Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2025-12-25 @ 11:44 PM
Study NCT ID:
NCT01318694
Status:
COMPLETED
Last Update Posted:
2016-09-30
First Post:
2011-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of Alisporivir Triple Therapy in Chronic Hepatitis C Genotype 1 Treatment-naïve Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Brazil', 'Turkey (Türkiye)']}, 'conditionBrowseModule': {'meshes': [{'id': 'D006526', 'term': 'Hepatitis C'}, {'id': 'D019698', 'term': 'Hepatitis C, Chronic'}], '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'}, {'id': 'D006521', 'term': 'Hepatitis, Chronic'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C499715', 'term': 'alisporivir'}, {'id': 'C100416', 'term': 'peginterferon alfa-2a'}, {'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': 'info-international@debiopharm.com', 'phone': '4121 321 01 11', 'title': 'Vice President Clinical Research & Development', 'organization': 'Debiopharm International S.A.'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'In April 2012, ALV and placebo were discontinued in all participants. Participants remained on PEG and RBV treatment.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Treatment Arm A', 'description': 'Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by an additional 23 or 47 weeks according to RGT', 'otherNumAtRisk': 273, 'otherNumAffected': 256, 'seriousNumAtRisk': 273, 'seriousNumAffected': 24}, {'id': 'EG001', 'title': 'Treatment Arm B', 'description': 'Alisporivir (ALV) 400 mg twice daily (BID) with PEG and RBV for 24 or 48 weeks according to response-guided treatment duration (RGT)', 'otherNumAtRisk': 268, 'otherNumAffected': 261, 'seriousNumAtRisk': 268, 'seriousNumAffected': 28}, {'id': 'EG002', 'title': 'Treatment Arm C', 'description': 'Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg QD for 47 weeks', 'otherNumAtRisk': 265, 'otherNumAffected': 250, 'seriousNumAtRisk': 265, 'seriousNumAffected': 21}, {'id': 'EG003', 'title': 'Treatment Arm D', 'description': 'ALV Placebo with PEG and RBV for 48 weeks', 'otherNumAtRisk': 265, 'otherNumAffected': 242, 'seriousNumAtRisk': 265, 'seriousNumAffected': 28}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 113}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 124}, {'groupId': 'EG002', 'numAtRisk': 265, 'numAffected': 91}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 88}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 48}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 265, 'numAffected': 48}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 27}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 265, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 8}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 86}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 80}, {'groupId': 'EG002', 'numAtRisk': 265, 'numAffected': 86}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 67}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 73}, {'groupId': 'EG002', 'numAtRisk': 265, 'numAffected': 49}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 16}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 265, 'numAffected': 23}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 12}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Ocular icterus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 265, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 265, 'numAffected': 22}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 265, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 265, 'numAffected': 38}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 37}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 265, 'numAffected': 32}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 265, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 66}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 67}, {'groupId': 'EG002', 'numAtRisk': 265, 'numAffected': 62}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 45}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 39}, {'groupId': 'EG002', 'numAtRisk': 265, 'numAffected': 29}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 19}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 46}, {'groupId': 'EG002', 'numAtRisk': 265, 'numAffected': 46}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 48}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 265, 'numAffected': 33}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 21}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 84}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 99}, {'groupId': 'EG002', 'numAtRisk': 265, 'numAffected': 87}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 86}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 56}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 52}, {'groupId': 'EG002', 'numAtRisk': 265, 'numAffected': 38}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 40}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 265, 'numAffected': 