Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2026-02-24 @ 9:37 AM
Study NCT ID:
NCT00984620
Status:
COMPLETED
Last Update Posted:
2015-09-07
First Post:
2009-09-24
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Short Term Treatment With BI 201335, Peginterferon-alpha 2a and Ribavirin in Hepatitis c Virus Genotype-1 Treatment-naïve Patients (SILEN-C3)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Taiwan']}, 'conditionBrowseModule': {'meshes': [{'id': 'D006526', 'term': 'Hepatitis C'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C552340', 'term': 'faldaprevir'}, {'id': 'D012254', 'term': 'Ribavirin'}], 'ancestors': [{'id': 'D012263', 'term': 'Ribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': '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}}, 'adverseEventsModule': {'timeFrame': 'up to 24 weeks + 30 days washout.', 'description': 'One patient, randomised to the 12 week treatment, received PegIFN/RBV during the lead-in phase but never started treatment with Faldaprevir and therefore is not included in the adverse event summary.', 'eventGroups': [{'id': 'EG000', 'title': 'Faldaprevir 120 mg (12 Weeks)', 'description': 'Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks.', 'otherNumAtRisk': 80, 'otherNumAffected': 73, 'seriousNumAtRisk': 80, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Faldaprevir 120 mg (24 Weeks)', 'description': 'Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV).', 'otherNumAtRisk': 79, 'otherNumAffected': 68, 'seriousNumAtRisk': 79, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 13}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 7}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1'}, {'term': 'Jaundice', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 4}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 13}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 9}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1'}, {'term': 'Disturbance in attention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 18}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 7}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 13}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 15}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1'}, {'term': 'Sleep disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 5}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 13}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 16}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 26}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 17}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1'}, {'term': 'Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 79, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MEDDRA 14.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Virological Response at Week 28 (W28VR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faldaprevir 120 mg (12 Weeks)', 'description': 'Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.'}, {'id': 'OG001', 'title': 'Faldaprevir 120 mg (24 Weeks)', 'description': 'Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.855', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted percent difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.25', 'ciLowerLimit': '-14.3', 'ciUpperLimit': '11.8', 'estimateComment': 'p-value presented is 2-sided. The percent differences and p-values are based on a comparison to the Faldaprevir 120mg (12 Weeks).', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on an Cochran-Mantel-Haenszel method adjusted by HCV genotype (1a and 1b only).', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '28 weeks', 'description': 'Virological response at Week 28: The patients who reached plasma hepatitis C virus ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at Week 28.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Set (PPS): included all patients in the FAS without important protocol deviations.'}, {'type': 'SECONDARY', 'title': 'Rapid Virological Response at Week 4 (RVR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faldaprevir 120 mg (12 Weeks)', 'description': 'Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.'}, {'id': 'OG001', 'title': 'Faldaprevir 120 mg (24 Weeks)', 'description': 'Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.229', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted percent difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.02', 'ciLowerLimit': '-5.3', 'ciUpperLimit': '23.3', 'estimateComment': 'p-value presented is 2-sided. The percent differences and p-values are based on a comparison to the Faldaprevir 120mg (12 Weeks).', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on an Cochran-Mantel-Haenszel method adjusted by HCV genotype (1a and 1b only).', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '4 weeks', 'description': 'Rapid virological response at week 4 (RVR): The patients who reached plasma hepatitis C virus ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at week 4.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'PPS'}, {'type': 'SECONDARY', 'title': 'Virological Response at Week 24 (W24VR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faldaprevir 120 mg (12 Weeks)', 'description': 'Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.'}, {'id': 'OG001', 'title': 'Faldaprevir 120 mg (24 Weeks)', 'description': 'Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.417', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted percent difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.48', 'ciLowerLimit': '-7.3', 'ciUpperLimit': '18.3', 'estimateComment': 'p-value presented is 2-sided. The percent differences and p-values are based on a comparison to the Faldaprevir 120mg (12 Weeks).', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on an Cochran-Mantel-Haenszel method adjusted by HCV genotype (1a and 1b only).', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '24 weeks', 'description': 'virological response at week 24 (W24VR): The patients who reached plasma hepatitis C virus ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at week 24.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'PPS'}, {'type': 'SECONDARY', 'title': 'Virological Response at Week 36 (W36VR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faldaprevir 120 mg (12 Weeks)', 'description': 'Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.'}, {'id': 'OG001', 'title': 'Faldaprevir 120 mg (24 Weeks)', 'description': 'Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.676', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted percent difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.99', 'ciLowerLimit': '-10.6', 'ciUpperLimit': '16.6', 'estimateComment': 'p-value presented is 2-sided. The percent differences and p-values are based on a comparison to the Faldaprevir 120mg (12 Weeks).', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on an Cochran-Mantel-Haenszel method adjusted by HCV genotype (1a and 1b only).', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '36 weeks', 'description': 'Virological response at week 36 (W36VR): the patients who reached plasma hepatitis C virus ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at week 36.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'PPS'}, {'type': 'SECONDARY', 'title': 'End of Treatment Response (ETR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faldaprevir 120 mg (12 Weeks)', 'description': 'Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.'