Ignite Creation Date:
2025-12-24 @ 9:32 PM
Ignite Modification Date:
2025-12-25 @ 7:17 PM
Study NCT ID:
NCT00705432
Status:
COMPLETED
Last Update Posted:
2017-04-07
First Post:
2008-06-24
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of Boceprevir in Previously Untreated Subjects With Chronic Hepatitis C Genotype 1 (Study P05216AM2) (COMPLETED)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Argentina', 'Belgium', 'Canada', 'France', 'Germany', 'Italy', 'Netherlands', 'Puerto Rico', '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': 'C417083', 'term': 'peginterferon alfa-2b'}, {'id': 'D012254', 'term': 'Ribavirin'}, {'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'}], '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': 'In this multicenter trial, initially, the investigator may only publish study results together with the other sites, unless specific written permission is obtained in advance from the sponsor.\n\nThe disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a 45 day period from the time submitted to the sponsor for review.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'PEG + RBV', 'description': 'Cohort I (White participants) and Cohort II (Black participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing \\[WBD\\]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.', 'otherNumAtRisk': 363, 'otherNumAffected': 353, 'seriousNumAtRisk': 363, 'seriousNumAffected': 31}, {'id': 'EG001', 'title': 'BOCEPREVIR + PEG + RBV - 24 WEEKS', 'description': 'Cohort I (White participants) and Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.\n\n* At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.\n* At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up.', 'otherNumAtRisk': 368, 'otherNumAffected': 365, 'seriousNumAtRisk': 368, 'seriousNumAffected': 42}, {'id': 'EG002', 'title': 'BOCEPRIVIR + PEG + RBV - 44 WEEKS', 'description': 'Cohort I (White participants) and Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.', 'otherNumAtRisk': 366, 'otherNumAffected': 363, 'seriousNumAtRisk': 366, 'seriousNumAffected': 45}], 'otherEvents': [{'term': 'ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numEvents': 188, 'numAffected': 107}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 292, 'numAffected': 182}, {'groupId': 'EG002', 'numAtRisk': 366, 'numEvents': 352, 'numAffected': 179}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'LEUKOPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numEvents': 81, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 83, 'numAffected': 31}, {'groupId': 'EG002', 'numAtRisk': 366, 'numEvents': 126, 'numAffected': 45}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'NEUTROPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numEvents': 208, 'numAffected': 77}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 216, 'numAffected': 91}, {'groupId': 'EG002', 'numAtRisk': 366, 'numEvents': 257, 'numAffected': 93}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'THROMBOCYTOPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numEvents': 16, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 50, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 366, 'numEvents': 38, 'numAffected': 19}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'DRY EYE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 366, 'numEvents': 24, 'numAffected': 22}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'VISION BLURRED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numEvents': 15, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 25, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 366, 'numEvents': 25, 'numAffected': 22}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'ABDOMINAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numEvents': 30, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 28, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 366, 'numEvents': 28, 'numAffected': 23}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'ABDOMINAL PAIN UPPER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numEvents': 40, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 41, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 366, 'numEvents': 54, 'numAffected': 44}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'CONSTIPATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numEvents': 34, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 24, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 366, 'numEvents': 34, 'numAffected': 32}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numEvents': 103, 'numAffected': 79}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 104, 'numAffected': 80}, {'groupId': 'EG002', 'numAtRisk': 366, 'numEvents': 125, 'numAffected': 100}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'DRY MOUTH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numEvents': 45, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 42, 'numAffected': 39}, {'groupId': 'EG002', 'numAtRisk': 366, 'numEvents': 51, 'numAffected': 43}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'DYSPEPSIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numEvents': 39, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 35, 'numAffected': 29}, {'groupId': 'EG002', 'numAtRisk': 366, 'numEvents': 40, 'numAffected': 33}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'GASTROOESOPHAGEAL REFLUX DISEASE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 22, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 366, 'numEvents': 22, 'numAffected': 20}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numEvents': 199, 'numAffected': 153}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 231, 'numAffected': 175}, {'groupId': 'EG002', 'numAtRisk': 366, 'numEvents': 212, 'numAffected': 159}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'VOMITING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numEvents': 70, 'numAffected': 57}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 99, 'numAffected': 75}, {'groupId': 'EG002', 'numAtRisk': 366, 'numEvents': 90, 'numAffected': 70}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'ASTHENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numEvents': 129, 'numAffected': 70}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 86, 'numAffected': 55}, {'groupId': 'EG002', 'numAtRisk': 366, 'numEvents': 132, 'numAffected': 70}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'CHILLS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numEvents': 114, 'numAffected': 102}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 156, 'numAffected': 134}, {'groupId': 'EG002', 'numAtRisk': 366, 'numEvents': 139, 'numAffected': 121}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'FATIGUE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numEvents': 279, 'numAffected': 217}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 250, 'numAffected': 196}, {'groupId': 'EG002', 'numAtRisk': 366, 'numEvents': 290, 'numAffected': 209}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'INFLUENZA LIKE ILLNESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numEvents': 160, 'numAffected': 93}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 113, 'numAffected': 91}, {'groupId': 'EG002', 'numAtRisk': 366, 'numEvents': 102, 