17}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 265, 'numAffected': 21}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 22}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 78}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 93}, {'groupId': 'EG002', 'numAtRisk': 265, 'numAffected': 82}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 74}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Hyperbilirubinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 61}, {'groupId': 'EG002', 'numAtRisk': 265, 'numAffected': 25}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Jaundice', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 265, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 265, 'numAffected': 17}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 265, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 265, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 265, 'numAffected': 26}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 18}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 61}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 59}, {'groupId': 'EG002', 'numAtRisk': 265, 'numAffected': 58}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 42}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Hypertriglyceridaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 265, 'numAffected': 22}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 14}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 35}, {'groupId': 'EG002', 'numAtRisk': 265, 'numAffected': 39}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 29}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 265, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 20}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 265, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 10}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 59}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 53}, {'groupId': 'EG002', 'numAtRisk': 265, 'numAffected': 56}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 52}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 34}, {'groupId': 'EG002', 'numAtRisk': 265, 'numAffected': 25}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 30}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 265, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 11}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 91}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 94}, {'groupId': 'EG002', 'numAtRisk': 265, 'numAffected': 94}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 80}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 265, 'numAffected': 25}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 29}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 29}, {'groupId': 'EG002', 'numAtRisk': 265, 'numAffected': 28}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 23}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 61}, {'groupId': 'EG002', 'numAtRisk': 265, 'numAffected': 50}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 60}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 54}, {'groupId': 'EG002', 'numAtRisk': 265, 'numAffected': 59}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 53}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 265, 'numAffected': 23}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 26}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 265, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 10}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 265, 'numAffected': 19}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 11}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 60}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 45}, {'groupId': 'EG002', 'numAtRisk': 265, 'numAffected': 57}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 47}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 23}, 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disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 265, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 265, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Vasculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 273, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 268, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 265, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 265, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Who Achieved Sustained Virologic Response (SVR) 12 Weeks After the End of Treatment (SVR12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '274', 'groupId': 'OG000'}, {'value': '270', 'groupId': 'OG001'}, {'value': '265', 'groupId': 'OG002'}, {'value': '268', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Arm A', 'description': 'Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by an additional 23 or 47 weeks according to RGT'}, {'id': 'OG001', 'title': 'Treatment Arm B', 'description': 'Alisporivir (ALV) 400 mg BID with PEG and RBV for 24 or 48 weeks according to RGT'}, {'id': 'OG002', 'title': 'Treatment Arm C', 'description': 'Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg QD for 47 weeks'}, {'id': 'OG003', 'title': 'Treatment Arm D', 'description': 'ALV Placebo with PEG and RBV for 48 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '68.6', 'groupId': 'OG000'}, {'value': '68.9', 'groupId': 'OG001'}, {'value': '69.4', 'groupId': 'OG002'}, {'value': '52.5', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks after the end of treatment', 'description': 'SVR12 was defined as hepatitis C virus (HCV) RNA laboratory value below the level of quantification (\\< LOQ; i.e., 25 IU/ml) 12 weeks after the end of treatment.