Ignite Creation Date:
2025-12-24 @ 11:46 PM
Ignite Modification Date:
2025-12-25 @ 9:40 PM
Study NCT ID:
NCT00160251
Status:
COMPLETED
Last Update Posted:
2015-10-14
First Post:
2005-09-08
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Boceprevir (SCH 503034) Plus Peg-Intron, With and Without Added Ribavirin, in Patients With Chronic Hepatitis C, Genotype 1, Who Did Not Respond to Previous Treatment With Peginterferon Alfa Plus Ribavirin (Study P03659AM2)(COMPLETED)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['France', 'Germany', 'Italy', 'Spain', 'United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D019698', 'term': 'Hepatitis C, Chronic'}], 'ancestors': [{'id': 'D006526', 'term': 'Hepatitis C'}, {'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': 'C512204', 'term': 'N-(3-amino-1-(cyclobutylmethyl)-2,3-dioxopropyl)-3-(2-((((1,1-dimethylethyl)amino)carbonyl)amino)-3,3-dimethyl-1-oxobutyl)-6,6-dimethyl-3-azabicyclo(3.1.0)hexan-2-carboxamide'}, {'id': 'C417083', 'term': 'peginterferon alfa-2b'}, {'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', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp.'}, 'certainAgreement': {'otherDetails': 'The principal investigator (PI) agrees to provide review copies to the sponsor 30 days prior to submission. The sponsor shall have editorial rights and the right to review and comment on the data analysis and presentation with regard to proprietary information, accuracy of information, and to ensure that the presentation is fairly balanced and in compliance with regulations. If the parties disagree, the PI agrees to meet with the sponsor to discuss and resolve any such issues or disagreement.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The implementation of amendment 2 led to changes in boceprevir dose in all treatment arms and different overall lengths of therapy within the same treatment arm, making the SVR endpoint uninterpretable.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'PEG + RBV', 'description': 'Arm 1A: A single dose of PEG was given first, followed 1 week later by PEG + RBV for 12 weeks. If participant was HCV-RNA negative, PEG + RBV was continued for another 36 weeks.', 'otherNumAtRisk': 15, 'otherNumAffected': 14, 'seriousNumAtRisk': 15, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'PEG + RBV + BOC 400 (24 Weeks)', 'description': 'Arm 1B: A single dose of PEG was given first, followed 1 week later by PEG + RBV for 12 weeks. If HCV-RNA was detectable, BOC 400 was added for another 36 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.', 'otherNumAtRisk': 34, 'otherNumAffected': 33, 'seriousNumAtRisk': 34, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'PEG + BOC 100 (48 Weeks)', 'description': 'Arm 2: A single dose of PEG was given first, followed 1 week later by PEG + BOC 100 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.', 'otherNumAtRisk': 48, 'otherNumAffected': 48, 'seriousNumAtRisk': 48, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'PEG + BOC 200 (48 Weeks)', 'description': 'Arm 3: A single dose of PEG was given first, followed 1 week later by PEG + BOC 200 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.', 'otherNumAtRisk': 49, 'otherNumAffected': 48, 'seriousNumAtRisk': 49, 'seriousNumAffected': 4}, {'id': 'EG004', 'title': 'PEG + RBV + BOC 400 (48 Weeks)', 'description': 'Arm 5: A single dose of PEG was given first, followed 1 week later by PEG + RBV + BOC 400. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.', 'otherNumAtRisk': 49, 'otherNumAffected': 47, 'seriousNumAtRisk': 49, 'seriousNumAffected': 2}, {'id': 'EG005', 'title': 'PEG + BOC 400 (24 + 48 Weeks)', 'description': 'Arms 4 + 6: A single dose of PEG was given first, followed 1 week later by PEG + BOC (24 or 48 weeks). By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.', 'otherNumAtRisk': 97, 'otherNumAffected': 96, 'seriousNumAtRisk': 97, 'seriousNumAffected': 4}, {'id': 'EG006', 'title': 'PEG + BOC 800 (24 Weeks)', 'description': 'Arm 7: A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.', 'otherNumAtRisk': 65, 'otherNumAffected': 64, 'seriousNumAtRisk': 65, 'seriousNumAffected': 3}, {'id': 'EG007', 'title': 'PEG + RBV + BOC 800', 'description': 'Arm 8: By protocol amendment 2, participants from all arms except Arm 1A were rolled over into PEG + RBV + BOC 800 for the remainder of the treatment period.', 'otherNumAtRisk': 143, 'otherNumAffected': 136, 'seriousNumAtRisk': 143, 'seriousNumAffected': 12}], 'otherEvents': [{'term': 'ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 49, 'numEvents': 12, 'numAffected': 8}, {'groupId': 'EG005', 'numAtRisk': 97, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 65, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 143, 'numEvents': 58, 'numAffected': 54}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'LEUKOPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 49, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 97, 'numEvents': 6, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 143, 'numEvents': 13, 'numAffected': 7}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'NEUTROPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 48, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 49, 'numEvents': 16, 'numAffected': 9}, {'groupId': 'EG005', 'numAtRisk': 97, 'numEvents': 20, 'numAffected': 12}, {'groupId': 'EG006', 'numAtRisk': 65, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG007', 'numAtRisk': 143, 'numEvents': 37, 'numAffected': 25}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'SPLENOMEGALY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 48, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 97, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'THROMBOCYTOPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 49, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 97, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 143, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'PALPITATIONS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 97, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 143, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'EAR DISCOMFORT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 49, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 97, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 143, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'TINNITUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 48, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 49, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'VERTIGO', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 49, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'HYPERTHYROIDISM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'HYPOTHYROIDISM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 97, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 65, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 143, 'numEvents': 8, 'numAffected': 6}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'DRY EYE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 97, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'EYE IRRITATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 97, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'EYE PRURITUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'LACRIMATION INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'VISION BLURRED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 49, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 97, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 65, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 143, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'VISUAL