Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2026-03-01 @ 4:46 PM
Study NCT ID:
NCT01467505
Status:
TERMINATED
Last Update Posted:
2015-06-18
First Post:
2011-11-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
An Open Label Study of the Effect of Telaprevir in Combination With Ribavirin and Peginterferon on HCV Infection in Stable Liver Transplant Patients
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': 'C486464', 'term': 'telaprevir'}, {'id': 'D012254', 'term': 'Ribavirin'}, {'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': {'email': 'medicalinfo@vrtx.com', 'phone': '617-341-6777', 'title': 'Medical Monitor', 'organization': 'Vertex Pharmaceuticals Incorporated'}, 'certainAgreement': {'otherDetails': 'PI is free to publish results of the study after (1) the first multi-center publication, (2) if the sponsor elects not to publish the results, or (3) 18 months after close of the study, whichever occurs first. Proposed publications are to be submitted to the sponsor for review and comment for a period of at least 45 days (which may be extended under certain circumstances related to protection of intellectual property); the sponsor cannot require changes to the proposed publications.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'It was decided by Sponsor on 13 January 2014 to terminate the study early at the primary efficacy endpoint (SVR12) as part of a decision to modify the drug development plan. Eligible participants completed virologic follow-up after termination.'}}, 'adverseEventsModule': {'timeFrame': 'Baseline up to Week 52', 'description': 'Other Adverse Events section includes both Serious Adverse Events (SAEs) and Non-Serious Adverse Events (Non-SAEs) as Non-SAEs were not planned to be summarized separately for this study.', 'eventGroups': [{'id': 'EG000', 'title': 'T/PR + Immunosuppressant Regimen (Tacrolimus)', 'description': 'Participants who were receiving TAC based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \\<75 kg and 1200 mg/day for subjects weighing \\>=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.', 'otherNumAtRisk': 51, 'otherNumAffected': 51, 'seriousNumAtRisk': 51, 'seriousNumAffected': 11}, {'id': 'EG001', 'title': 'T/PR + Immunosuppressant Regimen (Cyclosporine)', 'description': 'Participants who were receiving CsA based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \\<75 kg and 1200 mg/day for subjects weighing \\>=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.', 'otherNumAtRisk': 10, 'otherNumAffected': 10, 'seriousNumAtRisk': 10, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Anorectal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Anal pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Proctalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Glossitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Abdominal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Abdominal tenderness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Bowel movement irregularity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Chapped lips', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Cheilitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Faeces discoloured', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Faeces soft', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Frequent bowel movements', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Gingival bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Glossodynia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Haematochezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Impaired gastric emptying', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Lip swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Mouth ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Mucous stools', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Oral mucosal blistering', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Palatal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Perianal erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Retching', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Swollen tongue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Feeling jittery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Early satiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Feeling abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Gait disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Generalised oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Injection site haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Injection site irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Injection site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Injection site rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Local swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Nodule', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 7}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pruritus generalised', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Blister', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Drug eruption', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Night sweats', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Psoriasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Rash generalised', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Actinic keratosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Cold sweat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 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'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Autoimmune hepatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hyperbilirubinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Portal vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Ear discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Erectile dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pelvic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Cushingoid', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Liver transplant rejection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}], 'seriousEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Impaired gastric emptying', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Proctalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Portal vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Rhabdomyolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Sustained Viral Response 12 Weeks After Last Planned Dose of Study Drug (SVR12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'T/PR + Immunosuppressant Regimen (Tacrolimus)', 'description': 'Participants who were receiving TAC based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \\<75 kg and 1200 mg/day for subjects weighing \\>=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.'