'numAffected': 83}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'INJECTION SITE ERYTHEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numEvents': 55, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 48, 'numAffected': 46}, {'groupId': 'EG002', 'numAtRisk': 366, 'numEvents': 38, 'numAffected': 37}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'INJECTION SITE REACTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numEvents': 46, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 46, 'numAffected': 45}, {'groupId': 'EG002', 'numAtRisk': 366, 'numEvents': 39, 'numAffected': 39}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'IRRITABILITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numEvents': 106, 'numAffected': 86}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 104, 'numAffected': 81}, {'groupId': 'EG002', 'numAtRisk': 366, 'numEvents': 111, 'numAffected': 83}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numEvents': 36, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 43, 'numAffected': 41}, {'groupId': 'EG002', 'numAtRisk': 366, 'numEvents': 41, 'numAffected': 37}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'PYREXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numEvents': 196, 'numAffected': 120}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 180, 'numAffected': 123}, {'groupId': 'EG002', 'numAtRisk': 366, 'numEvents': 218, 'numAffected': 117}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'SINUSITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numEvents': 18, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 20, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 366, 'numEvents': 22, 'numAffected': 19}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'WEIGHT DECREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numEvents': 54, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 50, 'numAffected': 43}, {'groupId': 'EG002', 'numAtRisk': 366, 'numEvents': 64, 'numAffected': 52}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'DECREASED APPETITE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numEvents': 101, 'numAffected': 90}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 107, 'numAffected': 97}, {'groupId': 'EG002', 'numAtRisk': 366, 'numEvents': 98, 'numAffected': 89}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'ARTHRALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numEvents': 84, 'numAffected': 66}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 87, 'numAffected': 69}, {'groupId': 'EG002', 'numAtRisk': 366, 'numEvents': 103, 'numAffected': 72}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'BACK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numEvents': 45, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 33, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 366, 'numEvents': 45, 'numAffected': 40}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'MUSCLE SPASMS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numEvents': 25, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 20, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 366, 'numEvents': 20, 'numAffected': 18}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'MYALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numEvents': 125, 'numAffected': 94}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 98, 'numAffected': 78}, {'groupId': 'EG002', 'numAtRisk': 366, 'numEvents': 120, 'numAffected': 92}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'PAIN IN EXTREMITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numEvents': 21, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 366, 'numEvents': 24, 'numAffected': 21}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'DISTURBANCE IN ATTENTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numEvents': 30, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 23, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 366, 'numEvents': 18, 'numAffected': 18}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'DIZZINESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numEvents': 74, 'numAffected': 59}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 97, 'numAffected': 80}, {'groupId': 'EG002', 'numAtRisk': 366, 'numEvents': 70, 'numAffected': 66}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'DYSGEUSIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numEvents': 68, 'numAffected': 64}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 143, 'numAffected': 137}, {'groupId': 'EG002', 'numAtRisk': 366, 'numEvents': 164, 'numAffected': 156}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numEvents': 264, 'numAffected': 153}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 233, 'numAffected': 168}, {'groupId': 'EG002', 'numAtRisk': 366, 'numEvents': 311, 'numAffected': 167}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'MEMORY IMPAIRMENT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numEvents': 21, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 366, 'numEvents': 28, 'numAffected': 24}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'PARAESTHESIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numEvents': 32, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 366, 'numEvents': 23, 'numAffected': 19}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'ANXIETY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numEvents': 49, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 57, 'numAffected': 50}, {'groupId': 'EG002', 'numAtRisk': 366, 'numEvents': 65, 'numAffected': 48}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'DEPRESSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numEvents': 86, 'numAffected': 78}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 103, 'numAffected': 82}, {'groupId': 'EG002', 'numAtRisk': 366, 'numEvents': 85, 'numAffected': 69}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'INSOMNIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numEvents': 137, 'numAffected': 118}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 145, 'numAffected': 117}, {'groupId': 'EG002', 'numAtRisk': 366, 'numEvents': 141, 'numAffected': 122}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'MOOD SWINGS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 17, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 366, 'numEvents': 21, 'numAffected': 19}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'COUGH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numEvents': 87, 'numAffected': 76}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 69, 'numAffected': 56}, {'groupId': 'EG002', 'numAtRisk': 366, 'numEvents': 100, 'numAffected': 74}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'DYSPNOEA', 'stats': [{'groupId': 'EG000', 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'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'HYPOAESTHESIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 366, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'LOSS OF CONSCIOUSNESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 366, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'MOTOR NEURONE DISEASE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 366, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'MUSCLE SPASTICITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 366, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'SYNCOPE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 366, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'AFFECTIVE DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 366, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'ALCOHOL ABUSE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 366, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'ANXIETY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 366, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'BIPOLAR I DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 366, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'COMPLETED SUICIDE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 366, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'DEPRESSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 366, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'DRUG ABUSE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 366, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'DRUG DEPENDENCE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 366, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'INTENTIONAL SELF-INJURY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 366, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'PERSONALITY DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 366, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'PSYCHIATRIC DECOMPENSATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 366, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'SUICIDAL IDEATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 366, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'SUICIDE ATTEMPT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 366, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'GLOMERULONEPHRITIS MINIMAL LESION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 366, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'RENAL TUBULAR NECROSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 366, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'SCROTAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 366, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'COUGH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 366, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'DYSPNOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 366, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'HAEMOPTYSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 366, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'PLEURAL FIBROSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 366, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'PNEUMOTHORAX', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 366, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'PULMONARY EMBOLISM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 366, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'PRURITUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 366, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'RASH ERYTHEMATOUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 366, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'ALCOHOL USE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 366, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'PHYSICAL ASSAULT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 366, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'CHOLECYSTECTOMY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 366, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'LARYNGEAL OPERATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 366, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'SKIN NEOPLASM EXCISION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 366, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'ACCELERATED HYPERTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 366, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'ARTERIAL THROMBOSIS LIMB', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 366, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'HYPERTENSIVE CRISIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 366, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'HYPOTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 368, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 366, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Sustained Virologic Response (SVR) Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '311', 'groupId': 'OG000'}, {'value': '316', 'groupId': 'OG001'}, {'value': '311', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}, {'value': '52', 'groupId': 'OG004'}, {'value': '55', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort I - 1. Placebo + PEG + RBV', 'description': 'Cohort I (White participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing \\[WBD\\]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.'}, {'id': 'OG001', 'title': 'Cohort I - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)', 'description': 'Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.\n\n* At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.\n* At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up.'}, {'id': 'OG002', 'title': 'Cohort I - 3. Boceprevir + PEG + RBV - 44 Weeks', 'description': 'Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.'}, {'id': 'OG003', 'title': 'Cohort II - 1. Placebo + PEG + RBV', 'description': 'Cohort II (Black participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing \\[WBD\\]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.'}, {'id': 'OG004', 'title': 'Cohort II - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)', 'description': 'Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.\n\n* At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.\n* At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up.'}, {'id': 'OG005', 'title': 'Cohort II - 3. Boceprevir + PEG + RBV - 44 Weeks', 'description': 'Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.'}], 'classes': [{'categories': [{'measurements': [{'value': '40.2', 'groupId': 'OG000'}, {'value': '66.8', 'groupId': 'OG001'}, {'value': '68.5', 'groupId': 'OG002'}, {'value': '23.1', 'groupId': 'OG003'}, {'value': '42.3', 'groupId': 'OG004'}, {'value': '52.7', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'The difference in SVR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '26.6', 'ciLowerLimit': '19.1', 'ciUpperLimit': '34.1', 'statisticalMethod': 'Cochran-Mantel Haenszel Chi-square test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjustments were made for for baseline stratification factors: viral load (\\>400,000 vs. ≤400,000 IU/mL) and Genotype (1a vs 1b).'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'The difference in SVR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '28.3', 'ciLowerLimit': '20.8', 'ciUpperLimit': '35.8', 'statisticalMethod': 'Cochran-Mantel Haenszel Chi-square test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjustments were made for baseline stratification factors: viral load (\\>400,000 vs. ≤400,000 IU/mL) and Genotype (1a vs 1b).'