Ignite Creation Date:
2025-12-25 @ 12:57 AM
Ignite Modification Date:
2025-12-26 @ 1:28 PM
Study NCT ID:
NCT00793793
Status:
COMPLETED
Last Update Posted:
2018-09-05
First Post:
2008-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety, Antiviral Activity and PK of MRD of BI 201335 in Chronic Hepatitis C Patients Both Treatment Naive and -Experienced
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019698', 'term': 'Hepatitis C, Chronic'}], 'ancestors': [{'id': 'D006526', 'term': 'Hepatitis C'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006521', 'term': 'Hepatitis, Chronic'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C552340', 'term': 'faldaprevir'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '1-800-243-0127', 'title': 'Boehringer Ingelheim Call Center', 'organization': 'Boehringer Ingelheim'}, 'certainAgreement': {'otherDetails': "Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Additional secondary endpoints were listed in the original protocol. Those endpoints are of exploratory nature only and were not considered relevant for trial conclusions. For more information see tab "Full Text Review", section "More Information".'}}, 'adverseEventsModule': {'timeFrame': 'day 1 and up to 4 weeks + washout', 'eventGroups': [{'id': 'EG000', 'title': 'Treatment Naive (TN): Placebo', 'description': 'TN patient to receive Placebo +/- Pegylated interferon alpha-2a solution for injection/Ribavirin tablet (PegIFN/RBV) for 28 days', 'otherNumAtRisk': 8, 'otherNumAffected': 5, 'seriousNumAtRisk': 8, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Treatment Naive(TN): 20mg QD', 'description': 'TN patient to receive 20mg QD solution Faldaprevir (BI201335) qd +/- PegIFN/RBV for 28 days', 'otherNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'TN: 48mg QD', 'description': 'TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days', 'otherNumAtRisk': 7, 'otherNumAffected': 7, 'seriousNumAtRisk': 7, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'TN: 120mg QD', 'description': 'TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days', 'otherNumAtRisk': 7, 'otherNumAffected': 4, 'seriousNumAtRisk': 7, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'TN: 240mg QD', 'description': 'TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days', 'otherNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Treatment Experienced (TE) Non-cirrhotic: 48 mg QD', 'description': 'TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days', 'otherNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'TE Non-cirrhotic: 120 mg QD', 'description': 'TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days', 'otherNumAtRisk': 7, 'otherNumAffected': 7, 'seriousNumAtRisk': 7, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'TE Non-cirrhotic: 240 mg QD', 'description': 'TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days', 'otherNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG008', 'title': 'TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)', 'description': 'TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days', 'otherNumAtRisk': 15, 'otherNumAffected': 15, 'seriousNumAtRisk': 15, 'seriousNumAffected': 0}, {'id': 'EG009', 'title': 'TE Non-cirrhotic: 240 mg BID SGC', 'description': 'TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days', 'otherNumAtRisk': 15, 'otherNumAffected': 15, 'seriousNumAtRisk': 15, 'seriousNumAffected': 0}, {'id': 'EG010', 'title': 'TE With Cirrhosis: 240 mg QD SGC', 'description': 'TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days', 'otherNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG011', 'title': 'TE With Cirrhosis: 240 mg BID SGC', 'description': 'TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days', 'otherNumAtRisk': 7, 'otherNumAffected': 7, 'seriousNumAtRisk': 7, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 3}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG010', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 13.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG010', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 13.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 13.1'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 13.1'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 13.1'}, {'term': 'Supraventricular extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 13.1'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 13.1'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 7, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 13.1'}, {'term': 'Abnormal sensation in eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 13.1'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 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'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 13.1'}, {'term': 'Photophobia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 13.1'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 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'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 13.1'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 13.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 13.1'}], 'seriousEvents': [{'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 13.1'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 13.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 13.1'}, {'term': 'Hypoalbuminaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 13.1'}, {'term': 'Metabolic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 13.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Efficacy: VR (Virologic Response) of >=2 log10 Reduction in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) From Baseline at Any Time up to Day 14 (naïve Patients) or Day 28 (Experienced Patients)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '15', 'groupId': 'OG008'}, {'value': '15', 'groupId': 'OG009'}, {'value': '6', 'groupId': 'OG010'}, {'value': '7', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'TN: Placebo', 'description': 'TN patient to receive Placebo +/- PegIFN/RBV for 28 days'}, {'id': 'OG001', 'title': 'Treatment Naive(TN): 20mg QD', 'description': 'TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG002', 'title': 'TN: 48mg QD', 'description': 'TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG003', 'title': 'TN: 120mg QD', 'description': 'TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG004', 'title': 'TN: 240mg QD', 'description': 'TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG005', 'title': 'Treatment Experienced (TE) Non-cirrhotic: 48 mg QD', 'description': 'TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG006', 'title': 'TE Non-cirrhotic: 120 mg QD', 'description': 'TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG007', 'title': 'TE Non-cirrhotic: 240 mg QD', 'description': 'TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG008', 'title': 'TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)', 'description': 'TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG009', 'title': 'TE Non-cirrhotic: 240 mg BID SGC', 'description': 'TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG010', 'title': 'TE With Cirrhosis: 240 mg QD SGC', 'description': 'TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG011', 'title': 'TE With Cirrhosis: 240 mg BID SGC', 'description': 'TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}], 'classes': [{'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.000', 'upperLimit': '33.627'}, {'value': '83.33', 'groupId': 'OG001', 'lowerLimit': '42.128', 'upperLimit': '96.331'}, {'value': '100.00', 'groupId': 'OG002', 'lowerLimit': '63.058', 'upperLimit': '100.000'}, {'value': '100.00', 'groupId': 'OG003', 'lowerLimit': '63.058', 'upperLimit': '100.000'}, {'value': '100.00', 'groupId': 'OG004', 'lowerLimit': '59.038', 'upperLimit': '100.000'}, {'value': '100.00', 'groupId': 'OG005', 'lowerLimit': '59.038', 'upperLimit': '100.000'}, {'value': '100.00', 'groupId': 'OG006', 'lowerLimit': '63.058', 'upperLimit': '100.000'}, {'value': '100.00', 'groupId': 'OG007', 'lowerLimit': '59.038', 'upperLimit': '100.000'}, {'value': '100.00', 'groupId': 'OG008', 'lowerLimit': '79.409', 'upperLimit': '100.000'}, {'value': '100.00', 'groupId': 'OG009', 'lowerLimit': '79.409', 'upperLimit': '100.000'}, {'value': '100.00', 'groupId': 'OG010', 'lowerLimit': '59.038', 'upperLimit': '100.000'}, {'value': '100.00', 'groupId': 'OG011', 'lowerLimit': '63.058', 'upperLimit': '100.000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and up to 4 weeks', 'description': 'Efficacy endpoint: VR (virologic response) of \\>=2 log10 reduction in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) from baseline at any time up to Day 14 (naïve patients) or Day 28 (experienced patients).', 'unitOfMeasure': 'percentage of responders', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): All randomized TN 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Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)', 'description': 'TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG009', 'title': 'TE Non-cirrhotic: 240 mg BID SGC', 'description': 'TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG010', 'title': 'TE With Cirrhosis: 240 mg QD SGC', 'description': 'TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG011', 'title': 'TE With Cirrhosis: 240 mg BID SGC', 'description': 'TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}], 'classes': [{'categories': [{'measurements': [{'value': '62.5', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}, {'value': '100.0', 'groupId': 'OG002'}, {'value': '57.1', 'groupId': 'OG003'}, {'value': '100.0', 'groupId': 'OG004'}, {'value': '100.0', 'groupId': 'OG005'}, {'value': '100.0', 'groupId': 'OG006'}, {'value': '100.0', 'groupId': 'OG007'}, {'value': '100.0', 'groupId': 'OG008'}, {'value': '100.0', 'groupId': 'OG009'}, {'value': '100.0', 'groupId': 'OG010'}, {'value': '100.0', 'groupId': 'OG011'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'from day 1 and up to 4 weeks + 4 days washout', 'description': 'Occurrence of Adverse Events (AEs) during BI201335 + washout period. For placebo patients include all AEs through 30 days after trial discontinuation.', 'unitOfMeasure': 'percentage of participants with AEs', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated Set (TS): This patient set included all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment regardless of randomization.'}, {'type': 'PRIMARY', 'title': 'Occurrence of Serious Adverse Events (SAEs) During BI201335 + Washout Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '15', 'groupId': 'OG008'}, {'value': '15', 'groupId': 'OG009'}, {'value': '6', 'groupId': 'OG010'}, {'value': '7', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'TN: Placebo', 'description': 'TN patient to receive Placebo +/- PegIFN/RBV for 28 days'}, {'id': 'OG001', 'title': 'Treatment Naive(TN): 20mg QD', 'description': 'TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG002', 'title': 'TN: 48mg QD', 'description': 'TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG003', 'title': 'TN: 120mg QD', 'description': 'TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG004', 'title': 'TN: 240mg QD', 'description': 'TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG005', 'title': 'Treatment Experienced (TE) Non-cirrhotic: 48 mg QD', 'description': 'TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG006', 'title': 'TE Non-cirrhotic: 120 mg QD', 'description': 'TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG007', 'title': 'TE Non-cirrhotic: 240 mg QD', 'description': 'TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG008', 'title': 'TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)', 'description': 'TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG009', 'title': 'TE Non-cirrhotic: 240 mg BID SGC', 'description': 'TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG010', 'title': 'TE With Cirrhosis: 240 mg QD SGC', 'description': 'TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG011', 'title': 'TE With Cirrhosis: 240 mg BID SGC', 'description': 'TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '16.7', 'groupId': 'OG001'}, {'value': '14.3', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}, {'value': '0.0', 'groupId': 'OG005'}, {'value': '0.0', 'groupId': 'OG006'}, {'value': '0.0', 'groupId': 'OG007'}, {'value': '0.0', 'groupId': 'OG008'}, {'value': '0.0', 'groupId': 'OG009'}, {'value': '0.0', 'groupId': 'OG010'}, {'value': '28.6', 'groupId': 'OG011'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'from day 1 and up to 4 weeks + 4 days washout', 'description': 'Occurrence of Serious Adverse Events (SAEs)during BI201335 or BI201335+ washout period. For placebo patients include all SAEs through 30 days after trial discontinuation.', 'unitOfMeasure': 'percentage of participants with SAEs', 'reportingStatus': 'POSTED', 'populationDescription': 'TS'}, {'type': 'PRIMARY', 'title': 'Occurrence of Laboratory Test Abnormalities and With Respect to Division of AIDS (DAIDS) Classification and Laboratory Test Values Change Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '15', 'groupId': 'OG008'}, {'value': '15', 'groupId': 'OG009'}, {'value': '6', 'groupId': 'OG010'}, {'value': '7', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'TN: Placebo', 'description': 'TN patient to receive Placebo +/- PegIFN/RBV for 28 days'}, {'id': 'OG001', 'title': 'Treatment Naive(TN): 20mg QD', 'description': 'TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG002', 'title': 'TN: 48mg QD', 'description': 'TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG003', 'title': 'TN: 120mg QD', 'description': 'TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG004', 'title': 'TN: 240mg QD', 'description': 'TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG005', 'title': 'Treatment Experienced (TE) Non-cirrhotic: 48 mg QD', 'description': 'TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG006', 'title': 'TE Non-cirrhotic: 120 mg QD', 'description': 'TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG007', 'title': 'TE Non-cirrhotic: 240 mg QD', 'description': 'TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG008', 'title': 'TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)', 'description': 'TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG009', 'title': 'TE Non-cirrhotic: 240 mg BID SGC', 'description': 'TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG010', 'title': 'TE With Cirrhosis: 240 mg QD SGC', 'description': 'TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG011', 'title': 'TE With Cirrhosis: 240 mg BID SGC', 'description': 'TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}], 'classes': [{'title': 'ALT/GPT SGPT increase, with grade 3 or 4 abnormal', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}, {'title': 'AST/GOT SGOT increase, with grade 3 or 4 abnormal', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}]}]}, {'title': 'Lipase increase, with grade 3 or 4 abnormal', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}, {'title': 'Bilirubin total increa, with grade 3 or 4 abnormal', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '8', 'groupId': 'OG008'}, {'value': '12', 'groupId': 'OG009'}, {'value': '5', 'groupId': 'OG010'}, {'value': '5', 'groupId': 'OG011'}]}]}, {'title': 'Uric acid increase, with grade 3 or 4 abnormal', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}]}]}, {'title': 'Triglyceride increase, with grade 3 or 4 abnormal', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and up to 4 weeks', 'description': 'Occurrence of laboratory test abnormalities and with respect to Division of AIDS (DAIDS) classification and laboratory test values change over time.