ACUITY REDUCED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 143, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'ABDOMINAL DISTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'ABDOMINAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 48, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 49, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 97, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 65, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 143, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'ABDOMINAL PAIN UPPER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 48, 'numEvents': 12, 'numAffected': 9}, {'groupId': 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'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'VOMITING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'CHEST PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 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0}, {'groupId': 'EG005', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'MASTOIDITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and 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0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'BLADDER NEOPLASM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'HEPATIC NEOPLASM MALIGNANT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 143, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'SQUAMOUS CELL CARCINOMA', 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'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'CONVULSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'RADIAL NERVE PALSY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 97, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'SYNCOPE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'ENDOMETRIOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 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'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'ASTHMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'PLEURISY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'PULMONARY EMBOLISM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'LIVER TRANSPLANT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'HYPERTENSIVE CRISIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent of Participants Who Were Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Negative at the End of Treatment (EoT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '97', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}, {'value': '65', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1B: PEG + RBV + BOC 400', 'description': 'A single dose of PEG was given first, followed 1 week later by PEG + RBV for 12 weeks. If HCV-RNA was detectable, BOC 400 was added for another 36 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.'}, {'id': 'OG001', 'title': 'Arm 2: PEG + BOC 100 (48 Weeks)', 'description': 'A single dose of PEG was given first, followed 1 week later by PEG + BOC 100 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.'}, {'id': 'OG002', 'title': 'Arm 3: PEG + BOC 200 (48 Weeks)', 'description': 'A single dose of PEG was given first, followed 1 week later by PEG + BOC 200 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.'}, {'id': 'OG003', 'title': 'Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks)', 'description': 'A single dose of PEG was given first, followed 1 week later by PEG + BOC (24 or 48 weeks). By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.'}, {'id': 'OG004', 'title': 'Arm 5: PEG + RBV + BOC 400', 'description': 'A single dose of PEG was given first, followed 1 week A single dose of PEG was given first, followed 1 week later by PEG + RBV + BOC 400. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.'}, {'id': 'OG005', 'title': 'Arm 7: PEG + BOC 800', 'description': 'A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '35.0', 'groupId': 'OG000'}, {'value': '6.3', 'groupId': 'OG001'}, {'value': '16.3', 'groupId': 'OG002'}, {'value': '13.4', 'groupId': 'OG003'}, {'value': '20.4', 'groupId': 'OG004'}, {'value': '21.5', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Week 49', 'description': 'Sustained Viral Response (SVR) was defined as the percentage of participants with HCV-RNA undetectable at the follow-up Week 24.\n\nAll percentages were based on the total number of participants originally randomized/enrolled to that particular arm.\n\nFor Arm 1B, the denominator for the percentages was the number who received at least 1 dose of BOC.\n\nArm 1A was not analyzed.', 'unitOfMeasure': 'Percent of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'For PEG + RBV + BOC number of participants was number who received at least one dose of BOC. For all others, it was number of randomized participants. The PEG + BOC 800 arm was not randomized.'}, {'type': 'SECONDARY', 'title': 'Percent of Participants Who Achieved Sustained Viral Response (SVR) by Time to First Negative HCV-RNA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '0 to ≤ 4 Weeks to First Negative HCV-RNA Group', 'description': 'Participants who achieved first negative HCV RNA within the first 4 weeks of treatment.'}, {'id': 'OG001', 'title': '>4 to 8 Weeks to First Negative HCV-RNA Group', 'description': 'Participants who achieved first negative HCV RNA between weeks 4 to 8.'}, {'id': 'OG002', 'title': '>8 to 12 Weeks to First Negative HCV-RNA Group', 'description': 'Participants who achieved first negative HCV RNA between weeks 8 to 12.'}, {'id': 'OG003', 'title': '>12 to 36 Weeks to First Negative HCV-RNA Group', 'description': 'Participants who achieved first negative HCV RNA between weeks 12 to 36.'}], 'classes': [{'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Week 73 [24 weeks after EoT]', 'description': 'Percentage of participants who became HCV-RNA undetectable within the first 13 weeks and subsequently became HCV-RNA positive were not considered negative for this analysis.', 'unitOfMeasure': 'Percent of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants across all treatment arms who achieved negative HCV-RNA'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Were HCV-RNA Negative at EoT After Receiving 1 Week of Treatment With PegIntron (PEG) by Log Drop', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arms 2, 3, 4, 6: PEG + BOC 100, 200, or 400', 'description': 'A single dose of PEG was given first, followed 1 week later by PEG + BOC. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.'}, {'id': 'OG001', 'title': 'Arm 5: PEG + RBV + BOC 400', 'description': 'A single dose of PEG was given first, followed 1 week later by PEG + RBV + BOC 400. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.'}, {'id': 'OG002', 'title': 'Arm 7: PEG + BOC 800', 'description': 'A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.'}], 'classes': [{'title': 'Log drop <0 (Arm2-4,6 n=21/Arm5 n=6/Arm7 n=3)', 'categories': [{'measurements': [{'value': '9.5', 'groupId': 'OG000'}, {'value': '16.7', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Log drop 0-0.5 (Arm2-4,6 n=55/Arm5 n=17/Arm7 n=16)', 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000'}, {'value': '17.6', 'groupId': 'OG001'}, {'value': '18.8', 'groupId': 'OG002'}]}]}, {'title': 'Log drop 0.5to<1(Arm2-4,6 n=73/Arm5 n=11/Arm7 n=9)', 'categories': [{'measurements': [{'value': '12.3', 'groupId': 'OG000'}, {'value': '9.1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Log drop 1to<1.5(Arm2-4,6 n=31/Arm5 n=9/Arm7 n=18)', 'categories': [{'measurements': [{'value': '25.8', 'groupId': 'OG000'}, {'value': '33.3', 'groupId': 'OG001'}, {'value': '16.7', 'groupId': 'OG002'}]}]}, {'title': 'Log drop ≥1.5 (Arm2-4,6 n=12/Arm5 n=4/Arm7 n=18)', 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}, {'value': '50.0', 'groupId': 'OG001'}, {'value': '44.4', 'groupId': 'OG002'}]}]}, {'title': 'Missing (Arm2-4,6 n=2/Arm5 n=2/Arm7 n=1)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 1 and Week 49', 'description': 'For each log drop category (\\<0, 0 to 0.5, 0.5 to \\<1, 1 to \\<1.5, ≥1.5, and Missing), the percentage of participants receiving combination therapy who were HCV-RNA negative at EoT (Week 49) was calculated as follows:\n\nNumber of participants in a log category who were HCV-RNA negative divided by the total number of participants in that log drop category (n).