}, {'pValue': '0.0440', 'groupIds': ['OG003', 'OG004'], 'paramType': 'The difference in SVR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '19.2', 'ciLowerLimit': '1.6', 'ciUpperLimit': '36.9', 'statisticalMethod': 'Cochran-Mantel Haenszel Chi-square test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjustments were made for the baseline stratification factors: viral load (\\>400,000 vs. ≤400,000 IU/mL) and Genotype (1a vs 1b).'}, {'pValue': '0.0035', 'groupIds': ['OG003', 'OG005'], 'paramType': 'The difference in SVR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '29.7', 'ciLowerLimit': '12.2', 'ciUpperLimit': '47.1', 'statisticalMethod': 'Cochran-Mantel Haenszel Chi-square', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjustments were made for the baseline stratification factors: viral load (\\>400,000 vs. ≤400,000 IU/mL) and Genotype (1a vs 1b).'}], 'paramType': 'NUMBER', 'timeFrame': 'At Follow-up Week (FW) 24', 'description': 'Previously untreated adults with CHC genotype 1 were treated with the assigned study medication. Participants who had undetectable plasma HCV-RNA at FW 24 had achieved SVR. SVR rate is the percent of participants achieving SVR.\n\nHCV-RNA was detected by a nucleic acid amplification test and the limit of detection for this assay is 9.3 IU/mL.\n\nIf a participant was missing data at FW 24 after having had undetectable HCV-RNA at FW 12, the participant was to be considered to have SVR.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS). All randomized participants who received at least one dose of any study medication (PEG, RBV or boceprevir).'}, {'type': 'SECONDARY', 'title': 'Sustained Virologic Response (SVR) Rate in Participants Treated With Study Drug (Boceprevir or Placebo)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '297', 'groupId': 'OG000'}, {'value': '303', 'groupId': 'OG001'}, {'value': '299', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}, {'value': '47', 'groupId': 'OG004'}, {'value': '55', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort I - 1. Placebo + PEG + RBV', 'description': 'Cohort I (White participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing \\[WBD\\]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.'}, {'id': 'OG001', 'title': 'Cohort I - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)', 'description': 'Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.\n\n* At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.\n* At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up.'}, {'id': 'OG002', 'title': 'Cohort I - 3. Boceprevir + PEG + RBV - 44 Weeks', 'description': 'Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.'}, {'id': 'OG003', 'title': 'Cohort II - 1. Placebo + PEG + RBV', 'description': 'Cohort II (Black participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing \\[WBD\\]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.'}, {'id': 'OG004', 'title': 'Cohort II - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)', 'description': 'Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.\n\n* At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.\n* At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up.'}, {'id': 'OG005', 'title': 'Cohort II - 3. Boceprevir + PEG + RBV - 44 Weeks', 'description': 'Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.'}], 'classes': [{'categories': [{'measurements': [{'value': '42.1', 'groupId': 'OG000'}, {'value': '69.6', 'groupId': 'OG001'}, {'value': '71.2', 'groupId': 'OG002'}, {'value': '25.5', 'groupId': 'OG003'}, {'value': '46.8', 'groupId': 'OG004'}, {'value': '52.7', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'The difference in SVR rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '27.5', 'ciLowerLimit': '19.2', 'ciUpperLimit': '35.2', 'statisticalMethod': 'Cochran-Mantel Haenszel Chi-square', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjustments were made for the baseline stratification factors: viral load (\\>400,000 vs. ≤400,000 IU/mL) and Genotype (1a vs 1b).'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'The difference in SVR rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '29.1', 'ciLowerLimit': '21.5', 'ciUpperLimit': '36.8', 'statisticalMethod': 'Cochran-Mantel Haenszel Chi-square', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjustments were made for the baseline stratification factors: viral load (\\>400,000 vs. ≤400,000 IU/mL) and Genotype (1a vs 1b).'}, {'pValue': '0.0366', 'groupIds': ['OG003', 'OG004'], 'paramType': 'The difference in SVR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '21.3', 'ciLowerLimit': '2.3', 'ciUpperLimit': '40.2', 'statisticalMethod': 'Cochran-Mantel Haenszel Chi-square test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjustments were made for the baseline stratification factors: viral load (\\>400,000 vs. ≤400,000 IU/mL) and Genotype (1a vs 1b).'}, {'pValue': '0.0107', 'groupIds': ['OG003', 'OG005'], 'paramType': 'The difference in SVR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '27.2', 'ciLowerLimit': '9.0', 'ciUpperLimit': '45.3', 'statisticalMethod': 'Cochran-Mantel Haenszel Chi-square', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjustments were made for the baseline stratification factors: viral load (\\>400,000 vs. ≤400,000 IU/mL) and Genotype (1a vs 1b).'}], 'paramType': 'NUMBER', 'timeFrame': 'At FW 24', 'description': "Previously untreated adults with CHC genotype 1 were treated with the assigned study medication. Participants who had undetectable plasma HCV-RNA at FW 24 had achieved SVR. SVR rate was the percentage of participants treated with at least one dose of boceprevir or placebo who had achieved SVR.\n\nHCV-RNA in participant's plasma samples was detected by a nucleic acid amplification assay with a limit of detection of 9.3 IU/mL.\n\nIf a participant was missing data at FW 24 after having had undetectable HCV-RNA at FW 12, the participant was to be considered to have a SVR.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat set (mITT). All randomized participants who received at least one dose of boceprevir or placebo.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Undetectable HCV-RNA at Follow-up Week 12 and at 72 Weeks After Randomization.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '311', 'groupId': 'OG000'}, {'value': '316', 'groupId': 'OG001'}, {'value': '311', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}, {'value': '52', 'groupId': 'OG004'}, {'value': '55', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort I - 1. Placebo + PEG + RBV', 'description': 'Cohort I (White participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing \\[WBD\\]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.'}, {'id': 'OG001', 'title': 'Cohort I - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)', 'description': 'Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.\n\n* At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.\n* At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up.'}, {'id': 'OG002', 'title': 'Cohort I - 3. Boceprevir + PEG + RBV - 44 Weeks', 'description': 'Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.'}, {'id': 'OG003', 'title': 'Cohort II - 1. Placebo + PEG + RBV', 'description': 'Cohort II (Black participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing \\[WBD\\]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.'