Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-26 @ 1:34 AM
Study NCT ID:
NCT01241760
Status:
COMPLETED
Last Update Posted:
2014-06-04
First Post:
2010-10-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
VX-950-C211 - A Dosing Regimen Study (Twice Daily Versus Every 8 Hours) of Telaprevir in Treatment-naïve Participants With Genotype 1 Chronic Hepatitis C Virus Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006526', 'term': 'Hepatitis C'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012254', 'term': 'Ribavirin'}, {'id': 'C486464', 'term': 'telaprevir'}, {'id': 'C100416', 'term': 'peginterferon alfa-2a'}], 'ancestors': [{'id': 'D012263', 'term': 'Ribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '32 14 64 13 70', 'title': 'Compound Development Team Leader', 'organization': 'Janssen Infectious Diseases BVBA'}, 'certainAgreement': {'otherDetails': 'If the PI (Investigator) wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data were collected for the duration of study (12 weeks after the last dose).', 'description': 'The total number of adverse events listed in the "Other (non-Serious) Adverse Events" table are based upon a cut-off of greater than or equal to 5 percent of patients experiencing the adverse event in any treatment arm.', 'eventGroups': [{'id': 'EG000', 'title': 'T12(q8h)/PR', 'description': 'Telaprevir 750 mg (2 oral tablets) every 8 hours for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.', 'otherNumAtRisk': 371, 'otherNumAffected': 359, 'seriousNumAtRisk': 371, 'seriousNumAffected': 35}, {'id': 'EG001', 'title': 'T12(b.i.d.)/PR', 'description': 'Telaprevir 1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.', 'otherNumAtRisk': 369, 'otherNumAffected': 358, 'seriousNumAtRisk': 369, 'seriousNumAffected': 28}, {'id': 'EG002', 'title': 'Total', 'description': 'All', 'otherNumAtRisk': 740, 'otherNumAffected': 717, 'seriousNumAtRisk': 740, 'seriousNumAffected': 63}], 'otherEvents': [{'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 371, 'numAffected': 178}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 173}, {'groupId': 'EG002', 'numAtRisk': 740, 'numAffected': 351}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 371, 'numAffected': 78}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 62}, {'groupId': 'EG002', 'numAtRisk': 740, 'numAffected': 140}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 371, 'numAffected': 72}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 65}, {'groupId': 'EG002', 'numAtRisk': 740, 'numAffected': 137}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 371, 'numAffected': 60}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 75}, {'groupId': 'EG002', 'numAtRisk': 740, 'numAffected': 135}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 371, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 740, 'numAffected': 65}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 371, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 740, 'numAffected': 48}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 371, 'numAffected': 158}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 158}, {'groupId': 'EG002', 'numAtRisk': 740, 'numAffected': 316}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 371, 'numAffected': 133}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 129}, {'groupId': 'EG002', 'numAtRisk': 740, 'numAffected': 262}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 371, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 43}, {'groupId': 'EG002', 'numAtRisk': 740, 'numAffected': 78}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 371, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 740, 'numAffected': 42}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 371, 'numAffected': 143}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 129}, {'groupId': 'EG002', 'numAtRisk': 740, 'numAffected': 272}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 371, 'numAffected': 71}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 49}, {'groupId': 'EG002', 'numAtRisk': 740, 'numAffected': 120}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Anal pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 371, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 740, 'numAffected': 73}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 371, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 38}, {'groupId': 'EG002', 'numAtRisk': 740, 'numAffected': 79}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Anorectal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 371, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 39}, {'groupId': 'EG002', 'numAtRisk': 740, 'numAffected': 75}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 371, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 740, 'numAffected': 59}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 371, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 740, 'numAffected': 47}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 371, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 740, 'numAffected': 37}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Proctalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 371, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 740, 'numAffected': 39}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 371, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 740, 'numAffected': 29}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 371, 'numAffected': 148}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 155}, {'groupId': 'EG002', 'numAtRisk': 740, 'numAffected': 303}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 371, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 36}, {'groupId': 'EG002', 'numAtRisk': 740, 'numAffected': 66}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 371, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 29}, {'groupId': 'EG002', 'numAtRisk': 740, 'numAffected': 59}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 371, 'numAffected': 108}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 87}, {'groupId': 'EG002', 'numAtRisk': 740, 'numAffected': 195}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 371, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 36}, {'groupId': 'EG002', 'numAtRisk': 740, 'numAffected': 82}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 371, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 41}, {'groupId': 'EG002', 'numAtRisk': 740, 'numAffected': 71}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 371, 'numAffected': 68}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 69}, {'groupId': 'EG002', 'numAtRisk': 740, 'numAffected': 137}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Mood altered', 'stats': [{'groupId': 'EG000', 'numAtRisk': 371, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 37}, {'groupId': 'EG002', 'numAtRisk': 740, 'numAffected': 84}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 371, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 740, 'numAffected': 63}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 371, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 740, 'numAffected': 46}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 371, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 39}, {'groupId': 'EG002', 'numAtRisk': 740, 'numAffected': 83}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 371, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 36}, {'groupId': 'EG002', 'numAtRisk': 740, 'numAffected': 71}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dyspnoea exertional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 371, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 740, 'numAffected': 36}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 371, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 33}, {'groupId': 'EG002', 'numAtRisk': 740, 'numAffected': 74}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 371, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 740, 'numAffected': 49}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 371, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 740, 'numAffected': 66}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 371, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 740, 'numAffected': 41}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 371, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 740, 'numAffected': 37}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 371, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 740, 'numAffected': 27}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 371, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 740, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 371, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 740, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 371, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 740, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 371, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 740, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 371, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 740, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 371, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 740, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Escherichia sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 371, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 740, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 371, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 740, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Subcutaneous abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 371, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 740, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 371, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 740, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 371, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 740, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 371, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 740, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 371, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 740, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 371, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 740, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 371, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 740, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 371, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 740, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 371, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 740, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Drug eruption', 'stats': [{'groupId': 'EG000', 'numAtRisk': 371, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 740, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 371, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 740, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Rash generalised', 'stats': [{'groupId': 'EG000', 'numAtRisk': 371, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 740, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 371, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 740, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Drug rash with eosinophilia and systemic symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 371, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 740, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 371, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 740, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 371, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 740, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Facial palsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 371, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 740, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hemiparesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 371, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 740, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 371, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 740, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Myoclonus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 371, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 740, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 371, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 740, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Menorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 371, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 740, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Postmenopausal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 371, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 740, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Vaginal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 371, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 740, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 371, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 740, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 371, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 740, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Brain neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 371, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 740, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Uterine leiomyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 371, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 740, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 371, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 740, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Haematochezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 371, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 740, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hyperbilirubinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 371, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 740, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 371, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 740, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Electrocardiogram t wave inversion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 371, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 740, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 371, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 740, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 371, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 740, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 371, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 740, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Disorientation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 371, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 740, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Mental status changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 371, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 740, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 371, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 740, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pulmonary hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 371, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 740, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 371, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 740, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 371, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 740, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 371, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 740, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 371, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 740, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Foot fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 371, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 369, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 740, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After the Last Planned Dose of Study Drugs (SVR12 Planned)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '371', 'groupId': 'OG000'}, {'value': '369', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'T12(q8h)/PR', 'description': 'Telaprevir 750 mg (2 oral tablets) every 8 hours for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.'}, {'id': 'OG001', 'title': 'T12(b.i.d.)/PR', 'description': 'Telaprevir 1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.'}], 'classes': [{'categories': [{'measurements': [{'value': '72.8', 'groupId': 'OG000'}, {'value': '74.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportion of response, %', 'ciPctValue': '95', 'paramValue': '1.5', 'ciLowerLimit': '-4.9', 'ciUpperLimit': '12', 'estimateComment': 'Observed data', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'The 95% confidence interval of the difference in proportions was estimated using a logistic regression model.', 'testedNonInferiority': True, 'nonInferiorityComment': 'If the lower limit of the 95% confidence interval of the difference in proportions was above the pre-determined non-inferiority margin of -11%, non-inferiority was established.'