}, {'id': 'OG001', 'title': 'Faldaprevir 120 mg (24 Weeks)', 'description': 'Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.588', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted percent difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.24', 'ciLowerLimit': '-8.1', 'ciUpperLimit': '14.6', 'estimateComment': 'p-value presented is 2-sided. The percent differences and p-values are based on a comparison to the Faldaprevir 120mg (12 Weeks).', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on an Cochran-Mantel-Haenszel method adjusted by HCV genotype (1a and 1b only).', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'up to 48 weeks', 'description': 'End of Treatment Response (ETR): The patients who reached plasma hepatitis C virus ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at end of all therapy.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'PPS'}, {'type': 'SECONDARY', 'title': 'Sustained Virological Response (SVR24) at 24 Weeks After Completion of All Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faldaprevir 120 mg (12 Weeks)', 'description': 'Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.'}, {'id': 'OG001', 'title': 'Faldaprevir 120 mg (24 Weeks)', 'description': 'Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.512', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted percent difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.78', 'ciLowerLimit': '-9.0', 'ciUpperLimit': '18.6', 'estimateComment': 'p-value presented is 2-sided. The percent differences and p-values are based on a comparison to the Faldaprevir 120mg (12 Weeks).', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on an Cochran-Mantel-Haenszel method adjusted by HCV genotype (1a and 1b only).', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '72 weeks', 'description': 'Sustained Virological Response (SVR24) at 24 weeks: The patients who reached plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at 24 weeks after completion of all Hepatitis C virus (HCV) therapy.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'PPS'}, {'type': 'SECONDARY', 'title': 'Viral Load (HCV RNA) at All Visits During Treatment and Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faldaprevir 120 mg (12 Weeks)', 'description': 'Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.'}, {'id': 'OG001', 'title': 'Faldaprevir 120 mg (24 Weeks)', 'description': 'Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.'}], 'classes': [{'title': 'week 2, change from baseline (N=76, N=78)', 'categories': [{'measurements': [{'value': '-4.724', 'spread': '0.9059', 'groupId': 'OG000'}, {'value': '-4.866', 'spread': '0.8664', 'groupId': 'OG001'}]}]}, {'title': 'week 4, change from baseline (N=76, N=77)', 'categories': [{'measurements': [{'value': '-4.993', 'spread': '1.1168', 'groupId': 'OG000'}, {'value': '-5.081', 'spread': '1.1195', 'groupId': 'OG001'}]}]}, {'title': 'week 8, change from baseline (N=75, N=76)', 'categories': [{'measurements': [{'value': '-5.128', 'spread': '1.1159', 'groupId': 'OG000'}, {'value': '-5.088', 'spread': '1.3150', 'groupId': 'OG001'}]}]}, {'title': 'week 12, change from baseline (N=76, N=76)', 'categories': [{'measurements': [{'value': '-5.117', 'spread': '1.1495', 'groupId': 'OG000'}, {'value': '-5.107', 'spread': '1.2852', 'groupId': 'OG001'}]}]}, {'title': 'week 16, change from baseline (N=18, N=13)', 'categories': [{'measurements': [{'value': '-5.363', 'spread': '1.2341', 'groupId': 'OG000'}, {'value': '-5.262', 'spread': '0.5820', 'groupId': 'OG001'}]}]}, {'title': 'week 20, change from baseline (N=52, N=57)', 'categories': [{'measurements': [{'value': '-5.056', 'spread': '1.0894', 'groupId': 'OG000'}, {'value': '-5.366', 'spread': '0.7319', 'groupId': 'OG001'}]}]}, {'title': 'week 24, change from baseline (N=12, N=8)', 'categories': [{'measurements': [{'value': '-4.176', 'spread': '2.1635', 'groupId': 'OG000'}, {'value': '-4.740', 'spread': '1.6576', 'groupId': 'OG001'}]}]}, {'title': 'week 28, change from baseline (N=4, N=4)', 'categories': [{'measurements': [{'value': '-5.723', 'spread': '0.6795', 'groupId': 'OG000'}, {'value': '-4.369', 'spread': '2.2917', 'groupId': 'OG001'}]}]}, {'title': 'week 36, change from baseline (N=4, N=2)', 'categories': [{'measurements': [{'value': '-5.624', 'spread': '0.7059', 'groupId': 'OG000'}, {'value': '-5.958', 'spread': '0.1909', 'groupId': 'OG001'}]}]}, {'title': 'End of TRT, change from baseline (N=80, N=78)', 'categories': [{'measurements': [{'value': '-4.910', 'spread': '1.4690', 'groupId': 'OG000'}, {'value': '-5.017', 'spread': '1.4434', 'groupId': 'OG001'}]}]}, {'title': '4 wks after TRT, change from baseline (N=75, N=77)', 'categories': [{'measurements': [{'value': '-4.296', 'spread': '2.2499', 'groupId': 'OG000'}, {'value': '-4.367', 'spread': '2.1849', 'groupId': 'OG001'}]}]}, {'title': '12 wks after TRT, change from baseline (N=75,N=75)', 'categories': [{'measurements': [{'value': '-4.154', 'spread': '2.3356', 'groupId': 'OG000'}, {'value': '-4.353', 'spread': '2.1588', 'groupId': 'OG001'}]}]}, {'title': '24 wks after TRT, change from baseline (N=73,N=75)', 'categories': [{'measurements': [{'value': '-4.103', 'spread': '2.3673', 'groupId': 'OG000'}, {'value': '-4.250', 'spread': '2.2439', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to 72 weeks', 'description': 'Viral load of Hepatitis C virus Ribonucleic acid (HCV RNA) at all visits during treatment (TRT) and follow-up, ie. change from baseline viral load at all visits.', 'unitOfMeasure': 'IU/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PPS'}, {'type': 'SECONDARY', 'title': 'Time to Reach a Plasma HCV RNA Level BLD While on Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faldaprevir 120 mg (12 Weeks)', 'description': 'Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.'}, {'id': 'OG001', 'title': 'Faldaprevir 120 mg (24 Weeks)', 'description': 'Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.1', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '8'}, {'value': '4.1', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '8'}]}]}], 'analyses': [{'pValue': '0.1397', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Compare 120 MG Faldaprevir 120mg (24 Weeks) over 120 MG Faldaprevir 120mg (12 Weeks) using log-rank test.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': '48 weeks', 'description': 'Time to reach a plasma Hepatitis C Virus Ribonucleic Acid (HCV RNA) level below the lower limit of detection (BLD) while on treatment', 'unitOfMeasure': 'week', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PPS'}, {'type': 'SECONDARY', 'title': 'Laboratory Test Abnormalities and Study Medication Tolerabilities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faldaprevir 120 mg (12 Weeks)', 'description': 'Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.'}, {'id': 'OG001', 'title': 'Faldaprevir 120 mg (24 Weeks)', 'description': 'Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.'}], 'classes': [{'title': 'Red blood cell count: low (N=81, N=79)', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'haematocrit: low (N=81, N=79)', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'haematocrit: high(N=81, N=79)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'white blood cell count: low(N=81, N=79)', 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}]}, {'title': 'platelets: low(N=81, N=78)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'eosinophils: high (N=81, N=79)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'PT-INR: high (N=81, N=79)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'sodium: low (N=81, N=79)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'bicarbonate: low (N=79, N=74)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'bicarbonate: high (N=79, N=74)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'AST/GOT, SGOT: high (N=75, N=71)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'ALT/GPT, SGPT: high (N=68, N=64)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'alkaline phosphatase: high (N=80, N=79)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'GGT: high (N=74, N=72)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'creatine kinase: high (N=80, N=79)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'lipase: high (N=79, N=79)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'amylase: high (N=81, N=79)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'glucose: low (N=80, N=79)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'cholesterol, total: high (N=80, N=75)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'triglyceride: high (N=74, N=71)', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '48 weeks', 'description': 'Participants with possible clinically significant laboratory test abnormalities observed in functional groups: Haematology, Coagulation, Electrolytes, Enzymes, Substrates and Differentials, automatic.