\n\nALT=Alanine transaminase (SGPT), AST=Aspartate transaminase (SGOT).', 'unitOfMeasure': 'participants with grade 3 or 4 abnormal', 'reportingStatus': 'POSTED', 'populationDescription': 'TS'}, {'type': 'SECONDARY', 'title': 'Maximum Viral Load Reduction From Baseline up to Day 14 for Treatment-naïve Patients and Day 28 Treatment for Treatment-experienced Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '15', 'groupId': 'OG008'}, {'value': '15', 'groupId': 'OG009'}, {'value': '6', 'groupId': 'OG010'}, {'value': '7', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'TN: Placebo', 'description': 'TN patient to receive Placebo +/- PegIFN/RBV for 28 days'}, {'id': 'OG001', 'title': 'Treatment Naive(TN): 20mg QD', 'description': 'TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG002', 'title': 'TN: 48mg QD', 'description': 'TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG003', 'title': 'TN: 120mg QD', 'description': 'TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG004', 'title': 'TN: 240mg QD', 'description': 'TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG005', 'title': 'Treatment Experienced (TE) Non-cirrhotic: 48 mg QD', 'description': 'TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG006', 'title': 'TE Non-cirrhotic: 120 mg QD', 'description': 'TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG007', 'title': 'TE Non-cirrhotic: 240 mg QD', 'description': 'TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG008', 'title': 'TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)', 'description': 'TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG009', 'title': 'TE Non-cirrhotic: 240 mg BID SGC', 'description': 'TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG010', 'title': 'TE With Cirrhosis: 240 mg QD SGC', 'description': 'TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG011', 'title': 'TE With Cirrhosis: 240 mg BID SGC', 'description': 'TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.060', 'groupId': 'OG000', 'lowerLimit': '-0.216', 'upperLimit': '0.012'}, {'value': '-3.049', 'groupId': 'OG001', 'lowerLimit': '-3.376', 'upperLimit': '-2.181'}, {'value': '-3.624', 'groupId': 'OG002', 'lowerLimit': '-3.744', 'upperLimit': '-3.359'}, {'value': '-3.740', 'groupId': 'OG003', 'lowerLimit': '-3.869', 'upperLimit': '-3.426'}, {'value': '-4.413', 'groupId': 'OG004', 'lowerLimit': '-4.438', 'upperLimit': '-3.943'}, {'value': '-5.023', 'groupId': 'OG005', 'lowerLimit': '-5.150', 'upperLimit': '-4.342'}, {'value': '-5.244', 'groupId': 'OG006', 'lowerLimit': '-5.796', 'upperLimit': '-4.035'}, {'value': '-5.334', 'groupId': 'OG007', 'lowerLimit': '-5.692', 'upperLimit': '-4.916'}, {'value': '-5.246', 'groupId': 'OG008', 'lowerLimit': '-5.621', 'upperLimit': '-5.133'}, {'value': '-5.404', 'groupId': 'OG009', 'lowerLimit': '-5.469', 'upperLimit': '-4.936'}, {'value': '-4.841', 'groupId': 'OG010', 'lowerLimit': '-5.322', 'upperLimit': '-4.763'}, {'value': '-5.476', 'groupId': 'OG011', 'lowerLimit': '-5.544', 'upperLimit': '-3.853'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and up to 4 weeks', 'description': 'Maximum viral load reduction from baseline up to Day 14 for treatment-naïve patients and Day 28 treatment for treatment-experienced patients.', 'unitOfMeasure': 'log10 IU/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS (as randomised)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Viral Load on Day 14 for Treatment-naïve Patients and on Day 28 Treatment for Treatment-experienced Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '15', 'groupId': 'OG008'}, {'value': '15', 'groupId': 'OG009'}, {'value': '6', 'groupId': 'OG010'}, {'value': '6', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Naive (TN): Placebo', 'description': 'TN patient to receive Placebo +/- Pegylated interferon alpha-2a solution for injection/Ribavirin tablet (PegIFN/RBV) for 28 days'}, {'id': 'OG001', 'title': 'Treatment Naive(TN): 20mg Per Day (QD)', 'description': 'TN patient to receive 20mg QD solution Faldaprevir (BI201335) qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG002', 'title': 'TN: 48mg QD', 'description': 'TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG003', 'title': 'TN: 120mg QD', 'description': 'TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG004', 'title': 'TN: 240mg QD', 'description': 'TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG005', 'title': 'Treatment Experienced (TE) Non-cirrhotic: 48 mg QD', 'description': 'TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG006', 'title': 'TE Non-cirrhotic: 120 mg QD', 'description': 'TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG007', 'title': 'TE Non-cirrhotic: 240 mg QD', 'description': 'TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG008', 'title': 'TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)', 'description': 'TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG009', 'title': 'TE Non-cirrhotic: 240 mg BID SGC', 'description': 'TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG010', 'title': 'TE With Cirrhosis: 240 mg QD SGC', 'description': 'TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG011', 'title': 'TE With Cirrhosis: 240 mg BID SGC', 'description': 'TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}], 'classes': [{'categories': [{'measurements': [{'value': '0.209', 'groupId': 'OG000', 'lowerLimit': '0.165', 'upperLimit': '0.321'}, {'value': '-1.226', 'groupId': 'OG001', 'lowerLimit': '-1.492', 'upperLimit': '-0.831'}, {'value': '-1.539', 'groupId': 'OG002', 'lowerLimit': '-2.885', 'upperLimit': '-0.782'}, {'value': '-0.781', 'groupId': 'OG003', 'lowerLimit': '-1.967', 'upperLimit': '-0.046'}, {'value': '-2.449', 'groupId': 'OG004', 'lowerLimit': '-3.502', 'upperLimit': '-1.360'}, {'value': '-5.023', 'groupId': 'OG005', 'lowerLimit': '-5.150', 'upperLimit': '-3.049'}, {'value': '-5.244', 'groupId': 'OG006', 'lowerLimit': '-5.800', 'upperLimit': '-4.035'}, {'value': '-5.386', 'groupId': 'OG007', 'lowerLimit': '-5.692', 'upperLimit': '-5.283'}, {'value': '-5.246', 'groupId': 'OG008', 'lowerLimit': '-5.621', 'upperLimit': '-5.133'}, {'value': '-5.404', 'groupId': 'OG009', 'lowerLimit': '-5.469', 'upperLimit': '-4.797'}, {'value': '-4.782', 'groupId': 'OG010', 'lowerLimit': '-5.322', 'upperLimit': '-4.628'}, {'value': '-5.497', 'groupId': 'OG011', 'lowerLimit': '-5.544', 'upperLimit': '-5.300'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and up to 4 weeks', 'description': 'Change from baseline in viral load on Day 14 for treatment-naïve patients and on Day 28 treatment for treatment-experienced patients.', 'unitOfMeasure': 'Log10 IU/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS (as randomised) including patients with available viral load data.'}, {'type': 'SECONDARY', 'title': 'Rapid Virologic Response (RVR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '15', 'groupId': 'OG008'}, {'value': '15', 'groupId': 'OG009'}, {'value': '6', 'groupId': 'OG010'}, {'value': '7', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'TN: Placebo', 'description': 'TN patient to receive Placebo +/- PegIFN/RBV for 28 days'}, {'id': 'OG001', 'title': 'Treatment Naive(TN): 20mg QD', 'description': 'TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG002', 'title': 'TN: 48mg QD', 'description': 'TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG003', 'title': 'TN: 120mg QD', 'description': 'TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG004', 'title': 'TN: 240mg QD', 'description': 'TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG005', 'title': 'Treatment Experienced (TE) Non-cirrhotic: 48 mg QD', 'description': 'TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG006', 'title': 'TE Non-cirrhotic: 120 mg QD', 'description': 'TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG007', 'title': 'TE Non-cirrhotic: 240 mg QD', 'description': 'TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG008', 'title': 'TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)', 'description': 'TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG009', 'title': 'TE Non-cirrhotic: 240 mg BID SGC', 'description': 'TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG010', 'title': 'TE With Cirrhosis: 240 mg QD SGC', 'description': 'TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG011', 'title': 'TE With Cirrhosis: 240 mg BID SGC', 'description': 'TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}], 'classes': [{'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.000', 'upperLimit': '33.627'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '0.000', 'upperLimit': '40.962'}, {'value': '28.57', 'groupId': 'OG002', 'lowerLimit': '8.523', 'upperLimit': '65.086'}, {'value': '14.29', 'groupId': 'OG003', 'lowerLimit': '3.185', 'upperLimit': '52.651'}, {'value': '16.67', 'groupId': 'OG004', 'lowerLimit': '3.669', 'upperLimit': '57.872'}, {'value': '33.33', 'groupId': 'OG005', 'lowerLimit': '9.899', 'upperLimit': '70.958'}, {'value': '14.29', 'groupId': 'OG006', 'lowerLimit': '3.185', 'upperLimit': '52.651'}, {'value': '16.67', 'groupId': 'OG007', 'lowerLimit': '3.669', 'upperLimit': '57.872'}, {'value': '26.67', 'groupId': 'OG008', 'lowerLimit': '11.017', 'upperLimit': '52.377'}, {'value': '26.67', 'groupId': 'OG009', 'lowerLimit': '11.017', 'upperLimit': '52.377'}, {'value': '66.67', 'groupId': 'OG010', 'lowerLimit': '29.042', 'upperLimit': '90.101'}, {'value': '14.29', 'groupId': 'OG011', 'lowerLimit': '3.185', 'upperLimit': '52.651'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'week 4', 'description': 'Rapid virologic response (RVR): Plasma HCV RNA level below the limit of detection of the Roche COBAS Taqman HCV/HPS assay (10 IU/mL) on Day 28 for all patients.', 'unitOfMeasure': 'percentage of responders', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS (as randomized)'}, {'type': 'SECONDARY', 'title': 'Early Virologic Response (EVR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '15', 'groupId': 'OG008'}, {'value': '15', 'groupId': 'OG009'}, {'value': '6', 'groupId': 'OG010'}, {'value': '7', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'TN: Placebo', 'description': 'TN patient to receive Placebo +/- PegIFN/RBV for 28 days'}, {'id': 'OG001', 'title': 'Treatment Naive(TN): 20mg QD', 'description': 'TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG002', 'title': 'TN: 48mg QD', 'description': 'TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG003', 'title': 'TN: 120mg QD', 'description': 'TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG004', 'title': 'TN: 240mg QD', 'description': 'TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG005', 'title': 'Treatment Experienced (TE) Non-cirrhotic: 48 mg QD', 'description': 'TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG006', 'title': 'TE Non-cirrhotic: 120 mg QD', 'description': 'TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG007', 'title': 'TE Non-cirrhotic: 240 mg QD', 'description': 'TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG008', 'title': 'TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)', 'description': 'TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG009', 'title': 'TE Non-cirrhotic: 240 mg BID SGC', 'description': 'TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG010', 'title': 'TE With Cirrhosis: 240 mg QD SGC', 'description': 'TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG011', 'title': 'TE With Cirrhosis: 240 mg BID SGC', 'description': 'TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}, {'value': '100.0', 'groupId': 'OG002'}, {'value': '85.7', 'groupId': 'OG003'}, {'value': '83.3', 'groupId': 'OG004'}, {'value': '83.3', 'groupId': 'OG005'}, {'value': '71.4', 'groupId': 'OG006'}, {'value': '100.0', 'groupId': 'OG007'}, {'value': '86.7', 'groupId': 'OG008'}, {'value': '86.7', 'groupId': 'OG009'}, {'value': '100.0', 'groupId': 'OG010'}, {'value': '71.4', 'groupId': 'OG011'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'week 12', 'description': 'Early Virologic Response (EVR): \\>=2 log10 reduction in plasma HCV RNA level from baseline at week 12 (day 84)', 'unitOfMeasure': 'percentage of responders', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Complete EVR1 (cEVR1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '15', 'groupId': 'OG008'}, {'value': '15', 'groupId': 'OG009'}, {'value': '6', 'groupId': 'OG010'}, {'value': '7', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Naive (TN): Placebo', 