\n\nPercentages were NOT derived using treatment arm N values. The sum of the n values for all 6 log drop categories within a treatment arm equals the overall N for that treatment group.', 'unitOfMeasure': 'Percent of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'N=Number of Participants Analyzed, n=number of participants in each log category group. The PEG + BOC 100, 200, or 400 arm combined the following treatment arms: Arm 2 PEG + BOC 100 (48 weeks), Arm 3 PEG + BOC 200 (48 weeks), Arm 4 PEG + BOC 400 (48 weeks), Arm 6 PEG + BOC 400 (24 weeks).'}, {'type': 'SECONDARY', 'title': 'Percent of Participants With Virologic Response Prior to Amendment 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}, {'value': '97', 'groupId': 'OG004'}, {'value': '65', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1A: PEG + RBV and Arm 1B: PEG + RBV + BOC 400', 'description': 'Arm 1A: A single dose of PEG was given first, followed 1 week later by PEG + RBV for 12 weeks. If participant was HCV-RNA negative, PEG + RBV was continued for another 36 weeks.\n\nArm 1B: A single dose of PEG was given first, followed 1 week later by PEG + RBV for 12 weeks. If HCV-RNA was detectable, BOC 400 was added for another 36 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.'}, {'id': 'OG001', 'title': 'Arm 2: PEG + BOC 100 (48 Weeks)', 'description': 'A single dose of PEG was given first, followed 1 week later by PEG + BOC 100 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.'}, {'id': 'OG002', 'title': 'Arm 3: PEG + BOC 200 (48 Weeks)', 'description': 'A single dose of PEG was given first, followed 1 week later by PEG + BOC 200 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.'}, {'id': 'OG003', 'title': 'Arm 5: PEG + RBV + BOC 400', 'description': 'A single dose of PEG was given first, followed 1 week later by PEG + RBV + BOC 400. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.'}, {'id': 'OG004', 'title': 'Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks)', 'description': 'A single dose of PEG was given first, followed 1 week later by PEG + BOC (24 or 48 weeks). By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.'}, {'id': 'OG005', 'title': 'Arm 7: PEG + BOC 800', 'description': 'A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.'}], 'classes': [{'title': 'Week 3', 'categories': [{'measurements': [{'value': '4.1', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '5.2', 'groupId': 'OG004'}, {'value': '4.6', 'groupId': 'OG005'}]}]}, {'title': 'Week 5', 'categories': [{'measurements': [{'value': '4.1', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '8.2', 'groupId': 'OG002'}, {'value': '12.2', 'groupId': 'OG003'}, {'value': '9.3', 'groupId': 'OG004'}, {'value': '15.4', 'groupId': 'OG005'}]}]}, {'title': 'Week 13', 'categories': [{'measurements': [{'value': '6.1', 'groupId': 'OG000'}, {'value': '2.1', 'groupId': 'OG001'}, {'value': '14.3', 'groupId': 'OG002'}, {'value': '30.6', 'groupId': 'OG003'}, {'value': '13.4', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 3, Week 5, Week 13', 'description': 'Virologic response was defined as the percentage of participants with Hepatitis C Virus Ribonucleic Acid (HCV-RNA) ≤10,000 IU/mL.', 'unitOfMeasure': 'Percent of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Peak Plasma Concentration of Boceprevir (BOC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '64', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'BOC 100 mg Dose', 'description': 'A single dose of PEG was given first, followed 1 week later by Arm 2 (PEG + BOC 100). By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.'}, {'id': 'OG001', 'title': 'BOC 200 mg Dose', 'description': 'A single dose of PEG was given first, followed 1 week later by Arm 3 (PEG + BOC 200). By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.'}, {'id': 'OG002', 'title': 'BOC 400 mg Dose', 'description': 'A single dose of PEG was given first, followed 1 week later by Arms 1B, 4, 5, 6, or 7. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.'}, {'id': 'OG003', 'title': 'BOC 800 mg Dose', 'description': 'A single dose of PEG was given first, followed 1 week later by PEG + BOC 800 or PEG + RBV + BOC 800. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '203', 'spread': '5', 'groupId': 'OG000'}, {'value': '427', 'spread': '18', 'groupId': 'OG001'}, {'value': '704', 'spread': '16', 'groupId': 'OG002'}, {'value': '1312', 'spread': '45', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'All visits during treatment (baseline to Week 49) except Day 1 of Week 1', 'description': 'All plasma samples were assayed using a validated liquid chromatography with tandem mass spectrometric detection (LCMS/MS) method.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants were only included in the analysis if the recorded previous dose of boceprevir was taken \\< 8.5 hours prior to sample collection. Participants also must have started BOC treatment or amendment 2 dosing more than 1 week prior to sample collection.'}, {'type': 'SECONDARY', 'title': 'Area Under the Plasma Concentration-time Curve of Boceprevir Plasma Concentration for an 8-hour Dosing Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '64', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'BOC 100 mg Dose', 'description': 'A single dose of PEG was given first, followed 1 week later by Arm 2 (PEG + BOC 100). By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.'}, {'id': 'OG001', 'title': 'BOC 200 mg Dose', 'description': 'A single dose of PEG was given first, followed 1 week later by Arm 3 (PEG + BOC 200). By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.'}, {'id': 'OG002', 'title': 'BOC 400 mg Dose', 'description': 'A single dose of PEG was given first, followed 1 week later by Arms 1B, 4, 5, 6, or 7. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.'}, {'id': 'OG003', 'title': 'BOC 800 mg Dose', 'description': 'A single dose of PEG was given first, followed 1 week later by PEG + BOC 800 or PEG + RBV + BOC 800. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '1042', 'spread': '25', 'groupId': 'OG000'}, {'value': '2184', 'spread': '181', 'groupId': 'OG001'}, {'value': '3633', 'spread': '88', 'groupId': 'OG002'}, {'value': '6276', 'spread': '337', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'All visits during treatment (baseline to Week 49) except Day 1 of Week 1', 'description': 'All plasma samples were assayed using a validated liquid chromatography with tandem mass spectrometric detection (LCMS/MS) method.\n\nThe dosing interval of 8 hours is represented as the hr in the unit of measure.', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants were only included in the analysis if the recorded previous dose of boceprevir was taken \\< 8.5 hours prior to sample collection. Participants also must have started BOC treatment or amendment 2 dosing more than 1 week prior to sample collection.'