groupId': 'OG002'}, {'value': '19.0', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Adjusted difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '53.6', 'ciLowerLimit': '34.5', 'ciUpperLimit': '69.1', 'estimateComment': 'Adjusted difference subtracts the percentage of PBO-treated participants (i.e., 19.0%) that achieved SVR24 and stratifies by prior treatment response.', 'statisticalMethod': 'Miettinen and Nurminen method', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Adjusted difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '64.4', 'ciLowerLimit': '45.2', 'ciUpperLimit': '78.3', 'estimateComment': 'Adjusted difference subtracts the percentage of PBO-treated participants (i.e., 19.0%) that achieved SVR24 and stratifies by prior treatment response.', 'statisticalMethod': 'Miettinen and Nurminen method', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Adjusted difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '59.0', 'ciLowerLimit': '40.2', 'ciUpperLimit': '73.4', 'estimateComment': 'Adjusted difference subtracts the percentage of PBO-treated participants (i.e., 19.0%) that achieved SVR24 and stratifies by prior treatment response.', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 72 weeks', 'description': 'The percentage of non-cirrhotic participants with undetectable Hepatits C virus (HCV) ribonucleic acid (RNA) 24 weeks after completing treatment was determined for each Vaniprevir 600 mg b.i.d. and control regimen. Results for Vaniprevir 300 mg are presented as a Secondary Outcome Measure.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) population consists of all non-cirrhotic participants who received at least 1 dose of study treatment, have post-dose endpoint data, and have baseline data for measures that require baseline data.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Experiencing an Adverse Event (AE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}, {'value': '42', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': '24- or 48-wk Vaniprevir 600 mg + Peg-IFN/RBV', 'description': 'Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 24 or 48 weeks.'}, {'id': 'OG001', 'title': '24-wk Vaniprevir 600 mg, 24-wk PBO + Peg-IFN/RBV', 'description': 'Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 24 weeks, followed by PBO and RBV (1000 mg or 1200 mg based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for an additional 24 weeks.'}, {'id': 'OG002', 'title': '48-wk Vaniprevir 300 mg + Peg-IFN/RBV', 'description': 'Vaniprevir 300 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 48 weeks.'}, {'id': 'OG003', 'title': '48-wk Vaniprevir 600 mg + Peg-IFN/RBV', 'description': 'Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 48 weeks.'}, {'id': 'OG004', 'title': '48-wk PBO + Peg-IFN/RBV', 'description': 'PBO and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 48 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}, {'value': '41', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 73 weeks', 'description': 'The number of non-cirrhotic participants experiencing AEs during the active Vaniprevir/PBO treatment and 14-day follow-up periods was monitored for each treatment regimen. An AE was defined as any unfavorable and unintended change in the structure (signs), function (symptoms), or chemistry (laboratory data) of the body temporally associated with any use of a Sponsor product, whether or not considered related to the use of the product.', 'unitOfMeasure': 'Number of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The All-Patients-as-Treated (APaT) population was employed for safety analyses. The APaT population consists of all non-cirrhotic randomized patients who received at least one dose of study treatment.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Discontinuing From Study Treatment Due to AEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}, {'value': '42', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': '24- or 48-wk Vaniprevir 600 mg + Peg-IFN/RBV', 'description': 'Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 24 or 48 weeks.'}, {'id': 'OG001', 'title': '24-wk Vaniprevir 600 mg, 24-wk PBO + Peg-IFN/RBV', 'description': 'Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 24 weeks, followed by PBO and RBV (1000 mg or 1200 mg based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for an additional 24 weeks.'}, {'id': 'OG002', 'title': '48-wk Vaniprevir 300 mg + Peg-IFN/RBV', 'description': 'Vaniprevir 300 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 48 weeks.'}, {'id': 'OG003', 'title': '48-wk Vaniprevir 600 mg + Peg-IFN/RBV', 'description': 'Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 48 weeks.'