'description': 'TN patient to receive Placebo +/- Pegylated interferon alpha-2a solution for injection/Ribavirin tablet (PegIFN/RBV) for 28 days'}, {'id': 'OG001', 'title': 'Treatment Naive(TN): 20mg Per Day (QD)', 'description': 'TN patient to receive 20mg QD solution Faldaprevir (BI201335) qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG002', 'title': 'TN: 48mg QD', 'description': 'TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG003', 'title': 'TN: 120mg QD', 'description': 'TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG004', 'title': 'TN: 240mg QD', 'description': 'TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG005', 'title': 'Treatment Experienced (TE) Non-cirrhotic: 48 mg QD', 'description': 'TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG006', 'title': 'TE Non-cirrhotic: 120 mg QD', 'description': 'TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG007', 'title': 'TE Non-cirrhotic: 240 mg QD', 'description': 'TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG008', 'title': 'TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)', 'description': 'TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG009', 'title': 'TE Non-cirrhotic: 240 mg BID SGC', 'description': 'TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG010', 'title': 'TE With Cirrhosis: 240 mg QD SGC', 'description': 'TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG011', 'title': 'TE With Cirrhosis: 240 mg BID SGC', 'description': 'TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '16.7', 'groupId': 'OG001'}, {'value': '28.6', 'groupId': 'OG002'}, {'value': '28.6', 'groupId': 'OG003'}, {'value': '50.0', 'groupId': 'OG004'}, {'value': '50.0', 'groupId': 'OG005'}, {'value': '57.1', 'groupId': 'OG006'}, {'value': '83.3', 'groupId': 'OG007'}, {'value': '53.3', 'groupId': 'OG008'}, {'value': '60.0', 'groupId': 'OG009'}, {'value': '83.3', 'groupId': 'OG010'}, {'value': '57.1', 'groupId': 'OG011'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'week 4 and week 12', 'description': 'VL (Viral load) below the limit of quantification of the Roche COBAS Taqman HCV/HPS assay (25 IU/mL) at 4 weeks and below the limit of detection of the Roche COBAS Taqman HCV/HPS assay (10 IU/mL) at 12 weeks', 'unitOfMeasure': 'percentage of responders', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Complete EVR2 (cEVR2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '15', 'groupId': 'OG008'}, {'value': '15', 'groupId': 'OG009'}, {'value': '6', 'groupId': 'OG010'}, {'value': '7', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Naive (TN): Placebo', 'description': 'TN patient to receive Placebo +/- Pegylated interferon alpha-2a solution for injection/Ribavirin tablet (PegIFN/RBV) for 28 days'}, {'id': 'OG001', 'title': 'Treatment Naive(TN): 20mg Per Day (QD)', 'description': 'TN patient to receive 20mg QD solution Faldaprevir (BI201335) qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG002', 'title': 'TN: 48mg QD', 'description': 'TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG003', 'title': 'TN: 120mg QD', 'description': 'TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG004', 'title': 'TN: 240mg QD', 'description': 'TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG005', 'title': 'Treatment Experienced (TE) Non-cirrhotic: 48 mg QD', 'description': 'TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG006', 'title': 'TE Non-cirrhotic: 120 mg QD', 'description': 'TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG007', 'title': 'TE Non-cirrhotic: 240 mg QD', 'description': 'TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG008', 'title': 'TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)', 'description': 'TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG009', 'title': 'TE Non-cirrhotic: 240 mg BID SGC', 'description': 'TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG010', 'title': 'TE With Cirrhosis: 240 mg QD SGC', 'description': 'TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG011', 'title': 'TE With Cirrhosis: 240 mg BID SGC', 'description': 'TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '28.6', 'groupId': 'OG002'}, {'value': '14.3', 'groupId': 'OG003'}, {'value': '33.3', 'groupId': 'OG004'}, {'value': '50.0', 'groupId': 'OG005'}, {'value': '14.3', 'groupId': 'OG006'}, {'value': '16.7', 'groupId': 'OG007'}, {'value': '33.3', 'groupId': 'OG008'}, {'value': '20.0', 'groupId': 'OG009'}, {'value': '33.3', 'groupId': 'OG010'}, {'value': '28.6', 'groupId': 'OG011'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'week 4 and week 12', 'description': 'VL below the limit of detection at both 4 weeks and 12 weeks', 'unitOfMeasure': 'percentage of responders', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'End of Treatment Response (ETR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '15', 'groupId': 'OG008'}, {'value': '15', 'groupId': 'OG009'}, {'value': '6', 'groupId': 'OG010'}, {'value': '7', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'TN: Placebo', 'description': 'TN patient to receive Placebo +/- PegIFN/RBV for 28 days'}, {'id': 'OG001', 'title': 'Treatment Naive(TN): 20mg QD', 'description': 'TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG002', 'title': 'TN: 48mg QD', 'description': 'TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG003', 'title': 'TN: 120mg QD', 'description': 'TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG004', 'title': 'TN: 240mg QD', 'description': 'TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG005', 'title': 'Treatment Experienced (TE) Non-cirrhotic: 48 mg QD', 'description': 'TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG006', 'title': 'TE Non-cirrhotic: 120 mg QD', 'description': 'TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG007', 'title': 'TE Non-cirrhotic: 240 mg QD', 'description': 'TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG008', 'title': 'TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)', 'description': 'TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG009', 'title': 'TE Non-cirrhotic: 240 mg BID SGC', 'description': 'TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG010', 'title': 'TE With Cirrhosis: 240 mg QD SGC', 'description': 'TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG011', 'title': 'TE With Cirrhosis: 240 mg BID SGC', 'description': 'TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '83.3', 'groupId': 'OG001'}, {'value': '57.1', 'groupId': 'OG002'}, {'value': '57.1', 'groupId': 'OG003'}, {'value': '66.7', 'groupId': 'OG004'}, {'value': '33.3', 'groupId': 'OG005'}, {'value': '57.1', 'groupId': 'OG006'}, {'value': '66.7', 'groupId': 'OG007'}, {'value': '53.3', 'groupId': 'OG008'}, {'value': '40.0', 'groupId': 'OG009'}, {'value': '50.0', 'groupId': 'OG010'}, {'value': '14.3', 'groupId': 'OG011'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'week 48', 'description': 'End of Treatment Response (ETR): Plasma HCV RNA level below the limit of detection of the Roche COBAS Taqman HCV/HPS assay (10 IU/mL) at week 48 (Day 336).', 'unitOfMeasure': 'percentage of responders', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Sustained Virologic Response (SVR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '15', 'groupId': 'OG008'}, {'value': '15', 'groupId': 'OG009'}, {'value': '6', 'groupId': 'OG010'}, {'value': '7', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'TN: Placebo', 'description': 'TN patient to receive Placebo +/- PegIFN/RBV for 28 days'}, {'id': 'OG001', 'title': 'Treatment Naive(TN): 20mg QD', 'description': 'TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG002', 'title': 'TN: 48mg QD', 'description': 'TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG003', 'title': 'TN: 120mg QD', 'description': 'TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG004', 'title': 'TN: 240mg QD', 'description': 'TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG005', 'title': 'Treatment Experienced (TE) Non-cirrhotic: 48 mg QD', 'description': 'TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG006', 'title': 'TE Non-cirrhotic: 120 mg QD', 'description': 'TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG007', 'title': 'TE Non-cirrhotic: 240 mg QD', 'description': 'TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG008', 'title': 'TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)', 'description': 'TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG009', 'title': 'TE Non-cirrhotic: 240 mg BID SGC', 'description': 'TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG010', 'title': 'TE With Cirrhosis: 240 mg QD SGC', 'description': 'TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG011', 'title': 'TE With Cirrhosis: 240 mg BID SGC', 'description': 'TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '50.0', 'groupId': 'OG001'}, {'value': '42.9', 'groupId': 'OG002'}, {'value': '42.9', 'groupId': 'OG003'}, {'value': '50.0', 'groupId': 'OG004'}, {'value': '50.0', 'groupId': 'OG005'}, {'value': '42.9', 'groupId': 'OG006'}, {'value': '50.0', 'groupId': 'OG007'}, {'value': '46.7', 'groupId': 'OG008'}, {'value': '40.0', 'groupId': 'OG009'}, {'value': '50.0', 'groupId': 'OG010'}, {'value': '14.3', 'groupId': 'OG011'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'week 72', 'description': 'Sustained Virologic Response (SVR): Plasma HCV RNA level below the limit of detection of the Roche COBAS Taqman HCV/HPS assay (10 IU/mL) at week 72 (Day 504).', 'unitOfMeasure': 'percentage of responders', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Achievement of an HCV RNA Level Below the Limit of Detection Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '15', 'groupId': 'OG008'}, {'value': '15', 'groupId': 'OG009'}, {'value': '6', 'groupId': 'OG010'}, {'value': '7', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'TN: Placebo', 'description': 'TN patient to receive Placebo +/- Pegylated interferon alpha-2a solution for injection/Ribavirin tablet (PegIFN/RBV) for 28 days'}, {'id': 'OG001', 'title': 'Treatment Naive(TN): 20mg QD', 'description': 'TN patient to receive 20mg QD solution Faldaprevir (BI201335) qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG002', 'title': 'TN: 48mg QD', 'description': 'TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG003', 'title': 'TN: 120mg QD', 'description': 'TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG004', 'title': 'TN: 240mg QD', 'description': 'TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG005', 'title': 'Treatment Experienced (TE) Non-cirrhotic: 48 mg QD', 'description': 'TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG006', 'title': 'TE Non-cirrhotic: 120 mg QD', 'description': 'TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG007', 'title': 'TE Non-cirrhotic: 240 mg QD', 'description': 'TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG008', 'title': 'TE Non-cirrhotic: 240 mg BID SGC', 'description': 'TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG009', 'title': 'TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)', 'description': 'TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG010', 'title': 'TE With Cirrhosis: 240 mg QD SGC', 'description': 'TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG011', 'title': 'TE With Cirrhosis: 240 mg BID SGC', 'description': 'TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '28.6', 'groupId': 'OG002'}, {'value': '14.3', 'groupId': 'OG003'}, {'value': '16.7', 'groupId': 'OG004'}, {'value': '33.3', 'groupId': 'OG005'}, {'value': '14.3', 'groupId': 'OG006'}, {'value': '16.7', 'groupId': 'OG007'}, {'value': '26.7', 'groupId': 'OG008'}, {'value': '26.7', 'groupId': 'OG009'}, {'value': '66.7', 'groupId': 'OG010'}, {'value': '14.3', 'groupId': 'OG011'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'from day 1 and up to 4 weeks', 'description': 'Achievement of an HCV RNA level below the limit of detection of the Roche COBAS Taqman HCV/HPS assay (10 IU/mL) over time', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Achievement of an HCV RNA Level Below the Limit of Quantification Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '15', 'groupId': 'OG008'}, {'value': '15', 'groupId': 'OG009'}, {'value': '6', 'groupId': 'OG010'}, {'value': '7', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'TN: Placebo', 'description': 'TN patient to receive Placebo +/- Pegylated interferon alpha-2a solution for injection/Ribavirin tablet (PegIFN/RBV) for 28 days'}, {'id': 'OG001', 'title': 'Treatment Naive(TN): 20mg QD', 'description': 'TN patient to receive 20mg QD solution Faldaprevir (BI201335) qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG002', 'title': 'TN: 48mg QD', 'description': 'TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG003', 'title': 'TN: 120mg QD', 'description': 'TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG004', 'title': 'TN: 240mg QD', 'description': 'TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG005', 'title': 'Treatment Experienced (TE) Non-cirrhotic: 48 mg QD', 'description': 'TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG006', 'title': 'TE Non-cirrhotic: 120 mg QD', 'description': 'TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG007', 'title': 'TE Non-cirrhotic: 240 mg QD', 'description': 'TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG008', 'title': 'TE Non-cirrhotic: 240 mg BID SGC', 'description': 'TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG009', 'title': 'TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)', 'description': 'TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG010', 'title': 'TE With Cirrhosis: 240 mg QD SGC', 'description': 'TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG011', 'title': 'TE With Cirrhosis: 240 mg BID SGC', 'description': 'TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '16.7', 'groupId': 'OG001'}, {'value': '28.6', 'groupId': 'OG002'}, {'value': '28.6', 'groupId': 'OG003'}, {'value': '50.0', 'groupId': 'OG004'}, {'value': '50.0', 'groupId': 'OG005'}, {'value': '57.1', 'groupId': 'OG006'}, {'value': '83.3', 'groupId': 'OG007'}, {'value': '66.7', 