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Achieved SVR 24 Weeks After the End of Treatment (SVR24)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '273', 'groupId': 'OG000'}, {'value': '268', 'groupId': 'OG001'}, {'value': '265', 'groupId': 'OG002'}, {'value': '265', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Arm A', 'description': 'Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by an additional 23 or 47 weeks according to RGT'}, {'id': 'OG001', 'title': 'Treatment Arm B', 'description': 'Alisporivir (ALV) 400 mg BID with PEG and RBV for 24 or 48 weeks according to RGT'}, {'id': 'OG002', 'title': 'Treatment Arm C', 'description': 'Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg QD for 47 weeks'}, {'id': 'OG003', 'title': 'Treatment Arm D', 'description': 'ALV Placebo with PEG and RBV for 48 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '68.5', 'groupId': 'OG000'}, {'value': '69.0', 'groupId': 'OG001'}, {'value': '68.3', 'groupId': 'OG002'}, {'value': '51.7', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 weeks after the end of treatment', 'description': 'SVR24 was defined as HCV RNA laboratory value \\< LOQ 24 weeks after the end of treatment.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set with available data'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Rapid Virologic Response (RVR) After 4 Weeks of Treatment (RVR4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '268', 'groupId': 'OG000'}, {'value': '258', 'groupId': 'OG001'}, {'value': '258', 'groupId': 'OG002'}, {'value': '261', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Arm A', 'description': 'Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by an additional 23 or 47 weeks according to RGT'}, {'id': 'OG001', 'title': 'Treatment Arm B', 'description': 'Alisporivir (ALV) 400 mg BID with PEG and RBV for 24 or 48 weeks according to RGT'}, {'id': 'OG002', 'title': 'Treatment Arm C', 'description': 'Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg QD for 47 weeks'}, {'id': 'OG003', 'title': 'Treatment Arm D', 'description': 'ALV Placebo with PEG and RBV for 48 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '60.1', 'groupId': 'OG000'}, {'value': '72.5', 'groupId': 'OG001'}, {'value': '56.6', 'groupId': 'OG002'}, {'value': '28.4', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'after 4 weeks of treatment', 'description': 'RVR4 was defined as serum HCV RNA \\< LOQ after 4 weeks of treatment.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set with available data'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Early Virologic Response (EVR) After 12 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'OG000'}, {'value': '242', 'groupId': 'OG001'}, {'value': '247', 'groupId': 'OG002'}, {'value': '256', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Arm A', 'description': 'Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by an additional 23 or 47 weeks according to RGT'}, {'id': 'OG001', 'title': 'Treatment Arm B', 'description': 'Alisporivir (ALV) 400 mg BID with PEG and RBV for 24 or 48 weeks according to RGT'}, {'id': 'OG002', 'title': 'Treatment Arm C', 'description': 'Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg QD for 47 weeks'}, {'id': 'OG003', 'title': 'Treatment Arm D', 'description': 'ALV Placebo with PEG and RBV for 48 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '97.7', 'groupId': 'OG000'}, {'value': '98.3', 'groupId': 'OG001'}, {'value': '99.6', 'groupId': 'OG002'}, {'value': '89.8', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'after 12 weeks of treatment', 'description': 'EVR was defined as a ≥ 2 log10 decrease in HCV RNA or HCV RNA \\< LOQ after 12 weeks of treatment.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set with available data'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Partial Early Virologic Response (pEVR) After 12 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'OG000'}, {'value': '242', 'groupId': 'OG001'}, {'value': '247', 'groupId': 'OG002'}, {'value': '256', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Arm A', 'description': 'Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by an additional 23 or 47 weeks according to RGT'}, {'id': 'OG001', 'title': 'Treatment Arm B', 'description': 'Alisporivir (ALV) 400 mg BID with PEG and RBV for 24 or 48 weeks according to RGT'}, {'id': 'OG002', 'title': 'Treatment Arm C', 'description': 'Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg QD for 47 weeks'}, {'id': 'OG003', 'title': 'Treatment Arm D', 'description': 'ALV Placebo with PEG and RBV for 48 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '8.1', 'groupId': 'OG000'}, {'value': '2.1', 'groupId': 'OG001'}, {'value': '10.5', 'groupId': 'OG002'}, {'value': '19.5', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'after 12 weeks of treatment', 'description': 'pEVR was defined as a ≥ 2 log10 decrease in HCV RNA and still detectable (≥ LOQ) after 12 weeks of treatment.