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated Set (TS): comprised all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment regardless of randomisation.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinically Relevant Abnormalities Vital Signs, and Physical Examination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faldaprevir 120mg (12 Weeks)', 'description': 'Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.'}, {'id': 'OG001', 'title': 'Faldaprevir 120mg (24 Weeks)', 'description': 'Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '48 weeks', 'description': 'No number of participants with clinically relevant abnormalities in vital signs and physical examination.', 'unitOfMeasure': 'participants with abnormality', 'reportingStatus': 'POSTED', 'populationDescription': 'TS'}, {'type': 'SECONDARY', 'title': 'Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faldaprevir 120mg (12 Weeks)', 'description': 'Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.'}, {'id': 'OG001', 'title': 'Faldaprevir 120mg (24 Weeks)', 'description': 'Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.'}], 'classes': [{'title': 'Red blood cell (10^12cells/L) CFB,Day 1(N=77,N=75)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '0.3', 'groupId': 'OG001'}]}]}, {'title': 'Red blood cell (10^12cells/L) CFB, wk2 (N=75,N=77)', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '0.5', 'groupId': 'OG001'}]}]}, {'title': 'Red blood cell (10^12cells/L) CFB, wk4(N=74, N=76)', 'categories': [{'measurements': [{'value': '-0.8', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '0.6', 'groupId': 'OG001'}]}]}, {'title': 'Red blood cell (10^12cells/L) CFB, wk8(N=75, N=74)', 'categories': [{'measurements': [{'value': '-1.0', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '0.5', 'groupId': 'OG001'}]}]}, {'title': 'Red blood cell (10^12cells/L) CFB, wk12(N=74,N=74)', 'categories': [{'measurements': [{'value': '-1.1', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '-1.2', 'spread': '0.5', 'groupId': 'OG001'}]}]}, {'title': 'Red blood cell (10^12cells/L) CFB, wk18(N=66,N=69)', 'categories': [{'measurements': [{'value': '-1.2', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '-1.2', 'spread': '0.5', 'groupId': 'OG001'}]}]}, {'title': 'Red blood cell (10^12cells/L) CFB, wk24(N=12, N=4)', 'categories': [{'measurements': [{'value': '-1.2', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '0.4', 'groupId': 'OG001'}]}]}, {'title': 'Red blood cell (10^12cells/L) CFB, wk28(N=4, N=3)', 'categories': [{'measurements': [{'value': '-1.1', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '0.7', 'groupId': 'OG001'}]}]}, {'title': 'Red blood cell (10^12cells/L) CFB, wk36(N=4, N=2)', 'categories': [{'measurements': [{'value': '-0.9', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '-1.4', 'spread': '0.2', 'groupId': 'OG001'}]}]}, {'title': 'Red blood cell (10^12cells/L) CFB, EoT(N=67, N=73)', 'categories': [{'measurements': [{'value': '-1.2', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '-1.2', 'spread': '0.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 48 weeks', 'description': 'Change from baseline (CFB) in Red blood cells.', 'unitOfMeasure': '10^12 cells/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'TS'}, {'type': 'SECONDARY', 'title': 'Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faldaprevir 120mg (12 Weeks)', 'description': 'Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.'}, {'id': 'OG001', 'title': 'Faldaprevir 120mg (24 Weeks)', 'description': 'Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.'}], 'classes': [{'title': 'haematocrit (%) CFB, Day1 (N=77, N=75)', 'categories': [{'measurements': [{'value': '-0.9', 'spread': '3.0', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '2.7', 'groupId': 'OG001'}]}]}, {'title': 'haematocrit (%) CFB, wk2 (N=75, N=77)', 'categories': [{'measurements': [{'value': '-4.3', 'spread': '4.4', 'groupId': 'OG000'}, {'value': '-4.7', 'spread': '4.2', 'groupId': 'OG001'}]}]}, {'title': 'haematocrit (%) CFB, wk4 (N=74, N=76)', 'categories': [{'measurements': [{'value': '-8.0', 'spread': '4.9', 'groupId': 'OG000'}, {'value': '-7.9', 'spread': '4.5', 'groupId': 'OG001'}]}]}, {'title': 'haematocrit (%) CFB, wk8 (N=75, N=74)', 'categories': [{'measurements': [{'value': '-8.4', 'spread': '4.6', 'groupId': 'OG000'}, {'value': '-7.1', 'spread': '4.0', 'groupId': 'OG001'}]}]}, {'title': 'haematocrit (%) CFB, wk12 (N=72, N=74)', 'categories': [{'measurements': [{'value': '-8.5', 'spread': '4.9', 'groupId': 'OG000'}, {'value': '-7.8', 'spread': '3.9', 'groupId': 'OG001'}]}]}, {'title': 'haematocrit (%) CFB, wk18 (N=66, N=69)', 'categories': [{'measurements': [{'value': '-7.3', 'spread': '5.4', 'groupId': 'OG000'}, {'value': '-6.5', 'spread': '4.4', 'groupId': 'OG001'}]}]}, {'title': 'haematocrit (%) CFB, wk24 (N=11, N=4)', 'categories': [{'measurements': [{'value': '-6.6', 'spread': '6.2', 'groupId': 'OG000'}, {'value': '-2.7', 'spread': '2.4', 'groupId': 'OG001'}]}]}, {'title': 'haematocrit (%) CFB, wk28 (N=4, N=3)', 'categories': [{'measurements': [{'value': '-3.8', 'spread': '3.9', 'groupId': 'OG000'}, {'value': '-1.2', 'spread': '4.4', 'groupId': 'OG001'}]}]}, {'title': 'haematocrit (%) CFB, wk36 (N=4, N=2)', 'categories': [{'measurements': [{'value': '-3.0', 'spread': '8.0', 'groupId': 'OG000'}, {'value': '-3.6', 'spread': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'haematocrit (%) CFB, EoT (N=66, N=70)', 'categories': [{'measurements': [{'value': '-6.0', 'spread': '4.7', 'groupId': 'OG000'}, {'value': '-6.0', 'spread': '4.6', 'groupId': 'OG001'}]}]}, {'title': 'Eosinophils(%), CFB, day1 (N=77, N=75)', 'categories': [{'measurements': [{'value': '0', 'spread': '1', 'groupId': 'OG000'}, {'value': '0', 'spread': '1', 'groupId': 'OG001'}]}]}, {'title': 'Eosinophils(%), CFB, wk2 (N=75, N=76)', 'categories': [{'measurements': [{'value': '0', 'spread': '2', 'groupId': 'OG000'}, {'value': '0', 'spread': '1', 'groupId': 'OG001'}]}]}, {'title': 'Eosinophils(%), CFB, wk4 (N=73, N=74)', 'categories': [{'measurements': [{'value': '-1', 'spread': '1', 'groupId': 'OG000'}, {'value': '0', 'spread': '2', 'groupId': 'OG001'}]}]}, {'title': 'Eosinophils(%), CFB, wk8 (N=74, N=73)', 'categories': [{'measurements': [{'value': '0', 'spread': '2', 'groupId': 'OG000'}, {'value': '0', 'spread': '5', 'groupId': 'OG001'}]}]}, {'title': 'Eosinophils(%), CFB, wk12 (N=72, N=72)', 'categories': [{'measurements': [{'value': '0', 'spread': '2', 'groupId': 'OG000'}, {'value': '0', 'spread': '3', 'groupId': 'OG001'}]}]}, {'title': 'Eosinophils(%), CFB, wk18 (N=62, N=65)', 'categories': [{'measurements': [{'value': '0', 'spread': '3', 'groupId': 'OG000'}, {'value': '0', 'spread': '2', 'groupId': 'OG001'}]}]}, {'title': 'Eosinophils(%), CFB, wk24 (N=12, N=4)', 'categories': [{'measurements': [{'value': '-1', 'spread': '1', 'groupId': 'OG000'}, {'value': '-1', 'spread': '2', 'groupId': 'OG001'}]}]}, {'title': 'Eosinophils(%), CFB, wk28 (N=4, N=3)', 'categories': [{'measurements': [{'value': '-1', 'spread': '1', 'groupId': 'OG000'}, {'value': '-2', 'spread': '2', 'groupId': 'OG001'}]}]}, {'title': 'Eosinophils(%), CFB, wk36 (N=4, N=2)', 'categories': [{'measurements': [{'value': '-1', 'spread': '1', 'groupId': 'OG000'}, {'value': '-1', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Eosinophils(%), CFB, EoT (N=66, N=70)', 'categories': [{'measurements': [{'value': '0', 'spread': '2', 'groupId': 'OG000'}, {'value': '1', 'spread': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 48 weeks', 'description': 'Change from baseline (CFB) in haematocrit and Eosinophils.', 'unitOfMeasure': '% of laboratory test substance', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'TS'}, {'type': 'SECONDARY', 'title': 'Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faldaprevir 120mg (12 Weeks)', 'description': 'Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.'