'groupId': 'OG008'}, {'value': '60.0', 'groupId': 'OG009'}, {'value': '83.3', 'groupId': 'OG010'}, {'value': '85.7', 'groupId': 'OG011'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'from day 1 and up to 4 weeks', 'description': 'Achievement of an HCV RNA Level Below the Limit of quantification of the Roche COBAS Taqman HCV/HPS assay (25 IU/mL) Over Time', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Achievement of a >= 2 log10 Reduction in Plasma HCV RNA Level From Baseline Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '15', 'groupId': 'OG008'}, {'value': '15', 'groupId': 'OG009'}, {'value': '6', 'groupId': 'OG010'}, {'value': '7', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'TN: Placebo', 'description': 'TN patient to receive Placebo +/- Pegylated interferon alpha-2a solution for injection/Ribavirin tablet (PegIFN/RBV) for 28 days'}, {'id': 'OG001', 'title': 'Treatment Naive(TN): 20mg QD', 'description': 'TN patient to receive 20mg QD solution Faldaprevir (BI201335) qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG002', 'title': 'TN: 48mg QD', 'description': 'TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG003', 'title': 'TN: 120mg QD', 'description': 'TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG004', 'title': 'TN: 240mg QD', 'description': 'TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG005', 'title': 'Treatment Experienced (TE) Non-cirrhotic: 48 mg QD', 'description': 'TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG006', 'title': 'TE Non-cirrhotic: 120 mg QD', 'description': 'TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG007', 'title': 'TE Non-cirrhotic: 240 mg QD', 'description': 'TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG008', 'title': 'TE Non-cirrhotic: 240 mg BID SGC', 'description': 'TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG009', 'title': 'TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)', 'description': 'TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG010', 'title': 'TE With Cirrhosis: 240 mg QD SGC', 'description': 'TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG011', 'title': 'TE With Cirrhosis: 240 mg BID SGC', 'description': 'TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '83.3', 'groupId': 'OG001'}, {'value': '100.0', 'groupId': 'OG002'}, {'value': '100.0', 'groupId': 'OG003'}, {'value': '100.0', 'groupId': 'OG004'}, {'value': '100.0', 'groupId': 'OG005'}, {'value': '100.0', 'groupId': 'OG006'}, {'value': '100.0', 'groupId': 'OG007'}, {'value': '100.0', 'groupId': 'OG008'}, {'value': '100.0', 'groupId': 'OG009'}, {'value': '100.0', 'groupId': 'OG010'}, {'value': '100.0', 'groupId': 'OG011'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'from day 1 and up to 4 weeks', 'description': 'Achievement of a \\>= 2 log10 reduction in plasma HCV RNA level from baseline over time.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Occurrence of AEs, by Action Taken With Regard to Study Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '15', 'groupId': 'OG008'}, {'value': '15', 'groupId': 'OG009'}, {'value': '6', 'groupId': 'OG010'}, {'value': '7', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Naive (TN): Placebo', 'description': 'TN patient to receive Placebo +/- PegIFN/RBV for 28 days'}, {'id': 'OG001', 'title': 'Treatment Naive(TN): 20mg QD', 'description': 'TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG002', 'title': 'TN: 48mg QD', 'description': 'TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG003', 'title': 'TN: 120mg QD', 'description': 'TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG004', 'title': 'TN: 240mg QD', 'description': 'TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG005', 'title': 'Treatment Experienced (TE) Non-cirrhotic: 48 mg QD', 'description': 'TE patient non-cirrhotic to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG006', 'title': 'TE Non-cirrhotic: 120 mg QD', 'description': 'TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG007', 'title': 'TE Non-cirrhotic: 240 mg QD', 'description': 'TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG008', 'title': 'TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)', 'description': 'TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG009', 'title': 'TE Non-cirrhotic: 240 mg BID SGC', 'description': 'TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG010', 'title': 'TE With Cirrhosis: 240 mg QD SGC', 'description': 'TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG011', 'title': 'TE With Cirrhosis: 240 mg BID SGC', 'description': 'TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}], 'classes': [{'title': 'Action taken: decreasing dose', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}, {'value': '0.0', 'groupId': 'OG005'}, {'value': '0.0', 'groupId': 'OG006'}, {'value': '0.0', 'groupId': 'OG007'}, {'value': '0.0', 'groupId': 'OG008'}, {'value': '6.7', 'groupId': 'OG009'}, {'value': '16.7', 'groupId': 'OG010'}, {'value': '0.0', 'groupId': 'OG011'}]}]}, {'title': 'Action taken: stop trial medication', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}, {'value': '0.0', 'groupId': 'OG005'}, {'value': '0.0', 'groupId': 'OG006'}, {'value': '0.0', 'groupId': 'OG007'}, {'value': '0.0', 'groupId': 'OG008'}, {'value': '0.0', 'groupId': 'OG009'}, {'value': '0.0', 'groupId': 'OG010'}, {'value': '28.6', 'groupId': 'OG011'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'from day 1 and up to 4 weeks', 'description': 'Occurrence of AEs, by action taken with regard to study medication.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'TS'}, {'type': 'SECONDARY', 'title': 'Occurrence of Discontinuations Due to AEs During BI201335 or BI201335+PegIFN/RBV Combination Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '15', 'groupId': 'OG008'}, {'value': '15', 'groupId': 'OG009'}, {'value': '6', 'groupId': 'OG010'}, {'value': '7', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'TN: Placebo', 'description': 'TN patient to receive Placebo +/- PegIFN/RBV for 28 days'}, {'id': 'OG001', 'title': 'Treatment Naive(TN): 20mg QD', 'description': 'TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG002', 'title': 'TN: 48mg QD', 'description': 'TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG003', 'title': 'TN: 120mg QD', 'description': 'TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG004', 'title': 'TN: 240mg QD', 'description': 'TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG005', 'title': 'Treatment Experienced (TE) Non-cirrhotic: 48 mg QD', 'description': 'TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG006', 'title': 'TE Non-cirrhotic: 120 mg QD', 'description': 'TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG007', 'title': 'TE Non-cirrhotic: 240 mg QD', 'description': 'TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG008', 'title': 'TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)', 'description': 'TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG009', 'title': 'TE Non-cirrhotic: 240 mg BID SGC', 'description': 'TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG010', 'title': 'TE With Cirrhosis: 240 mg QD SGC', 'description': 'TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG011', 'title': 'TE With Cirrhosis: 240 mg BID SGC', 'description': 'TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}, {'value': '0.0', 'groupId': 'OG005'}, {'value': '0.0', 'groupId': 'OG006'}, {'value': '0.0', 'groupId': 'OG007'}, {'value': '0.0', 'groupId': 'OG008'}, {'value': '0.0', 'groupId': 'OG009'}, {'value': '0.0', 'groupId': 'OG010'}, {'value': '28.6', 'groupId': 'OG011'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'from day 1 and up to 4 weeks', 'description': 'Occurrence of discontinuations due to AEs during BI201335 or BI201335+PegIFN/RBV combination treatment period.', 'unitOfMeasure': 'percentage of participants discontinued', 'reportingStatus': 'POSTED', 'populationDescription': 'TS'}, {'type': 'SECONDARY', 'title': 'PK (Pharmacokinetic) Parameter After the First Dose: Cmax ( Maximum Measured Concentration of the Analyte in Plasma)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}, {'value': '15', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '7', 'groupId': 'OG010'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Naive(TN): 20mg QD', 'description': 'TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG001', 'title': 'TN: 48mg QD', 'description': 'TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG002', 'title': 'TN: 120mg QD', 'description': 'TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG003', 'title': 'TN: 240mg QD', 'description': 'TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG004', 'title': 'Treatment Experienced (TE) Non-cirrhotic: 48 mg QD', 'description': 'TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG005', 'title': 'TE Non-cirrhotic: 120 mg QD', 'description': 'TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG006', 'title': 'TE Non-cirrhotic: 240 mg QD', 'description': 'TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG007', 'title': 'TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)', 'description': 'TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG008', 'title': 'TE Non-cirrhotic: 240 mg BID SGC', 'description': 'TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG009', 'title': 'TE With Cirrhosis: 240 mg QD SGC', 'description': 'TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG010', 'title': 'TE With Cirrhosis: 240 mg BID SGC', 'description': 'TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}], 'classes': [{'categories': [{'measurements': [{'value': '45.3', 'spread': '53.9', 'groupId': 'OG000'}, {'value': '170', 'spread': '21.3', 'groupId': 'OG001'}, {'value': '964', 'spread': '66.1', 'groupId': 'OG002'}, {'value': '2910', 'spread': '51.6', 'groupId': 'OG003'}, {'value': '164', 'spread': '58.1', 'groupId': 'OG004'}, {'value': '954', 'spread': '30.5', 'groupId': 'OG005'}, {'value': '2360', 'spread': '48.3', 'groupId': 'OG006'}, {'value': '7220', 'spread': '48.8', 'groupId': 'OG007'}, {'value': '7110', 'spread': '86.8', 'groupId': 'OG008'}, {'value': '5970', 'spread': '162', 'groupId': 'OG009'}, {'value': '7660', 'spread': '68.1', 'groupId': 'OG010'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Times of -0:15, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, and 16:00 h relative to first administration of trial medication (on day 1)', 'description': 'PK (pharmacokinetic) parameter after the first dose: Cmax ( Maximum measured concentration of the analyte in plasma ).\n\n.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'TS'}, {'type': 'SECONDARY', 'title': 'PK Parameter After the First Dose: Tmax (Time From (Last) Dosing to the Maximum Measured Concentration of the Analyte in Plasma)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}, {'value': '15', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '7', 'groupId': 'OG010'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Naive(TN): 20mg QD', 'description': 'TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG001', 'title': 'TN: 48mg QD', 'description': 'TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG002', 'title': 'TN: 120mg QD', 'description': 'TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG003', 'title': 'TN: 240mg QD', 'description': 'TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG004', 'title': 'Treatment Experienced (TE) Non-cirrhotic: 48 mg QD', 'description': 'TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG005', 'title': 'TE Non-cirrhotic: 120 mg QD', 'description': 'TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG006', 'title': 'TE Non-cirrhotic: 240 mg QD', 'description': 'TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG007', 'title': 'TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)', 'description': 'TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG008', 'title': 'TE Non-cirrhotic: 240 mg BID SGC', 'description': 'TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG009', 'title': 'TE With Cirrhosis: 240 mg QD SGC', 'description': 'TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG010', 'title': 'TE With Cirrhosis: 240 mg BID SGC', 'description': 'TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}], 'classes': [{'categories': [{'measurements': [{'value': '7.07', 'spread': '29.0', 'groupId': 'OG000'}, {'value': '2.48', 'spread': '149', 'groupId': 'OG001'}, {'value': '2.12', 'spread': '56.6', 'groupId': 'OG002'}, {'value': '3.89', 'spread': '44.1', 'groupId': 'OG003'}, {'value': '3.89', 'spread': '162', 'groupId': 'OG004'}, {'value': '2.25', 'spread': '59.1', 'groupId': 'OG005'}, {'value': '3.23', 'spread': '27.9', 'groupId': 'OG006'}, {'value': '5.24', 'spread': '49.2', 'groupId': 'OG007'}, {'value': '5.30', 'spread': '34.6', 'groupId': 'OG008'}, {'value': '6.61', 'spread': '14.9', 'groupId': 'OG009'}, {'value': '5.63', 'spread': '87.4', 'groupId': 'OG010'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Times of -0:15, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, and 16:00 h relative to first administration of trial medication (on day 1)', 'description': 'PK parameter after the first dose: tmax (Time from (last) dosing to the maximum measured concentration of the analyte in plasma).', 'unitOfMeasure': 'h', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'TS'}, {'type': 'SECONDARY', 'title': 'PK Parameter After the First Dose: AUCτ,1 (Area Under the Concentration-time Curve of the Analyte in Plasma Over a Uniform Dosing Interval τ on Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}, {'value': '15', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '7', 'groupId': 'OG010'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Naive(TN): 20mg QD', 'description': 'TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG001', 'title': 'TN: 48mg QD', 'description': 'TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG002', 'title': 'TN: 120mg QD', 'description': 'TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG003', 'title': 'TN: 240mg QD', 'description': 'TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG004', 