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set with available data'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Complete Early Virologic Response (cEVR) After 12 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'OG000'}, {'value': '242', 'groupId': 'OG001'}, {'value': '247', 'groupId': 'OG002'}, {'value': '256', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Arm A', 'description': 'Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by an additional 23 or 47 weeks according to RGT'}, {'id': 'OG001', 'title': 'Treatment Arm B', 'description': 'Alisporivir (ALV) 400 mg BID with PEG and RBV for 24 or 48 weeks according to RGT'}, {'id': 'OG002', 'title': 'Treatment Arm C', 'description': 'Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg QD for 47 weeks'}, {'id': 'OG003', 'title': 'Treatment Arm D', 'description': 'ALV Placebo with PEG and RBV for 48 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '89.6', 'groupId': 'OG000'}, {'value': '96.3', 'groupId': 'OG001'}, {'value': '89.1', 'groupId': 'OG002'}, {'value': '70.3', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'after 12 weeks of treatment', 'description': 'cEVR was defined as serum HCV RNA \\< LOQ after 12 weeks of treatment.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set with available data'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Extended Rapid Virologic Response (eRVR) From 4 to 12 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '259', 'groupId': 'OG000'}, {'value': '242', 'groupId': 'OG001'}, {'value': '247', 'groupId': 'OG002'}, {'value': '256', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Arm A', 'description': 'Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by an additional 23 or 47 weeks according to RGT'}, {'id': 'OG001', 'title': 'Treatment Arm B', 'description': 'Alisporivir (ALV) 400 mg BID with PEG and RBV for 24 or 48 weeks according to RGT'}, {'id': 'OG002', 'title': 'Treatment Arm C', 'description': 'Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg QD for 47 weeks'}, {'id': 'OG003', 'title': 'Treatment Arm D', 'description': 'ALV Placebo with PEG and RBV for 48 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '60.2', 'groupId': 'OG000'}, {'value': '71.1', 'groupId': 'OG001'}, {'value': '56.7', 'groupId': 'OG002'}, {'value': '28.1', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'from 4 to 12 weeks of treatment', 'description': 'eRVR was defined as achieving RVR4 and maintaining HCV RNA \\< LOQ until Week 12.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set with available data'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With End of Treatment Response (ETR) at Treatment End Within 48 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'OG000'}, {'value': '268', 'groupId': 'OG001'}, {'value': '264', 'groupId': 'OG002'}, {'value': '265', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Arm A', 'description': 'Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by an additional 23 or 47 weeks according to RGT'}, {'id': 'OG001', 'title': 'Treatment Arm B', 'description': 'Alisporivir (ALV) 400 mg BID with PEG and RBV for 24 or 48 weeks according to RGT'}, {'id': 'OG002', 'title': 'Treatment Arm C', 'description': 'Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg QD for 47 weeks'}, {'id': 'OG003', 'title': 'Treatment Arm D', 'description': 'ALV Placebo with PEG and RBV for 48 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '88.2', 'groupId': 'OG000'}, {'value': '87.7', 'groupId': 'OG001'}, {'value': '87.5', 'groupId': 'OG002'}, {'value': '80.0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'at treatment end within 48 weeks', 'description': 'ETR was defined as serum HCV RNA \\< LOQ at treatment end (completed or prematurely discontinued).