}, {'id': 'OG004', 'title': 'Cohort II - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)', 'description': 'Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.\n\n* At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.\n* At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up.'}, {'id': 'OG005', 'title': 'Cohort II - 3. Boceprevir + PEG + RBV - 44 Weeks', 'description': 'Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.'}], 'classes': [{'title': 'At follow-up week 12', 'categories': [{'measurements': [{'value': '127', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}, {'value': '209', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}, {'value': '29', 'groupId': 'OG005'}]}]}, {'title': '72 weeks after randomization', 'categories': [{'measurements': [{'value': '120', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}, {'value': '205', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}, {'value': '27', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At FW 12 and at 72 weeks after randomization', 'description': 'Previously untreated adults with CHC genotype 1 were treated with the assigned study medication. The number of participants who had undetectable plasma HCV-RNA at FW 12, and 72 weeks after randomization are reported.\n\nHCV-RNA was detected by a nucleic acid amplification test and the limit of detection for this assay is 9.3 IU/mL.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS). All randomized participants who received at least one dose of any study medication (PEG, RBV or boceprevir).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Early Virologic Response (Undetectable HCV-RNA at Treatment Week 2, 4, 8, 12, 16, or 20)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '311', 'groupId': 'OG000'}, {'value': '316', 'groupId': 'OG001'}, {'value': '311', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}, {'value': '52', 'groupId': 'OG004'}, {'value': '55', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort I - 1. Placebo + PEG + RBV', 'description': 'Cohort I (White participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing \\[WBD\\]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.'}, {'id': 'OG001', 'title': 'Cohort I - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)', 'description': 'Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.\n\n* At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.\n* At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up.'}, {'id': 'OG002', 'title': 'Cohort I - 3. Boceprevir + PEG + RBV - 44 Weeks', 'description': 'Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.'}, {'id': 'OG003', 'title': 'Cohort II - 1. Placebo + PEG + RBV', 'description': 'Cohort II (Black participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing \\[WBD\\]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.'}, {'id': 'OG004', 'title': 'Cohort II - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)', 'description': 'Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.\n\n* At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.\n* At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up.'}, {'id': 'OG005', 'title': 'Cohort II - 3. Boceprevir + PEG + RBV - 44 Weeks', 'description': 'Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.'}], 'classes': [{'title': 'Treatment week 2', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Treatment week 4', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Treatment week 8', 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}, {'value': '182', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}, {'value': '22', 'groupId': 'OG005'}]}]}, {'title': 'Treatment week 12', 'categories': [{'measurements': [{'value': '108', 'groupId': 'OG000'}, {'value': '237', 'groupId': 'OG001'}, {'value': '231', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}, {'value': '33', 'groupId': 'OG005'}]}]}, {'title': 'Treatment week 16', 'categories': [{'measurements': [{'value': '138', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}, {'value': '237', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}, {'value': '36', 'groupId': 'OG005'}]}]}, {'title': 'Treatment week 20', 'categories': [{'measurements': [{'value': '157', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}, {'value': '231', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '27', 'groupId': 'OG004'}, {'value': '32', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Treatment Week 2, 4, 8, 12, 16, or 20', 'description': "Early virologic response was defined as undetectable HCV-RNA at in participants by treatment week 2, 4, 8, 12, 16, or 20.\n\nHCV-RNA in participant's plasma samples was detected by a nucleic acid amplification assay with a limit of detection of 9.3 IU/mL.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS). All randomized participants who received at least one dose of any study medication (PEG, RBV or boceprevir).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Early Virologic Response (Undetectable HCV-RNA at Treatment Week 4, 8, 12, 16, or 20) Who Achieved SVR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '311', 'groupId': 'OG000'}, {'value': '316', 'groupId': 'OG001'}, {'value': '311', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}, {'value': '52', 'groupId': 'OG004'}, {'value': '55', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort I - 1. Placebo + PEG + RBV', 'description': 'Cohort I (White participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing \\[WBD\\]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.'}, {'id': 'OG001', 'title': 'Cohort I - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)', 'description': 'Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.\n\n* At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.\n* At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up.'}, {'id': 'OG002', 'title': 'Cohort I - 3. Boceprevir + PEG + RBV - 44 Weeks', 'description': 'Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.'}, {'id': 'OG003', 'title': 'Cohort II - 1. Placebo + PEG + RBV', 'description': 'Cohort II (Black participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing \\[WBD\\]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.'}, {'id': 'OG004', 'title': 'Cohort II - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)', 'description': 'Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.\n\n* At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.\n* At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up.'}, {'id': 'OG005', 'title': 'Cohort II - 3. Boceprevir + PEG + RBV - 44 Weeks', 'description': 'Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.'