}, {'id': 'OG004', 'title': '48-wk PBO + Peg-IFN/RBV', 'description': 'PBO and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 48 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 48 weeks', 'description': 'The number of non-cirrhotic participants withdrawing from study treatment due to AEs during the active Vaniprevir/PBO treatment and 14-day follow-up periods was monitored for each treatment regimen.', 'unitOfMeasure': 'Number of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The All-Patients-as-Treated (APaT) population was employed for safety analyses. The APaT population consists of all randomized non-cirrhotic patients who received at least one dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving SVR24 Following Treatment With Vaniprevir 300 mg b.i.d.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '48-wk Vaniprevir 300 mg + Peg-IFN/RBV', 'description': 'Vaniprevir 300 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 48 weeks.'}, {'id': 'OG001', 'title': '48-wk PBO + Peg-IFN/RBV', 'description': 'PBO and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 48 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}, {'value': '19.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '47.3', 'ciLowerLimit': '29.2', 'ciUpperLimit': '63.2', 'estimateComment': 'Adjusted difference subtracts the percentage of PBO-treated participants (i.e., 19.0%) that achieved SVR24 and stratifies by prior treatment response.', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '72 weeks', 'description': 'The percentage of non-cirrhotic participants treated with Vaniprevir 300 mg b.i.d. with undetectable HCV RNA 24 weeks after completing treatment was determined.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) population consists of all non-cirrhotic participants who received at least 1 dose of study treatment, have post-dose endpoint data, and have baseline data for measures that require baseline data.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving cEVR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '24- or 48-wk Vaniprevir 600 mg + Peg-IFN/RBV', 'description': 'Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 24 or 48 weeks.'}, {'id': 'OG001', 'title': '48-wk Vaniprevir 300 mg + Peg-IFN/RBV', 'description': 'Vaniprevir 300 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 48 weeks.'}, {'id': 'OG002', 'title': 'PBO + Peg-IFN/RBV', 'description': 'PBO and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 48 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '92.0', 'groupId': 'OG000'}, {'value': '85.4', 'groupId': 'OG001'}, {'value': '9.5', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '82.6', 'ciLowerLimit': '69.5', 'ciUpperLimit': '90.2', 'estimateComment': 'Adjusted difference subtracts the percentage of PBO-treated participants (i.e., 9.5%) that achieved cEVR and stratifies by prior treatment response.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Adjusted difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '76.1', 'ciLowerLimit': '60.1', 'ciUpperLimit': '86.7', 'estimateComment': 'Adjusted difference subtracts the percentage of PBO-treated participants (i.e., 9.5%) that achieved cEVR and stratifies by prior treatment response.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Week 60', 'description': 'The percentage of non-cirrhotic participants with complete early viral response (cEVR; undetectable HCV RNA at Week 12) was determined for each Vaniprevir dose. Since each of the Vaniprevir 600 mg arms had the same treatment history at this point in the study, the data were pooled for analysis.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) population consists of all non-cirrhotic participants who received at least 1 dose of study treatment, have post-dose endpoint data, and have baseline data for measures that require baseline data. The 3 Vaniprevir 600 mg b.i.d. arms were combined in this analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving SVR24 After 24 Weeks of Vaniprevir 600 mg b.i.d.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '24- or 48-wk Vaniprevir 600 mg + Peg-IFN/RBV', 'description': 'Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 24 or 48 weeks.'}, {'id': 'OG001', 'title': '48-wk PBO + Peg-IFN/RBV', 'description': 'PBO and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 48 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '71.1', 'groupId': 'OG000'}, {'value': '36.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '35.8', 'ciLowerLimit': '15.5', 'ciUpperLimit': '53.4', 'estimateComment': 'Adjusted difference subtracts the percentage of PBO patients (36.6%) with undetectable HCV RNA at Week 48 and stratifies by prior treatment response.', 'statisticalMethod': 'Miettinen and Nurminen method', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 48', 'description': 'The percentage of participants achieving SVR24 after the 24-week Vaniprevir 600 mg b.i.d. regimen at Week 48 was compared to the control regimen.