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set with available data'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Alanine Aminotransferase (ALT) Abnormalities Within 48 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'OG000'}, {'value': '267', 'groupId': 'OG001'}, {'value': '264', 'groupId': 'OG002'}, {'value': '264', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Arm A', 'description': 'Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by an additional 23 or 47 weeks according to RGT'}, {'id': 'OG001', 'title': 'Treatment Arm B', 'description': 'Alisporivir (ALV) 400 mg BID with PEG and RBV for 24 or 48 weeks according to RGT'}, {'id': 'OG002', 'title': 'Treatment Arm C', 'description': 'Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg QD for 47 weeks'}, {'id': 'OG003', 'title': 'Treatment Arm D', 'description': 'ALV Placebo with PEG and RBV for 48 weeks'}], 'classes': [{'title': '> 2 x ULN and > 2 x baseline', 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000'}, {'value': '0.4', 'groupId': 'OG001'}, {'value': '1.9', 'groupId': 'OG002'}, {'value': '1.5', 'groupId': 'OG003'}]}]}, {'title': '> 3 x ULN and > 2 x baseline', 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '1.5', 'groupId': 'OG002'}, {'value': '0.8', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'within 48 weeks', 'description': 'ALT abnormalities were summarized as participants who had either:\n\n* ALT \\> 2 x upper limit of normal (ULN) during the study and \\> 2 x ULN at baseline\n* ALT \\> 3 x ULN during the study and \\> 2 x ULN at baseline', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Safety Set, defined as having received at least one dose of study medication, with available data'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Grade 3 or 4 Anemia During Treatment Within 48 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'OG000'}, {'value': '267', 'groupId': 'OG001'}, {'value': '264', 'groupId': 'OG002'}, {'value': '264', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Arm A', 'description': 'Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by an additional 23 or 47 weeks according to RGT'}, {'id': 'OG001', 'title': 'Treatment Arm B', 'description': 'Alisporivir (ALV) 400 mg BID with PEG and RBV for 24 or 48 weeks according to RGT'}, {'id': 'OG002', 'title': 'Treatment Arm C', 'description': 'Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg QD for 47 weeks'}, {'id': 'OG003', 'title': 'Treatment Arm D', 'description': 'ALV Placebo with PEG and RBV for 48 weeks'}], 'classes': [{'title': 'Grade 3', 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000'}, {'value': '3.4', 'groupId': 'OG001'}, {'value': '0.8', 'groupId': 'OG002'}, {'value': '1.9', 'groupId': 'OG003'}]}]}, {'title': 'Grade 4', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.4', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'within 48 weeks', 'description': 'Grading was according to the Modified Division of Microbiology \\& Infectious Diseases (DMID) Toxicity Tables (version 2.0).\n\nParticipants with multiple abnormalities were counted only once in the worst category.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Safety Set with available data'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Grade 3 or 4 Neutropenia During Treatment Within 48 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'OG000'}, {'value': '263', 'groupId': 'OG001'}, {'value': '264', 'groupId': 'OG002'}, {'value': '264', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Arm A', 'description': 'Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by an additional 23 or 47 weeks according to RGT'}, {'id': 'OG001', 'title': 'Treatment Arm B', 'description': 'Alisporivir (ALV) 400 mg BID with PEG and RBV for 24 or 48 weeks according to RGT'}, {'id': 'OG002', 'title': 'Treatment Arm C', 'description': 'Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg QD for 47 weeks'}, {'id': 'OG003', 'title': 'Treatment Arm D', 'description': 'ALV Placebo with PEG and RBV for 48 weeks'}], 'classes': [{'title': 'Grade 3', 'categories': [{'measurements': [{'value': '24.4', 'groupId': 'OG000'}, {'value': '24.7', 'groupId': 'OG001'}, {'value': '23.1', 'groupId': 'OG002'}, {'value': '12.9', 'groupId': 'OG003'}]}]}, {'title': 'Grade 4', 'categories': [{'measurements': [{'value': '4.4', 'groupId': 'OG000'}, {'value': '8.0', 'groupId': 'OG001'}, {'value': '7.2', 'groupId': 'OG002'}, {'value': '2.7', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'within 48 weeks', 'description': 'Grading was according to the DMID Toxicity Tables (version 2.0). Participants with multiple abnormalities were counted only once in the worst category.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Safety Set with available data'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Grade 3 or 4 Thrombocytopenia During Treatment Within 48 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'OG000'}, {'value': '265', 'groupId': 'OG001'}, {'value': '264', 'groupId': 'OG002'}, {'value': '264', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Arm A', 'description': 'Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by an additional 23 or 47 weeks according to RGT'}, {'id': 'OG001', 'title': 'Treatment Arm B', 'description': 'Alisporivir (ALV) 400 mg BID with PEG and RBV for 24 or 48 weeks according to RGT'}, {'id': 'OG002', 'title': 'Treatment Arm C', 'description': 'Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg QD for 47 weeks'}, {'id': 'OG003', 'title': 'Treatment Arm D', 'description': 'ALV Placebo with PEG and RBV for 48 weeks'}], 'classes': [{'title': 'Grade 3', 'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000'}, {'value': '21.9', 'groupId': 'OG001'}, {'value': '12.5', 'groupId': 'OG002'}, {'value': '1.9', 'groupId': 'OG003'}]}]}, {'title': 'Grade 4', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.1', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'within 48 weeks', 'description': 'Grading was according to the DMID Toxicity Tables (version 2.0). Participants with multiple abnormalities were counted only once in the worst category.