'title': 'Treatment Experienced (TE) Non-cirrhotic: 48 mg QD', 'description': 'TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG005', 'title': 'TE Non-cirrhotic: 120 mg QD', 'description': 'TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG006', 'title': 'TE Non-cirrhotic: 240 mg QD', 'description': 'TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG007', 'title': 'TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)', 'description': 'TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG008', 'title': 'TE Non-cirrhotic: 240 mg BID SGC', 'description': 'TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG009', 'title': 'TE With Cirrhosis: 240 mg QD SGC', 'description': 'TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG010', 'title': 'TE With Cirrhosis: 240 mg BID SGC', 'description': 'TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}], 'classes': [{'categories': [{'measurements': [{'value': '736', 'spread': '57.0', 'groupId': 'OG000'}, {'value': '2650', 'spread': '16.5', 'groupId': 'OG001'}, {'value': '11600', 'spread': '52.9', 'groupId': 'OG002'}, {'value': '35700', 'spread': '48.2', 'groupId': 'OG003'}, {'value': '2550', 'spread': '48.3', 'groupId': 'OG004'}, {'value': '12300', 'spread': '47.5', 'groupId': 'OG005'}, {'value': '27700', 'spread': '59.9', 'groupId': 'OG006'}, {'value': '108000', 'spread': '55.5', 'groupId': 'OG007'}, {'value': '52800', 'spread': '82.6', 'groupId': 'OG008'}, {'value': '78400', 'spread': '157', 'groupId': 'OG009'}, {'value': '56800', 'spread': '55.7', 'groupId': 'OG010'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Times of -0:15, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, and 16:00 h relative to first administration of trial medication (on day 1)', 'description': 'PK parameter after the first dose: AUCτ,1 (Area under the concentration-time curve of the analyte in plasma over a uniform dosing interval τ on day 1).', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'TS'}, {'type': 'SECONDARY', 'title': 'PK Parameter at Steady State After the Last Dose: Cmax,ss (Maximum Measured Concentration of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval τ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}, {'value': '15', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '5', 'groupId': 'OG010'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Naive(TN): 20mg QD', 'description': 'TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG001', 'title': 'TN: 48mg QD', 'description': 'TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG002', 'title': 'TN: 120mg QD', 'description': 'TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG003', 'title': 'TN: 240mg QD', 'description': 'TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG004', 'title': 'Treatment Experienced (TE) Non-cirrhotic: 48 mg QD', 'description': 'TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG005', 'title': 'TE Non-cirrhotic: 120 mg QD', 'description': 'TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG006', 'title': 'TE Non-cirrhotic: 240 mg QD', 'description': 'TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG007', 'title': 'TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)', 'description': 'TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG008', 'title': 'TE Non-cirrhotic: 240 mg BID SGC', 'description': 'TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG009', 'title': 'TE With Cirrhosis: 240 mg QD SGC', 'description': 'TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG010', 'title': 'TE With Cirrhosis: 240 mg BID SGC', 'description': 'TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}], 'classes': [{'categories': [{'measurements': [{'value': '150', 'spread': '52.1', 'groupId': 'OG000'}, {'value': '616', 'spread': '62.4', 'groupId': 'OG001'}, {'value': '4050', 'spread': '43.3', 'groupId': 'OG002'}, {'value': '15400', 'spread': '40.4', 'groupId': 'OG003'}, {'value': '478', 'spread': '19.3', 'groupId': 'OG004'}, {'value': '4170', 'spread': '71.7', 'groupId': 'OG005'}, {'value': '15400', 'spread': '59.8', 'groupId': 'OG006'}, {'value': '17700', 'spread': '81.7', 'groupId': 'OG007'}, {'value': '32200', 'spread': '74.1', 'groupId': 'OG008'}, {'value': '16400', 'spread': '98.3', 'groupId': 'OG009'}, {'value': '60400', 'spread': '55.8', 'groupId': 'OG010'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to last administration of trial medication (on day 28)', 'description': 'PK parameter at steady state after the last dose: Cmax,ss (Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ).', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'TS including patients with available Cmax,ss data'}, {'type': 'SECONDARY', 'title': 'PK Parameter at Steady State After the Last Dose: Tmax,ss (Time From Last Dosing to the Maximum Measured Concentration of the Analyte in Plasma at Steady State )', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}, {'value': '15', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '5', 'groupId': 'OG010'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Naive(TN): 20mg QD', 'description': 'TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG001', 'title': 'TN: 48mg QD', 'description': 'TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG002', 'title': 'TN: 120mg QD', 'description': 'TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG003', 'title': 'TN: 240mg QD', 'description': 'TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG004', 'title': 'Treatment Experienced (TE) Non-cirrhotic: 48 mg QD', 'description': 'TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG005', 'title': 'TE Non-cirrhotic: 120 mg QD', 'description': 'TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG006', 'title': 'TE Non-cirrhotic: 240 mg QD', 'description': 'TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG007', 'title': 'TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)', 'description': 'TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG008', 'title': 'TE Non-cirrhotic: 240 mg BID SGC', 'description': 'TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG009', 'title': 'TE With Cirrhosis: 240 mg QD SGC', 'description': 'TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG010', 'title': 'TE With Cirrhosis: 240 mg BID SGC', 'description': 'TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}], 'classes': [{'categories': [{'measurements': [{'value': '4.89', 'spread': '52.0', 'groupId': 'OG000'}, {'value': '3.38', 'spread': '109', 'groupId': 'OG001'}, {'value': '2.75', 'spread': '27.6', 'groupId': 'OG002'}, {'value': '3.36', 'spread': '67.5', 'groupId': 'OG003'}, {'value': '2.15', 'spread': '45.5', 'groupId': 'OG004'}, {'value': '1.94', 'spread': '33.6', 'groupId': 'OG005'}, {'value': '1.99', 'spread': '46.7', 'groupId': 'OG006'}, {'value': '3.23', 'spread': '59.3', 'groupId': 'OG007'}, {'value': '14.6', 'spread': '14.1', 'groupId': 'OG008'}, {'value': '4.12', 'spread': '53.1', 'groupId': 'OG009'}, {'value': '17.4', 'spread': '18.2', 'groupId': 'OG010'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to last administration of trial medication (on day 28)', 'description': 'PK parameter at steady state after the last dose: tmax,ss (Time from last dosing to the maximum measured concentration of the analyte in plasma at steady state ).', 'unitOfMeasure': 'h', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'TS including patients with available tmax,ss data'}, {'type': 'SECONDARY', 'title': 'PK Parameter at Steady State After the Last Dose: Cmin,ss (Minimum Measured Concentration of the Analyte in Plasma)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}, {'value': '15', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '5', 'groupId': 'OG010'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Naive(TN): 20mg QD', 'description': 'TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG001', 'title': 'TN: 48mg QD', 'description': 'TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG002', 'title': 'TN: 120mg QD', 'description': 'TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG003', 'title': 'TN: 240mg QD', 'description': 'TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG004', 'title': 'Treatment Experienced (TE) Non-cirrhotic: 48 mg QD', 'description': 'TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG005', 'title': 'TE Non-cirrhotic: 120 mg QD', 'description': 'TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG006', 'title': 'TE Non-cirrhotic: 240 mg QD', 'description': 'TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG007', 'title': 'TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)', 'description': 'TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG008', 'title': 'TE Non-cirrhotic: 240 mg BID SGC', 'description': 'TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG009', 'title': 'TE With Cirrhosis: 240 mg QD SGC', 'description': 'TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG010', 'title': 'TE With Cirrhosis: 240 mg BID SGC', 'description': 'TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}], 'classes': [{'categories': [{'measurements': [{'value': '68.0', 'spread': '52.4', 'groupId': 'OG000'}, {'value': '199', 'spread': '64.0', 'groupId': 'OG001'}, {'value': '1120', 'spread': '42.5', 'groupId': 'OG002'}, {'value': '4040', 'spread': '23.3', 'groupId': 'OG003'}, {'value': '147', 'spread': '43.6', 'groupId': 'OG004'}, {'value': '863', 'spread': '88.3', 'groupId': 'OG005'}, {'value': '3640', 'spread': '105', 'groupId': 'OG006'}, {'value': '4970', 'spread': '124', 'groupId': 'OG007'}, {'value': '25500', 'spread': '80.4', 'groupId': 'OG008'}, {'value': '5870', 'spread': '94.0', 'groupId': 'OG009'}, {'value': '45400', 'spread': '43.1', 'groupId': 'OG010'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to last administration of trial medication (on day 28)', 'description': 'PK parameter at steady state after the last dose: Cmin,ss (Minimum measured concentration of the analyte in plasma).', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'TS including patients with available Cmin,ss data'}, {'type': 'SECONDARY', 'title': 'PK Parameter at Steady State After the Last Dose: AUCτ,ss (Area Under the Concentration-time Curve of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval τ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}, {'value': '15', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '5', 'groupId': 'OG010'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Naive(TN): 20mg QD', 'description': 'TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG001', 'title': 'TN: 48mg QD', 'description': 'TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG002', 'title': 'TN: 120mg QD', 'description': 'TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG003', 'title': 'TN: 240mg QD', 'description': 'TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG004', 'title': 'Treatment Experienced (TE) Non-cirrhotic: 48 mg QD', 'description': 'TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG005', 'title': 'TE Non-cirrhotic: 120 mg QD', 'description': 'TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG006', 'title': 'TE Non-cirrhotic: 240 mg QD', 'description': 'TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG007', 'title': 'TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)', 'description': 'TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG008', 'title': 'TE Non-cirrhotic: 240 mg BID SGC', 'description': 'TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG009', 'title': 'TE With Cirrhosis: 240 mg QD SGC', 'description': 'TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG010', 'title': 'TE With Cirrhosis: 240 mg BID SGC', 'description': 'TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}], 'classes': [{'categories': [{'measurements': [{'value': '2460', 'spread': '53.9', 'groupId': 'OG000'}, {'value': '8520', 'spread': '55.6', 'groupId': 'OG001'}, {'value': '49400', 'spread': '42.8', 'groupId': 'OG002'}, {'value': '185000', 'spread': '21.1', 'groupId': 'OG003'}, {'value': '6820', 'spread': '22.1', 'groupId': 'OG004'}, {'value': '43400', 'spread': '75.9', 'groupId': 'OG005'}, {'value': '164000', 'spread': '83.8', 'groupId': 'OG006'}, {'value': '221000', 'spread': '82.2', 'groupId': 'OG007'}, {'value': '350000', 'spread': '75.6', 'groupId': 'OG008'}, {'value': '243000', 'spread': '75.8', 'groupId': 'OG009'}, {'value': '642000', 'spread': '46.1', 'groupId': 'OG010'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to last administration of trial medication (on day 28)', 'description': 'PK parameter at steady state after the last dose: AUCτ,ss ((Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ).', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'TS including patients with available AUCτ,ss data'}, {'type': 'SECONDARY', 'title': 'PK Parameter at Steady State After the Last Dose: t1/2,ss (Terminal Half-life of the Analyte in Plasma at Steady State )', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}, {'value': '15', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '5', 'groupId': 'OG010'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Naive(TN): 20mg QD', 'description': 'TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG001', 'title': 'TN: 48mg QD', 'description': 'TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG002', 'title': 'TN: 120mg QD', 'description': 'TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG003', 'title': 'TN: 240mg QD', 'description': 'TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG004', 'title': 'Treatment Experienced (TE) Non-cirrhotic: 48 mg QD', 'description': 'TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG005', 'title': 'TE Non-cirrhotic: 120 mg QD', 'description': 'TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG006', 'title': 'TE Non-cirrhotic: 240 mg QD', 'description': 'TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG007', 'title': 'TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)', 'description': 'TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG008', 'title': 'TE Non-cirrhotic: 240 mg BID SGC', 'description': 'TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG009', 