}], 'classes': [{'title': 'Treatment week 4 (n=28, 18, 20, 2, 1, 0)', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Treatment week 8 (n=56, 190, 182, 4, 18, 22)', 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}, {'value': '166', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '18', 'groupId': 'OG005'}]}]}, {'title': 'Treatment week 12 (n=108, 237, 231, 10, 25, 33)', 'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}, {'value': '204', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}, {'value': '26', 'groupId': 'OG005'}]}]}, {'title': 'Treatment week 16 (n=138, 231, 237, 15, 26, 36)', 'categories': [{'measurements': [{'value': '106', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}, {'value': '210', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}, {'value': '26', 'groupId': 'OG005'}]}]}, {'title': 'Treatment week 20 (n=157, 231, 231, 15, 27, 32)', 'categories': [{'measurements': [{'value': '118', 'groupId': 'OG000'}, {'value': '201', 'groupId': 'OG001'}, {'value': '208', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}, {'value': '26', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Treatment Week 4, 8, 12, 16, 20', 'description': "Participants with early virologic response were those who had undetectable HCV-RNA by treatment week 4, 8, 12, 16, or 20. Participants who had undetectable plasma HCV-RNA at FW 24 had SVR. The number of participants with early virologic response that also achieved SVR is reported.\n\nHCV-RNA in participant's plasma samples was detected by a nucleic acid amplification assay with a limit of detection of 9.3 IU/mL.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants that had undetectable HCV RNA for the treatment weeks 4, 8, 12, 16, and 20.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cohort I - 1. Placebo + PEG + RBV', 'description': 'Cohort I (White participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing \\[WBD\\]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.'}, {'id': 'FG001', 'title': 'Cohort I - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)', 'description': 'Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.\n\n* At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.\n* At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up.'}, {'id': 'FG002', 'title': 'Cohort I - 3. Boceprevir + PEG + RBV - 44 Weeks', 'description': 'Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.'}, {'id': 'FG003', 'title': 'Cohort II - 1. Placebo + PEG + RBV', 'description': 'Cohort II (Black participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing \\[WBD\\]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.'}, {'id': 'FG004', 'title': 'Cohort II - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)', 'description': 'Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.\n\n* At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.\n* At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up.'}, {'id': 'FG005', 'title': 'Cohort II - 3. Boceprevir + PEG + RBV - 44 Weeks', 'description': 'Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.'}], 'periods': [{'title': 'Treatment Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '311'}, {'groupId': 'FG001', 'numSubjects': '316'}, {'groupId': 'FG002', 'numSubjects': '311'}, {'groupId': 'FG003', 'numSubjects': '52'}, {'groupId': 'FG004', 'numSubjects': '52'}, {'groupId': 'FG005', 'numSubjects': '55'}]}, {'type': 'STARTED BOCEPREVIR/PLACEBO', 'achievements': [{'groupId': 'FG000', 'numSubjects': '297'}, {'groupId': 'FG001', 'numSubjects': '303'}, {'groupId': 'FG002', 'numSubjects': '299'}, {'groupId': 'FG003', 'numSubjects': '47'}, {'groupId': 'FG004', 'numSubjects': '47'}, {'groupId': 'FG005', 'numSubjects': '55'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '148'}, {'groupId': 'FG001', 'numSubjects': '205'}, {'groupId': 'FG002', 'numSubjects': '190'}, {'groupId': 'FG003', 'numSubjects': '11'}, {'groupId': 'FG004', 'numSubjects': '24'}, {'groupId': 'FG005', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '163'}, {'groupId': 'FG001', 'numSubjects': '111'}, {'groupId': 'FG002', 'numSubjects': '121'}, {'groupId': 'FG003', 'numSubjects': '41'}, {'groupId': 'FG004', 'numSubjects': '28'}, {'groupId': 'FG005', 'numSubjects': '30'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '45'}, {'groupId': 'FG001', 'numSubjects': '37'}, {'groupId': 'FG002', 'numSubjects': '51'}, {'groupId': 'FG003', 'numSubjects': '12'}, {'groupId': 'FG004', 'numSubjects': '8'}, {'groupId': 'FG005', 'numSubjects': '9'}]}, {'type': 'Treatment failure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '92'}, {'groupId': 'FG001', 'numSubjects': '42'}, {'groupId': 'FG002', 'numSubjects': '33'}, {'groupId': 'FG003', 'numSubjects': '25'}, {'groupId': 'FG004', 'numSubjects': '13'}, {'groupId': 'FG005', 'numSubjects': '14'}]}, {'type': 'Non medical reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '32'}, {'groupId': 'FG002', 'numSubjects': '37'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '7'}, {'groupId': 'FG005', 'numSubjects': '7'}]}]}, {'title': 'Follow-up Period (Upto Week 72)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '278'}, {'groupId': 'FG001', 'numSubjects': '295'}, {'groupId': 'FG002', 'numSubjects': '291'}, {'groupId': 'FG003', 'numSubjects': '42'}, {'groupId': 'FG004', 'numSubjects': '44'}, {'groupId': 'FG005', 'numSubjects': '53'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '207'}, {'groupId': 'FG001', 'numSubjects': '252'}, {'groupId': 'FG002', 'numSubjects': '266'}, {'groupId': 'FG003', 'numSubjects': '28'}, {'groupId': 'FG004', 'numSubjects': '38'}, {'groupId': 'FG005', 'numSubjects': '46'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '71'}, {'groupId': 'FG001', 'numSubjects': '43'}, {'groupId': 'FG002', 'numSubjects': '25'}, {'groupId': 'FG003', 'numSubjects': '14'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Non medical reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '69'}, {'groupId': 'FG001', 'numSubjects': '42'}, {'groupId': 'FG002', 'numSubjects': '24'}, {'groupId': 'FG003', 'numSubjects': '14'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '7'}]}]}], 'recruitmentDetails': '1472 participants were enrolled in this study.', 'preAssignmentDetails': '373 participants were screened but not randomized. 1099 participants were randomized. Only 1097 received at least one dose of PegIntron (PEG) + Ribavirin (RBV) (lead-in treatment).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '311', 'groupId': 'BG000'}, {'value': '316', 'groupId': 'BG001'}, {'value': '311', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}, {'value': '52', 'groupId': 'BG004'}, {'value': '55', 'groupId': 'BG005'}, {'value': '1097', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Cohort I - 1. Placebo + PEG + RBV', 'description': 'Cohort I (White participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing \\[WBD\\]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.'}, {'id': 'BG001', 'title': 'Cohort I - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)', 'description': 'Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.\n\n* At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.\n* At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up.'}, {'id': 'BG002', 'title': 'Cohort I - 3. Boceprevir + PEG + RBV - 44 Weeks', 'description': 'Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.'}, {'id': 'BG003', 'title': 'Cohort II - 1. Placebo + PEG + RBV', 'description': 'Cohort II (Black participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing \\[WBD\\]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.'}, {'id': 'BG004', 'title': 'Cohort II - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)', 'description': 'Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.\n\n* At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up.\n* At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up.'