}, {'id': 'OG001', 'title': 'Faldaprevir 120mg (24 Weeks)', 'description': 'Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.'}], 'classes': [{'title': 'Platelets CFB, Day 1 (N=77, N=73)', 'categories': [{'measurements': [{'value': '3', 'spread': '35', 'groupId': 'OG000'}, {'value': '2', 'spread': '29', 'groupId': 'OG001'}]}]}, {'title': 'Platelets CFB, wk2 (N=74, N=74)', 'categories': [{'measurements': [{'value': '-35', 'spread': '40', 'groupId': 'OG000'}, {'value': '-35', 'spread': '34', 'groupId': 'OG001'}]}]}, {'title': 'Platelets CFB, wk4 (N=73, N=74)', 'categories': [{'measurements': [{'value': '-35', 'spread': '41', 'groupId': 'OG000'}, {'value': '-39', 'spread': '42', 'groupId': 'OG001'}]}]}, {'title': 'Platelets CFB, wk8 (N=73, N=71)', 'categories': [{'measurements': [{'value': '-55', 'spread': '37', 'groupId': 'OG000'}, {'value': '-48', 'spread': '38', 'groupId': 'OG001'}]}]}, {'title': 'Platelets CFB, wk12 (N=72, N=72)', 'categories': [{'measurements': [{'value': '-61', 'spread': '38', 'groupId': 'OG000'}, {'value': '-50', 'spread': '40', 'groupId': 'OG001'}]}]}, {'title': 'Platelets CFB, wk18 (N=66, N=68)', 'categories': [{'measurements': [{'value': '-55', 'spread': '46', 'groupId': 'OG000'}, {'value': '-51', 'spread': '45', 'groupId': 'OG001'}]}]}, {'title': 'Platelets CFB, wk24 (N=12, N=3)', 'categories': [{'measurements': [{'value': '-46', 'spread': '37', 'groupId': 'OG000'}, {'value': '-50', 'spread': '43', 'groupId': 'OG001'}]}]}, {'title': 'Platelets CFB, wk28 (N=4, N=2)', 'categories': [{'measurements': [{'value': '-22', 'spread': '77', 'groupId': 'OG000'}, {'value': '-83', 'spread': '6', 'groupId': 'OG001'}]}]}, {'title': 'Platelets CFB, wk36 (N=4, N=2)', 'categories': [{'measurements': [{'value': '-47', 'spread': '31', 'groupId': 'OG000'}, {'value': '-85', 'spread': '2', 'groupId': 'OG001'}]}]}, {'title': 'Platelets CFB, EoT (N=67, N=71)', 'categories': [{'measurements': [{'value': '-59', 'spread': '46', 'groupId': 'OG000'}, {'value': '-50', 'spread': '48', 'groupId': 'OG001'}]}]}, {'title': 'white blood cell CFB, day1 (N=77, N=75)', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '1.3', 'groupId': 'OG001'}]}]}, {'title': 'white blood cell CFB, wk2 (N=75, N=77)', 'categories': [{'measurements': [{'value': '-2.2', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '-1.8', 'spread': '1.9', 'groupId': 'OG001'}]}]}, {'title': 'white blood cell CFB, wk4 (N=74, N=76)', 'categories': [{'measurements': [{'value': '-2.6', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '-2.6', 'spread': '1.9', 'groupId': 'OG001'}]}]}, {'title': 'white blood cell CFB, wk8 (N=75, N=74)', 'categories': [{'measurements': [{'value': '-3.2', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '-2.9', 'spread': '1.4', 'groupId': 'OG001'}]}]}, {'title': 'white blood cell CFB, wk12 (N=74, N=74)', 'categories': [{'measurements': [{'value': '-3.4', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '-2.8', 'spread': '1.8', 'groupId': 'OG001'}]}]}, {'title': 'white blood cell CFB, wk18 (N=66, N=69)', 'categories': [{'measurements': [{'value': '-3.2', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '-3.1', 'spread': '1.6', 'groupId': 'OG001'}]}]}, {'title': 'white blood cell CFB, wk24 (N=12, N=4)', 'categories': [{'measurements': [{'value': '-4.0', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '-2.0', 'spread': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'white blood cell CFB, wk28 (N=4, N=3)', 'categories': [{'measurements': [{'value': '-2.8', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '-1.9', 'spread': '2.0', 'groupId': 'OG001'}]}]}, {'title': 'white blood cell CFB, wk36 (N=4, N=2)', 'categories': [{'measurements': [{'value': '-2.5', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '-3.0', 'spread': '1.1', 'groupId': 'OG001'}]}]}, {'title': 'white blood cell CFB, EoT (N=67, N=73)', 'categories': [{'measurements': [{'value': '-3.4', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '-3.1', 'spread': '1.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 48 weeks', 'description': 'Change from baseline (CFB) in Platelets and white blood cells.', 'unitOfMeasure': '10^9 cells/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'TS'}, {'type': 'SECONDARY', 'title': 'Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faldaprevir 120mg (12 Weeks)', 'description': 'Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.'}, {'id': 'OG001', 'title': 'Faldaprevir 120mg (24 Weeks)', 'description': 'Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.'}], 'classes': [{'title': 'Sodium (mmol/L) CFB, Day 1(N=77, N=74)', 'categories': [{'measurements': [{'value': '0', 'spread': '2', 'groupId': 'OG000'}, {'value': '1', 'spread': '2', 'groupId': 'OG001'}]}]}, {'title': 'Sodium (mmol/L) CFB, wk2 (N=76, N=78)', 'categories': [{'measurements': [{'value': '0', 'spread': '2', 'groupId': 'OG000'}, {'value': '0', 'spread': '2', 'groupId': 'OG001'}]}]}, {'title': 'Sodium (mmol/L) CFB, wk4 (N=76, N=77)', 'categories': [{'measurements': [{'value': '0', 'spread': '2', 'groupId': 'OG000'}, {'value': '0', 'spread': '2', 'groupId': 'OG001'}]}]}, {'title': 'Sodium (mmol/L) CFB, wk8 (N=73, N=76)', 'categories': [{'measurements': [{'value': '1', 'spread': '3', 'groupId': 'OG000'}, {'value': '1', 'spread': '2', 'groupId': 'OG001'}]}]}, {'title': 'Sodium (mmol/L) CFB, wk12 (N=75, N=76)', 'categories': [{'measurements': [{'value': '0', 'spread': '2', 'groupId': 'OG000'}, {'value': '1', 'spread': '2', 'groupId': 'OG001'}]}]}, {'title': 'Sodium (mmol/L) CFB, wk18 (N=68, N=70)', 'categories': [{'measurements': [{'value': '0', 'spread': '2', 'groupId': 'OG000'}, {'value': '0', 'spread': '2', 'groupId': 'OG001'}]}]}, {'title': 'Sodium (mmol/L) CFB, wk24 (N=12, N=4)', 'categories': [{'measurements': [{'value': '-1', 'spread': '2', 'groupId': 'OG000'}, {'value': '0', 'spread': '1', 'groupId': 'OG001'}]}]}, {'title': 'Sodium (mmol/L) CFB, wk28 (N=5, N=3)', 'categories': [{'measurements': [{'value': '-2', 'spread': '2', 'groupId': 'OG000'}, {'value': '-1', 'spread': '3', 'groupId': 'OG001'}]}]}, {'title': 'Sodium (mmol/L) CFB, wk36 (N=4, N=2)', 'categories': [{'measurements': [{'value': '-1', 'spread': '2', 'groupId': 'OG000'}, {'value': '-1', 'spread': '2', 'groupId': 'OG001'}]}]}, {'title': 'Sodium (mmol/L) CFB, EoT (N=67, N=73)', 'categories': [{'measurements': [{'value': '0', 'spread': '2', 'groupId': 'OG000'}, {'value': '0', 'spread': '3', 'groupId': 'OG001'}]}]}, {'title': 'Bicarbonate (mmol/L), CFB, day1 (N=76, N=75)', 'categories': [{'measurements': [{'value': '0.1', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '1.3', 'groupId': 'OG001'}]}]}, {'title': 'Bicarbonate (mmol/L), CFB, wk2 (N=75, N=78)', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '1.3', 'groupId': 'OG001'}]}]}, {'title': 'Bicarbonate (mmol/L), CFB, wk4 (N=74, N=77)', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '1.3', 'groupId': 'OG001'}]}]}, {'title': 'Bicarbonate (mmol/L), CFB, wk8 (N=74, N=76)', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '1.4', 'groupId': 'OG001'}]}]}, {'title': 'Bicarbonate (mmol/L), CFB, wk12 (N=74, N=76)', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '1.5', 'groupId': 'OG001'}]}]}, {'title': 'Bicarbonate (mmol/L), CFB, wk18 (N=66, N=69)', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '1.3', 'groupId': 'OG001'}]}]}, {'title': 'Bicarbonate (mmol/L), CFB, wk24 (N=12, N=4)', 'categories': [{'measurements': [{'value': '-0.4', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '1.9', 'groupId': 'OG001'}]}]}, {'title': 'Bicarbonate (mmol/L), CFB, wk28 (N=4, N=3)', 'categories': [{'measurements': [{'value': '-1.2', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '0.9', 'groupId': 'OG001'}]}]}, {'title': 'Bicarbonate (mmol/L), CFB, wk36 (N=4, N=2)', 'categories': [{'measurements': [{'value': '-2.6', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '0.7', 'groupId': 'OG001'}]}]}, {'title': 'Bicarbonate (mmol/L), CFB, EoT (N=64, N=71)', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '1.4', 'groupId': 'OG001'}]}]}, {'title': 'Cholesterol tot. (mmol/L), CFB, day1 (n=77, N=75)', 'categories': [{'measurements': [{'value': '0.03', 'spread': '0.47', 'groupId': 'OG000'}, {'value': '-0.05', 'spread': '0.48', 'groupId': 'OG001'}]}]}, {'title': 'Cholesterol tot. (mmol/L), CFB, wk2 (n=76, N=78)', 'categories': [{'measurements': [{'value': '-0.48', 'spread': '0.57', 'groupId': 'OG000'}, {'value': '-0.54', 'spread': '0.57', 'groupId': 'OG001'}]}]}, {'title': 'Cholesterol tot. (mmol/L), CFB, wk4 (n=76, N=77)', 'categories': [{'measurements': [{'value': '-0.51', 'spread': '0.55', 'groupId': 'OG000'}, {'value': '-0.67', 'spread': '0.68', 'groupId': 'OG001'}]}]}, {'title': 'Cholesterol tot. (mmol/L), CFB, wk8 (n=75, N=76)', 'categories': [{'measurements': [{'value': '-0.58', 'spread': '0.59', 'groupId': 'OG000'}, {'value': '-0.60', 'spread': '0.62', 'groupId': 'OG001'}]}]}, {'title': 'Cholesterol tot. (mmol/L), CFB, wk12 (n=75, N=76)', 'categories': [{'measurements': [{'value': '-0.64', 'spread': '0.62', 'groupId': 'OG000'}, {'value': '-0.74', 'spread': '0.63', 'groupId': 'OG001'}]}]}, {'title': 'Cholesterol tot. (mmol/L), CFB, wk18 (n=68, N=70)', 'categories': [{'measurements': [{'value': '-0.51', 'spread': '0.64', 'groupId': 'OG000'}, {'value': '-0.80', 'spread': '0.69', 'groupId': 'OG001'}]}]}, {'title': 'Cholesterol tot. (mmol/L), CFB, wk24 (n=12, N=4)', 'categories': [{'measurements': [{'value': '-0.36', 'spread': '0.46', 'groupId': 'OG000'}, {'value': '-0.37', 'spread': '0.30', 'groupId': 'OG001'}]}]}, {'title': 'Cholesterol tot. (mmol/L), CFB, wk28 (n=5, N=3)', 'categories': [{'measurements': [{'value': '0.10', 'spread': '0.53', 'groupId': 'OG000'}, {'value': '-0.09', 'spread': '0.20', 'groupId': 'OG001'}]}]}, {'title': 'Cholesterol tot. (mmol/L), CFB, wk36 (n=4, N=2)', 'categories': [{'measurements': [{'value': '-0.35', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '-0.23', 'spread': '0.20', 'groupId': 'OG001'}]}]}, {'title': 'Cholesterol tot. (mmol/L), CFB, EoT (n=67, N=73)', 'categories': [{'measurements': [{'value': '-0.43', 'spread': '0.70', 'groupId': 'OG000'}, {'value': '-0.74', 'spread': '0.68', 'groupId': 'OG001'}]}]}, {'title': 'Triglyceride (mmol/L), CFB, day1 (N=77, N=75)', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '0.3', 'groupId': 'OG001'}]}]}, {'title': 'Triglyceride (mmol/L), CFB, wk2 (N=76, N=78)', 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.4', 'groupId': 'OG001'}]}]}, {'title': 'Triglyceride (mmol/L), CFB, wk4 (N=76, N=77)', 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '0.6', 'groupId': 'OG001'}]}]}, {'title': 'Triglyceride (mmol/L), CFB, wk8 (N=75, N=76)', 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.4', 'groupId': 'OG001'}]}]}, {'title': 'Triglyceride (mmol/L), CFB, wk12 (N=75, N=76)', 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.5', 'groupId': 'OG001'}]}]}, {'title': 'Triglyceride (mmol/L), CFB, wk18 (N=68, N=70)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '0.5', 'groupId': 'OG001'}]}]}, {'title': 'Triglyceride (mmol/L), CFB, wk24 (N=12, N=4)', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '0.3', 'groupId': 'OG001'}]}]}, {'title': 'Triglyceride (mmol/L), CFB, wk28 (N=5, N=3)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '0.4', 'groupId': 'OG001'}]}]}, {'title': 'Triglyceride (mmol/L), CFB, wk36 (N=4, N=2)', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.5', 'groupId': 'OG001'}]}]}, {'title': 'Triglyceride (mmol/L), CFB, EoT (N=67, N=73)', 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.6', 'groupId': 'OG001'}]}]}, {'title': 'Glucose (mmol/L), CFB, day1 (N=76, N=75)', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '0.9', 'groupId': 'OG001'}]}]}, {'title': 'Glucose (mmol/L), CFB, wk2 (N=75, N=78)', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '1.0', 'groupId': 'OG001'}]}]}, {'title': 'Glucose (mmol/L), CFB, wk4 (N=74, N=77)', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.9', 'groupId': 'OG001'}]}]}, {'title': 'Glucose (mmol/L), CFB, wk8 (N=74, N=76)', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.9', 'groupId': 'OG001'}]}]}, {'title': 'Glucose (mmol/L), CFB, wk12 (N=73, N=76)', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '1.0', 'groupId': 'OG001'}]}]}, {'title': 'Glucose (mmol/L), CFB, wk18 (N=67, N=70)', 'categories': [{'measurements': [{'value': '-0.4', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '0.7', 'groupId': 'OG001'}]}]}, {'title': 'Glucose (mmol/L), CFB, wk24 (N=12, N=4)', 'categories': [{'measurements': [{'value': '-0.7', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '0.7', 'groupId': 'OG001'}]}]}, {'title': 'Glucose (mmol/L), CFB, wk28 (N=5, N=3)', 'categories': [{'measurements': [{'value': '-0.4', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.7', 'groupId': 'OG001'}]}]}, {'title': 'Glucose (mmol/L), CFB, wk36 (N=4, N=2)', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '0.4', 'groupId': 'OG001'}]}]}, {'title': 'Glucose (mmol/L), CFB, EoT (N=66, N=71)', 'categories': [{'measurements': [{'value': '-0.4', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '1.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 48 weeks', 'description': 'Change from baseline (CFB) in Sodium, Bicarbonate, Cholesterol total, Triglyceride, and Glucose.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'TS'}, {'type': 'SECONDARY', 'title': 'Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faldaprevir 120mg (12 Weeks)', 'description': 'Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.'}, {'id': 'OG001', 'title': 'Faldaprevir 120mg (24 Weeks)', 'description': 'Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.'