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) population consists of all non-cirrhotic participants who received at least 1 dose of study treatment, have post-dose endpoint data, and have baseline data for measures that require baseline data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '24-wk Vaniprevir 600 mg + Peg-IFN/RBV', 'description': 'Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and peg-IFN 180 mcg injection once weekly for 24 weeks.'}, {'id': 'FG001', 'title': '24-wk Vaniprevir 600 mg, 24-wk PBO + Peg-IFN/RBV', 'description': 'Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for 24 weeks, followed by PBO and RBV (1000 mg or 1200 mg based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for an additional 24 weeks.'}, {'id': 'FG002', 'title': '48-wk Vaniprevir 300 mg + Peg-IFN/RBV', 'description': 'Vaniprevir 300 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for 48 weeks.'}, {'id': 'FG003', 'title': '48-wk Vaniprevir 600 mg + Peg-IFN/RBV', 'description': 'Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for 48 weeks.'}, {'id': 'FG004', 'title': '48-wk PBO + Peg-IFN/RBV', 'description': 'PBO and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 48 weeks.'}], 'periods': [{'title': 'Overall Study (NC Population)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '44'}, {'groupId': 'FG002', 'numSubjects': '41'}, {'groupId': 'FG003', 'numSubjects': '42'}, {'groupId': 'FG004', 'numSubjects': '42'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '40'}, {'groupId': 'FG002', 'numSubjects': '38'}, {'groupId': 'FG003', 'numSubjects': '38'}, {'groupId': 'FG004', 'numSubjects': '37'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '2'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}]}, {'title': 'Overall Study (C Population)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '15'}, {'groupId': 'FG003', 'numSubjects': '15'}, {'groupId': 'FG004', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '14'}, {'groupId': 'FG003', 'numSubjects': '14'}, {'groupId': 'FG004', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Non-cirrhotic (NC) and cirrhotic (C) participants were screened and enrolled separately in this study. The NC population was used for all safety, tolerability, and efficacy outcome measures. Primary analyses of the outcome measures only included the NC population. Adverse events (AEs) were monitored in both the NC and C populations.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}, {'value': '57', 'groupId': 'BG003'}, {'value': '56', 'groupId': 'BG004'}, {'value': '285', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': '24-wk Vaniprevir 600 mg + Peg-IFN/RBV', 'description': 'Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and peg-IFN 180 mcg injection once weekly for 24 weeks.'}, {'id': 'BG001', 'title': '24-wk Vaniprevir 600 mg, 24-wk PBO + Peg-IFN/RBV', 'description': 'Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for 24 weeks, followed by PBO and RBV (1000 mg or 1200 mg based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for an additional 24 weeks.'}, {'id': 'BG002', 'title': '48-wk Vaniprevir 300 mg + Peg-IFN/RBV', 'description': 'Vaniprevir 300 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for 48 weeks.'}, {'id': 'BG003', 'title': '48-wk Vaniprevir 600 mg + Peg-IFN/RBV', 'description': 'Vaniprevir 600 mg and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and peg-IFN 180 mcg injection once weekly for 48 weeks.'}, {'id': 'BG004', 'title': '48-wk PBO + Peg-IFN/RBV', 'description': 'PBO and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 48 weeks.'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50.0', 'spread': '8.4', 'groupId': 'BG000'}, {'value': '51.6', 'spread': '8.1', 'groupId': 'BG001'}, {'value': '50.6', 'spread': '7.5', 'groupId': 'BG002'}, {'value': '52.1', 'spread': '8.7', 'groupId': 'BG003'}, {'value': '49.9', 'spread': '7.8', 'groupId': 'BG004'}, {'value': '50.8', 'spread': '8.1', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}, {'value': '21', 'groupId': 'BG004'}, {'value': '105', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}, {'value': '38', 'groupId': 'BG003'}, {'value': '35', 'groupId': 'BG004'}, {'value': '180', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The Baseline Population consists of all randomized C and NC participants.