}, {'type': 'SECONDARY', 'title': 'Trough Plasma Concentration Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '64', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'BOC 100 mg Dose', 'description': 'A single dose of PEG was given first, followed 1 week later by Arm 2 (PEG + BOC 100). By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.'}, {'id': 'OG001', 'title': 'BOC 200 mg Dose', 'description': 'A single dose of PEG was given first, followed 1 week later by Arm 3 (PEG + BOC 200). By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.'}, {'id': 'OG002', 'title': 'BOC 400 mg Dose', 'description': 'A single dose of PEG was given first, followed 1 week later by Arms 1B, 4, 5, 6, or 7. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.'}, {'id': 'OG003', 'title': 'BOC 800 mg Dose', 'description': 'A single dose of PEG was given first, followed 1 week later by PEG + BOC 800 or PEG + RBV + BOC 800. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '56.7', 'spread': '3', 'groupId': 'OG000'}, {'value': '133.0', 'spread': '27', 'groupId': 'OG001'}, {'value': '214.0', 'spread': '10', 'groupId': 'OG002'}, {'value': '355', 'spread': '42', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'All visits during treatment (baseline to Week 49) except Day 1 of Week 1', 'description': 'All plasma samples were assayed using a validated liquid chromatography with tandem mass spectrometric detection (LCMS/MS) method.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants were only included in the analysis if the recorded previous dose of boceprevir was taken \\< 8.5 hours prior to sample collection. Participants also must have started BOC treatment or amendment 2 dosing more than 1 week prior to sample collection.'}, {'type': 'SECONDARY', 'title': 'Change in Alanine Aminotransferase (ALT) Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}, {'value': '48', 'groupId': 'OG004'}, {'value': '97', 'groupId': 'OG005'}, {'value': '64', 'groupId': 'OG006'}, {'value': '143', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1A: PEG + RBV', 'description': 'Arm 1A: A single dose of PEG was given first, followed 1 week later by PEG + RBV for 12 weeks. If participant was HCV-RNA negative, PEG + RBV was continued for another 36 weeks.'}, {'id': 'OG001', 'title': 'Arm 1B: PEG + RBV + BOC 400', 'description': 'Arm 1B: A single dose of PEG was given first, followed 1 week later by PEG + RBV for 12 weeks. If HCV-RNA was detectable, BOC 400 was added for another 36 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.'}, {'id': 'OG002', 'title': 'Arm 2: PEG + BOC 100 (48 Weeks)', 'description': 'A single dose of PEG was given first, followed 1 week later by PEG + BOC 100 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.'}, {'id': 'OG003', 'title': 'Arm 3: PEG + BOC 200', 'description': 'A single dose of PEG was given first, followed 1 week later by PEG + BOC 200 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.'}, {'id': 'OG004', 'title': 'Arm 5: PEG + RBV + BOC 400', 'description': 'A single dose of PEG was given first, followed 1 week later by PEG + RBV + BOC 400. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.'}, {'id': 'OG005', 'title': 'Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks)', 'description': 'A single dose of PEG was given first, followed 1 week later by PEG + BOC (24 or 48 weeks). By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.'}, {'id': 'OG006', 'title': 'Arm 7: PEG + BOC 800', 'description': 'A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.'}, {'id': 'OG007', 'title': 'Arm 8: PEG + RBV + BOC 800', 'description': 'By protocol amendment 2, participants from all arms except Arm 1A were rolled over into PEG + RBV + BOC 800 for the remainder of the treatment period.'}], 'classes': [{'title': '<2.00 x baseline ALT value', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '47', 'groupId': 'OG004'}, {'value': '84', 'groupId': 'OG005'}, {'value': '61', 'groupId': 'OG006'}, {'value': '119', 'groupId': 'OG007'}]}]}, {'title': '2.00-2.09 x baseline ALT value', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}]}]}, {'title': '2.10-5.09 x baseline ALT value', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '18', 'groupId': 'OG007'}]}]}, {'title': '5.10-10.0 x baseline ALT value', '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'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}]}]}, {'title': '>10.0 x baseline ALT value', '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'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to dosing change (> 25 weeks)', 'description': 'Change in ALT levels during initial treatment regimen and after rolling into amendment 2 as compared to baseline.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants with at least one value for the laboratory test were included.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on Arms 2 (PEG+BOC 100), 3 (PEG+BOC 200), 4 (PEG+BOC 400 [48 Weeks]), 6 (PEG+BOC 400 [24 Weeks])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Log Drop 0 to <1', 'description': 'All arms were given single dose of PEG first, followed 1 week later by PEG + BOC 100 for 48 weeks for Arm 2 (PEG+BOC 100), followed by PEG + BOC 200 for 48 weeks for Arm 3 (PEG+BOC 200), followed by PEG + BOC (24 or 48 weeks) for Arm 4 (PEG+BOC 400 \\[48 weeks\\]) and Arm 6 (PEG+BOC 400 \\[24 weeks\\]). By protocol amendment 2, participants were switched to an increased dose of BOC 800 TID plus RBV with PEG for an additional 24 Weeks of Treatment.'}, {'id': 'OG001', 'title': 'Log Drop 1 to <2', 'description': 'All arms were given single dose of PEG first, followed 1 week later by PEG + BOC 100 for 48 weeks for Arm 2 (PEG+BOC 100), followed by PEG + BOC 200 for 48 weeks for Arm 3 (PEG+BOC 200), followed by PEG + BOC (24 or 48 weeks) for Arm 4 (PEG+BOC 400 \\[48 weeks\\]) and Arm 6 (PEG+BOC 400 \\[24 weeks\\]). By protocol amendment 2, participants were switched to an increased dose of BOC 800 TID plus RBV with PEG for an additional 24 Weeks of Treatment.'}, {'id': 'OG002', 'title': 'Log Drop 2 to <3', 'description': 'All arms were given single dose of PEG first, followed 1 week later by PEG + BOC 100 for 48 weeks for Arm 2 (PEG+BOC 100), followed by PEG + BOC 200 for 48 weeks for Arm 3 (PEG+BOC 200), followed by PEG + BOC (24 or 48 weeks) for Arm 4 (PEG+BOC 400 \\[48 weeks\\]) and Arm 6 (PEG+BOC 400 \\[24 weeks\\]). By protocol amendment 2, participants were switched to an increased dose of BOC 800 TID plus RBV with PEG for an additional 24 Weeks of Treatment.'}, {'id': 'OG003', 'title': 'Log Drop 3 to <4', 'description': 'All arms were given single dose of PEG first, followed 1 week later by PEG + BOC 100 for 48 weeks for Arm 2 (PEG+BOC 100), followed by PEG + BOC 200 for 48 weeks for Arm 3 (PEG+BOC 200), followed by PEG + BOC (24 or 48 weeks) for Arm 4 (PEG+BOC 400 \\[48 weeks\\]) and Arm 6 (PEG+BOC 400 \\[24 weeks\\]). By protocol amendment 2, participants were switched to an increased dose of BOC 800 TID plus RBV with PEG for an additional 24 Weeks of Treatment.'}, {'id': 'OG004', 'title': 'Log Drop 4 to <5', 'description': 'All arms were given single dose of PEG first, followed 1 week later by PEG + BOC 100 for 48 weeks for Arm 2 (PEG+BOC 100), followed by PEG + BOC 200 for 48 weeks for Arm 3 (PEG+BOC 200), followed by PEG + BOC (24 or 48 weeks) for Arm 4 (PEG+BOC 400 \\[48 weeks\\]) and Arm 6 (PEG+BOC 400 \\[24 weeks\\]). By protocol amendment 2, participants were switched to an increased dose of BOC 800 TID plus RBV with PEG for an additional 24 Weeks of Treatment.'