Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2025-12-25 @ 9:25 PM
Study NCT ID:
NCT01280656
Status:
COMPLETED
Last Update Posted:
2016-11-29
First Post:
2011-01-20
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Retrospective Study to Assess the Impact of the Use of Interferon in Patients With Chronic Hepatitis C (DECISION)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019698', 'term': 'Hepatitis C, Chronic'}], 'ancestors': [{'id': 'D006526', 'term': 'Hepatitis C'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006521', 'term': 'Hepatitis, Chronic'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C100416', 'term': 'peginterferon alfa-2a'}, {'id': 'C417083', 'term': 'peginterferon alfa-2b'}, {'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': 'global.trial_information@roche.com', 'phone': '+41 61 6878333', 'title': 'Roche Trial Information Hotline', 'organization': 'F. Hoffmann-La Roche AG'}, 'certainAgreement': {'otherDetails': "The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to Week 72', 'description': 'Serious adverse events and non-serious adverse events are reported in ITT population set.', 'eventGroups': [{'id': 'EG000', 'title': 'Conventional Interferon Plus Ribavirin', 'description': 'Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were retrospectively assessed up to a minimum of 12 weeks after the end of therapy.', 'otherNumAtRisk': 62, 'otherNumAffected': 55, 'seriousNumAtRisk': 62, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Peginterferon Alfa-2a Plus Ribavirin', 'description': 'Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were retrospectively assessed up to a minimum of 12 weeks after the end of therapy', 'otherNumAtRisk': 312, 'otherNumAffected': 275, 'seriousNumAtRisk': 312, 'seriousNumAffected': 15}, {'id': 'EG002', 'title': 'Peginterferon Alfa-2b Plus Ribavirin', 'description': 'Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were retrospectively assessed up to a minimum of 12 weeks after the end of therapy.', 'otherNumAtRisk': 286, 'otherNumAffected': 262, 'seriousNumAtRisk': 286, 'seriousNumAffected': 9}], 'otherEvents': [{'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 286, 'numAffected': 26}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Itch', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 50}, {'groupId': 'EG002', 'numAtRisk': 286, 'numAffected': 44}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 286, 'numAffected': 16}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Pain in extremities', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 286, 'numAffected': 16}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Dorsalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 286, 'numAffected': 19}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 51}, {'groupId': 'EG002', 'numAtRisk': 286, 'numAffected': 33}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 75}, {'groupId': 'EG002', 'numAtRisk': 286, 'numAffected': 52}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Cachexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 286, 'numAffected': 17}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 109}, {'groupId': 'EG002', 'numAtRisk': 286, 'numAffected': 111}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Leucopaenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 286, 'numAffected': 20}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Neutropaenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 60}, {'groupId': 'EG002', 'numAtRisk': 286, 'numAffected': 45}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Thrombocytopaenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 286, 'numAffected': 21}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 67}, {'groupId': 'EG002', 'numAtRisk': 286, 'numAffected': 67}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 43}, {'groupId': 'EG002', 'numAtRisk': 286, 'numAffected': 30}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 286, 'numAffected': 25}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 286, 'numAffected': 27}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 286, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'High abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 286, 'numAffected': 23}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 57}, {'groupId': 'EG002', 'numAtRisk': 286, 'numAffected': 45}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 286, 'numAffected': 20}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 286, 'numAffected': 11}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 286, 'numAffected': 19}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 36}, {'groupId': 'EG002', 'numAtRisk': 286, 'numAffected': 35}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 41}, {'groupId': 'EG002', 'numAtRisk': 286, 'numAffected': 31}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 114}, {'groupId': 'EG002', 'numAtRisk': 286, 'numAffected': 107}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 286, 'numAffected': 30}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Flu condition', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 286, 'numAffected': 50}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 36}, {'groupId': 'EG002', 'numAtRisk': 286, 'numAffected': 35}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 286, 'numAffected': 21}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 65}, {'groupId': 'EG002', 'numAtRisk': 286, 'numAffected': 66}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}], 'seriousEvents': [{'term': 'Gallstones', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 286, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Multiple injuries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 286, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Thoracic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 286, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 286, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Diabetic Ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 286, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 286, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Bone marrow failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 286, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Neutropaenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 286, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Febrile neutropaenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 286, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Thrombocytopaenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 286, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Cryoglobulinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 286, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Breast mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 286, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 286, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 286, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 286, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 286, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 286, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 286, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Cell tissue inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 286, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 286, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Hepatocellular carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 286, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Vocal cord neoplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 286, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Breast tumour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 286, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 286, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'Thrombophlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 312, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 286, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Sustained Virologic Response at 12 Weeks After End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}, {'value': '101', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional Interferon Plus Ribavirin', 'description': 'Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).'}, {'id': 'OG001', 'title': 'Peginterferon Alfa-2a Plus Ribavirin', 'description': 'Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).'