'title': 'TE With Cirrhosis: 240 mg QD SGC', 'description': 'TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG010', 'title': 'TE With Cirrhosis: 240 mg BID SGC', 'description': 'TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}], 'classes': [{'categories': [{'measurements': [{'value': '30.5', 'spread': '17.0', 'groupId': 'OG000'}, {'value': '38.8', 'spread': '41.2', 'groupId': 'OG001'}, {'value': '25.5', 'spread': '25.5', 'groupId': 'OG002'}, {'value': '19.3', 'spread': '12.4', 'groupId': 'OG003'}, {'value': '33.2', 'spread': '8.58', 'groupId': 'OG004'}, {'value': '22.5', 'spread': '17.4', 'groupId': 'OG005'}, {'value': '22.1', 'spread': '27.3', 'groupId': 'OG006'}, {'value': '19.9', 'spread': '25.0', 'groupId': 'OG007'}, {'value': '27.3', 'spread': '61.5', 'groupId': 'OG008'}, {'value': '22.7', 'spread': '33.0', 'groupId': 'OG009'}, {'value': '41.5', 'spread': '63.4', 'groupId': 'OG010'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to last administration of trial medication (on day 28)', 'description': 'PK parameter at steady state after the last dose: t1/2,ss (Terminal half-life of the analyte in plasma at steady state \\[h\\] )', 'unitOfMeasure': 'h', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'TS including patients with available t1/2,ss data'}, {'type': 'SECONDARY', 'title': 'PK Parameter at Steady State After the Last Dose: MRTpo,ss (Mean Residence Time of the Analyte in the Body at Steady State After Oral Administration)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}, {'value': '15', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '5', 'groupId': 'OG010'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Naive(TN): 20mg QD', 'description': 'TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG001', 'title': 'TN: 48mg QD', 'description': 'TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG002', 'title': 'TN: 120mg QD', 'description': 'TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG003', 'title': 'TN: 240mg QD', 'description': 'TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG004', 'title': 'Treatment Experienced (TE) Non-cirrhotic: 48 mg QD', 'description': 'TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG005', 'title': 'TE Non-cirrhotic: 120 mg QD', 'description': 'TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG006', 'title': 'TE Non-cirrhotic: 240 mg QD', 'description': 'TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG007', 'title': 'TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)', 'description': 'TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG008', 'title': 'TE Non-cirrhotic: 240 mg BID SGC', 'description': 'TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG009', 'title': 'TE With Cirrhosis: 240 mg QD SGC', 'description': 'TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG010', 'title': 'TE With Cirrhosis: 240 mg BID SGC', 'description': 'TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}], 'classes': [{'categories': [{'measurements': [{'value': '44.4', 'spread': '17.0', 'groupId': 'OG000'}, {'value': '60.2', 'spread': '61.9', 'groupId': 'OG001'}, {'value': '33.3', 'spread': '23.5', 'groupId': 'OG002'}, {'value': '26.7', 'spread': '19.3', 'groupId': 'OG003'}, {'value': '39.7', 'spread': '14.0', 'groupId': 'OG004'}, {'value': '26.6', 'spread': '22.0', 'groupId': 'OG005'}, {'value': '27.2', 'spread': '37.4', 'groupId': 'OG006'}, {'value': '30.7', 'spread': '32.5', 'groupId': 'OG007'}, {'value': '50.5', 'spread': '59.9', 'groupId': 'OG008'}, {'value': '34.2', 'spread': '34.9', 'groupId': 'OG009'}, {'value': '82.0', 'spread': '71.6', 'groupId': 'OG010'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to last administration of trial medication (on day 28)', 'description': 'PK parameter at steady state after the last dose: MRTpo,ss (Mean residence time of the analyte in the body at steady state after oral administration \\[h\\] )', 'unitOfMeasure': 'h', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'TS including patients with available MRTpo,ss data'}, {'type': 'SECONDARY', 'title': 'PK Parameter at Steady State After the Last Dose: CL/F,ss (Apparent Clearance of the Analyte in Plasma at Steady State Following Multiple Oral Dose Administration )', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}, {'value': '15', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '5', 'groupId': 'OG010'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Naive(TN): 20mg QD', 'description': 'TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG001', 'title': 'TN: 48mg QD', 'description': 'TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG002', 'title': 'TN: 120mg QD', 'description': 'TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG003', 'title': 'TN: 240mg QD', 'description': 'TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG004', 'title': 'Treatment Experienced (TE) Non-cirrhotic: 48 mg QD', 'description': 'TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG005', 'title': 'TE Non-cirrhotic: 120 mg QD', 'description': 'TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG006', 'title': 'TE Non-cirrhotic: 240 mg QD', 'description': 'TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG007', 'title': 'TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)', 'description': 'TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG008', 'title': 'TE Non-cirrhotic: 240 mg BID SGC', 'description': 'TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG009', 'title': 'TE With Cirrhosis: 240 mg QD SGC', 'description': 'TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG010', 'title': 'TE With Cirrhosis: 240 mg BID SGC', 'description': 'TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}], 'classes': [{'categories': [{'measurements': [{'value': '136', 'spread': '53.9', 'groupId': 'OG000'}, {'value': '93.9', 'spread': '55.6', 'groupId': 'OG001'}, {'value': '40.4', 'spread': '42.8', 'groupId': 'OG002'}, {'value': '21.6', 'spread': '21.1', 'groupId': 'OG003'}, {'value': '117', 'spread': '22.1', 'groupId': 'OG004'}, {'value': '46.1', 'spread': '75.9', 'groupId': 'OG005'}, {'value': '24.4', 'spread': '83.8', 'groupId': 'OG006'}, {'value': '18.1', 'spread': '82.2', 'groupId': 'OG007'}, {'value': '11.4', 'spread': '75.6', 'groupId': 'OG008'}, {'value': '16.4', 'spread': '75.8', 'groupId': 'OG009'}, {'value': '6.23', 'spread': '46.1', 'groupId': 'OG010'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to last administration of trial medication (on day 28)', 'description': 'PK parameter at steady state after the last dose (if applicable): CL/F,ss (ss Apparent clearance of the analyte in plasma at steady state following multiple oral dose administration \\[mL/min\\] )', 'unitOfMeasure': 'mL/min', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'TS including patients with available CL/F,ss data'}, {'type': 'SECONDARY', 'title': 'PK Parameter at Steady State After the Last Dose: Vz/F,ss (Apparent Volume of Distribution During the Terminal Phase z at Steady State Following an Oral Administration )', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}, {'value': '15', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '5', 'groupId': 'OG010'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Naive(TN): 20mg QD', 'description': 'TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG001', 'title': 'TN: 48mg QD', 'description': 'TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG002', 'title': 'TN: 120mg QD', 'description': 'TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG003', 'title': 'TN: 240mg QD', 'description': 'TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG004', 'title': 'Treatment Experienced (TE) Non-cirrhotic: 48 mg QD', 'description': 'TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG005', 'title': 'TE Non-cirrhotic: 120 mg QD', 'description': 'TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG006', 'title': 'TE Non-cirrhotic: 240 mg QD', 'description': 'TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG007', 'title': 'TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)', 'description': 'TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG008', 'title': 'TE Non-cirrhotic: 240 mg BID SGC', 'description': 'TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG009', 'title': 'TE With Cirrhosis: 240 mg QD SGC', 'description': 'TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG010', 'title': 'TE With Cirrhosis: 240 mg BID SGC', 'description': 'TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}], 'classes': [{'categories': [{'measurements': [{'value': '358', 'spread': '46.7', 'groupId': 'OG000'}, {'value': '315', 'spread': '69.0', 'groupId': 'OG001'}, {'value': '89.4', 'spread': '34.1', 'groupId': 'OG002'}, {'value': '36.1', 'spread': '17.9', 'groupId': 'OG003'}, {'value': '337', 'spread': '26.7', 'groupId': 'OG004'}, {'value': '89.9', 'spread': '80.4', 'groupId': 'OG005'}, {'value': '46.7', 'spread': '65.3', 'groupId': 'OG006'}, {'value': '31.0', 'spread': '67.4', 'groupId': 'OG007'}, {'value': '27.0', 'spread': '54.4', 'groupId': 'OG008'}, {'value': '32.3', 'spread': '40.0', 'groupId': 'OG009'}, {'value': '22.4', 'spread': '27.1', 'groupId': 'OG010'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to last administration of trial medication (on day 28)', 'description': 'PK parameter at steady state after the last dose: Vz/F,ss (Apparent volume of distribution during the terminal phase z at steady state following an oral administration \\[L\\] )', 'unitOfMeasure': 'L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'TS including patients with available Vz/F,ss data'}, {'type': 'SECONDARY', 'title': 'PK Parameter for Drug-drug Interaction (naïve Patients With ≥1 Log Reduction on Day 10): AUCτ,ss (Area Under the Concentration-time Curve of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval τ )', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Naive(TN): 20mg QD', 'description': 'TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG001', 'title': 'TN: 48mg QD', 'description': 'TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG002', 'title': 'TN: 120mg QD', 'description': 'TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG003', 'title': 'TN: 240mg QD', 'description': 'TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days'}], 'classes': [{'categories': [{'measurements': [{'value': '1970', 'spread': '46.5', 'groupId': 'OG000'}, {'value': '8740', 'spread': '52.1', 'groupId': 'OG001'}, {'value': '45800', 'spread': '85.4', 'groupId': 'OG002'}, {'value': '180000', 'spread': '42.0', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to administration of trial medication in the morning of Day 14 (on day 14)', 'description': 'PK parameter for drug-drug interaction (naïve patients with ≥1 log reduction on Day 10): AUCτ,ss ( Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ ).', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'TS (for TN patients only)'}, {'type': 'SECONDARY', 'title': 'PK Parameter for Drug-drug Interaction (naïve Patients With ≥1 Log Reduction on Day 10): Cmax,ss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Naive(TN): 20mg QD', 'description': 'TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG001', 'title': 'TN: 48mg QD', 'description': 'TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG002', 'title': 'TN: 120mg QD', 'description': 'TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG003', 'title': 'TN: 240mg QD', 'description': 'TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days'}], 'classes': [{'categories': [{'measurements': [{'value': '106', 'spread': '47.5', 'groupId': 'OG000'}, {'value': '693', 'spread': '61.1', 'groupId': 'OG001'}, {'value': '3880', 'spread': '82.8', 'groupId': 'OG002'}, {'value': '13100', 'spread': '38.2', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to administration of trial medication in the morning of Day 14 (on day 14)', 'description': 'PK parameter for drug-drug interaction (naïve patients with ≥1 log reduction on Day 10): Cmax,ss.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'TS (for TN patients only)'}, {'type': 'SECONDARY', 'title': 'PK Parameter for Drug-drug Interaction (naïve Patients With ≥1 Log Reduction on Day 10): Cmin, ss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Naive(TN): 20mg QD', 'description': 'TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG001', 'title': 'TN: 48mg QD', 'description': 'TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG002', 'title': 'TN: 120mg QD', 'description': 'TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG003', 'title': 'TN: 240mg QD', 'description': 'TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days'}], 'classes': [{'categories': [{'measurements': [{'value': '57.8', 'spread': '46.2', 'groupId': 'OG000'}, {'value': '185', 'spread': '64.8', 'groupId': 'OG001'}, {'value': '1010', 'spread': '97.9', 'groupId': 'OG002'}, {'value': '4320', 'spread': '42.3', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to administration of trial medication in the morning of Day 14 (on day 14)', 'description': 'PK parameter for drug-drug interaction (naïve patients with ≥1 log reduction on Day 10): Cmin, ss.