}], 'classes': [{'title': 'AST/GOT (U/L), CFB, Day 1(N=74, N=75)', 'categories': [{'measurements': [{'value': '0', 'spread': '28', 'groupId': 'OG000'}, {'value': '-5', 'spread': '29', 'groupId': 'OG001'}]}]}, {'title': 'AST/GOT (U/L), CFB, wk2 (N=75, N=78)', 'categories': [{'measurements': [{'value': '-24', 'spread': '30', 'groupId': 'OG000'}, {'value': '-29', 'spread': '43', 'groupId': 'OG001'}]}]}, {'title': 'AST/GOT (U/L), CFB, wk4 (N=74, N=76)', 'categories': [{'measurements': [{'value': '-25', 'spread': '31', 'groupId': 'OG000'}, {'value': '-29', 'spread': '49', 'groupId': 'OG001'}]}]}, {'title': 'AST/GOT (U/L), CFB, wk8 (N=74, N=76)', 'categories': [{'measurements': [{'value': '-22', 'spread': '36', 'groupId': 'OG000'}, {'value': '-27', 'spread': '47', 'groupId': 'OG001'}]}]}, {'title': 'AST/GOT (U/L), CFB, wk12 (N=74, N=76)', 'categories': [{'measurements': [{'value': '-24', 'spread': '29', 'groupId': 'OG000'}, {'value': '-27', 'spread': '44', 'groupId': 'OG001'}]}]}, {'title': 'AST/GOT (U/L), CFB, wk18 (N=67, N=70)', 'categories': [{'measurements': [{'value': '-25', 'spread': '33', 'groupId': 'OG000'}, {'value': '-30', 'spread': '50', 'groupId': 'OG001'}]}]}, {'title': 'AST/GOT (U/L), CFB, wk24 (N=12, N=4)', 'categories': [{'measurements': [{'value': '-23', 'spread': '60', 'groupId': 'OG000'}, {'value': '-10', 'spread': '15', 'groupId': 'OG001'}]}]}, {'title': 'AST/GOT (U/L), CFB, wk28 (N=5, N=3)', 'categories': [{'measurements': [{'value': '-20', 'spread': '27', 'groupId': 'OG000'}, {'value': '-16', 'spread': '24', 'groupId': 'OG001'}]}]}, {'title': 'AST/GOT (U/L), CFB, wk36 (N=4, N=2)', 'categories': [{'measurements': [{'value': '-21', 'spread': '40', 'groupId': 'OG000'}, {'value': '11', 'spread': '4', 'groupId': 'OG001'}]}]}, {'title': 'AST/GOT (U/L), CFB, EoT (N=66, N=71)', 'categories': [{'measurements': [{'value': '-25', 'spread': '41', 'groupId': 'OG000'}, {'value': '-27', 'spread': '49', 'groupId': 'OG001'}]}]}, {'title': 'ALT/GPT (U/L), CFB, day1 (N=76, N=75)', 'categories': [{'measurements': [{'value': '1', 'spread': '24', 'groupId': 'OG000'}, {'value': '-2', 'spread': '22', 'groupId': 'OG001'}]}]}, {'title': 'ALT/GPT (U/L), CFB, wk2 (N=75, N=78)', 'categories': [{'measurements': [{'value': '-37', 'spread': '36', 'groupId': 'OG000'}, {'value': '-34', 'spread': '40', 'groupId': 'OG001'}]}]}, {'title': 'ALT/GPT (U/L), CFB, wk4 (N=74, N=77)', 'categories': [{'measurements': [{'value': '-37', 'spread': '40', 'groupId': 'OG000'}, {'value': '-34', 'spread': '50', 'groupId': 'OG001'}]}]}, {'title': 'ALT/GPT (U/L), CFB, wk8 (N=74, N=76)', 'categories': [{'measurements': [{'value': '-36', 'spread': '43', 'groupId': 'OG000'}, {'value': '-35', 'spread': '49', 'groupId': 'OG001'}]}]}, {'title': 'ALT/GPT (U/L), CFB, wk12 (N=74, N=76)', 'categories': [{'measurements': [{'value': '-37', 'spread': '36', 'groupId': 'OG000'}, {'value': '-36', 'spread': '48', 'groupId': 'OG001'}]}]}, {'title': 'ALT/GPT (U/L), CFB, wk18 (N=67, N=70)', 'categories': [{'measurements': [{'value': '-41', 'spread': '40', 'groupId': 'OG000'}, {'value': '-42', 'spread': '52', 'groupId': 'OG001'}]}]}, {'title': 'ALT/GPT (U/L), CFB, wk24 (N=12, N=4)', 'categories': [{'measurements': [{'value': '-40', 'spread': '50', 'groupId': 'OG000'}, {'value': '-24', 'spread': '22', 'groupId': 'OG001'}]}]}, {'title': 'ALT/GPT (U/L), CFB, wk28 (N=5, N=3)', 'categories': [{'measurements': [{'value': '-45', 'spread': '38', 'groupId': 'OG000'}, {'value': '-22', 'spread': '15', 'groupId': 'OG001'}]}]}, {'title': 'ALT/GPT (U/L), CFB, wk36 (N=4, N=2)', 'categories': [{'measurements': [{'value': '-47', 'spread': '46', 'groupId': 'OG000'}, {'value': '-6', 'spread': '4', 'groupId': 'OG001'}]}]}, {'title': 'ALT/GPT (U/L), CFB, EoT (N=66, N=71)', 'categories': [{'measurements': [{'value': '-42', 'spread': '42', 'groupId': 'OG000'}, {'value': '-42', 'spread': '45', 'groupId': 'OG001'}]}]}, {'title': 'Alka. phosphatase (U/L), CFB, day1 (n=77, N=75)', 'categories': [{'measurements': [{'value': '1', 'spread': '11', 'groupId': 'OG000'}, {'value': '1', 'spread': '13', 'groupId': 'OG001'}]}]}, {'title': 'Alka. phosphatase (U/L), CFB, wk2 (n=76, N=78)', 'categories': [{'measurements': [{'value': '5', 'spread': '10', 'groupId': 'OG000'}, {'value': '7', 'spread': '11', 'groupId': 'OG001'}]}]}, {'title': 'Alka. phosphatase (U/L), CFB, wk4 (n=76, N=77)', 'categories': [{'measurements': [{'value': '7', 'spread': '13', 'groupId': 'OG000'}, {'value': '10', 'spread': '13', 'groupId': 'OG001'}]}]}, {'title': 'Alka. phosphatase (U/L), CFB, wk8 (n=75, N=76)', 'categories': [{'measurements': [{'value': '7', 'spread': '13', 'groupId': 'OG000'}, {'value': '9', 'spread': '15', 'groupId': 'OG001'}]}]}, {'title': 'Alka. phosphatase (U/L), CFB, wk12 (n=75, N=76)', 'categories': [{'measurements': [{'value': '5', 'spread': '14', 'groupId': 'OG000'}, {'value': '6', 'spread': '14', 'groupId': 'OG001'}]}]}, {'title': 'Alka. phosphatase (U/L), CFB, wk18 (n=68, N=70)', 'categories': [{'measurements': [{'value': '-2', 'spread': '20', 'groupId': 'OG000'}, {'value': '5', 'spread': '14', 'groupId': 'OG001'}]}]}, {'title': 'Alka. phosphatase (U/L), CFB, wk24 (n=12, N=4)', 'categories': [{'measurements': [{'value': '-14', 'spread': '24', 'groupId': 'OG000'}, {'value': '13', 'spread': '13', 'groupId': 'OG001'}]}]}, {'title': 'Alka. phosphatase (U/L), CFB, wk28 (n=5, N=3)', 'categories': [{'measurements': [{'value': '-2', 'spread': '14', 'groupId': 'OG000'}, {'value': '15', 'spread': '3', 'groupId': 'OG001'}]}]}, {'title': 'Alka. phosphatase (U/L), CFB, wk36 (n=4, N=2)', 'categories': [{'measurements': [{'value': '-5', 'spread': '16', 'groupId': 'OG000'}, {'value': '18', 'spread': '4', 'groupId': 'OG001'}]}]}, {'title': 'Alka. phosphatase (U/L), CFB, EoT (n=67, N=73)', 'categories': [{'measurements': [{'value': '1', 'spread': '22', 'groupId': 'OG000'}, {'value': '5', 'spread': '16', 'groupId': 'OG001'}]}]}, {'title': 'GGT (U/L), CFB, day1 (N=77, N=75)', 'categories': [{'measurements': [{'value': '-5', 'spread': '39', 'groupId': 'OG000'}, {'value': '-5', 'spread': '88', 'groupId': 'OG001'}]}]}, {'title': 'GGT (U/L), CFB, wk2 (N=76, N=78)', 'categories': [{'measurements': [{'value': '-34', 'spread': '71', 'groupId': 'OG000'}, {'value': '-38', 'spread': '117', 'groupId': 'OG001'}]}]}, {'title': 'GGT (U/L), CFB, wk4 (N=76, N=77)', 'categories': [{'measurements': [{'value': '-59', 'spread': '86', 'groupId': 'OG000'}, {'value': '-60', 'spread': '135', 'groupId': 'OG001'}]}]}, {'title': 'GGT (U/L), CFB, wk8 (N=75, N=76)', 'categories': [{'measurements': [{'value': '-76', 'spread': '96', 'groupId': 'OG000'}, {'value': '-70', 'spread': '143', 'groupId': 'OG001'}]}]}, {'title': 'GGT (U/L), CFB, wk12 (N=75, N=76)', 'categories': [{'measurements': [{'value': '-71', 'spread': '103', 'groupId': 'OG000'}, {'value': '-69', 'spread': '150', 'groupId': 'OG001'}]}]}, {'title': 'GGT (U/L), CFB, wk18 (N=68, N=70)', 'categories': [{'measurements': [{'value': '-62', 'spread': '105', 'groupId': 'OG000'}, {'value': '-64', 'spread': '146', 'groupId': 'OG001'}]}]}, {'title': 'GGT (U/L), CFB, wk24 (N=12, N=4)', 'categories': [{'measurements': [{'value': '-118', 'spread': '200', 'groupId': 'OG000'}, {'value': '-131', 'spread': '50', 'groupId': 'OG001'}]}]}, {'title': 'GGT (U/L), CFB, wk28 (N=5, N=3)', 'categories': [{'measurements': [{'value': '-52', 'spread': '126', 'groupId': 'OG000'}, {'value': '-113', 'spread': '42', 'groupId': 'OG001'}]}]}, {'title': 'GGT (U/L), CFB, wk36 (N=4, N=2)', 'categories': [{'measurements': [{'value': '-23', 'spread': '132', 'groupId': 'OG000'}, {'value': '-14', 'spread': '73', 'groupId': 'OG001'}]}]}, {'title': 'GGT (U/L), CFB, EoT (N=67, N=73)', 'categories': [{'measurements': [{'value': '-39', 'spread': '106', 'groupId': 'OG000'}, {'value': '-59', 'spread': '148', 'groupId': 'OG001'}]}]}, {'title': 'Creatine kinase (U/L), CFB, day1 (N=76, N=75)', 'categories': [{'measurements': [{'value': '-2', 'spread': '140', 'groupId': 'OG000'}, {'value': '30', 'spread': '308', 'groupId': 'OG001'}]}]}, {'title': 'Creatine kinase (U/L), CFB, wk2 (N=75, N=78)', 'categories': [{'measurements': [{'value': '-59', 'spread': '158', 'groupId': 'OG000'}, {'value': '-41', 'spread': '118', 'groupId': 'OG001'}]}]}, {'title': 'Creatine kinase (U/L), CFB, wk4 (N=74, N=77)', 'categories': [{'measurements': [{'value': '-69', 'spread': '173', 'groupId': 'OG000'}, {'value': '-62', 'spread': '134', 'groupId': 'OG001'}]}]}, {'title': 'Creatine kinase (U/L), CFB, wk8 (N=74, N=76)', 'categories': [{'measurements': [{'value': '-92', 'spread': '176', 'groupId': 'OG000'}, {'value': '-75', 'spread': '131', 'groupId': 'OG001'}]}]}, {'title': 'Creatine kinase (U/L), CFB, wk12 (N=74, N=75)', 'categories': [{'measurements': [{'value': '-98', 'spread': '186', 'groupId': 'OG000'}, {'value': '-84', 'spread': '132', 'groupId': 'OG001'}]}]}, {'title': 'Creatine kinase (U/L), CFB, wk18 (N=67, N=70)', 'categories': [{'measurements': [{'value': '-93', 'spread': '202', 'groupId': 