}, {'id': 'OG005', 'title': 'Log Drop ≥5', 'description': 'All arms were given single dose of PEG first, followed 1 week later by PEG + BOC 100 for 48 weeks for Arm 2 (PEG+BOC 100), followed by PEG + BOC 200 for 48 weeks for Arm 3 (PEG+BOC 200), followed by PEG + BOC (24 or 48 weeks) for Arm 4 (PEG+BOC 400 \\[48 weeks\\]) and Arm 6 (PEG+BOC 400 \\[24 weeks\\]). By protocol amendment 2, participants were switched to an increased dose of BOC 800 TID plus RBV with PEG for an additional 24 Weeks of Treatment.'}], 'classes': [{'title': 'Week 3 after dosing change', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}]}, {'title': 'Week 6 after dosing change', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': 'Week 9 after dosing change', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': 'Week 12 after dosing change', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': 'Week 18 after dosing change', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': 'Week 24 after dosing change', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': 'End of treatment', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': 'Follow-up Week 4 after dosing change', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': 'Follow-up Week 8 after dosing change', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': 'Follow-up Week 12 after dosing change', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': 'Follow-up Week 24 after dosing change', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': 'End of follow-up after dosing change', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From dosing change to end of follow-up (Week 73)(up to 48 weeks)', 'description': 'Log drop at baseline of dosing change = difference of log viral loads between baseline (closest to the treatment begin date) and dosing change baseline (virology value closest to the dosing change begin date).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants, per the second amendment to P03659, with significant HCV-RNA decrease (HCV\\_RNA ≤ 10,000 IU) switched to continuing triple therapy.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Rebetol (RVB) + Boceprevir (BOC) 400 (Arm 5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Log Drop 1 to <2', 'description': 'Arm 5: A single dose of PEG first, followed 1 week later by PEG + RBV + BOC 400 for 48 weeks. By protocol amendment 2, participants were switched to an increased dose of BOC 800 plus RBV with PEG for an additional 24 Weeks of Treatment.'}, {'id': 'OG001', 'title': 'Log Drop 2 to <3', 'description': 'Arm 5: A single dose of PEG first, followed 1 week later by PEG + RBV + BOC 400 for 48 weeks. By protocol amendment 2, participants were switched to an increased dose of BOC 800 plus RBV with PEG for an additional 24 Weeks of Treatment.'}, {'id': 'OG002', 'title': 'Log Drop 3 to <4', 'description': 'Arm 5: A single dose of PEG first, followed 1 week later by PEG + RBV + BOC 400 for 48 weeks. By protocol amendment 2, participants were switched to an increased dose of BOC 800 plus RBV with PEG for an additional 24 Weeks of Treatment.'}, {'id': 'OG003', 'title': 'Log Drop 4 to <5', 'description': 'Arm 5: A single dose of PEG first, followed 1 week later by PEG + RBV + BOC 400 for 48 weeks. By protocol amendment 2, participants were switched to an increased dose of BOC 800 plus RBV with PEG for an additional 24 Weeks of Treatment.'}, {'id': 'OG004', 'title': 'Log Drop ≥5', 'description': 'Arm 5: A single dose of PEG first, followed 1 week later by PEG + RBV + BOC 400 for 48 weeks. By protocol amendment 2, participants were switched to an increased dose of BOC 800 plus RBV with PEG for an additional 24 Weeks of Treatment.'}], 'classes': [{'title': 'Week 3 after dosing change', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Week 6 after dosing change', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Week 9 after dosing change', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Week 12 after dosing change', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Week 18 after dosing change', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Week 24 after dosing change', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'End of treatment', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Follow-up Week 4 after dosing change', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Follow-up Week 8 after dosing change', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Follow-up Week 12 after dosing change', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Follow-up Week 24 after dosing change', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'End of follow-up after dosing change', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From dosing change to end of follow-up (Week 73)(up to 48 weeks)', 'description': 'Log drop at baseline of dosing change = difference of log viral loads between baseline (closest to the treatment begin date) and dosing change baseline (virology value closest to the dosing change begin date).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants, per the second amendment to P03659, with significant HCV-RNA decrease (HCV\\_RNA ≤ 10,000 IU) switched to continuing triple therapy.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Log Drop <0', 'description': 'Arm 7: A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were switched to PEG + RBV + BOC 800 for an additional 24 Weeks of Treatment.'}, {'id': 'OG001', 'title': 'Log Drop 0 to <1', 'description': 'Arm 7: A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were switched to PEG + RBV + BOC 800 for an additional 24 Weeks of Treatment.'}, {'id': 'OG002', 'title': 'Log Drop 1 to <2', 'description': 'Arm 7: A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were switched to PEG + RBV + BOC 800 for an additional 24 Weeks of Treatment.'}, {'id': 'OG003', 'title': 'Log Drop 2 to <3', 'description': 'Arm 7: A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were switched to PEG + RBV + BOC 800 for an additional 24 Weeks of Treatment.'}, {'id': 'OG004', 'title': 'Log Drop 3 to <4', 'description': 'Arm 7: A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were switched to PEG + RBV + BOC 800 for an additional 24 Weeks of Treatment.'}, {'id': 'OG005', 'title': 'Log Drop 4 to <5', 'description': 'Arm 7: A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were switched to PEG + RBV + BOC 800 for an additional 24 Weeks of Treatment.'}, {'id': 'OG006', 'title': 'Log Drop ≥5', 'description': 'Arm 7: A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were switched to PEG + RBV + BOC 800 for an additional 24 Weeks of Treatment.'}, {'id': 'OG007', 'title': 'Missing Data', 'description': 'Arm 7: A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were switched to PEG + RBV + BOC 800 for an additional 24 Weeks of Treatment.'}], 'classes': [{'title': 'Week 3 after dosing change', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}]}]}, {'title': 'Week 6 after dosing change', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}]}]}, {'title': 'Week 9 after dosing change', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}]}]}, {'title': 'Week 12 after dosing change', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}]}]}, {'title': 'Week 18 after dosing change', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}]}]}, {'title': 'Week 24 after dosing change', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}]}]}, {'title': 'End of treatment', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}]}]}, {'title': 'Follow-up Week 4 after dosing change', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Follow-up Week 8 after dosing change', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Follow-up Week 12 after dosing change', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Follow-up Week 24 after dosing change', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'End of follow-up after dosing change', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From dosing change to end of follow-up (Week 73) (up to 48 weeks)', 'description': 'Log drop at baseline of dosing change = difference of log viral loads between baseline (closest to the treatment begin date) and dosing change baseline (virology value closest to the dosing change begin date).