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'TS (for TN patients only)'}, {'type': 'SECONDARY', 'title': 'Accumulation Ratio of the Analyte in Plasma Following Multiple Doses Over a Uniform Dosing Interval: RAcmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}, {'value': '15', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '5', 'groupId': 'OG010'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Naive(TN): 20mg Per Day (QD)', 'description': 'TN patient to receive 20mg QD solution Faldaprevir (BI201335) qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG001', 'title': 'TN: 48mg QD', 'description': 'TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG002', 'title': 'TN: 120mg QD', 'description': 'TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG003', 'title': 'TN: 240mg QD', 'description': 'TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG004', 'title': 'Treatment Experienced (TE) Non-cirrhotic: 48 mg QD', 'description': 'TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG005', 'title': 'TE Non-cirrhotic: 120 mg QD', 'description': 'TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG006', 'title': 'TE Non-cirrhotic: 240 mg QD', 'description': 'TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG007', 'title': 'TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)', 'description': 'TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG008', 'title': 'TE Non-cirrhotic: 240 mg BID SGC', 'description': 'TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG009', 'title': 'TE With Cirrhosis: 240 mg QD SGC', 'description': 'TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG010', 'title': 'TE With Cirrhosis: 240 mg BID SGC', 'description': 'TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}], 'classes': [{'categories': [{'measurements': [{'value': '2.34', 'spread': '29.1', 'groupId': 'OG000'}, {'value': '4.08', 'spread': '66.6', 'groupId': 'OG001'}, {'value': '3.74', 'spread': '32.5', 'groupId': 'OG002'}, {'value': '4.49', 'spread': '36.2', 'groupId': 'OG003'}, {'value': '2.91', 'spread': '58.7', 'groupId': 'OG004'}, {'value': '4.37', 'spread': '50.6', 'groupId': 'OG005'}, {'value': '6.53', 'spread': '75.7', 'groupId': 'OG006'}, {'value': '2.45', 'spread': '89.4', 'groupId': 'OG007'}, {'value': '4.53', 'spread': '96.0', 'groupId': 'OG008'}, {'value': '2.74', 'spread': '90.5', 'groupId': 'OG009'}, {'value': '6.81', 'spread': '154', 'groupId': 'OG010'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1, Day 14, and Day 28', 'description': 'For TN patients, comparing exposure on Day 14 to the first dose on Day 1; for TE patients, comparing exposure on Day 28 to the first dose on Day 1.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'TS including patients with available RAcmax data'}, {'type': 'SECONDARY', 'title': 'Accumulation Ratio of the Analyte in Plasma Following Multiple Doses Over a Uniform Dosing Interval: RAauc', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}, {'value': '15', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '5', 'groupId': 'OG010'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Naive(TN): 20mg Per Day (QD)', 'description': 'TN patient to receive 20mg QD solution Faldaprevir (BI201335) qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG001', 'title': 'TN: 48mg QD', 'description': 'TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG002', 'title': 'TN: 120mg QD', 'description': 'TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG003', 'title': 'TN: 240mg QD', 'description': 'TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG004', 'title': 'Treatment Experienced (TE) Non-cirrhotic: 48 mg QD', 'description': 'TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG005', 'title': 'TE Non-cirrhotic: 120 mg QD', 'description': 'TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG006', 'title': 'TE Non-cirrhotic: 240 mg QD', 'description': 'TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG007', 'title': 'TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)', 'description': 'TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG008', 'title': 'TE Non-cirrhotic: 240 mg BID SGC', 'description': 'TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG009', 'title': 'TE With Cirrhosis: 240 mg QD SGC', 'description': 'TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'OG010', 'title': 'TE With Cirrhosis: 240 mg BID SGC', 'description': 'TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}], 'classes': [{'categories': [{'measurements': [{'value': '2.68', 'spread': '19.6', 'groupId': 'OG000'}, {'value': '3.30', 'spread': '49.9', 'groupId': 'OG001'}, {'value': '3.61', 'spread': '42.0', 'groupId': 'OG002'}, {'value': '5.03', 'spread': '45.3', 'groupId': 'OG003'}, {'value': '2.68', 'spread': '36.2', 'groupId': 'OG004'}, {'value': '3.52', 'spread': '34.0', 'groupId': 'OG005'}, {'value': '5.90', 'spread': '56.6', 'groupId': 'OG006'}, {'value': '2.05', 'spread': '88.8', 'groupId': 'OG007'}, {'value': '6.62', 'spread': '88.8', 'groupId': 'OG008'}, {'value': '3.11', 'spread': '96.6', 'groupId': 'OG009'}, {'value': '10.0', 'spread': '111', 'groupId': 'OG010'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1, Day 14, and Day 28', 'description': 'For TN patients, comparing exposure on Day 14 to the first dose on Day 1; for TE patients, comparing exposure on Day 28 to the first dose on Day 1.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'TS including patients with available RAauc data'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment Naive (TN): Placebo', 'description': 'TN patient to receive Placebo +/- Pegylated interferon alpha-2a solution for injection/Ribavirin tablet (PegIFN/RBV) for 28 days'}, {'id': 'FG001', 'title': 'Treatment Naive(TN): 20mg Per Day (QD)', 'description': 'TN patient to receive 20mg QD solution Faldaprevir (BI201335) qd +/- PegIFN/RBV for 28 days'}, {'id': 'FG002', 'title': 'TN: 48mg QD', 'description': 'TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'FG003', 'title': 'TN: 120mg QD', 'description': 'TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'FG004', 'title': 'TN: 240mg QD', 'description': 'TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'FG005', 'title': 'Treatment Experienced (TE) Non-cirrhotic: 48 mg QD', 'description': 'TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'FG006', 'title': 'TE Non-cirrhotic: 120 mg QD', 'description': 'TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'FG007', 'title': 'TE Non-cirrhotic: 240 mg QD', 'description': 'TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'FG008', 'title': 'TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)', 'description': 'TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'FG009', 'title': 'TE Non-cirrhotic: 240 mg Twice a Day (BID) SGC', 'description': 'TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'FG010', 'title': 'TE With Cirrhosis: 240 mg QD SGC', 'description': 'TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'FG011', 'title': 'TE With Cirrhosis: 240 mg BID SGC', 'description': 'TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '6'}, {'groupId': 'FG006', 'numSubjects': '7'}, {'groupId': 'FG007', 'numSubjects': '6'}, {'groupId': 'FG008', 'numSubjects': '15'}, {'groupId': 'FG009', 'numSubjects': '15'}, {'groupId': 'FG010', 'numSubjects': '6'}, {'groupId': 'FG011', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '4'}, {'groupId': 'FG006', 'numSubjects': '3'}, {'groupId': 'FG007', 'numSubjects': '6'}, {'groupId': 'FG008', 'numSubjects': '6'}, {'groupId': 'FG009', 'numSubjects': '6'}, {'groupId': 'FG010', 'numSubjects': '3'}, {'groupId': 'FG011', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '4'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '9'}, {'groupId': 'FG009', 'numSubjects': '9'}, {'groupId': 'FG010', 'numSubjects': '3'}, {'groupId': 'FG011', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '3'}, {'groupId': 'FG010', 'numSubjects': '1'}, {'groupId': 'FG011', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}, {'type': 'reason not specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '7'}, {'groupId': 'FG009', 'numSubjects': '6'}, {'groupId': 'FG010', 'numSubjects': '2'}, {'groupId': 'FG011', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '7', 'groupId': 'BG006'}, {'value': '6', 'groupId': 'BG007'}, {'value': '15', 'groupId': 'BG008'}, {'value': '15', 'groupId': 'BG009'}, {'value': '6', 'groupId': 'BG010'}, {'value': '7', 'groupId': 'BG011'}, {'value': '96', 'groupId': 'BG012'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment Naive (TN): Placebo', 'description': 'TN patient to receive Placebo + PegIFN/RBV for 28 days'}, {'id': 'BG001', 'title': 'TN: 20mg QD', 'description': 'TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'BG002', 'title': 'TN: 48mg QD', 'description': 'TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'BG003', 'title': 'TN: 120mg QD', 'description': 'TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'BG004', 'title': 'TN: 240mg QD', 'description': 'TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'BG005', 'title': 'Treatment Experienced (TE) Non-cirrhotic: 48 mg QD', 'description': 'TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'BG006', 'title': 'TE Non-cirrhotic: 120 mg QD', 'description': 'TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'BG007', 'title': 'TE Non-cirrhotic: 240 mg QD', 'description': 'TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'BG008', 'title': 'TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)', 'description': 'TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'BG009', 'title': 'TE Non-cirrhotic: 240 mg BID SGC', 'description': 'TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'BG010', 'title': 'TE With Cirrhosis: 240 mg QD SGC', 'description': 'TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'BG011', 'title': 'TE With Cirrhosis: 240 mg BID SGC', 'description': 'TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days'}, {'id': 'BG012', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '49.88', 'spread': '8.36', 'groupId': 'BG000'}, {'value': '51.00', 'spread': '7.97', 'groupId': 'BG001'}, {'value': '47.14', 'spread': '13.84', 'groupId': 'BG002'}, {'value': '48.57', 'spread': '16.31', 'groupId': 'BG003'}, {'value': '47.83', 'spread': '9.26', 'groupId': 'BG004'}, {'value': '46.83', 'spread': '11.82', 'groupId': 'BG005'}, {'value': '46.71', 'spread': '4.79', 'groupId': 'BG006'}, {'value': '49.33', 'spread': '10.11', 'groupId': 'BG007'}, {'value': '50.93', 'spread': '8.13', 'groupId': 'BG008'}, {'value': '48.93', 'spread': '13.10', 'groupId': 'BG009'}, {'value': '53.67', 'spread': '5.32', 'groupId': 'BG010'}, {'value': '53.57', 'spread': '8.36', 'groupId': 'BG011'}, {'value': '49.59', 'spread': '10.08', 'groupId': 'BG012'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '5', 'groupId': 'BG008'}, {'value': '7', 'groupId': 'BG009'}, {'value': '1', 'groupId': 'BG010'}, {'value': '2', 'groupId': 'BG011'}, {'value': '30', 'groupId': 'BG012'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '10', 'groupId': 'BG008'}, {'value': '8', 'groupId': 'BG009'}, {'value': '5', 'groupId': 'BG010'}, {'value': '5', 'groupId': 'BG011'}, {'value': '66', 'groupId': 'BG012'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Full Analysis Set (FAS): All randomized patients who were dispensed trial medication and were documented to have taken at least 1 dose of trial medication.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 96}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2011-01-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-07', 'studyFirstSubmitDate': '2008-09-23', 'resultsFirstSubmitDate': '2015-07-03', 'studyFirstSubmitQcDate': '2008-11-18', 'lastUpdatePostDateStruct': {'date': '2018-09-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-08-18', 'studyFirstPostDateStruct': {'date': '2008-11-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-09-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy: VR (Virologic Response) of >=2 log10 Reduction in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) From Baseline at Any Time up to Day 14 (naïve Patients) or Day 28 (Experienced Patients)', 'timeFrame': 'Baseline and up to 4 weeks', 'description': 'Efficacy endpoint: VR (virologic response) of \\>=2 log10 reduction in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) from baseline at any time up to Day 14 (naïve patients) or Day 28 (experienced patients).'}, {'measure': 'Occurrence of Adverse Events (AEs) During BI201335 + Washout Period', 'timeFrame': 'from day 1 and up to 4 weeks + 4 days washout', 'description': 'Occurrence of Adverse Events (AEs) during BI201335 + washout period. For placebo patients include all AEs through 30 days after trial discontinuation.'}, {'measure': 'Occurrence of Serious Adverse Events (SAEs) During BI201335 + Washout Period', 'timeFrame': 'from day 1 and up to 4 weeks + 4 days washout', 'description': 'Occurrence of Serious Adverse Events (SAEs)during BI201335 or BI201335+ washout period. For placebo patients include all SAEs through 30 days after trial discontinuation.'}, {'measure': 'Occurrence of Laboratory Test Abnormalities and With Respect to Division of AIDS (DAIDS) Classification and Laboratory Test Values Change Over Time', 'timeFrame': 'Baseline and up to 4 weeks', 'description': 'Occurrence of laboratory test abnormalities and with respect to Division of AIDS (DAIDS) classification and laboratory test values change over time.\n\nALT=Alanine transaminase (SGPT), AST=Aspartate transaminase (SGOT).'}], 'secondaryOutcomes': [{'measure': 'Maximum Viral Load Reduction From Baseline up to Day 14 for Treatment-naïve Patients and Day 28 Treatment for Treatment-experienced Patients', 'timeFrame': 'Baseline and up to 4 weeks', 'description': 'Maximum viral load reduction from baseline up to Day 14 for treatment-naïve patients and Day 28 treatment for treatment-experienced patients.'}, {'measure': 'Change From Baseline in Viral Load on Day 14 for Treatment-naïve Patients and on Day 28 Treatment for Treatment-experienced Patients', 'timeFrame': 'Baseline and up to 4 weeks', 'description': 'Change from baseline in viral load on Day 14 for treatment-naïve patients and on Day 28 treatment for treatment-experienced patients.'}, {'measure': 'Rapid Virologic Response (RVR)', 'timeFrame': 'week 4', 'description': 'Rapid virologic response (RVR): Plasma HCV RNA level below the limit of detection of the Roche COBAS Taqman HCV/HPS assay (10 IU/mL) on Day 28 for all patients.'}, {'measure': 'Early Virologic Response (EVR)', 'timeFrame': 'week 12', 'description': 'Early Virologic Response (EVR): \\>=2 log10 reduction in plasma HCV RNA level from baseline at week 12 (day 84)'}, {'measure': 'Complete EVR1 (cEVR1)', 'timeFrame': 'week 4 and week 12', 'description': 'VL (Viral load) below the limit of quantification of the Roche COBAS Taqman HCV/HPS assay (25 IU/mL) at 4 weeks and below the limit of detection of the Roche COBAS Taqman HCV/HPS assay (10 IU/mL) at 12 weeks'}, {'measure': 'Complete EVR2 (cEVR2)', 'timeFrame': 'week 4 and week 12', 'description': 'VL below the limit of detection at both 4 weeks and 12 weeks'}, {'measure': 'End of Treatment Response (ETR)', 'timeFrame': 'week 48', 'description': 'End of Treatment Response (ETR): Plasma HCV RNA level below the limit of detection of the Roche COBAS Taqman HCV/HPS assay (10 IU/mL) at week 48 (Day 336).'