'OG000'}, {'value': '-60', 'spread': '216', 'groupId': 'OG001'}]}]}, {'title': 'Creatine kinase (U/L), CFB, wk24 (N=12, N=4)', 'categories': [{'measurements': [{'value': '-69', 'spread': '78', 'groupId': 'OG000'}, {'value': '-42', 'spread': '30', 'groupId': 'OG001'}]}]}, {'title': 'Creatine kinase (U/L), CFB, wk28 (N=5, N=3)', 'categories': [{'measurements': [{'value': '-48', 'spread': '75', 'groupId': 'OG000'}, {'value': '-32', 'spread': '26', 'groupId': 'OG001'}]}]}, {'title': 'Creatine kinase (U/L), CFB, wk36 (N=4, N=2)', 'categories': [{'measurements': [{'value': '-68', 'spread': '83', 'groupId': 'OG000'}, {'value': '-37', 'spread': '22', 'groupId': 'OG001'}]}]}, {'title': 'Creatine kinase (U/L), CFB, EoT (N=66, N=71)', 'categories': [{'measurements': [{'value': '-89', 'spread': '187', 'groupId': 'OG000'}, {'value': '-21', 'spread': '331', 'groupId': 'OG001'}]}]}, {'title': 'Lipase (U/L). CFB, day1 (N=77, N=75)', 'categories': [{'measurements': [{'value': '-2', 'spread': '52', 'groupId': 'OG000'}, {'value': '26', 'spread': '239', 'groupId': 'OG001'}]}]}, {'title': 'Lipase (U/L). CFB, wk2 (N=76, N=78)', 'categories': [{'measurements': [{'value': '5', 'spread': '65', 'groupId': 'OG000'}, {'value': '9', 'spread': '30', 'groupId': 'OG001'}]}]}, {'title': 'Lipase (U/L). CFB, wk4 (N=76, N=76)', 'categories': [{'measurements': [{'value': '-1', 'spread': '52', 'groupId': 'OG000'}, {'value': '6', 'spread': '36', 'groupId': 'OG001'}]}]}, {'title': 'Lipase (U/L). CFB, wk8 (N=75, N=76)', 'categories': [{'measurements': [{'value': '-11', 'spread': '69', 'groupId': 'OG000'}, {'value': '2', 'spread': '57', 'groupId': 'OG001'}]}]}, {'title': 'Lipase (U/L). CFB, wk12 (N=75, N=75)', 'categories': [{'measurements': [{'value': '-12', 'spread': '70', 'groupId': 'OG000'}, {'value': '4', 'spread': '90', 'groupId': 'OG001'}]}]}, {'title': 'Lipase (U/L). CFB, wk18 (N=68, N=70)', 'categories': [{'measurements': [{'value': '-13', 'spread': '64', 'groupId': 'OG000'}, {'value': '-4', 'spread': '32', 'groupId': 'OG001'}]}]}, {'title': 'Lipase (U/L). CFB, wk24 (N=12, N=4)', 'categories': [{'measurements': [{'value': '2', 'spread': '31', 'groupId': 'OG000'}, {'value': '-17', 'spread': '22', 'groupId': 'OG001'}]}]}, {'title': 'Lipase (U/L). CFB, wk28 (N=5, N=3)', 'categories': [{'measurements': [{'value': '-1', 'spread': '13', 'groupId': 'OG000'}, {'value': '0', 'spread': '11', 'groupId': 'OG001'}]}]}, {'title': 'Lipase (U/L). CFB, wk36 (N=4, N=2)', 'categories': [{'measurements': [{'value': '-4', 'spread': '12', 'groupId': 'OG000'}, {'value': '-15', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Lipase (U/L). CFB, EoT (N=67, N=73)', 'categories': [{'measurements': [{'value': '-6', 'spread': '82', 'groupId': 'OG000'}, {'value': '-5', 'spread': '27', 'groupId': 'OG001'}]}]}, {'title': 'Amylase (U/L), CFB, day1 (N=77, N=75)', 'categories': [{'measurements': [{'value': '1', 'spread': '26', 'groupId': 'OG000'}, {'value': '7', 'spread': '68', 'groupId': 'OG001'}]}]}, {'title': 'Amylase (U/L), CFB, wk2 (N=76, N=78)', 'categories': [{'measurements': [{'value': '5', 'spread': '41', 'groupId': 'OG000'}, {'value': '3', 'spread': '23', 'groupId': 'OG001'}]}]}, {'title': 'Amylase (U/L), CFB, wk4 (N=76, N=77)', 'categories': [{'measurements': [{'value': '2', 'spread': '30', 'groupId': 'OG000'}, {'value': '5', 'spread': '27', 'groupId': 'OG001'}]}]}, {'title': 'Amylase (U/L), CFB, wk8 (N=75, N=76)', 'categories': [{'measurements': [{'value': '-5', 'spread': '33', 'groupId': 'OG000'}, {'value': '-2', 'spread': '29', 'groupId': 'OG001'}]}]}, {'title': 'Amylase (U/L), CFB, wk12 (N=75, N=75)', 'categories': [{'measurements': [{'value': '-10', 'spread': '33', 'groupId': 'OG000'}, {'value': '-4', 'spread': '33', 'groupId': 'OG001'}]}]}, {'title': 'Amylase (U/L), CFB, wk18 (N=68, N=70)', 'categories': [{'measurements': [{'value': '-7', 'spread': '34', 'groupId': 'OG000'}, {'value': '-7', 'spread': '28', 'groupId': 'OG001'}]}]}, {'title': 'Amylase (U/L), CFB, wk24 (N=12, N=4)', 'categories': [{'measurements': [{'value': '-14', 'spread': '35', 'groupId': 'OG000'}, {'value': '-16', 'spread': '23', 'groupId': 'OG001'}]}]}, {'title': 'Amylase (U/L), CFB, wk28 (N=5, N=3)', 'categories': [{'measurements': [{'value': '-21', 'spread': '34', 'groupId': 'OG000'}, {'value': '-8', 'spread': '7', 'groupId': 'OG001'}]}]}, {'title': 'Amylase (U/L), CFB, wk36 (N=4, N=2)', 'categories': [{'measurements': [{'value': '-35', 'spread': '24', 'groupId': 'OG000'}, {'value': '-19', 'spread': '9', 'groupId': 'OG001'}]}]}, {'title': 'Amylase (U/L), CFB, EoT (N=67, N=73)', 'categories': [{'measurements': [{'value': '0', 'spread': '37', 'groupId': 'OG000'}, {'value': '-4', 'spread': '27', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 48 weeks', 'description': 'Change from baseline (CFB) in AST/GOT, ALT/GPT, Alka. phosphatase, GGT, Creatine kinase, Lipase, and Amylase.', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'TS'}, {'type': 'SECONDARY', 'title': 'Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Faldaprevir 120mg (12 Weeks)', 'description': 'Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.'}, {'id': 'OG001', 'title': 'Faldaprevir 120mg (24 Weeks)', 'description': 'Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.'}], 'classes': [{'title': 'PT-INR (ratio), CFB, Day 1(N=77, N=72)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.1', 'groupId': 'OG001'}]}]}, {'title': 'PT-INR (ratio), CFB, wk2 (N=76, N=78)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.1', 'groupId': 'OG001'}]}]}, {'title': 'PT-INR (ratio), CFB, wk4(N=74, N=76)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.1', 'groupId': 'OG001'}]}]}, {'title': 'PT-INR (ratio), CFB, wk8(N=73, N=75)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.1', 'groupId': 'OG001'}]}]}, {'title': 'PT-INR (ratio), CFB, wk12(N=74, N=72)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.1', 'groupId': 'OG001'}]}]}, {'title': 'PT-INR (ratio), CFB, wk18(N=69, N=70)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.1', 'groupId': 'OG001'}]}]}, {'title': 'PT-INR (ratio), CFB, wk24(N=12, N=4)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.1', 'groupId': 'OG001'}]}]}, {'title': 'PT-INR (ratio), CFB, wk28(N=5, N=3)', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.1', 'groupId': 'OG001'}]}]}, {'title': 'PT-INR (ratio), CFB, wk36(N=4, N=2)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '0.1', 'groupId': 'OG001'}]}]}, {'title': 'PT-INR (ratio), CFB, EoT(N=68, N=73)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 48 weeks', 'description': 'Change from baseline (CFB) in PT-INR (ratio).', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'TS'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Faldaprevir 120mg (12 Weeks)', 'description': 'Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.'}, {'id': 'FG001', 'title': 'Faldaprevir 120mg (24 Weeks)', 'description': 'Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '81'}, {'groupId': 'FG001', 'numSubjects': '79'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '75'}, {'groupId': 'FG001', 'numSubjects': '67'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '12'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'reason other than listed above', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '160', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Faldaprevir 120 mg (12 Weeks)', 'description': 'Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.'}, {'id': 'BG001', 'title': 'Faldaprevir 120 mg (24 Weeks)', 'description': 'Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '48.1', 'spread': '9.4', 'groupId': 'BG000'}, {'value': '44.9', 'spread': '11.9', 'groupId': 'BG001'}, {'value': '46.5', 'spread': '10.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Full Analysis Set (FAS): contained all randomised patients who were dispensed study medication and were documented to have taken at least one dose of study medication.