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants, per the second amendment to P03659, with significant HCV-RNA decrease (HCV\\_RNA ≤ 10,000 IU) switched to continuing triple therapy.'}, {'type': 'PRIMARY', 'title': 'Percent of Participants Who Achieved Sustained Virologic Response (SVR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '97', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}, {'value': '65', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1B: PEG + RBV + BOC 400', 'description': 'A single dose of PEG was given first, followed 1 week later by PEG + RBV for 12 weeks. If HCV-RNA was detectable, BOC 400 was added for another 36 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.'}, {'id': 'OG001', 'title': 'Arm 2: PEG + BOC 100 (48 Weeks)', 'description': 'A single dose of PEG was given first, followed 1 week later by PEG + BOC 100 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.'}, {'id': 'OG002', 'title': 'Arm 3: PEG + BOC 200 (48 Weeks)', 'description': 'A single dose of PEG was given first, followed 1 week later by PEG + BOC 200 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.'}, {'id': 'OG003', 'title': 'Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks)', 'description': 'A single dose of PEG was given first, followed 1 week later by PEG + BOC (24 or 48 weeks). By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.'}, {'id': 'OG004', 'title': 'Arm 5: PEG + RBV + BOC 400', 'description': 'A single dose of PEG was given first, followed 1 week A single dose of PEG was given first, followed 1 week later by PEG + RBV + BOC 400. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.'}, {'id': 'OG005', 'title': 'Arm 7: PEG + BOC 800', 'description': 'A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.5', 'groupId': 'OG000'}, {'value': '2.1', 'groupId': 'OG001'}, {'value': '12.2', 'groupId': 'OG002'}, {'value': '5.2', 'groupId': 'OG003'}, {'value': '14.3', 'groupId': 'OG004'}, {'value': '4.6', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Week 73 [24 weeks after end of treatment (EoT)]', 'description': 'SVR was defined as the percentage of participants with Hepatitis C Virus Ribonucleic Acid (HCV-RNA) undetectable at the follow-up Week 24.\n\nAll percentages were based on the total number of participants originally randomized/enrolled to that particular arm.\n\nFor Arm 1B, the denominator for the percentages was the number who received at least 1 dose of BOC.\n\nArm 1A was not analyzed.', 'unitOfMeasure': 'Percent of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'For PEG + RBV + BOC number of participants was number who received at least one dose of BOC. For all others, it was number of randomized participants. The PEG + BOC 800 arm was not randomized.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm 1A: PEG + RBV', 'description': 'A single dose of PEG was given first, followed 1 week A single dose of PEG was given first, followed 1 week later by PEG + RBV + BOC 400. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.'}, {'id': 'FG001', 'title': 'Arm 1B: PEG + RBV + BOC', 'description': 'A single dose of PEG was given first, followed 1 week later by PEG + RBV for 12 weeks. If HCV-RNA was detectable, BOC 400 was added for another 36 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.'}, {'id': 'FG002', 'title': 'Arm 2: PEG + BOC 100 (48 Weeks)', 'description': 'A single dose of PEG was given first, followed 1 week later by PEG + BOC 100 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.'}, {'id': 'FG003', 'title': 'Arm 3: PEG + BOC 200 (48 Weeks)', 'description': 'A single dose of PEG was given first, followed 1 week later by PEG + BOC 200 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.'}, {'id': 'FG004', 'title': 'Arm 5: PEG + RBV + BOC 400', 'description': 'A single dose of PEG was given first, followed 1 week A single dose of PEG was given first, followed 1 week later by PEG + RBV + BOC 400. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.'}, {'id': 'FG005', 'title': 'ARM 4+6: PEG + BOC 400 (24 + 48 Weeks)', 'description': 'A single dose of PEG was given first, followed 1 week A single dose of PEG was given first, followed 1 week later by PEG + RBV + BOC 400. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.'}, {'id': 'FG006', 'title': 'Arm 7: PEG + BOC 800', 'description': 'A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.'}, {'id': 'FG007', 'title': 'Arm 8: PEG + RBV + BOC 800', 'description': 'By protocol amendment 2, participants from all arms except Arm 1A were rolled over into PEG + RBV + BOC 800 for the remainder of the treatment period.'}], 'periods': [{'title': 'Prior to Amendment 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '34'}, {'groupId': 'FG002', 'numSubjects': '48'}, {'groupId': 'FG003', 'numSubjects': '49'}, {'groupId': 'FG004', 'numSubjects': '49'}, {'groupId': 'FG005', 'numSubjects': '97'}, {'groupId': 'FG006', 'numSubjects': '65'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '28'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '9'}, {'groupId': 'FG004', 'numSubjects': '21'}, {'groupId': 'FG005', 'numSubjects': '14'}, {'groupId': 'FG006', 'numSubjects': '61'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '44'}, {'groupId': 'FG003', 'numSubjects': '40'}, {'groupId': 'FG004', 'numSubjects': '28'}, {'groupId': 'FG005', 'numSubjects': '83'}, {'groupId': 'FG006', 'numSubjects': '4'}, {'groupId': 'FG007', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '37'}, {'groupId': 'FG003', 'numSubjects': '35'}, {'groupId': 'FG004', 'numSubjects': '24'}, {'groupId': 'FG005', 'numSubjects': '55'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '3'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Noncompliance with protocol', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Completed Treatment Phase', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '23'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}]}, {'title': 'Post-amendment 2', 'milestones': [{'type': 'STARTED', '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'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '143'}]}, {'type': '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'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '88'}]}, {'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'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '55'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '20'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '24'}]}, {'type': 'Lost to follow-up/withdrawal by subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '11'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}, {'value': '49', 'groupId': 'BG003'}, {'value': '97', 'groupId': 'BG004'}, {'value': '65', 'groupId': 'BG005'}, {'value': '357', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm 1A: PEG + RBV OR Arm 1B: PEG + RBV + BOC 400', 'description': 'Arm 1A: A single dose of PEG was given first, followed 1 week later by PEG + RBV for 12 weeks. If participant was HCV-RNA negative, PEG + RBV was continued for another 36 weeks.\n\nArm 1B: A single dose of PEG was given first, followed 1 week later by PEG + RBV for 12 weeks. If HCV-RNA was detectable, BOC 400 was added for another 36 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.'