}], 'paramType': 'NUMBER', 'timeFrame': 'End of trial, 12 weeks after last planned dose', 'description': 'The table below shows the percentage of participants achieving Sustained Virologic Response 12 weeks after last planned dose of study medication (SVR12 planned). SVR was defined as having Hepatitis C Virus (HCV) ribonucleic acid (RNA) levels less than 25 international units/milliliter (IU/mL).', 'unitOfMeasure': 'percentage of participants with response', 'reportingStatus': 'POSTED', 'populationDescription': 'All analyses were performed on the full analysis (FA) set, which was defined as all randomized subjects who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Sustained Virologic Response 24 Weeks After the Last Planned Dose of Study Drugs (SVR24 Planned)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '371', 'groupId': 'OG000'}, {'value': '369', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'T12(q8h)/PR', 'description': 'Telaprevir 750 mg (2 oral tablets) every 8 hours for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.'}, {'id': 'OG001', 'title': 'T12(b.i.d.)/PR', 'description': 'Telaprevir 1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.'}], 'classes': [{'categories': [{'measurements': [{'value': '72.8', 'groupId': 'OG000'}, {'value': '74.8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'End of trial, 24 weeks after last planned dose', 'description': 'The table below shows the percentage of participants achieving SVR 24 weeks after the last planned dose of study medication. SVR was defined as having Hepatitis C Virus (HCV) ribonucleic acid (RNA) levels less than 25 international units/milliliter (IU/mL). The response for T12(b.i.d)/PR group is higher than that after 12 weeks because HCV RNA data for two participants were missing for SVR assessment at that time. Consequently, by definition of SVR12, they were counted as not having achieved SVR12.', 'unitOfMeasure': 'percentage of participants with response', 'reportingStatus': 'POSTED', 'populationDescription': 'All analyses were performed on the full analysis (FA) set, which was defined as all randomized subjects who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Sustained Virologic Response 72 Weeks After the Start of Study Medication (SVR72 Planned)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '371', 'groupId': 'OG000'}, {'value': '369', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'T12(q8h)/PR', 'description': 'Telaprevir 750 mg (2 oral tablets) every 8 hours for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.'}, {'id': 'OG001', 'title': 'T12(b.i.d.)/PR', 'description': 'Telaprevir 1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.'}], 'classes': [{'categories': [{'measurements': [{'value': '69.0', 'groupId': 'OG000'}, {'value': '70.2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'End of trial, 72 weeks after the start of study medication', 'description': 'The table below shows the percentage of participants achieving SVR 72 weeks after the start of study medication (SVR72 planned). SVR was defined as having plasma Hepatitis C Virus (HCV) ribonucleic acid (RNA) levels less than 25 IU/mL, target not detected, at end of treatment and up to 72 weeks after start of study medication (i.e., no confirmed detectable HCV RNA in between).', 'unitOfMeasure': 'percentage of participants with response', 'reportingStatus': 'POSTED', 'populationDescription': 'All analyses were performed on the full analysis (FA) set, which was defined as all randomized subjects who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values of Less Than 25 IU/ml, Target Not Detected, at Different Time Points.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '371', 'groupId': 'OG000'}, {'value': '369', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'T12(q8h)/PR', 'description': 'Telaprevir 750 mg (2 oral tablets) every 8 hours for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.'}, {'id': 'OG001', 'title': 'T12(b.i.d.)/PR', 'description': 'Telaprevir 1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'at Week 4', 'categories': [{'measurements': [{'value': '67.4', 'groupId': 'OG000'}, {'value': '69.4', 'groupId': 'OG001'}]}]}, {'title': 'at Week 4 and Week 12', 'categories': [{'measurements': [{'value': '63.1', 'groupId': 'OG000'}, {'value': '66.1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 4 and Week 4+12.', 'description': 'The table below shows the percentage of participants with undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) levels, which means less than 25 IU/ml, target not detected, at different time points during the study.', 'unitOfMeasure': 'percentage of participants with response', 'reportingStatus': 'POSTED', 'populationDescription': 'All analyses were performed on the full analysis (FA) set, which was defined as all randomized subjects who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With On-treatment Virologic Failure Which Required Them to Permanently Discontinue All Study Drugs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '371', 'groupId': 'OG000'}, {'value': '369', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'T12(q8h)/PR', 'description': 'Telaprevir 750 mg (2 oral tablets) every 8 hours for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.'}, {'id': 'OG001', 'title': 'T12(b.i.d.)/PR', 'description': 'Telaprevir 1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.7', 'groupId': 'OG000'}, {'value': '10.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 4, 12, 24, 32, 40', 'description': 'The table below shows the percentage of participants who met a stopping rule, defined as having a hepatitis C virus (HCV) ribonucleic acid (RNA) value at Week 4 \\>1000 IU/mL and at Weeks 12, 24, 32 and 40 ≥25 IU/mL.