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'dispFirstSubmitDate': '2014-03-27', 'lastUpdateSubmitDate': '2015-08-07', 'studyFirstSubmitDate': '2009-09-24', 'dispFirstSubmitQcDate': '2014-03-27', 'resultsFirstSubmitDate': '2015-07-03', 'studyFirstSubmitQcDate': '2009-09-24', 'dispFirstPostDateStruct': {'date': '2014-04-24', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2015-09-07', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-08-07', 'studyFirstPostDateStruct': {'date': '2009-09-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-09-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Virological Response at Week 28 (W28VR)', 'timeFrame': '28 weeks', 'description': 'Virological response at Week 28: The patients who reached plasma hepatitis C virus ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at Week 28.'}], 'secondaryOutcomes': [{'measure': 'Rapid Virological Response at Week 4 (RVR)', 'timeFrame': '4 weeks', 'description': 'Rapid virological response at week 4 (RVR): The patients who reached plasma hepatitis C virus ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at week 4.'}, {'measure': 'Virological Response at Week 24 (W24VR)', 'timeFrame': '24 weeks', 'description': 'virological response at week 24 (W24VR): The patients who reached plasma hepatitis C virus ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at week 24.'}, {'measure': 'Virological Response at Week 36 (W36VR)', 'timeFrame': '36 weeks', 'description': 'Virological response at week 36 (W36VR): the patients who reached plasma hepatitis C virus ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at week 36.'}, {'measure': 'End of Treatment Response (ETR)', 'timeFrame': 'up to 48 weeks', 'description': 'End of Treatment Response (ETR): The patients who reached plasma hepatitis C virus ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at end of all therapy.'}, {'measure': 'Sustained Virological Response (SVR24) at 24 Weeks After Completion of All Therapy', 'timeFrame': '72 weeks', 'description': 'Sustained Virological Response (SVR24) at 24 weeks: The patients who reached plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level below the lower limit of detection (BLD) at 24 weeks after completion of all Hepatitis C virus (HCV) therapy.'}, {'measure': 'Viral Load (HCV RNA) at All Visits During Treatment and Follow-up', 'timeFrame': 'From baseline to 72 weeks', 'description': 'Viral load of Hepatitis C virus Ribonucleic acid (HCV RNA) at all visits during treatment (TRT) and follow-up, ie. change from baseline viral load at all visits.'}, {'measure': 'Time to Reach a Plasma HCV RNA Level BLD While on Treatment', 'timeFrame': '48 weeks', 'description': 'Time to reach a plasma Hepatitis C Virus Ribonucleic Acid (HCV RNA) level below the lower limit of detection (BLD) while on treatment'}, {'measure': 'Laboratory Test Abnormalities and Study Medication Tolerabilities', 'timeFrame': '48 weeks', 'description': 'Participants with possible clinically significant laboratory test abnormalities observed in functional groups: Haematology, Coagulation, Electrolytes, Enzymes, Substrates and Differentials, automatic.'}, {'measure': 'Number of Participants With Clinically Relevant Abnormalities Vital Signs, and Physical Examination', 'timeFrame': '48 weeks', 'description': 'No number of participants with clinically relevant abnormalities in vital signs and physical examination.'}, {'measure': 'Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (1)', 'timeFrame': 'baseline and 48 weeks', 'description': 'Change from baseline (CFB) in Red blood cells.'}, {'measure': 'Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (2)', 'timeFrame': 'baseline and 48 weeks', 'description': 'Change from baseline (CFB) in haematocrit and Eosinophils.'}, {'measure': 'Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (3)', 'timeFrame': 'baseline and 48 weeks', 'description': 'Change from baseline (CFB) in Platelets and white blood cells.'}, {'measure': 'Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (4)', 'timeFrame': 'baseline and 48 weeks', 'description': 'Change from baseline (CFB) in Sodium, Bicarbonate, Cholesterol total, Triglyceride, and Glucose.'}, {'measure': 'Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (5)', 'timeFrame': 'baseline and 48 weeks', 'description': 'Change from baseline (CFB) in AST/GOT, ALT/GPT, Alka. phosphatase, GGT, Creatine kinase, Lipase, and Amylase.'}, {'measure': 'Laboratory Test Value Changes Over Time for Selected Lab Test Parameters (6)', 'timeFrame': 'baseline and 48 weeks', 'description': 'Change from baseline (CFB) in PT-INR (ratio).'}]}, 'conditionsModule': {'conditions': ['Hepatitis C']}, 'referencesModule': {'references': [{'pmid': '24709256', 'type': 'DERIVED', 'citation': 'Dieterich D, Asselah T, Guyader D, Berg T, Schuchmann M, Mauss S, Ratziu V, Ferenci P, Larrey D, Maieron A, Stern JO, Ozan M, Datsenko Y, Bocher WO, Steinmann G. SILEN-C3, a phase 2 randomized trial with faldaprevir plus pegylated interferon alpha-2a and ribavirin in treatment-naive hepatitis C virus genotype 1-infected patients. Antimicrob Agents Chemother. 2014 Jun;58(6):3429-36. doi: 10.1128/AAC.02497-13. Epub 2014 Apr 7.'}]}, 'descriptionModule': {'briefSummary': 'To compare the antiviral efficacy and safety of a 12-week with a 24-week treatment of BI 201335 at a dose of 120 mg once daily, with a 24-week background of pegylated interferon-alpha 2a (PegIFN) plus ribavirin (RBV), in treatment-naïve patients infected with hepatitis C virus (HCV) genotype 1'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. Chronic hepatitis C infection of genotype 1\n2. Therapy-naïve to interferon, pegylated interferon, and ribavirin\n3. HCV viral load \\> 100.000 IU/ml at screening\n4. Liver biopsy or fibroscan within two years prior to screening that provides evidence of any degree of fibrosis or cirrhosis\n5. Normal retinal finding on fundoscopy within 6 months prior to Day 1\n6. Age 18 to 70 years\n\nExclusion criteria:\n\n1. HCV of mixed genotype (1/2, 1/3, and 1/4) .\n2. Patients who have been previously treated with at least one dose of any protease inhibitor\n3. Evidence of liver disease due to causes other than chronic HCV infection\n4. Positive for HIV-1 or HIV-2 antibodies\n5. Hepatitis B virus (HBV) infection\n6. Decompensated liver disease, or history of decompensated liver disease\n7. Active malignancy or history of malignancy within the last 5 years\n8. History of alcohol or drug abuse (except cannabis) within the past 12 months.\n9. Body Mass Index \\< 18 or \\> 35 kg/m2.\n10. Usage of any investigational drugs within 30 days prior to enrolment\n11. Alpha fetoprotein value \\>100ng/mL at screening;\n12. Total bilirubin \\> 1.5 x ULN with ratio of direct/indirect \\> 1.\n13. ALT or AST level \\> 10 x ULN'}, 'identificationModule': {'nctId': 'NCT00984620', 'briefTitle': 'Short Term Treatment With BI 201335, Peginterferon-alpha 2a and Ribavirin in Hepatitis c Virus Genotype-1 Treatment-naïve Patients (SILEN-C3)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Antiviral Effect and Safety of Once Daily BI 201335 NA in Hepatitis C Virus Genotype 1 Infected Treatment-naive Patients for 12 or 24 Weeks as Combination Therapy With Pegylated Interferon-alpha 2a and Ribavirin (Randomised, Open Label, Phase II)', 'orgStudyIdInfo': {'id': '1220.40'}, 'secondaryIdInfos': [{'id': '2009-012579-90', 'type': 'EUDRACT_NUMBER', 'domain': 'EudraCT'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'short arm', 'description': 'patients to receive BI201335 with PegIFN/RBV for 12 wks followed by 12 weeks PegIFN/RBV with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 NA 3 days after 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