}, {'id': 'OG001', 'title': 'T/PR + Immunosuppressant Regimen (Cyclosporine)', 'description': 'Participants who were receiving CsA based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \\<75 kg and 1200 mg/day for subjects weighing \\>=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.'}], 'classes': [{'title': 'Naive (n= 16, 2)', 'categories': [{'measurements': [{'value': '75.0', 'groupId': 'OG000'}, {'value': '50.0', 'groupId': 'OG001'}]}]}, {'title': 'Prior Relapser (n= 10, 2)', 'categories': [{'measurements': [{'value': '60.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'Prior Null Responder (n=16, 4)', 'categories': [{'measurements': [{'value': '37.5', 'groupId': 'OG000'}, {'value': '50.0', 'groupId': 'OG001'}]}]}, {'title': 'Prior Partial Responder (n= 3, 1)', 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'Uncategorized (n= 6, 1)', 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'Total (n= 51, 10)', 'categories': [{'measurements': [{'value': '56.9', 'groupId': 'OG000'}, {'value': '70.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks after last planned dose of study drug (up to Week 60)', 'description': 'SVR12 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (\\<lower limit of quantification) at 12 weeks after last planned dose of study treatment. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Set included all participants who received at least 1 dose of study drug. Here, n = participants evaluable for specified category for each arm, respectively.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Sustained Viral Response 24 Weeks After Last Planned Dose of Study Drug (SVR24)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'T/PR + Immunosuppressant Regimen (Tacrolimus)', 'description': 'Participants who were receiving TAC based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \\<75 kg and 1200 mg/day for subjects weighing \\>=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.'}, {'id': 'OG001', 'title': 'T/PR + Immunosuppressant Regimen (Cyclosporine)', 'description': 'Participants who were receiving CsA based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \\<75 kg and 1200 mg/day for subjects weighing \\>=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.'}], 'classes': [{'title': 'Naive (n= 5,1)', 'categories': [{'measurements': [{'value': '60.0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Prior Relapser (n= 4,1)', 'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Prior Null Responder (n=10, 4)', 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000'}, {'value': '50.0', 'groupId': 'OG001'}]}]}, {'title': 'Prior Partial Responder (n= 0, 1)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'Uncategorized (n= 5, 0)', 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Total (n= 24, 7)', 'categories': [{'measurements': [{'value': '29.2', 'groupId': 'OG000'}, {'value': '42.9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 weeks after last planned dose of study drug (up to Week 72)', 'description': 'SVR24 was defined as an undetectable HCV RNA Levels at 24 weeks after last planned dose of study treatment. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Set included all participants who received at least 1 dose of study drug. Here, number of participants analyzed = participants evaluable for this measure and n = participants evaluable for specified category for each arm, respectively.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Rapid Viral Response (RVR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'T/PR + Immunosuppressant Regimen (Tacrolimus)', 'description': 'Participants who were receiving TAC based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \\<75 kg and 1200 mg/day for subjects weighing \\>=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.'}, {'id': 'OG001', 'title': 'T/PR + Immunosuppressant Regimen (Cyclosporine)', 'description': 'Participants who were receiving CsA based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \\<75 kg and 1200 mg/day for subjects weighing \\>=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.'}], 'classes': [{'title': 'Naive (n= 16, 2)', 'categories': [{'measurements': [{'value': '68.8', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Prior Relapser (n= 10, 2)', 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}, {'value': '50.0', 'groupId': 'OG001'}]}]}, {'title': 'Prior Null Responder (n=16, 4)', 'categories': [{'measurements': [{'value': '43.8', 'groupId': 'OG000'}, {'value': '25.0', 'groupId': 'OG001'}]}]}, {'title': 'Prior Partial Responder (n= 3, 1)', 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'Uncategorized (n= 6, 1)', 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Total (n= 51, 10)', 'categories': [{'measurements': [{'value': '52.9', 'groupId': 'OG000'}, {'value': '30.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 4', 'description': 'The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL. RVR was defined as undetectable HCV RNA 4 weeks after the start of study treatment.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Set included all participants who received at least 1 dose of study drug. Here, n = participants evaluable for specified category for each arm, respectively.