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All analyses were performed on the full analysis (FA) set, which was defined as all randomized subjects who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Relapsed During Follow-up Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '293', 'groupId': 'OG000'}, {'value': '300', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'T12(q8h)/PR', 'description': 'Telaprevir 750 mg (2 oral tablets) every 8 hours for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.'}, {'id': 'OG001', 'title': 'T12(b.i.d.)/PR', 'description': 'Telaprevir 1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.2', 'groupId': 'OG000'}, {'value': '7.7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During Follow-Up (24 weeks after the last dose of study drug)', 'description': 'The table below shows the percentage of participants who relapsed (ie, those having confirmed detectable hepatitis C virus \\[HCV\\] ribonucleic acid \\[RNA\\] during the 12-week follow-up period after previous HCV RNA \\<25 IU/mL, target not detected, at end of treatment).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on subjects with HCV RNA \\<25 IU/mL at the planned end of treatment, which included all randomized participants who received at least one dose of study drug and had data at the follow-up visit performed 24 weeks after the last dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants of Each IL28B Genotype Achieving Sustained Virologic Response 12 Weeks After the Last Planned Dose of Study Medication (SVR12 Planned)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '371', 'groupId': 'OG000'}, {'value': '369', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'T12(q8h)/PR', 'description': 'Telaprevir 750 mg (2 oral tablets) every 8 hours for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.'}, {'id': 'OG001', 'title': 'T12(b.i.d.)/PR', 'description': 'Telaprevir 1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.'}], 'classes': [{'title': 'CC genotype (n = 108; n = 103)', 'categories': [{'measurements': [{'value': '86.8', 'groupId': 'OG000'}, {'value': '92.4', 'groupId': 'OG001'}]}]}, {'title': 'CT genotype (n = 207; n = 207)', 'categories': [{'measurements': [{'value': '67.8', 'groupId': 'OG000'}, {'value': '67.5', 'groupId': 'OG001'}]}]}, {'title': 'TT genotype (n = 56; n = 59)', 'categories': [{'measurements': [{'value': '64.9', 'groupId': 'OG000'}, {'value': '65.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'End of trial, 12 weeks after the last planned dose', 'description': "The table below shows the effect of interleukin 28B (IL28B) gene's subtype (CC, CT or TT genotype) on the primary outcome measure: SVR12 planned.", 'unitOfMeasure': 'percentage of participants with response', 'reportingStatus': 'POSTED', 'populationDescription': 'All analyses were performed on the full analysis (FA) set, which was defined as all randomized subjects who received at least one dose of study drug.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'T12(q8h)/PR', 'description': 'Telaprevir 750 mg (2 oral tablets) every 8 hours for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.'}, {'id': 'FG001', 'title': 'T12(b.i.d.)/PR', 'description': 'Telaprevir 1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '371'}, {'groupId': 'FG001', 'numSubjects': '369'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '337'}, {'groupId': 'FG001', 'numSubjects': '329'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '40'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'Switch To Commercially Available Medicat', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'This study evaluated the effectiveness of telaprevir administered twice daily versus every 8 hours in combination with pegylated interferon and ribavirin in treatment-naïve participants with chronic HCV genotype 1 infection.', 'preAssignmentDetails': 'The study was conducted between 15 November 2010 and 02 August 2012 and recruited participants from 125 study centers in 14 countries worldwide. 744 participants were initially enrolled and 740 out of them randomly allocated to the 2 treatment arms.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '371', 'groupId': 'BG000'}, {'value': '369', 'groupId': 'BG001'}, {'value': '740', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'T12(q8h)/PR', 'description': 'Telaprevir 750 mg (2 oral tablets) every 8 hours for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.'}, {'id': 'BG001', 'title': 'T12(b.i.d.)/PR', 'description': 'Telaprevir 1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '351', 'groupId': 'BG000'}, {'value': '362', 'groupId': 'BG001'}, {'value': '713', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000', 'lowerLimit': '18', 'upperLimit': '70'}, {'value': '47.5', 'groupId': 'BG001', 'lowerLimit': '19', 'upperLimit': '70'}, {'value': '47.7', 'groupId': 'BG002', 'lowerLimit': '18', 'upperLimit': '70'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '136', 'groupId': 'BG000'}, {'value': '160', 'groupId': 'BG001'}, {'value': '296', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '235', 'groupId': 'BG000'}, {'value': '209', 'groupId': 'BG001'}, {'value': '444', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Europe', 'categories': [{'measurements': [{'value': '192', 'groupId': 'BG000'}, {'value': '179', 'groupId': 'BG001'}, {'value': '371', 'groupId': 'BG002'}]}]}, {'title': 'North-America', 'categories': [{'measurements': [{'value': '126', 'groupId': 'BG000'}, {'value': '137', 'groupId': 'BG001'}, {'value': '263', 'groupId': 'BG002'}]}]}, {'title': 'Australia', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}]}, {'title': 'Mexico', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}, {'title': 'Brazil', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 744}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-14', 'studyFirstSubmitDate': '2010-10-28', 'resultsFirstSubmitDate': '2013-09-23', 'studyFirstSubmitQcDate': '2010-11-12', 'lastUpdatePostDateStruct': {'date': '2014-06-04', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-05-14', 'studyFirstPostDateStruct': {'date': '2010-11-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-06-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After the Last Planned Dose of Study Drugs (SVR12 Planned)', 'timeFrame': 'End of trial, 12 weeks after last planned dose', 'description': 'The table below shows the percentage of participants achieving Sustained Virologic Response 12 weeks after last planned dose of study medication (SVR12 planned). SVR was defined as having Hepatitis C Virus (HCV) ribonucleic acid (RNA) levels less than 25 international units/milliliter (IU/mL).'