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Safety Set with available data'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment Arm A', 'description': 'Alisporivir (ALV) 600 mg twice daily (BID) with Peginterferon alfa-2a (PEG) and ribavirin (RBV) for 1 week, followed by an additional 23 or 47 weeks according to response-guided treatment duration (RGT)'}, {'id': 'FG001', 'title': 'Treatment Arm B', 'description': 'Alisporivir (ALV) 400 mg twice daily (BID) with PEG and RBV for 24 or 48 weeks according to response-guided treatment duration (RGT)'}, {'id': 'FG002', 'title': 'Treatment Arm C', 'description': 'Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg once daily (QD) for 47 weeks'}, {'id': 'FG003', 'title': 'Treatment Arm D', 'description': 'ALV Placebo with PEG and RBV for 48 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '275'}, {'groupId': 'FG001', 'numSubjects': '270'}, {'groupId': 'FG002', 'numSubjects': '268'}, {'groupId': 'FG003', 'numSubjects': '268'}]}, {'type': 'Full Analysis Set', 'achievements': [{'groupId': 'FG000', 'numSubjects': '274'}, {'groupId': 'FG001', 'numSubjects': '270'}, {'groupId': 'FG002', 'numSubjects': '265'}, {'groupId': 'FG003', 'numSubjects': '268'}]}, {'type': 'Safety Set', 'achievements': [{'groupId': 'FG000', 'numSubjects': '273'}, {'groupId': 'FG001', 'numSubjects': '268'}, {'groupId': 'FG002', 'numSubjects': '265'}, {'groupId': 'FG003', 'numSubjects': '265'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '223'}, {'groupId': 'FG001', 'numSubjects': '212'}, {'groupId': 'FG002', 'numSubjects': '225'}, {'groupId': 'FG003', 'numSubjects': '200'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '58'}, {'groupId': 'FG002', 'numSubjects': '43'}, {'groupId': 'FG003', 'numSubjects': '68'}]}]}], 'recruitmentDetails': 'Of the 1580 patients screened at multiple global sites, 1081 (68.4%) were randomized and 499 (31.6%) discontinued from the study prior to randomization.', 'preAssignmentDetails': 'Due to mis-randomization, four patients did not have a baseline visit and never started study medications. They were included in screened and randomized, but excluded from the Full Analysis Set and the Safety Set.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '274', 'groupId': 'BG000'}, {'value': '270', 'groupId': 'BG001'}, {'value': '265', 'groupId': 'BG002'}, {'value': '268', 'groupId': 'BG003'}, {'value': '1077', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment Arm A', 'description': 'Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by an additional 23 or 47 weeks according to RGT'}, {'id': 'BG001', 'title': 'Treatment Arm B', 'description': 'Alisporivir (ALV) 400 mg BID with PEG and RBV for 24 or 48 weeks according to RGT'}, {'id': 'BG002', 'title': 'Treatment Arm C', 'description': 'Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg QD for 47 weeks'}, {'id': 'BG003', 'title': 'Treatment Arm D', 'description': 'ALV Placebo with PEG and RBV for 48 weeks'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45.9', 'spread': '11.08', 'groupId': 'BG000'}, {'value': '45.8', 'spread': '11.95', 'groupId': 'BG001'}, {'value': '45.5', 'spread': '12.15', 'groupId': 'BG002'}, {'value': '46.3', 'spread': '11.53', 'groupId': 'BG003'}, {'value': '45.9', 'spread': '11.67', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '113', 'groupId': 'BG000'}, {'value': '106', 'groupId': 'BG001'}, {'value': '134', 'groupId': 'BG002'}, {'value': '114', 'groupId': 'BG003'}, {'value': '467', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '161', 'groupId': 'BG000'}, {'value': '164', 'groupId': 'BG001'}, {'value': '131', 'groupId': 'BG002'}, {'value': '154', 'groupId': 'BG003'}, {'value': '610', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Full Analysis Set (FAS), defined as all participants to whom study treatment was correctly assigned.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1081}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-05', 'studyFirstSubmitDate': '2011-03-17', 'resultsFirstSubmitDate': '2016-08-05', 'studyFirstSubmitQcDate': '2011-03-17', 'lastUpdatePostDateStruct': {'date': '2016-09-30', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-08-05', 'studyFirstPostDateStruct': {'date': '2011-03-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-09-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Who Achieved Sustained Virologic Response (SVR) 12 Weeks After the End of Treatment (SVR12)', 'timeFrame': '12 weeks after the end of treatment', 'description': 'SVR12 was defined as hepatitis C virus (HCV) RNA laboratory value below the level of quantification (\\< LOQ; i.e., 25 IU/ml) 12 weeks after the end of treatment.