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Extended Rapid Viral Response (eRVR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'T/PR + Immunosuppressant Regimen (Tacrolimus)', 'description': 'Participants who were receiving TAC based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \\<75 kg and 1200 mg/day for subjects weighing \\>=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.'}, {'id': 'OG001', 'title': 'T/PR + Immunosuppressant Regimen (Cyclosporine)', 'description': 'Participants who were receiving CsA based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \\<75 kg and 1200 mg/day for subjects weighing \\>=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.'}], 'classes': [{'title': 'Naive (n= 16, 2)', 'categories': [{'measurements': [{'value': '68.8', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Prior Relapser (n= 10, 2)', 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}, {'value': '50.0', 'groupId': 'OG001'}]}]}, {'title': 'Prior Null Responder (n=16, 4)', 'categories': [{'measurements': [{'value': '37.5', 'groupId': 'OG000'}, {'value': '25.0', 'groupId': 'OG001'}]}]}, {'title': 'Prior Partial Responder (n= 3, 1)', 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'Uncategorized (n= 6, 1)', 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Total (n= 51, 10)', 'categories': [{'measurements': [{'value': '51.0', 'groupId': 'OG000'}, {'value': '30.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 4 and Week 12', 'description': 'The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL. eRVR was defined as undetectable HCV RNA at both 4 weeks and 12 weeks after the start of study treatment.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Set included all participants who received at least 1 dose of study drug. Here, n = participants evaluable for specified category for each arm, respectively.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With On-Treatment Virologic Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'T/PR + Immunosuppressant Regimen (Tacrolimus)', 'description': 'Participants who were receiving TAC based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \\<75 kg and 1200 mg/day for subjects weighing \\>=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.'}, {'id': 'OG001', 'title': 'T/PR + Immunosuppressant Regimen (Cyclosporine)', 'description': 'Participants who were receiving CsA based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \\<75 kg and 1200 mg/day for subjects weighing \\>=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Week 48', 'description': 'On-treatment virologic failure was defined as subjects who met futility or who completed the assigned treatment duration and had detectable HCV RNA at planned end of treatment (up to 48 weeks). Data for this outcome was not planned to be reported by prior response.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Set included all participants who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Viral Relapse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'T/PR + Immunosuppressant Regimen (Tacrolimus)', 'description': 'Participants who were receiving TAC based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \\<75 kg and 1200 mg/day for subjects weighing \\>=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.'}, {'id': 'OG001', 'title': 'T/PR + Immunosuppressant Regimen (Cyclosporine)', 'description': 'Participants who were receiving CsA based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \\<75 kg and 1200 mg/day for subjects weighing \\>=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.'}], 'timeFrame': '48 weeks', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to early study termination as part of a decision to modify the drug development plan the data for this outcome measure was not collected, as planned.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics of Telaprevir, Peg-IFN, RBV , and Selected Immunosuppressant Medications (Tacrolimus and Cyclosporine)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'T/PR + Immunosuppressant Regimen (Tacrolimus)', 'description': 'Participants who were receiving TAC based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \\<75 kg and 1200 mg/day for subjects weighing \\>=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.'}, {'id': 'OG001', 'title': 'T/PR + Immunosuppressant Regimen (Cyclosporine)', 'description': 'Participants who were receiving CsA based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \\<75 kg and 1200 mg/day for subjects weighing \\>=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.'}], 'timeFrame': '48 weeks', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to early study termination as part of a decision to modify the drug development plan the data for this outcome measure was not collected, as planned.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Requiring Dose Titration of Immunosuppressant Medications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'T/PR + Immunosuppressant Regimen (Tacrolimus)', 'description': 'Participants who were receiving TAC based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \\<75 kg and 1200 mg/day for subjects weighing \\>=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.'}, {'id': 'OG001', 'title': 'T/PR + Immunosuppressant Regimen (Cyclosporine)', 'description': 'Participants who were receiving CsA based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \\<75 kg and 1200 mg/day for subjects weighing \\>=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.'}], 'timeFrame': '48 weeks', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to early study termination as part of a decision to modify the drug development plan the data for this outcome measure was not collected, as planned.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Biopsy Confirmed and Treated Rejection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'T/PR + Immunosuppressant Regimen (Tacrolimus)', 'description': 'Participants who were receiving TAC based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \\<75 kg and 1200 mg/day for subjects weighing \\>=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.'