}, {'measure': 'Sustained Virologic Response (SVR)', 'timeFrame': 'week 72', 'description': 'Sustained Virologic Response (SVR): Plasma HCV RNA level below the limit of detection of the Roche COBAS Taqman HCV/HPS assay (10 IU/mL) at week 72 (Day 504).'}, {'measure': 'Achievement of an HCV RNA Level Below the Limit of Detection Over Time', 'timeFrame': 'from day 1 and up to 4 weeks', 'description': 'Achievement of an HCV RNA level below the limit of detection of the Roche COBAS Taqman HCV/HPS assay (10 IU/mL) over time'}, {'measure': 'Achievement of an HCV RNA Level Below the Limit of Quantification Over Time', 'timeFrame': 'from day 1 and up to 4 weeks', 'description': 'Achievement of an HCV RNA Level Below the Limit of quantification of the Roche COBAS Taqman HCV/HPS assay (25 IU/mL) Over Time'}, {'measure': 'Achievement of a >= 2 log10 Reduction in Plasma HCV RNA Level From Baseline Over Time', 'timeFrame': 'from day 1 and up to 4 weeks', 'description': 'Achievement of a \\>= 2 log10 reduction in plasma HCV RNA level from baseline over time.'}, {'measure': 'Occurrence of AEs, by Action Taken With Regard to Study Medication', 'timeFrame': 'from day 1 and up to 4 weeks', 'description': 'Occurrence of AEs, by action taken with regard to study medication.'}, {'measure': 'Occurrence of Discontinuations Due to AEs During BI201335 or BI201335+PegIFN/RBV Combination Treatment Period', 'timeFrame': 'from day 1 and up to 4 weeks', 'description': 'Occurrence of discontinuations due to AEs during BI201335 or BI201335+PegIFN/RBV combination treatment period.'}, {'measure': 'PK (Pharmacokinetic) Parameter After the First Dose: Cmax ( Maximum Measured Concentration of the Analyte in Plasma)', 'timeFrame': 'Times of -0:15, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, and 16:00 h relative to first administration of trial medication (on day 1)', 'description': 'PK (pharmacokinetic) parameter after the first dose: Cmax ( Maximum measured concentration of the analyte in plasma ).\n\n.'}, {'measure': 'PK Parameter After the First Dose: Tmax (Time From (Last) Dosing to the Maximum Measured Concentration of the Analyte in Plasma)', 'timeFrame': 'Times of -0:15, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, and 16:00 h relative to first administration of trial medication (on day 1)', 'description': 'PK parameter after the first dose: tmax (Time from (last) dosing to the maximum measured concentration of the analyte in plasma).'}, {'measure': 'PK Parameter After the First Dose: AUCτ,1 (Area Under the Concentration-time Curve of the Analyte in Plasma Over a Uniform Dosing Interval τ on Day 1)', 'timeFrame': 'Times of -0:15, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, and 16:00 h relative to first administration of trial medication (on day 1)', 'description': 'PK parameter after the first dose: AUCτ,1 (Area under the concentration-time curve of the analyte in plasma over a uniform dosing interval τ on day 1).'}, {'measure': 'PK Parameter at Steady State After the Last Dose: Cmax,ss (Maximum Measured Concentration of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval τ)', 'timeFrame': 'Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to last administration of trial medication (on day 28)', 'description': 'PK parameter at steady state after the last dose: Cmax,ss (Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ).'}, {'measure': 'PK Parameter at Steady State After the Last Dose: Tmax,ss (Time From Last Dosing to the Maximum Measured Concentration of the Analyte in Plasma at Steady State )', 'timeFrame': 'Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to last administration of trial medication (on day 28)', 'description': 'PK parameter at steady state after the last dose: tmax,ss (Time from last dosing to the maximum measured concentration of the analyte in plasma at steady state ).'}, {'measure': 'PK Parameter at Steady State After the Last Dose: Cmin,ss (Minimum Measured Concentration of the Analyte in Plasma)', 'timeFrame': 'Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to last administration of trial medication (on day 28)', 'description': 'PK parameter at steady state after the last dose: Cmin,ss (Minimum measured concentration of the analyte in plasma).'}, {'measure': 'PK Parameter at Steady State After the Last Dose: AUCτ,ss (Area Under the Concentration-time Curve of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval τ)', 'timeFrame': 'Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to last administration of trial medication (on day 28)', 'description': 'PK parameter at steady state after the last dose: AUCτ,ss ((Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ).'}, {'measure': 'PK Parameter at Steady State After the Last Dose: t1/2,ss (Terminal Half-life of the Analyte in Plasma at Steady State )', 'timeFrame': 'Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to last administration of trial medication (on day 28)', 'description': 'PK parameter at steady state after the last dose: t1/2,ss (Terminal half-life of the analyte in plasma at steady state \\[h\\] )'}, {'measure': 'PK Parameter at Steady State After the Last Dose: MRTpo,ss (Mean Residence Time of the Analyte in the Body at Steady State After Oral Administration)', 'timeFrame': 'Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to last administration of trial medication (on day 28)', 'description': 'PK parameter at steady state after the last dose: MRTpo,ss (Mean residence time of the analyte in the body at steady state after oral administration \\[h\\] )'}, {'measure': 'PK Parameter at Steady State After the Last Dose: CL/F,ss (Apparent Clearance of the Analyte in Plasma at Steady State Following Multiple Oral Dose Administration )', 'timeFrame': 'Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to last administration of trial medication (on day 28)', 'description': 'PK parameter at steady state after the last dose (if applicable): CL/F,ss (ss Apparent clearance of the analyte in plasma at steady state following multiple oral dose administration \\[mL/min\\] )'}, {'measure': 'PK Parameter at Steady State After the Last Dose: Vz/F,ss (Apparent Volume of Distribution During the Terminal Phase z at Steady State Following an Oral Administration )', 'timeFrame': 'Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to last administration of trial medication (on day 28)', 'description': 'PK parameter at steady state after the last dose: Vz/F,ss (Apparent volume of distribution during the terminal phase z at steady state following an oral administration \\[L\\] )'}, {'measure': 'PK Parameter for Drug-drug Interaction (naïve Patients With ≥1 Log Reduction on Day 10): AUCτ,ss (Area Under the Concentration-time Curve of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval τ )', 'timeFrame': 'Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to administration of trial medication in the morning of Day 14 (on day 14)', 'description': 'PK parameter for drug-drug interaction (naïve patients with ≥1 log reduction on Day 10): AUCτ,ss ( Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ ).'}, {'measure': 'PK Parameter for Drug-drug Interaction (naïve Patients With ≥1 Log Reduction on Day 10): Cmax,ss', 'timeFrame': 'Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to administration of trial medication in the morning of Day 14 (on day 14)', 'description': 'PK parameter for drug-drug interaction (naïve patients with ≥1 log reduction on Day 10): Cmax,ss.'}, {'measure': 'PK Parameter for Drug-drug Interaction (naïve Patients With ≥1 Log Reduction on Day 10): Cmin, ss', 'timeFrame': 'Times of -0:05, 0:30, 1:00, 2:00, 3:00, 4:00, 6:00. 8:00. 12:00, 16:00, 24:00 h relative to administration of trial medication in the morning of Day 14 (on day 14)', 'description': 'PK parameter for drug-drug interaction (naïve patients with ≥1 log reduction on Day 10): Cmin, ss.'}, {'measure': 'Accumulation Ratio of the Analyte in Plasma Following Multiple Doses Over a Uniform Dosing Interval: RAcmax', 'timeFrame': 'Day 1, Day 14, and Day 28', 'description': 'For TN patients, comparing exposure on Day 14 to the first dose on Day 1; for TE patients, comparing exposure on Day 28 to the first dose on Day 1.'}, {'measure': 'Accumulation Ratio of the Analyte in Plasma Following Multiple Doses Over a Uniform Dosing Interval: RAauc', 'timeFrame': 'Day 1, Day 14, and Day 28', 'description': 'For TN patients, comparing exposure on Day 14 to the first dose on Day 1; for TE patients, comparing exposure on Day 28 to the first dose on Day 1.'}]}, 'conditionsModule': {'conditions': ['Hepatitis C, Chronic']}, 'referencesModule': {'references': [{'pmid': '23877706', 'type': 'DERIVED', 'citation': 'Berger KL, Lagace L, Triki I, Cartier M, Marquis M, Lawetz C, Bethell R, Scherer J, Kukolj G. Viral resistance in hepatitis C virus genotype 1-infected patients receiving the NS3 protease inhibitor Faldaprevir (BI 201335) in a phase 1b multiple-rising-dose study. Antimicrob Agents Chemother. 2013 Oct;57(10):4928-36. doi: 10.1128/AAC.00822-13. Epub 2013 Jul 22.'}, {'pmid': '21145839', 'type': 'DERIVED', 'citation': 'Manns MP, Bourliere M, Benhamou Y, Pol S, Bonacini M, Trepo C, Wright D, Berg T, Calleja JL, White PW, Stern JO, Steinmann G, Yong CL, Kukolj G, Scherer J, Boecher WO. Potency, safety, and pharmacokinetics of the NS3/4A protease inhibitor BI201335 in patients with chronic HCV genotype-1 infection. J Hepatol. 2011 Jun;54(6):1114-22. doi: 10.1016/j.jhep.2010.08.040. Epub 2010 Nov 11.'}]}, 'descriptionModule': {'briefSummary': 'This study will investigate safety, antiviral activity, and pharmacokinetics of BI 201335 NA in HCV genotype 1 infected patients treated for 14 days monotherapy followed by BI 201335 NA combination therapy with PegIFN/RBV for an additional 14 days for treatment-naïve patients; or for 28 days as BI 201335 NA combination therapy with PegIFN/RBV for treatment-experienced patients.\n\nA secondary objective is to investigate antiviral activity, potential drug-drug interactions and safety of combination therapy of BI 201335 NA and PegIFN/RBV up to 28 days for treatment-naïve patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n1a. For treatment-naïve patients: no prior therapy with interferon, peginterferon, or ribavirin for acute or chronic hepatitis C infection\n\n1b. For treatment-experienced patients: confirmed virological failure during or after combination treatment with an approved dose of alfa-2a or alfa-2b peginterferon combined with ribavirin; such patients must have received at least 12 weeks of therapy with a 90 day washout period prior to screening and must have documentation of medical history prior to enrolment in 1220.2 2. Age 18 years or older 3. Signed informed consent form prior to trial participation 4. Male or female with documented hysterectomy or menopausal female with last menstrual period at least 6 months prior to screening 5. Chronic hepatitis C infection of genotype 1, diagnosed by positive HCV serology test (HCV Ab positive) or detectable HCV RNA at least 6 months prior to screening 6. HCV viral load \\>= 100,000 IU/mL at screening 7. TSH and T4 within normal limits or adequately controlled thyroid function 8. Histological evidence within 36 months prior to study enrolment of any degree of chronic necroinflammatory activity or the presence of fibrosis (Ishak Grade 1-4 or Metavir Grade 1-3)\n\nExclusion criteria:\n\n1. Patients who have been previously treated with at least one dose of any protease inhibitor for acute or chronic hepatitis C infection\n2. Evidence of liver disease due to causes other than chronic HCV infection\n3. Positive ELISA for HIV-1 or HIV-2\n4. Hepatitis B virus (HBV) infection based on presence of Hbs Ag or HBV DNA\n5. Any previous liver biopsy consistent with cirrhosis\n6. Decompensated liver diseases as evidenced by ascites, portal hypertension, jaundice or hepatic encephalopathy\n7. Haemophilia\n8. Hemoglobinopathy (e.g., thalassemia major or sickle cell anemia)\n9. Severe pre-existing psychiatric disease\n10. Poorly controlled diabetes mellitus\n11. Ischaemic heart disease\n12. Chronic obstructive airway disease\n13. Autoimmune disease; including autoimmune hepatitis\n14. History of alcohol abuse within the past 12 months\n15. Hyperbilirubinemia (conjugated bilirubin) \\>1.5x ULN\n16. Alkaline phosphatase \\>1.5x ULN\n17. ALT and AST levels \\>= 5 x ULN\n18. Hemoglobin \\< 12.0 g/dL for women and \\< 13.0 g/dL for men\n19. White blood cell count \\< 2000 cells/mm3\n20. Absolute Neutrophil Count \\< 1500 cells/mm3\n21. Platelet count \\< 100,000 cells/mm3\n22. Prothrombin time INR (Institutional Normalized Ratio) prolonged to \\> 1.5 x ULN\n23. Usage of any investigational drug within 30 days prior to enrolment; or the planned usage of an investigational drug during the course of the current study\n24. Known hypersensitivity to study drugs'}, 'identificationModule': {'nctId': 'NCT00793793', 'briefTitle': 'Safety, Antiviral Activity and PK of MRD of BI 201335 in Chronic Hepatitis C Patients Both Treatment Naive and -Experienced', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Safety, Antiviral Activity, and Pharmacokinetics of Multiple Rising Oral Doses of BI 201335 NA in Treatment-naïve Patients With Chronic Hepatitis C Infection for 14 Days Monotherapy Followed by Combination With Pegylated Interferon and Ribavirin for an Additional 14 Days (Double-blind, Placebo Controlled), and in Treatment-experienced Patients With Chronic Hepatitis C Infection for 28 Days as Combination Therapy With Pegylated Interferon and Ribavirin (Open-label)', 'orgStudyIdInfo': {'id': '1220.2'}, 'secondaryIdInfos': [{'id': '2007-001158-19', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '20mg', 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