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Sustained Virologic Response 24 Weeks After the Last Planned Dose of Study Drugs (SVR24 Planned)', 'timeFrame': 'End of trial, 24 weeks after last planned dose', 'description': 'The table below shows the percentage of participants achieving SVR 24 weeks after the last planned dose of study medication. SVR was defined as having Hepatitis C Virus (HCV) ribonucleic acid (RNA) levels less than 25 international units/milliliter (IU/mL). The response for T12(b.i.d)/PR group is higher than that after 12 weeks because HCV RNA data for two participants were missing for SVR assessment at that time. Consequently, by definition of SVR12, they were counted as not having achieved SVR12.'}, {'measure': 'Percentage of Participants With Sustained Virologic Response 72 Weeks After the Start of Study Medication (SVR72 Planned)', 'timeFrame': 'End of trial, 72 weeks after the start of study medication', 'description': 'The table below shows the percentage of participants achieving SVR 72 weeks after the start of study medication (SVR72 planned). SVR was defined as having plasma Hepatitis C Virus (HCV) ribonucleic acid (RNA) levels less than 25 IU/mL, target not detected, at end of treatment and up to 72 weeks after start of study medication (i.e., no confirmed detectable HCV RNA in between).'}, {'measure': 'Percentage of Participants Achieving Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values of Less Than 25 IU/ml, Target Not Detected, at Different Time Points.', 'timeFrame': 'Baseline, Week 4 and Week 4+12.', 'description': 'The table below shows the percentage of participants with undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) levels, which means less than 25 IU/ml, target not detected, at different time points during the study.'}, {'measure': 'Percentage of Participants With On-treatment Virologic Failure Which Required Them to Permanently Discontinue All Study Drugs', 'timeFrame': 'Week 4, 12, 24, 32, 40', 'description': 'The table below shows the percentage of participants who met a stopping rule, defined as having a hepatitis C virus (HCV) ribonucleic acid (RNA) value at Week 4 \\>1000 IU/mL and at Weeks 12, 24, 32 and 40 ≥25 IU/mL.'}, {'measure': 'Percentage of Participants Who Relapsed During Follow-up Period', 'timeFrame': 'During Follow-Up (24 weeks after the last dose of study drug)', 'description': 'The table below shows the percentage of participants who relapsed (ie, those having confirmed detectable hepatitis C virus \\[HCV\\] ribonucleic acid \\[RNA\\] during the 12-week follow-up period after previous HCV RNA \\<25 IU/mL, target not detected, at end of treatment).'}, {'measure': 'Percentage of Participants of Each IL28B Genotype Achieving Sustained Virologic Response 12 Weeks After the Last Planned Dose of Study Medication (SVR12 Planned)', 'timeFrame': 'End of trial, 12 weeks after the last planned dose', 'description': "The table below shows the effect of interleukin 28B (IL28B) gene's subtype (CC, CT or TT genotype) on the primary outcome measure: SVR12 planned."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Genotype 1 chronic hepatitis C', 'VX-950-C211', 'VX-950', 'IL28B', 'Telaprevir', 'Hepatitis C', 'BID', 'Q8h', 'SOC'], 'conditions': ['Genotype 1 Chronic Hepatitis C', 'Treatment Naive']}, 'referencesModule': {'references': [{'pmid': '25653396', 'type': 'DERIVED', 'citation': 'Sarrazin C, Dierynck I, Cloherty G, Ghys A, Janssen K, Luo D, Witek J, Buti M, Picchio G, De Meyer S. An OPTIMIZE study retrospective analysis for management of telaprevir-treated hepatitis C virus (HCV)-infected patients by use of the Abbott RealTime HCV RNA assay. J Clin Microbiol. 2015 Apr;53(4):1264-9. doi: 10.1128/JCM.03030-14. Epub 2015 Feb 4.'}, {'pmid': '24316262', 'type': 'DERIVED', 'citation': 'Buti M, Agarwal K, Horsmans Y, Sievert W, Janczewska E, Zeuzem S, Nyberg L, Brown RS Jr, Hezode C, Rizzetto M, Parana R, De Meyer S, De Masi R, Luo D, Bertelsen K, Witek J. Telaprevir twice daily is noninferior to telaprevir every 8 hours for patients with chronic hepatitis C. Gastroenterology. 2014 Mar;146(3):744-753.e3. doi: 10.1053/j.gastro.2013.11.047. Epub 2013 Dec 4.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effectiveness of telaprevir administered twice daily versus every 8 hours in combination with Peg-IFN-alfa-2a and ribavirin in treatment-naïve participants with chronic HCV genotype 1 infection.', 'detailedDescription': "This is a randomized (study drug assigned by chance), open-label (all persons know the study drug assignment) multicenter study to evaluate the effectiveness of telaprevir administered orally as 1125 milligram (mg) twice daily versus 750mg every 8 hours in combination with Peg-IFN-alfa-2a, administered via intramuscular injection once a week, and ribavirin, administered as an oral tablet twice a day, in treatment-naïve study participants with chronic hepatitis C virus (HCV) genotype 1 infection.