}, {'id': 'OG001', 'title': 'T/PR + Immunosuppressant Regimen (Cyclosporine)', 'description': 'Participants who were receiving CsA based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \\<75 kg and 1200 mg/day for subjects weighing \\>=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.'}], 'timeFrame': '48 weeks', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to early study termination as part of a decision to modify the drug development plan the data for this outcome measure was not collected, as planned.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Histological Evidence of Stabilization or Improvement in Inflammation Grade or Fibrosis Stage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'T/PR + Immunosuppressant Regimen (Tacrolimus)', 'description': 'Participants who were receiving TAC based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \\<75 kg and 1200 mg/day for subjects weighing \\>=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.'}, {'id': 'OG001', 'title': 'T/PR + Immunosuppressant Regimen (Cyclosporine)', 'description': 'Participants who were receiving CsA based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \\<75 kg and 1200 mg/day for subjects weighing \\>=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.'}], 'timeFrame': '48 weeks', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to early study termination as part of a decision to modify the drug development plan the data for this outcome measure was not collected, as planned.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Telaprevir Resistant HCV Variant at Non-Structural Viral Protein 3-4A (NS3-4A) Region', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'T/PR + Immunosuppressant Regimen (Tacrolimus)', 'description': 'Participants who were receiving TAC based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \\<75 kg and 1200 mg/day for subjects weighing \\>=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.'}, {'id': 'OG001', 'title': 'T/PR + Immunosuppressant Regimen (Cyclosporine)', 'description': 'Participants who were receiving CsA based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \\<75 kg and 1200 mg/day for subjects weighing \\>=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.'}], 'timeFrame': '48 weeks', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to early study termination as part of a decision to modify the drug development plan the data for this outcome measure was not collected, as planned.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'T/PR + Immunosuppressant Regimen (Tacrolimus)', 'description': 'Participants who were receiving TAC based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \\<75 kg and 1200 mg/day for subjects weighing \\>=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.'}, {'id': 'OG001', 'title': 'T/PR + Immunosuppressant Regimen (Cyclosporine)', 'description': 'Participants who were receiving CsA based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \\<75 kg and 1200 mg/day for subjects weighing \\>=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.'}], 'classes': [{'title': 'AEs', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Week 52', 'description': 'Any adverse change from the participant\'s baseline (pre-treatment) condition, including any adverse experience, abnormal recording or clinical laboratory assessment value which occurs during the course of the study, whether it is considered related to the study drug or not. An adverse event includes any newly occurring event or previous condition that has increased in severity or frequency since the administration of study drug. SAE: medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. "Study drug" includes all investigational agents (including placebo, if applicable) administered during the course of the study.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Set included all participants who received at least 1 dose of study drug.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants With Sustained Viral Response 4 Weeks After Last Planned Dose of Study Drug (SVR4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'T/PR + Immunosuppressant Regimen (Tacrolimus)', 'description': 'Participants who were receiving TAC based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \\<75 kg and 1200 mg/day for subjects weighing \\>=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.'}, {'id': 'OG001', 'title': 'T/PR + Immunosuppressant Regimen (Cyclosporine)', 'description': 'Participants who were receiving CsA based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \\<75 kg and 1200 mg/day for subjects weighing \\>=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.'}], 'timeFrame': '4 weeks after last planned dose of study drug (up to Week 52)', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to early study termination as part of a decision to modify the drug development plan the data for this outcome measure was not collected, as planned.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'T/PR + Immunosuppressant Regimen (Tacrolimus)', 'description': 'Participants who were receiving tacrolimus (TAC) based immunosuppressant regimen at baseline, received telaprevir (T) 1125 milligram (mg) tablet twice daily for 12 weeks in combination with pegylated interferon alfa 2a (P) (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (R) (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (\\<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (\\>=) 75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.'