}, {'id': 'BG005', 'title': 'Cohort II - 3. Boceprevir + PEG + RBV - 44 Weeks', 'description': 'Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '<40 years', 'categories': [{'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '158', 'groupId': 'BG006'}]}]}, {'title': '>= 40 and <65 years', 'categories': [{'measurements': [{'value': '246', 'groupId': 'BG000'}, {'value': '261', 'groupId': 'BG001'}, {'value': '255', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}, {'value': '47', 'groupId': 'BG004'}, {'value': '51', 'groupId': 'BG005'}, {'value': '905', 'groupId': 'BG006'}]}]}, {'title': '>=65 years', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '34', 'groupId': 'BG006'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '140', 'groupId': 'BG000'}, {'value': '116', 'groupId': 'BG001'}, {'value': '123', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '23', 'groupId': 'BG004'}, {'value': '22', 'groupId': 'BG005'}, {'value': '441', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '171', 'groupId': 'BG000'}, {'value': '200', 'groupId': 'BG001'}, {'value': '188', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}, {'value': '29', 'groupId': 'BG004'}, {'value': '33', 'groupId': 'BG005'}, {'value': '656', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1472}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-09', 'studyFirstSubmitDate': '2008-06-24', 'resultsFirstSubmitDate': '2011-05-13', 'studyFirstSubmitQcDate': '2008-06-24', 'lastUpdatePostDateStruct': {'date': '2017-04-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2011-05-13', 'studyFirstPostDateStruct': {'date': '2008-06-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-06-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sustained Virologic Response (SVR) Rate', 'timeFrame': 'At Follow-up Week (FW) 24', 'description': 'Previously untreated adults with CHC genotype 1 were treated with the assigned study medication. Participants who had undetectable plasma HCV-RNA at FW 24 had achieved SVR. SVR rate is the percent of participants achieving SVR.\n\nHCV-RNA was detected by a nucleic acid amplification test and the limit of detection for this assay is 9.3 IU/mL.\n\nIf a participant was missing data at FW 24 after having had undetectable HCV-RNA at FW 12, the participant was to be considered to have SVR.'}], 'secondaryOutcomes': [{'measure': 'Sustained Virologic Response (SVR) Rate in Participants Treated With Study Drug (Boceprevir or Placebo)', 'timeFrame': 'At FW 24', 'description': "Previously untreated adults with CHC genotype 1 were treated with the assigned study medication. Participants who had undetectable plasma HCV-RNA at FW 24 had achieved SVR. SVR rate was the percentage of participants treated with at least one dose of boceprevir or placebo who had achieved SVR.\n\nHCV-RNA in participant's plasma samples was detected by a nucleic acid amplification assay with a limit of detection of 9.3 IU/mL.\n\nIf a participant was missing data at FW 24 after having had undetectable HCV-RNA at FW 12, the participant was to be considered to have a SVR."}, {'measure': 'Number of Participants With Undetectable HCV-RNA at Follow-up Week 12 and at 72 Weeks After Randomization.', 'timeFrame': 'At FW 12 and at 72 weeks after randomization', 'description': 'Previously untreated adults with CHC genotype 1 were treated with the assigned study medication. The number of participants who had undetectable plasma HCV-RNA at FW 12, and 72 weeks after randomization are reported.\n\nHCV-RNA was detected by a nucleic acid amplification test and the limit of detection for this assay is 9.3 IU/mL.'}, {'measure': 'Number of Participants With Early Virologic Response (Undetectable HCV-RNA at Treatment Week 2, 4, 8, 12, 16, or 20)', 'timeFrame': 'At Treatment Week 2, 4, 8, 12, 16, or 20', 'description': "Early virologic response was defined as undetectable HCV-RNA at in participants by treatment week 2, 4, 8, 12, 16, or 20.\n\nHCV-RNA in participant's plasma samples was detected by a nucleic acid amplification assay with a limit of detection of 9.3 IU/mL."}, {'measure': 'Number of Participants With Early Virologic Response (Undetectable HCV-RNA at Treatment Week 4, 8, 12, 16, or 20) Who Achieved SVR', 'timeFrame': 'At Treatment Week 4, 8, 12, 16, 20', 'description': "Participants with early virologic response were those who had undetectable HCV-RNA by treatment week 4, 8, 12, 16, or 20. Participants who had undetectable plasma HCV-RNA at FW 24 had SVR. The number of participants with early virologic response that also achieved SVR is reported.\n\nHCV-RNA in participant's plasma samples was detected by a nucleic acid amplification assay with a limit of detection of 9.3 IU/mL."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Hepatitis C, Chronic']}, 'referencesModule': {'references': [{'pmid': '23621902', 'type': 'DERIVED', 'citation': 'Ferrante SA, Chhatwal J, Brass CA, El Khoury AC, Poordad F, Bronowicki JP, Elbasha EH. Boceprevir for previously untreated patients with chronic hepatitis C Genotype 1 infection: a US-based cost-effectiveness modeling study. BMC Infect Dis. 2013 Apr 27;13:190. doi: 10.1186/1471-2334-13-190.'}, {'pmid': '22626609', 'type': 'DERIVED', 'citation': 'Poordad F, Bronowicki JP, Gordon SC, Zeuzem S, Jacobson IM, Sulkowski MS, Poynard T, Morgan TR, Molony C, Pedicone LD, Sings HL, Burroughs MH, Sniukiene V, Boparai N, Goteti VS, Brass CA, Albrecht JK, Bacon BR; SPRINT-2 and RESPOND-2 Investigators. Factors that predict response of patients with hepatitis C virus infection to boceprevir. Gastroenterology. 2012 Sep;143(3):608-618.e5. doi: 10.1053/j.gastro.2012.05.011. Epub 2012 May 21.'}, {'pmid': '21449783', 'type': 'DERIVED', 'citation': 'Poordad F, McCone J Jr, Bacon BR, Bruno S, Manns MP, Sulkowski MS, Jacobson IM, Reddy KR, Goodman ZD, Boparai N, DiNubile MJ, Sniukiene V, Brass CA, Albrecht JK, Bronowicki JP; SPRINT-2 Investigators. Boceprevir for untreated chronic HCV genotype 1 infection. N Engl J Med. 2011 Mar 31;364(13):1195-206. doi: 10.1056/NEJMoa1010494.'}]}, 'descriptionModule': {'briefSummary': 'This study involves treatment with boceprevir or placebo in combination with PegIntron (PEG) + Ribavirin (RBV) (weight-based dosing \\[WBD\\]) in previously untreated adult participants with chronic hepatitis C (CHC) genotype 1. It is hypothesized that the addition of a third active anti- Hepatitis C Virus (anti-HCV) drug may lead to more rapid viral response than therapy with two drugs, and therefore, the addition of boceprevir to PegIntron plus ribavirin therapy after a 4-week lead-in period may allow for both increased rates of sustained virologic response (SVR) and shorter treatment durations (in some populations) than treatment with PegIntron plus ribavirin alone.\n\nThe study includes two separate cohorts, Cohort I (White participants) and Cohort II (Black participants). Participants from each cohort are assigned (randomized) to one of three study arms, all of which have a 4-week lead-in period with (PEG + RBV).', 'detailedDescription': 'Participants from Cohort I and Cohort II are assigned (randomized) to one of three study arms, all of which have a 4-week lead-in period with (PEG + RBV).\n\n1. Control arm, participants are treated with (PEG + RBV + placebo) for 44 weeks after the lead-in.