}, {'id': 'BG001', 'title': 'Arm 2: PEG + BOC 100 (48 Weeks)', 'description': 'A single dose of PEG was given first, followed 1 week later by PEG + BOC 100 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.'}, {'id': 'BG002', 'title': 'Arm 3: PEG + BOC 200 (48 Weeks)', 'description': 'A single dose of PEG was given first, followed 1 week later by PEG + BOC 200 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.'}, {'id': 'BG003', 'title': 'Arm 5: PEG + RBV + BOC 400', 'description': 'A single dose of PEG was given first, followed 1 week later by PEG + RBV + BOC 400. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.'}, {'id': 'BG004', 'title': 'Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks)', 'description': 'A single dose of PEG was given first, followed 1 week later by PEG + BOC (24 or 48 weeks). By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.'}, {'id': 'BG005', 'title': 'Arm 7: PEG + BOC 800', 'description': 'A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '48.9', 'spread': '9.7', 'groupId': 'BG000'}, {'value': '51.6', 'spread': '7.0', 'groupId': 'BG001'}, {'value': '48.6', 'spread': '9.4', 'groupId': 'BG002'}, {'value': '48.2', 'spread': '8.9', 'groupId': 'BG003'}, {'value': '49.2', 'spread': '8.7', 'groupId': 'BG004'}, {'value': '50.4', 'spread': '7.3', 'groupId': 'BG005'}, {'value': '49.5', 'spread': '8.6', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '37', 'groupId': 'BG004'}, {'value': '24', 'groupId': 'BG005'}, {'value': '134', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}, {'value': '60', 'groupId': 'BG004'}, {'value': '41', 'groupId': 'BG005'}, {'value': '223', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 357}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2007-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-13', 'studyFirstSubmitDate': '2005-09-08', 'resultsFirstSubmitDate': '2011-05-13', 'studyFirstSubmitQcDate': '2005-09-08', 'lastUpdatePostDateStruct': {'date': '2015-10-14', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-11-23', 'studyFirstPostDateStruct': {'date': '2005-09-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-12-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent of Participants Who Were Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Negative at the End of Treatment (EoT)', 'timeFrame': 'Baseline up to Week 49', 'description': 'Sustained Viral Response (SVR) was defined as the percentage of participants with HCV-RNA undetectable at the follow-up Week 24.\n\nAll percentages were based on the total number of participants originally randomized/enrolled to that particular arm.\n\nFor Arm 1B, the denominator for the percentages was the number who received at least 1 dose of BOC.\n\nArm 1A was not analyzed.'}, {'measure': 'Percent of Participants Who Achieved Sustained Virologic Response (SVR)', 'timeFrame': 'Baseline up to Week 73 [24 weeks after end of treatment (EoT)]', 'description': 'SVR was defined as the percentage of participants with Hepatitis C Virus Ribonucleic Acid (HCV-RNA) undetectable at the follow-up Week 24.\n\nAll percentages were based on the total number of participants originally randomized/enrolled to that particular arm.\n\nFor Arm 1B, the denominator for the percentages was the number who received at least 1 dose of BOC.\n\nArm 1A was not analyzed.'}], 'secondaryOutcomes': [{'measure': 'Percent of Participants Who Achieved Sustained Viral Response (SVR) by Time to First Negative HCV-RNA', 'timeFrame': 'Baseline up to Week 73 [24 weeks after EoT]', 'description': 'Percentage of participants who became HCV-RNA undetectable within the first 13 weeks and subsequently became HCV-RNA positive were not considered negative for this analysis.'}, {'measure': 'Percentage of Participants Who Were HCV-RNA Negative at EoT After Receiving 1 Week of Treatment With PegIntron (PEG) by Log Drop', 'timeFrame': 'Week 1 and Week 49', 'description': 'For each log drop category (\\<0, 0 to 0.5, 0.5 to \\<1, 1 to \\<1.5, ≥1.5, and Missing), the percentage of participants receiving combination therapy who were HCV-RNA negative at EoT (Week 49) was calculated as follows:\n\nNumber of participants in a log category who were HCV-RNA negative divided by the total number of participants in that log drop category (n).\n\nPercentages were NOT derived using treatment arm N values. The sum of the n values for all 6 log drop categories within a treatment arm equals the overall N for that treatment group.'}, {'measure': 'Percent of Participants With Virologic Response Prior to Amendment 2', 'timeFrame': 'Week 3, Week 5, Week 13', 'description': 'Virologic response was defined as the percentage of participants with Hepatitis C Virus Ribonucleic Acid (HCV-RNA) ≤10,000 IU/mL.'}, {'measure': 'Peak Plasma Concentration of Boceprevir (BOC)', 'timeFrame': 'All visits during treatment (baseline to Week 49) except Day 1 of Week 1', 'description': 'All plasma samples were assayed using a validated liquid chromatography with tandem mass spectrometric detection (LCMS/MS) method.'}, {'measure': 'Area Under the Plasma Concentration-time Curve of Boceprevir Plasma Concentration for an 8-hour Dosing Period', 'timeFrame': 'All visits during treatment (baseline to Week 49) except Day 1 of Week 1', 'description': 'All plasma samples were assayed using a validated liquid chromatography with tandem mass spectrometric detection (LCMS/MS) method.\n\nThe dosing interval of 8 hours is represented as the hr in the unit of measure.'}, {'measure': 'Trough Plasma Concentration Level', 'timeFrame': 'All visits during treatment (baseline to Week 49) except Day 1 of Week 1', 'description': 'All plasma samples were assayed using a validated liquid chromatography with tandem mass spectrometric detection (LCMS/MS) method.'}, {'measure': 'Change in Alanine Aminotransferase (ALT) Levels', 'timeFrame': 'Baseline up to dosing change (> 25 weeks)', 'description': 'Change in ALT levels during initial treatment regimen and after rolling into amendment 2 as compared to baseline.'}, {'measure': 'Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on Arms 2 (PEG+BOC 100), 3 (PEG+BOC 200), 4 (PEG+BOC 400 [48 Weeks]), 6 (PEG+BOC 400 [24 Weeks])', 'timeFrame': 'From dosing change to end of follow-up (Week 73)(up to 48 weeks)', 'description': 'Log drop at baseline of dosing change = difference of log viral loads between baseline (closest to the treatment begin date) and dosing change baseline (virology value closest to the dosing change begin date).'}, {'measure': 'Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Rebetol (RVB) + Boceprevir (BOC) 400 (Arm 5)', 'timeFrame': 'From dosing change to end of follow-up (Week 73)(up to 48 weeks)', 'description': 'Log drop at baseline of dosing change = difference of log viral loads between baseline (closest to the treatment begin date) and dosing change baseline (virology value closest to the dosing change begin date).'}, {'measure': 'Number of Participants Who Were HCV-RNA Negative During Amendment 2 (AM2) for Those Who Started on PegIntron (PEG) + Boceprevir (BOC) 800 (Arm 7)', 'timeFrame': 'From dosing change to end of follow-up (Week 73) (up to 48 weeks)', 'description': 'Log drop at baseline of dosing change = difference of log viral loads between baseline (closest to the treatment begin date) and dosing change baseline (virology value closest to the dosing change begin date).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['PEG-Intron', 'Ribavirin', 'Protease Inhibitor'], 'conditions': ['Chronic Hepatitis C']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to determine the safe and effective dose range of boceprevir (SCH 503034) in combination with PEG-Intron in adult subjects who have chronic hepatitis C without cirrhosis, and who have failed an adequate course of combination therapy with peginterferon-alfa plus ribavirin. A secondary objective is to explore whether ribavirin provides an additional benefit when combined with PEG-Intron plus boceprevir.