}, {'id': 'FG001', 'title': 'T/PR + Immunosuppressant Regimen (Cyclosporine)', 'description': 'Participants who were receiving cyclosporine (CsA) based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \\<75 kg and 1200 mg/day for subjects weighing \\>=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Study Terminated by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'Study included Treatment-Naïve (no prior hepatitis C virus \\[HCV\\] therapy); Prior Relapser (prior treatment with pegylated interferon alfa/ribavirin \\[Peg-IFN/RBV\\] and experienced viral relapse); Prior Null/Partial Responder (prior treatment with Peg-IFN/RBV and had null/partial response); Uncategorized (could not tolerate treatment) participants.', 'preAssignmentDetails': 'Efficacy analyses were reported separately as per immunosuppressant regimen (reporting arms) and also separately as per prior response (in categories) (Treatment-Naive, Prior Relapser, Prior Null Responder, Prior Partial Responder, Uncategorized as well as for Total Participants), unless otherwise specified.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'T/PR + Immunosuppressant Regimen (Tacrolimus)', 'description': 'Participants who were receiving TAC based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \\<75 kg and 1200 mg/day for subjects weighing \\>=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.'}, {'id': 'BG001', 'title': 'T/PR + Immunosuppressant Regimen (Cyclosporine)', 'description': 'Participants who were receiving CsA based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \\<75 kg and 1200 mg/day for subjects weighing \\>=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.8', 'spread': '4.08', 'groupId': 'BG000'}, {'value': '59.5', 'spread': '2.95', 'groupId': 'BG001'}, {'value': '57.3', 'spread': '4.02', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Full analysis set included all participants who received at least 1 dose of study drug.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}}, 'statusModule': {'whyStopped': 'The study was terminated early by the sponsor on 13 January 2014 due to a decision to modify the drug development plan.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-01', 'studyFirstSubmitDate': '2011-11-03', 'resultsFirstSubmitDate': '2015-05-02', 'studyFirstSubmitQcDate': '2011-11-03', 'lastUpdatePostDateStruct': {'date': '2015-06-18', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-06-01', 'studyFirstPostDateStruct': {'date': '2011-11-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-06-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Percentage of Participants With Sustained Viral Response 4 Weeks After Last Planned Dose of Study Drug (SVR4)', 'timeFrame': '4 weeks after last planned dose of study drug (up to Week 52)'}], 'primaryOutcomes': [{'measure': 'Percentage of Participants With Sustained Viral Response 12 Weeks After Last Planned Dose of Study Drug (SVR12)', 'timeFrame': '12 weeks after last planned dose of study drug (up to Week 60)', 'description': 'SVR12 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (\\<lower limit of quantification) at 12 weeks after last planned dose of study treatment. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL).'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Sustained Viral Response 24 Weeks After Last Planned Dose of Study Drug (SVR24)', 'timeFrame': '24 weeks after last planned dose of study drug (up to Week 72)', 'description': 'SVR24 was defined as an undetectable HCV RNA Levels at 24 weeks after last planned dose of study treatment. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL.'}, {'measure': 'Percentage of Participants With Rapid Viral Response (RVR)', 'timeFrame': 'Week 4', 'description': 'The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL. RVR was defined as undetectable HCV RNA 4 weeks after the start of study treatment.'}, {'measure': 'Percentage of Participants With Extended Rapid Viral Response (eRVR)', 'timeFrame': 'Week 4 and Week 12', 'description': 'The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL. eRVR was defined as undetectable HCV RNA at both 4 weeks and 12 weeks after the start of study treatment.'}, {'measure': 'Percentage of Participants With On-Treatment Virologic Failure', 'timeFrame': 'Baseline up to Week 48', 'description': 'On-treatment virologic failure was defined as subjects who met futility or who completed the assigned treatment duration and had detectable HCV RNA at planned end of treatment (up to 48 weeks). Data for this outcome was not planned to be reported by prior response.'}, {'measure': 'Percentage of Participants With Viral Relapse', 'timeFrame': '48 weeks'}, {'measure': 'Pharmacokinetics of Telaprevir, Peg-IFN, RBV , and Selected Immunosuppressant Medications (Tacrolimus and Cyclosporine)', 'timeFrame': '48 weeks'}, {'measure': 'Percentage of Participants Requiring Dose Titration of Immunosuppressant Medications', 'timeFrame': '48 weeks'}, {'measure': 'Percentage of Participants With Biopsy Confirmed and Treated Rejection', 'timeFrame': '48 weeks'}, {'measure': 'Percentage of Participants With Histological Evidence of Stabilization or Improvement in Inflammation Grade or Fibrosis Stage', 'timeFrame': '48 weeks'}, {'measure': 'Number of Participants With Telaprevir Resistant HCV Variant at Non-Structural Viral Protein 3-4A (NS3-4A) Region', 'timeFrame': '48 weeks'}, {'measure': 'Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'Baseline up to Week 52', 'description': 'Any adverse change from the participant\'s baseline (pre-treatment) condition, including any adverse experience, abnormal recording or clinical laboratory assessment value which occurs during the course of the study, whether it is considered related to the study drug or not. An adverse event includes any newly occurring event or previous condition that has increased in severity or frequency since the administration of study drug. SAE: medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. "Study drug" includes all investigational agents (including placebo, if applicable) administered during the course of the study.