\n\nTelaprevir will be given orally (by mouth) from Day 1 through Week 12 as 3 tablets (1125mg) twice daily or 2 tablets (750mg) every 8 hours. Peg-IFN-alfa-2a will be administered once a week as an injection under the skin (180 microgram/week) from Day 1 through Week 24 or 48 (based on the patient's treatment response on week 4). Ribavirin is administered orally (by mouth) twice daily from Day 1 through Week 24 or 48 (based on the participant's treatment response on week 4) as 1,000-1,200 mg per day. After the end of treatment (Week 24, Week 48, or at early discontinuation of all study drugs), participants with undetectable HCV RNA at end of treatment will be required to attend follow-up visits until Week 72 safety/tolerability assessments will be performed throughout the treatment period and during the follow-up period."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient has chronic HCV infection genotype 1 with HCV RNA level \\> 1,000 IU/mL\n* Patients should not have had any previous treatment for hepatitis C\n* Patient must have documentation of a liver biopsy within 2 years before the screening visit or the patient must agree to have a biopsy performed within the screening period\n* Patients with cirrhosis should have serum alpha-fetoprotein (AFP) \\<= 50 ng/mL. If AFP \\> 50 ng/mL, absence of a mass must be demonstrated by ultrasound within the screening period\n* A female patient of childbearing potential and a nonvasectomized male patient who has a female partner of childbearing potential must agree to the use of 2 effective methods of birth control from screening until 6 months (female patient) or 7 months (male patient) after the last dose of RBV.\n\nExclusion Criteria:\n\n* Patient is infected or co-infected with HCV of another genotype than genotype 1 and/or patient is infected with more than one genotype subtype\n* Patient has a pre-existing psychiatric condition\n* Patient has history of decompensated liver disease or shows evidence of significant liver disease in addition to hepatitis C\n* Patient has human immunodeficiency virus (HIV) or hepatitis B virus (HBV) co-infection\n* Patient has active malignant disease or history of malignant disease within the past 5 years (with the exception of treated basal cell carcinoma).'}, 'identificationModule': {'nctId': 'NCT01241760', 'briefTitle': 'VX-950-C211 - A Dosing Regimen Study (Twice Daily Versus Every 8 Hours) of Telaprevir in Treatment-naïve Participants With Genotype 1 Chronic Hepatitis C Virus Infection', 'organization': {'class': 'INDUSTRY', 'fullName': 'Janssen Infectious Diseases BVBA'}, 'officialTitle': 'A Randomized, Open-Label, Phase 3 Study of Telaprevir Administered Twice Daily or Every 8 Hours in Combination With Pegylated Interferon Alfa-2a and Ribavirin in Treatment-Naïve Subjects With Genotype 1 Chronic Hepatitis C Virus Infection', 'orgStudyIdInfo': {'id': 'CR013711'}, 'secondaryIdInfos': [{'id': 'OPTIMIZE-HCV', 'type': 'OTHER', 'domain': 'Janssen Infectious Diseases BVBA'}, {'id': 'VX-950-C211', 'type': 'OTHER', 'domain': 'Janssen Infectious Diseases BVBA'}, {'id': '2010-021628-84', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '001 T(q8h) / PR', 'description': 'Telaprevir (T) 750 mg (2 oral tablets) every 8 hours for 12 weeks, in combination with pegylated interferon (P) and ribavirin (R)', 'interventionNames': ['Drug: Ribavirin', 'Drug: Pegylated interferon alfa-2a', 'Drug: Telaprevir']}, {'type': 'EXPERIMENTAL', 'label': '002 T(b.i.d.) / PR', 'description': 'Telaprevir (T) 1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks, in combination with pegylated interferon (P) and ribavirin (R)', 'interventionNames': ['Drug: Ribavirin', 'Drug: Telaprevir', 'Drug: Pegylated interferon alfa-2a']}], 'interventions': [{'name': 'Ribavirin', 'type': 'DRUG', 'description': "Ribavirin (RBV) 1000-1200 milligram (mg) per day (weight dependent) twice daily regimen oral tablets for 24 or 48 weeks depending on the patient's treatment response at week 4", 'armGroupLabels': ['001 T(q8h) / PR', '002 T(b.i.d.) / PR']}, {'name': 'Telaprevir', 'type': 'DRUG', 'description': '1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks', 'armGroupLabels': ['002 T(b.i.d.) / PR']}, {'name': 'Pegylated interferon alfa-2a', 'type': 'DRUG', 'description': "180 microgram (µg) per week, subcutaneous injection, for 24 or 48 weeks Pegylated interferon alfa-2a 180 microgram (µg) per week subcutaneous injection for 24 or 48 weeks depending on the patient's treatment response at week 4", 'armGroupLabels': ['001 T(q8h) / PR', '002 T(b.i.d.) / PR']}, {'name': 'Telaprevir', 'type': 'DRUG', 'description': '750 mg (2 oral tablets) every 8 hours for 12 weeks', 'armGroupLabels': ['001 T(q8h) / PR']}]}, 'contactsLocationsModule': {'locations': [{'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'San Diego', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'city': 'Bradenton', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 27.49893, 'lon': -82.57482}}, {'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'city': 'Marietta', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 33.9526, 'lon': -84.54993}}, {'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'city': 'Downers Grove', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 41.80892, 'lon': -88.01117}}, {'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'city': 'Lutherville', 'state': 'Maryland', 'country': 'United States', 'geoPoint': {'lat': 39.42122, 'lon': -76.62608}}, {'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'city': 'Lebanon', 'state': 'New Hampshire', 'country': 'United States', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}, {'city': 'Egg Harbor Twp', 'state': 'New Jersey', 'country': 'United States'}, {'city': 'Santa Fe', 'state': 'New Mexico', 'country': 'United States', 'geoPoint': {'lat': 35.68698, 'lon': -105.9378}}, {'city': 'New York', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'city': 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