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 285}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2012-09-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-10', 'studyFirstSubmitDate': '2008-06-23', 'resultsFirstSubmitDate': '2014-09-26', 'studyFirstSubmitQcDate': '2008-06-23', 'lastUpdatePostDateStruct': {'date': '2018-10-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-09-26', 'studyFirstPostDateStruct': {'date': '2008-06-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-09-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Achieving SVR24 Following Treatment With Vaniprevir 600 mg b.i.d.', 'timeFrame': 'Up to 72 weeks', 'description': 'The percentage of non-cirrhotic participants with undetectable Hepatits C virus (HCV) ribonucleic acid (RNA) 24 weeks after completing treatment was determined for each Vaniprevir 600 mg b.i.d. and control regimen. Results for Vaniprevir 300 mg are presented as a Secondary Outcome Measure.'}, {'measure': 'Number of Participants Experiencing an Adverse Event (AE)', 'timeFrame': 'Up to 73 weeks', 'description': 'The number of non-cirrhotic participants experiencing AEs during the active Vaniprevir/PBO treatment and 14-day follow-up periods was monitored for each treatment regimen. An AE was defined as any unfavorable and unintended change in the structure (signs), function (symptoms), or chemistry (laboratory data) of the body temporally associated with any use of a Sponsor product, whether or not considered related to the use of the product.'}, {'measure': 'Number of Participants Discontinuing From Study Treatment Due to AEs', 'timeFrame': 'Up to 48 weeks', 'description': 'The number of non-cirrhotic participants withdrawing from study treatment due to AEs during the active Vaniprevir/PBO treatment and 14-day follow-up periods was monitored for each treatment regimen.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Achieving SVR24 Following Treatment With Vaniprevir 300 mg b.i.d.', 'timeFrame': '72 weeks', 'description': 'The percentage of non-cirrhotic participants treated with Vaniprevir 300 mg b.i.d. with undetectable HCV RNA 24 weeks after completing treatment was determined.'}, {'measure': 'Percentage of Participants Achieving cEVR', 'timeFrame': 'Up to Week 60', 'description': 'The percentage of non-cirrhotic participants with complete early viral response (cEVR; undetectable HCV RNA at Week 12) was determined for each Vaniprevir dose. Since each of the Vaniprevir 600 mg arms had the same treatment history at this point in the study, the data were pooled for analysis.'}, {'measure': 'Percentage of Participants Achieving SVR24 After 24 Weeks of Vaniprevir 600 mg b.i.d.', 'timeFrame': 'Week 48', 'description': 'The percentage of participants achieving SVR24 after the 24-week Vaniprevir 600 mg b.i.d. regimen at Week 48 was compared to the control regimen.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['hepatitis C'], 'conditions': ['Hepatitis C, Chronic']}, 'referencesModule': {'availIpds': [{'url': 'http://www.merck.com/clinical-trials/study.html?id=7009-009&kw=7009-009&tab=access', 'type': 'CSR Synopsis'}], 'references': [{'pmid': '23439259', 'type': 'RESULT', 'citation': 'Lawitz E, Rodriguez-Torres M, Stoehr A, Gane EJ, Serfaty L, Bhanja S, Barnard RJ, An D, Gress J, Hwang P, Mobashery N. A phase 2B study of MK-7009 (vaniprevir) in patients with genotype 1 HCV infection who have failed previous pegylated interferon and ribavirin treatment. J Hepatol. 2013 Jul;59(1):11-7. doi: 10.1016/j.jhep.2013.02.008. Epub 2013 Feb 21.'}, {'pmid': '24120953', 'type': 'RESULT', 'citation': 'Rodriguez-Torres M, Stoehr A, Gane EJ, Serfaty L, Lawitz E, Zhou A, Bourque M, Bhanja S, Strizki J, Barnard RJ, Hwang PM, DiNubile MJ, Mobashery N. Combination of vaniprevir with peginterferon and ribavirin significantly increases the rate of SVR in treatment-experienced patients with chronic HCV genotype 1 infection and cirrhosis. Clin Gastroenterol Hepatol. 2014 Jun;12(6):1029-37.e5. doi: 10.1016/j.cgh.2013.09.067. Epub 2013 Oct 10.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test the safety, tolerability, and efficacy of 4 regimens of Vaniprevir + Peg-IFN and Ribavirin as compared to Placebo (PBO) + Peg-IFN/RBV. The primary hypotheses are that Vaniprevir is well tolerated, and that Vaniprevir 600 mg twice daily (b.i.d.) is superior to the control regimen for the percentage of non-cirrhotic (NC) participants achieving undetectable HCV ribonucleic acid (RNA) 24 weeks after the end of study therapy (SVR24).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Has chronic HCV genotype 1 infection\n* Is treatment-experienced\n* For the non-cirrhotic population, has had a liver biopsy without evidence of cirrhosis and hepatocellular carcinoma; for the cirrhotic population, has had a liver biopsy with evidence of cirrhosis and without evidence of hepatocellular carcinoma.