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Who Achieved SVR 24 Weeks After the End of Treatment (SVR24)', 'timeFrame': '24 weeks after the end of treatment', 'description': 'SVR24 was defined as HCV RNA laboratory value \\< LOQ 24 weeks after the end of treatment.'}, {'measure': 'Percentage of Participants With Rapid Virologic Response (RVR) After 4 Weeks of Treatment (RVR4)', 'timeFrame': 'after 4 weeks of treatment', 'description': 'RVR4 was defined as serum HCV RNA \\< LOQ after 4 weeks of treatment.'}, {'measure': 'Percentage of Participants With Early Virologic Response (EVR) After 12 Weeks of Treatment', 'timeFrame': 'after 12 weeks of treatment', 'description': 'EVR was defined as a ≥ 2 log10 decrease in HCV RNA or HCV RNA \\< LOQ after 12 weeks of treatment.'}, {'measure': 'Percentage of Participants With Partial Early Virologic Response (pEVR) After 12 Weeks of Treatment', 'timeFrame': 'after 12 weeks of treatment', 'description': 'pEVR was defined as a ≥ 2 log10 decrease in HCV RNA and still detectable (≥ LOQ) after 12 weeks of treatment.'}, {'measure': 'Percentage of Participants With Complete Early Virologic Response (cEVR) After 12 Weeks of Treatment', 'timeFrame': 'after 12 weeks of treatment', 'description': 'cEVR was defined as serum HCV RNA \\< LOQ after 12 weeks of treatment.'}, {'measure': 'Percentage of Participants With Extended Rapid Virologic Response (eRVR) From 4 to 12 Weeks of Treatment', 'timeFrame': 'from 4 to 12 weeks of treatment', 'description': 'eRVR was defined as achieving RVR4 and maintaining HCV RNA \\< LOQ until Week 12.'}, {'measure': 'Percentage of Participants With End of Treatment Response (ETR) at Treatment End Within 48 Weeks', 'timeFrame': 'at treatment end within 48 weeks', 'description': 'ETR was defined as serum HCV RNA \\< LOQ at treatment end (completed or prematurely discontinued).'}, {'measure': 'Percentage of Participants With Alanine Aminotransferase (ALT) Abnormalities Within 48 Weeks', 'timeFrame': 'within 48 weeks', 'description': 'ALT abnormalities were summarized as participants who had either:\n\n* ALT \\> 2 x upper limit of normal (ULN) during the study and \\> 2 x ULN at baseline\n* ALT \\> 3 x ULN during the study and \\> 2 x ULN at baseline'}, {'measure': 'Percentage of Participants With Grade 3 or 4 Anemia During Treatment Within 48 Weeks', 'timeFrame': 'within 48 weeks', 'description': 'Grading was according to the Modified Division of Microbiology \\& Infectious Diseases (DMID) Toxicity Tables (version 2.0).\n\nParticipants with multiple abnormalities were counted only once in the worst category.'}, {'measure': 'Percentage of Participants With Grade 3 or 4 Neutropenia During Treatment Within 48 Weeks', 'timeFrame': 'within 48 weeks', 'description': 'Grading was according to the DMID Toxicity Tables (version 2.0). Participants with multiple abnormalities were counted only once in the worst category.'}, {'measure': 'Percentage of Participants With Grade 3 or 4 Thrombocytopenia During Treatment Within 48 Weeks', 'timeFrame': 'within 48 weeks', 'description': 'Grading was according to the DMID Toxicity Tables (version 2.0). Participants with multiple abnormalities were counted only once in the worst category.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Chronic hepatitis C', 'Cyclophilin inhibitor'], 'conditions': ['Hepatitis C']}, 'descriptionModule': {'briefSummary': 'This study will assess the safety and efficacy of alisporivir (ALV; DEB025) triple therapy \\[i.e., when added to peginterferon alfa-2a (PEG) and ribavirin (RBV)\\] to optimize treatment in treatment-naïve participants with hepatitis C virus (HCV) genotype 1 (GT1)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Chronic HCV infection\n* HCV genotype 1\n* No previous treatment for hepatitis C infection\n* Serum HCV RNA level ≥ 1000 IU/ml assessed by quantitative polymerase chain reaction or equivalent at screening, no upper limit\n* Liver evaluation prior to baseline: liver biopsy within 3 years or Fibroscan within 6 months\n\nExclusion criteria:\n\n* HCV genotype different from genotype 1 or co-infection with other HCV genotype\n* Co-infection with Hepatitis B or HIV\n* Any other cause of relevant liver disease other than HCV\n* Presence or history of hepatic decompensation\n* Alanine aminotransferase (ALT) ≥ 10 times upper limit of normal (ULN), more than 1 episode of elevated bilirubin (\\> ULN) in past 6 months\n\nOther protocol-defined inclusion/exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT01318694', 'briefTitle': 'Efficacy and Safety of Alisporivir Triple Therapy in Chronic Hepatitis C Genotype 1 Treatment-naïve Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Debiopharm International SA'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled Trial of the Efficacy and Safety of DEB025/Alisporivir in Combination With Peg-IFNα2a and Ribavirin in Hepatitis C 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