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hepatitis C']}, 'descriptionModule': {'briefSummary': 'To assess efficacy of telaprevir, pegylated interferon alfa-2a (Peg-IFN-alfa-2a), and ribavirin (RBV) for hepatitis C virus (HCV) in a 48-week total treatment duration regimen following liver transplantation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female participants between the ages of 18 and 65 years\n* History of orthotopic liver transplantation less than 10 years before the Screening visit but no sooner than 6 months before Day 1\n* Taking a stable immunosuppressant regimen based on either tacrolimus or cyclosporine without substantial dose changes over the past 3 months\n* Naive to pegylated interferon/ribavirin treatment or experienced with pegylated interferon/ribavirin prior to transplantation with relapse, partial, or null response\n\nExclusion Criteria:\n\n* Documented cirrhosis after liver transplantation\n* Ascites or hepatic encephalopathy within 6 months before Screening\n* Retransplantation for recurrent hepatitis C\n* Treatment for hepatitis C post liver transplantation\n* History within the past 3 months of: rejection within 3 months or greater than (\\>) 1 rejection within 12 months\n* Current treatment with sirolimus or methylprednisolone. Low dose prednisone use (\\<5 milligram per day) is permitted\n* History within 3 months of any bacterial infection requiring \\>1 week of intravenous antibiotics, cytomegalovirus viremia or cytomegalovirus infection with end-organ involvement, fungal disease (except cutaneous and mild oral thrush)\n* History of post transplant lymphoproliferative disease\n* Acceptable laboratory values at Screening as specified in the protocol\n* Positive for human immunodeficiency virus 1/2 (HIV1/2) enzyme immunoassay (EIA) antibody screen or Hepatitis B deoxyribonucleic acid (DNA) or Hepatitis B surface antigen\n* History of hepatocellular carcinoma with high risk of recurrence\n* Any other cause of liver disease deemed clinically significant by the investigator in addition to hepatitis C\n* Autoimmune-mediated disease\n* History of acute pancreatitis within 5 years before the Screening visit\n* Prior treatment with an hepatitis C virus (HCV) protease inhibitor'}, 'identificationModule': {'nctId': 'NCT01467505', 'briefTitle': 'An Open Label Study of the Effect of Telaprevir in Combination With Ribavirin and Peginterferon on HCV Infection in Stable Liver Transplant Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vertex Pharmaceuticals Incorporated'}, 'officialTitle': 'A 2-Part, Open Label Study of Telaprevir in Combination With Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Subjects Chronically Infected With Genotype 1 Hepatitis C Virus Following Liver Transplantation', 'orgStudyIdInfo': {'id': 'VX11-950-117'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'T/PR + Immunosuppressant Regimen (Tacrolimus)', 'description': 'Participants who were receiving tacrolimus (TAC) based immunosuppressant regimen at baseline, received telaprevir (T) 1125 milligram (mg) tablet twice daily for 12 weeks in combination with pegylated interferon alfa 2a (P) (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (R) (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (\\<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (\\>=) 75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.', 'interventionNames': ['Drug: Telaprevir', 'Drug: Ribavirin', 'Drug: Pegylated Interferon Alfa-2a', 'Drug: Immunosuppressant Regimen']}, {'type': 'EXPERIMENTAL', 'label': 'T/PR + Immunosuppressant Regimen (Cyclosporine)', 'description': 'Participants who were receiving cyclosporine (CsA) based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \\<75 kg and 1200 mg/day for subjects weighing \\>=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.', 'interventionNames': ['Drug: Telaprevir', 'Drug: Ribavirin', 'Drug: Pegylated Interferon Alfa-2a', 'Drug: Immunosuppressant Regimen']}], 'interventions': [{'name': 'Telaprevir', 'type': 'DRUG', 'otherNames': ['VX-950'], 'description': 'Tablet', 'armGroupLabels': ['T/PR + Immunosuppressant Regimen (Cyclosporine)', 'T/PR + Immunosuppressant Regimen (Tacrolimus)']}, {'name': 'Ribavirin', 'type': 'DRUG', 'otherNames': ['Copegus®, RBV'], 'description': 'Tablet', 'armGroupLabels': ['T/PR + Immunosuppressant Regimen (Cyclosporine)', 'T/PR + Immunosuppressant Regimen (Tacrolimus)']}, {'name': 'Pegylated Interferon Alfa-2a', 'type': 'DRUG', 'otherNames': ['Pegasys®, Peg-IFN-alfa-2a'], 'description': 'Subcutaneous Injection', 'armGroupLabels': ['T/PR + Immunosuppressant Regimen (Cyclosporine)', 'T/PR + Immunosuppressant Regimen (Tacrolimus)']}, {'name': 'Immunosuppressant Regimen', 'type': 'DRUG', 'description': 'Cyclosporine (CsA) based immunosuppressant regimen or Tacrolimus (TAC) based immunosuppressant regimen, as per standard practice. Immunosuppressant regimen were not considered study drugs.', 'armGroupLabels': ['T/PR + Immunosuppressant Regimen (Cyclosporine)', 'T/PR + Immunosuppressant Regimen (Tacrolimus)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Alabama', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'California', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Colorado', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'city': 'Bradenton', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida', 'geoPoint': {'lat': 27.49893, 'lon': -82.57482}}, {'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'city': 'Evanston', 'state': 'Illinois', 'country': 'United States', 'facility': 'Illinios', 'geoPoint': {'lat': 42.04114, 'lon': -87.69006}}, {'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'city': 'Burlington', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts', 'geoPoint': {'lat': 42.50482, 'lon': -71.19561}}, {'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Michigan', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Missouri', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Nebraska', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'New York', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'North Carolina', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}], 'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Vertex Pharmaceuticals Incorporated'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vertex Pharmaceuticals Incorporated', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}