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key inclusion criteria:\n\n* Documented infection with chronic hepatitis C (CHC), genotype 1.\n* Documented failure to respond to an adequate course of treatment (minimum 12 weeks) with peginterferon-alfa plus ribavirin (failure defined as \\<2 log drop in HCV-RNA after 12 weeks of therapy or those who never become Hepatitis C Virus Ribonucleic Acid (HCV)-RNA negative)\n* No evidence of cirrhosis on liver biopsy.\n* Results of physical examination and laboratory tests within specified ranges.\n* Abstinence from use of abused substances.\n\nKey exclusion criteria:\n\n* Women who are pregnant or nursing a child.\n* Patients with cirrhosis, co-infection with Hepatitis B or human immunodeficiency virus (HIV), and African-American patients (by protocol amendment 2, African-American patients can enroll).\n* Previous treatment with any Hepatitis C Virus (HCV) polymerase or protease inhibitor.\n* Patients who relapsed following response to previous treatment.\n* Evidence of advanced liver disease, or liver disease from a cause other than CHC.\n* Pre-existing psychiatric condition.'}, 'identificationModule': {'nctId': 'NCT00160251', 'briefTitle': 'Boceprevir (SCH 503034) Plus Peg-Intron, With and Without Added Ribavirin, in Patients With Chronic Hepatitis C, Genotype 1, Who Did Not Respond to Previous Treatment With Peginterferon Alfa Plus Ribavirin (Study P03659AM2)(COMPLETED)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'PEG-Intron/REBETOL vs PEG-Intron/ SCH 503034 With and Without Ribavirin in Chronic Hepatitis C Virus Genotype 1 (HCV-1) Peginterferon Alfa/Ribavirin Nonresponders: A SCH 503034 Dose-Finding Phase 2 Study', 'orgStudyIdInfo': {'id': 'P03659'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 1A: PegIntron (PEG) + Ribavirin (RBV)', 'description': 'A single dose of PEG is given first, followed 1 week later by PEG + RBV for 12 weeks. If HCV-RNA is undetected, PEG + RBV will continue for another 36 weeks.', 'interventionNames': ['Biological: PegIntron (PEG)', 'Drug: Ribavirin (RBV)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 1B: PegIntron (PEG)+Ribavirin (RBV)+Boceprevir (BOC) 400', 'description': 'A single dose of PEG is given first, followed 1 week later by PEG + RBV for 12 weeks. If HCV-RNA is detectable, BOC 400 mg TID will be added for 36 weeks. By second protocol amendment to P03659, participants will be rolled over into Arm 8 for the remainder of the treatment period.', 'interventionNames': ['Drug: Boceprevir (BOC)', 'Biological: PegIntron (PEG)', 'Drug: Ribavirin (RBV)']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2: PegIntron (PEG) + Boceprevir (BOC) 100 (48 weeks)', 'description': 'A single dose of PEG is given first, followed 1 week later by PEB + BOC 100 for 48 weeks. By second protocol amendment to P03659, participants will be rolled over into Arm 8 for the remainder of the treatment period.', 'interventionNames': ['Drug: Boceprevir (BOC)', 'Biological: PegIntron (PEG)']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 3: PegIntron (PEG) + Boceprevir (BOC) 200 (48 Weeks)', 'description': 'A single dose of PEG is given first, followed 1 week later by PEG + BOC 200 for 48 weeks. By second protocol amendment to P03659, participants will be rolled over into Arm 8 for the remainder of the treatment period.', 'interventionNames': ['Drug: Boceprevir (BOC)', 'Biological: PegIntron (PEG)']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 4: PegIntron (PEG) + Boceprevir (BOC) 400 (48 weeks)', 'description': 'A single dose of PEG is given first, followed 1 week later by PEG + BOC 400 for 48 weeks. By second protocol amendment to P03659, participants will be rolled over into Arm 8 for the remainder of the treatment period.', 'interventionNames': ['Drug: Boceprevir (BOC)', 'Biological: PegIntron (PEG)']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 5: PegIntron (PEG)+Ribavirin (RBV)+Boceprevir (BOC) 400', 'description': 'A single dose of PEG is given first, followed 1 week later by PEG + RBV + BOC 400 for 48 weeks. By second protocol amendment to P03659, participants will be rolled over into Arm 8 for the remainder of the treatment period.', 'interventionNames': ['Drug: Boceprevir (BOC)', 'Biological: PegIntron (PEG)', 'Drug: Ribavirin (RBV)']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 6: PegIntron (PEG) + Boceprevir (BOC) 400 (24 Weeks)', 'description': 'A single dose of PEG is given first, followed 1 week later by PEG + BOC 400 for 24 weeks. By second protocol amendment to P03659, participants will be rolled over into Arm 8 for the remainder of the treatment period.', 'interventionNames': ['Drug: Boceprevir (BOC)', 'Biological: PegIntron (PEG)']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 7: PegIntron (PEG) + Boceprevir (BOC) 800', 'description': 'By first protocol amendment to P03659, this non-randomized arm is added. A single dose of PEG is given first, followed 1 week later by PEG + BOC 800 for 24 weeks. By second protocol amendment to P03659, participants will be rolled over into Arm 8 for the remainder of the treatment period.', 'interventionNames': ['Drug: Boceprevir (BOC)', 'Biological: PegIntron (PEG)']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 8: PegIntron (PEG)+Ribavirin (RBV)+Boceprevir (BOC) 800', 'description': 'By second protocol amendment to P03659, participants from all arms except Arm 1A will be rolled over into PEG + RBV + BOC 800 for the remainder of the treatment period.', 'interventionNames': ['Drug: Boceprevir (BOC)', 'Biological: PegIntron (PEG)', 'Drug: Ribavirin (RBV)']}], 'interventions': [{'name': 'Boceprevir (BOC)', 'type': 'DRUG', 'otherNames': ['SCH 503034'], 'description': '100 or 200 mg capusles taken orally as 100 mg, 200 mg, 400 mg, or 800 mg TID', 'armGroupLabels': ['Arm 1B: PegIntron (PEG)+Ribavirin (RBV)+Boceprevir (BOC) 400', 'Arm 2: PegIntron (PEG) + Boceprevir (BOC) 100 (48 weeks)', 'Arm 3: PegIntron (PEG) + Boceprevir (BOC) 200 (48 Weeks)', 'Arm 4: PegIntron (PEG) + Boceprevir (BOC) 400 (48 weeks)', 'Arm 5: PegIntron (PEG)+Ribavirin (RBV)+Boceprevir (BOC) 400', 'Arm 6: PegIntron (PEG) + Boceprevir (BOC) 400 (24 Weeks)', 'Arm 7: PegIntron (PEG) + Boceprevir (BOC) 800', 'Arm 8: PegIntron (PEG)+Ribavirin (RBV)+Boceprevir (BOC) 800']}, {'name': 'PegIntron (PEG)', 'type': 'BIOLOGICAL', 'description': '1.5 mcg/kg weekly subcutaneously', 'armGroupLabels': ['Arm 1A: PegIntron (PEG) + Ribavirin (RBV)', 'Arm 1B: PegIntron (PEG)+Ribavirin (RBV)+Boceprevir (BOC) 400', 'Arm 2: PegIntron (PEG) + Boceprevir (BOC) 100 (48 weeks)', 'Arm 3: PegIntron (PEG) + Boceprevir (BOC) 200 (48 Weeks)', 'Arm 4: PegIntron (PEG) + Boceprevir (BOC) 400 (48 weeks)', 'Arm 5: PegIntron (PEG)+Ribavirin (RBV)+Boceprevir (BOC) 400', 'Arm 6: PegIntron (PEG) + Boceprevir (BOC) 400 (24 Weeks)', 'Arm 7: PegIntron (PEG) + Boceprevir (BOC) 800', 'Arm 8: PegIntron (PEG)+Ribavirin (RBV)+Boceprevir (BOC) 800']}, {'name': 'Ribavirin (RBV)', 'type': 'DRUG', 'description': '200 mg capsules taken twice daily (BID) (total daily dose of 800-1400 mg/day, depending on weight \\[weight-based dosing {WBD}\\])', 'armGroupLabels': ['Arm 1A: PegIntron (PEG) + Ribavirin (RBV)', 'Arm 1B: PegIntron (PEG)+Ribavirin (RBV)+Boceprevir (BOC) 400', 'Arm 5: PegIntron (PEG)+Ribavirin (RBV)+Boceprevir (BOC) 400', 'Arm 8: PegIntron (PEG)+Ribavirin (RBV)+Boceprevir (BOC) 800']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}