\n2. Experimental arm with Response Guided Therapy (RGT)\n\n In this experimental arm, participants are treated with all three drugs (PEG + RBV + boceprevir) for 24 weeks after the lead-in. At treatment week 28, those participants with undetectable Hepatitis C Virus - ribonucleic acid (HCV-RNA) from week 8 (up to treatment week 24), will be considered to complete treatment, and will enter follow-up. Participants with detectable for HCV-RNA at week 8 or later will receive an additional 20 weeks of therapy with PegIntron and Ribavirin (PEG + RBV + placebo).\n3. Experimental arm, participants are treated with all three drugs (PEG + RBV + Ribavirin) for 44 weeks after the lead-in.\n\nAll participants were followed up to 72 weeks following randomization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participant must have previously documented CHC genotype 1 infection.\n* Participant must have a liver biopsy with histology consistent with CHC and no other etiology.\n* Participants with bridging fibrosis or cirrhosis must have an ultrasound within 6 months of the Screening Visit (or between Screening and Day 1) with no findings suspicious for hepatocellular carcinoma (HCC).\n* Participant must be \\>=18 years of age.\n* Participant must weigh between 40 kg and 125 kg.\n* Participant and participant's partner(s) must each agree to use acceptable methods of contraception for at least 2 weeks prior to Day 1 and continue until at least 6 months after last dose of study drug, or longer if dictated by local regulations.\n* Participants must be willing to give written informed consent.\n\nExclusion Criteria:\n\n* Coinfection with the human immunodeficiency virus (HIV) or hepatitis B virus (HBsAg positive).\n* Participants who received prior treatment for hepatitis C; other than herbal remedies, except those with known hepatotoxicity.\n* Treatment with any investigational drug within 30 days of the randomization visit in this study.\n* Participation in any other clinical trial within 30 days of randomization or intention to participate in another clinical trial during participation in this study.\n* Evidence of decompensated liver disease including, but not limited to, a history or presence of clinical ascites, bleeding varices, or hepatic encephalopathy.\n* Diabetic and/or hypertensive participants with clinically significant ocular examination findings: retinopathy, cotton wool spots, optic nerve disorder, retinal hemorrhage, or any other clinically significant abnormality.\n* Pre-existing psychiatric condition(s).\n* Clinical diagnosis of substance abuse of the specified drugs within the specified timeframes.\n* Any known pre-existing medical condition that could interfere with the participant's participation in and completion of the study.\n* Evidence of active or suspected malignancy, or a history of malignancy, within the last 5 years (except adequately treated carcinoma in situ and basal cell carcinoma of the skin). Participants under evaluation for malignancy are not eligible.\n* Participants who are pregnant or nursing. Participants who intend to become pregnant during the study period. Male participants with partners who are, or intend to become, pregnant during the study period.\n* Any other condition which, in the opinion of a physician, would make the participant unsuitable for enrollment or could interfere with the participant participating in and completing the study.\n* Participants who are part of the site personnel directly involved with this study.\n* Participants who are family members of the investigational study staff.\n* Participants who had life-threatening serious adverse event (SAE) during screening period.\n* Protocol-specified hematologic, biochemical, and serologic criteria: Hemoglobin \\<12 g/dL for females and \\<13 g/dL for males; Neutrophils \\<1500/mm\\^3 (blacks: \\<1200/mm\\^3); Platelets \\<100,000/mm\\^3; Direct bilirubin \\>1.5 x upper limit of normal (ULN)\n* Serum albumin \\< lower limit of normal (LLN)\n* Thyroid-stimulating hormone (TSH) \\>1.2 x ULN or \\<0.8 x LLN of laboratory, with certain exceptions.\n* Serum creatinine \\>ULN of the laboratory reference.\n* Protocol-specified serum glucose concentrations.\n* protocol-specified alpha fetoprotein levels.\n* Prothrombin time/partial thromboplastin time (PT/PTT) values \\>10% above laboratory reference range.\n* Anti-nuclear antibodies (ANA) \\>1:320."}, 'identificationModule': {'nctId': 'NCT00705432', 'acronym': 'SPRINT-2', 'briefTitle': 'Safety and Efficacy of Boceprevir in Previously Untreated Subjects With Chronic Hepatitis C Genotype 1 (Study P05216AM2) (COMPLETED)', 'nctIdAliases': ['NCT00795431'], 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Phase 3, Safety and Efficacy Study of Boceprevir in Previously Untreated Subjects With Chronic Hepatitis C Genotype 1', 'orgStudyIdInfo': {'id': 'P05216'}, 'secondaryIdInfos': [{'id': 'EUDRACT # 2007-005508-42'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': '1. Placebo + PEG + RBV', 'description': 'PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing \\[WBD\\]) for 4 weeks (lead in treatment) followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.', 'interventionNames': ['Biological: Peginterferon alfa-2b (PEG)', 'Drug: Ribavirin (RBV)', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': '2. Boceprevir + PEG + RBV - 24 Weeks (RGT)', 'description': 'PEG 1.5 μg/kg + RBV (WBD) for 4 weeks (lead in treatment) followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28.\n\n* At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable from Treatment Weeks 8 to Treatment Week 24, will proceed to the 44-week follow-up.\n* At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up.', 'interventionNames': ['Biological: Peginterferon alfa-2b (PEG)', 'Drug: Ribavirin (RBV)', 'Drug: Boceprevir']}, {'type': 'EXPERIMENTAL', 'label': '3. Boceprevir + PEG + RBV - 44 Weeks', 'description': 'PEG 1.5 μg/kg + RBV (WBD) for 4 weeks (lead in treatment) followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.', 'interventionNames': ['Biological: Peginterferon alfa-2b (PEG)', 'Drug: Ribavirin (RBV)', 'Drug: Boceprevir']}], 'interventions': [{'name': 'Peginterferon alfa-2b (PEG)', 'type': 'BIOLOGICAL', 'otherNames': ['PegIntron', 'PEG', 'SCH 54031'], 'description': 'Peginterferon alfa-2b 1.5 μg/kg/week subcutaneously (SC)', 'armGroupLabels': ['1. Placebo + PEG + RBV', '2. Boceprevir + PEG + RBV - 24 Weeks (RGT)', '3. Boceprevir + PEG + RBV - 44 Weeks']}, {'name': 'Ribavirin (RBV)', 'type': 'DRUG', 'otherNames': ['Rebetol', 'RBV', 'SCH 18908'], 'description': 'Ribavirin weight-based dosing (WBD) 600 mg/day to 1400 mg/day administered orally, divided twice daily (BID).', 'armGroupLabels': ['1. Placebo + PEG + RBV', '2. Boceprevir + PEG + RBV - 24 Weeks (RGT)', '3. Boceprevir + PEG + RBV - 44 Weeks']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo to boceprevir, 800 mg (4 x 200mg capsules) administered orally three times a day (TID).', 'armGroupLabels': ['1. Placebo + PEG + RBV']}, {'name': 'Boceprevir', 'type': 'DRUG', 'otherNames': ['SCH 503034, Victrelis'], 'description': 'Boceprevir, 800 mg (4 x 200 mg capsules) administered orally TID.', 'armGroupLabels': ['2. Boceprevir + PEG + RBV - 24 Weeks (RGT)', '3. Boceprevir + PEG + RBV - 44 Weeks']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\\_Updated%20July\\_9\\_2014.pdf\n\nhttp://engagezone.msd.com/ds\\_documentation.php'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}