\n\nExclusion criteria:\n\n* Has not tolerated previous course peg-IFN and RBV\n* Is unlikely to tolerate at least 24 weeks of continuous therapy with Peg-IFN and RBV\n* Is co-infected with Human Immunodeficiency Virus (HIV) and/or hepatitis B\n* Consumes excessive amounts of alcohol\n* Has a history of drug or alcohol abuse\n* If female, participant is pregnant or breastfeeding\n* Has been in a clinical trail with an investigational drug in the last 30 days\n* Has used IFN/Peg-IFN and RBV in the last 3 months'}, 'identificationModule': {'nctId': 'NCT00704405', 'briefTitle': 'Safety and Efficacy of Vaniprevir (MK-7009) With Pegylated Interferon (Peg-IFN) and Ribavirin (RBV) in Treatment-Experienced Hepatitis C Virus (HCV) Participants (MK-7009-009)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Phase II Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of 4 Different Regimens of MK-7009 When Administered Concomitantly With Pegylated Interferon and Ribavirin in Treatment-Experienced Patients With Chronic Genotype 1 Hepatitis C Virus Infection', 'orgStudyIdInfo': {'id': '7009-009'}, 'secondaryIdInfos': [{'id': '2007_659', 'type': 'OTHER', 'domain': 'Merck Registration Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '24-wk Vaniprevir 600 mg + Peg-IFN/RBV', 'description': 'Vaniprevir 600 mg (total daily dose) and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 24 weeks.', 'interventionNames': ['Drug: Vaniprevir', 'Drug: Pegylated Interferon (Peg-IFN)', 'Drug: Ribavirin (RBV)']}, {'type': 'EXPERIMENTAL', 'label': '24-wk Vaniprevir 600 mg + 24-wk PBO + Peg-IFN/RBV', 'description': 'Vaniprevir 600 mg (total daily dose) and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 24 weeks, followed by PBO and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for an additional 24 weeks.', 'interventionNames': ['Drug: Vaniprevir', 'Drug: Pegylated Interferon (Peg-IFN)', 'Drug: Ribavirin (RBV)', 'Drug: Placebo (PBO)']}, {'type': 'EXPERIMENTAL', 'label': '48-wk Vaniprevir 300 mg + Peg-IFN/RBV', 'description': 'Vaniprevir 300 mg (total daily dose, taken once daily \\[q.d.\\]) and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 48 weeks.', 'interventionNames': ['Drug: Vaniprevir', 'Drug: Pegylated Interferon (Peg-IFN)', 'Drug: Ribavirin (RBV)']}, {'type': 'EXPERIMENTAL', 'label': '48-wk Vaniprevir 600 mg + Peg-IFN/RBV', 'description': 'Vaniprevir 600 mg and RBV (1000 mg or 1200 mg based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 48 weeks.', 'interventionNames': ['Drug: Vaniprevir', 'Drug: Pegylated Interferon (Peg-IFN)', 'Drug: Ribavirin (RBV)']}, {'type': 'PLACEBO_COMPARATOR', 'label': '48-wk PBO + Peg-IFN/RBV', 'description': 'PBO and RBV (1000 mg or 1200 mg based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 48 weeks.', 'interventionNames': ['Drug: Pegylated Interferon (Peg-IFN)', 'Drug: Ribavirin (RBV)', 'Drug: Placebo (PBO)']}], 'interventions': [{'name': 'Vaniprevir', 'type': 'DRUG', 'otherNames': ['MK-7009'], 'description': 'Participants took capsules containing 100 mg Vaniprevir twice daily (b.i.d.), three in the morning (300 mg and 600 mg regimens) and three in the evening (600 mg regimen only), orally, for 24 or 48 weeks.', 'armGroupLabels': ['24-wk Vaniprevir 600 mg + 24-wk PBO + Peg-IFN/RBV', '24-wk Vaniprevir 600 mg + Peg-IFN/RBV', '48-wk Vaniprevir 300 mg + Peg-IFN/RBV', '48-wk Vaniprevir 600 mg + Peg-IFN/RBV']}, {'name': 'Pegylated Interferon (Peg-IFN)', 'type': 'DRUG', 'otherNames': ['PEGASYS™'], 'description': 'Participants used prefilled syringe containing 180 µg/0.5 mL Peg-IFN, for weekly subcutaneous injection, for 24 or 48 weeks', 'armGroupLabels': ['24-wk Vaniprevir 600 mg + 24-wk PBO + Peg-IFN/RBV', '24-wk Vaniprevir 600 mg + Peg-IFN/RBV', '48-wk PBO + Peg-IFN/RBV', '48-wk Vaniprevir 300 mg + Peg-IFN/RBV', '48-wk Vaniprevir 600 mg + Peg-IFN/RBV']}, {'name': 'Ribavirin (RBV)', 'type': 'DRUG', 'otherNames': ['COPEGUS™'], 'description': "Participants took tablets containing 200 mg RBV, 5 or 6 tablet dosage based on the participant's weight, with food, for 24 or 48 weeks. The dose was 1000 mg for participants weighing \\<=75 kg and 1200 mg for participants weighing \\>75 kg.", 'armGroupLabels': ['24-wk Vaniprevir 600 mg + 24-wk PBO + Peg-IFN/RBV', '24-wk Vaniprevir 600 mg + Peg-IFN/RBV', '48-wk PBO + Peg-IFN/RBV', '48-wk Vaniprevir 300 mg + Peg-IFN/RBV', '48-wk Vaniprevir 600 mg + Peg-IFN/RBV']}, {'name': 'Placebo (PBO)', 'type': 'DRUG', 'description': 'Participants took PBO capsules matching Vaniprevir capsules, three in the morning and three in the evening, for 24 or 48 weeks.', 'armGroupLabels': ['24-wk Vaniprevir 600 mg + 24-wk PBO + Peg-IFN/RBV', '48-wk PBO + Peg-IFN/RBV']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'ipdSharingStatementModule': {'url': 'http://engagezone.msd.com/ds_documentation.php', 'ipdSharing': 'YES', 'description': 'https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}