}, {'id': 'OG002', 'title': 'Peginterferon Alfa-2b Plus Ribavirin', 'description': 'Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '7.1', 'groupId': 'OG001'}, {'value': '20.8', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.003', 'groupIds': ['OG001', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 60', 'description': "Sustained virological response (SVR) was defined as virological response at 12 weeks after end of treatment (EOT). Virologic response was either defined as having undetectable (that is, no hepatitis C virus Ribonucleic acid \\[HCV RNA\\] was detected in the participants' plasma samples) or less than 50 international units/milliliter (IU/mL) HCV RNA (that is, the participants' plasma samples contained traces of HCV RNA at a concentration below the limit of quantification of the viral load assay or no HCV RNA was detected in the samples). EOT= Week 48. Participants who did not have viral load assessment at Week 12 were considered treatment failures, except in the specific case where the lack of assessment was not due to treatment shortening in function of response guided therapy.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent-to-treat (ITT) population consisted of participants who fulfilled all inclusion/ exclusion criteria. The analysis was performed in participants with virologic response at EOT in each group (16, 126, and 101 respectively).'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Sustained Virologic Response at 24 Weeks After End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}, {'value': '101', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional Interferon Plus Ribavirin', 'description': 'Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).'}, {'id': 'OG001', 'title': 'Peginterferon Alfa-2a Plus Ribavirin', 'description': 'Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).'}, {'id': 'OG002', 'title': 'Peginterferon Alfa-2b Plus Ribavirin', 'description': 'Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).'}], 'classes': [{'categories': [{'measurements': [{'value': '62.5', 'groupId': 'OG000'}, {'value': '74.6', 'groupId': 'OG001'}, {'value': '72.3', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.693', 'groupIds': ['OG001', 'OG002'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 72', 'description': "SVR was defined as virological response at 24 weeks after EOT, EOT= Week 48. Virologic response was either defined as having undetectable (that is, no hepatitis C virus Ribonucleic acid \\[HCV RNA\\] was detected in the participants' plasma samples) or less than 50 IU/mL HCV RNA (that is, the participants' plasma samples contained traces of HCV RNA at a concentration below the limit of quantification of the viral load assay or no HCV RNA was detected in the samples). Participants who did not have viral load assessment at Week 12 were considered treatment failures, except in the specific case where the lack of assessment was not due to treatment shortening in function of response guided therapy.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population consisted of participants who fulfilled all inclusion/ exclusion criteria. The analysis was performed in participants with virologic response at EOT in each group (16, 126, and 101 respectively).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Interferon Dose Reduction Rates in Function of the Interferon Type Being Used', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '302', 'groupId': 'OG001'}, {'value': '280', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional Interferon Plus Ribavirin', 'description': 'Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).'}, {'id': 'OG001', 'title': 'Peginterferon Alfa-2a Plus Ribavirin', 'description': 'Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).'}, {'id': 'OG002', 'title': 'Peginterferon Alfa-2b Plus Ribavirin', 'description': 'Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 24', 'description': 'The number of participants with Interferon dose reduction rates in function of the interferon type being used are reported', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population consisted of participants who fulfilled all inclusion/ exclusion criteria. The analysis was performed in the participants who were available for interferon dose reduction rates in each group (56, 302, and 280 respectively).'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Early Virologic Response at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '312', 'groupId': 'OG001'}, {'value': '286', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional Interferon Plus Ribavirin', 'description': 'Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).'}, {'id': 'OG001', 'title': 'Peginterferon Alfa-2a Plus Ribavirin', 'description': 'Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).'}, {'id': 'OG002', 'title': 'Peginterferon Alfa-2b Plus Ribavirin', 'description': 'Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).'}], 'classes': [{'categories': [{'measurements': [{'value': '14.5', 'groupId': 'OG000'}, {'value': '37.2', 'groupId': 'OG001'}, {'value': '35.0', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.573', 'groupIds': ['OG001', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 12', 'description': 'An early virologic response (EVR) was defined as a HCV-RNA decrease of at least two logarithmic scales (2 Log) or 100 times the pretreatment value or non-detection at Week 12 of treatment period.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population consisted of participants who fulfilled all inclusion/ exclusion criteria.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Sustained Virologic Response Treated at Interferon Application Centers and Treated at Home', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}, {'value': '92', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional Interferon Plus Ribavirin', 'description': 'Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).'}, {'id': 'OG001', 'title': 'Peginterferon Alfa-2a Plus Ribavirin', 'description': 'Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).'}, {'id': 'OG002', 'title': 'Peginterferon Alfa-2b Plus Ribavirin', 'description': 'Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).'}], 'classes': [{'title': 'SVR-12, treated at IAC (n=0, 40, 35)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'No participants were available for analysis in this arm.', 'groupId': 'OG000'}, {'value': '5.0', 'groupId': 'OG001'}, {'value': '2.9', 'groupId': 'OG002'}]}]}, {'title': 'SVR-12, treated at home (n=14, 81, 57)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '8.6', 'groupId': 'OG001'}, {'value': '33.3', 'groupId': 'OG002'}]}]}, {'title': 'SVR-24, treated at IAC (n=0, 40, 35)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'No participants were available for analysis in this arm.', 'groupId': 'OG000'}, {'value': '80.0', 'groupId': 'OG001'}, {'value': '77.1', 'groupId': 'OG002'}]}]}, {'title': 'SVR-24, treated at home (n=14, 81, 57)', 'categories': [{'measurements': [{'value': '64.3', 'groupId': 'OG000'}, {'value': '75.3', 'groupId': 'OG001'}, {'value': '68.4', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 60 (SVR 12) and Week 72 (SVR 24)', 'description': 'The percentage of participants with SVR-12 and SVR-24 treated at interferon application centers (IAC) and treated at home are presented.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population consisted of participants who fulfilled all inclusion/ exclusion criteria. The analysis was performed in participants with virologic response at EOT in each group excluding participants treated at an unknown location (2/16, 5/126, and 9/101 respectively).'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Were Treated at Interferon Application Centers and at Home and Discontinued Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '302', 'groupId': 'OG001'}, {'value': '263', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional Interferon Plus Ribavirin', 'description': 'Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).'}, {'id': 'OG001', 'title': 'Peginterferon Alfa-2a Plus Ribavirin', 'description': 'Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).'}, {'id': 'OG002', 'title': 'Peginterferon Alfa-2b Plus Ribavirin', 'description': 'Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).'}], 'classes': [{'title': 'At the site (n=0,98,126)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'No participants were available for analysis in this arm.', 'groupId': 'OG000'}, {'value': '17.4', 'groupId': 'OG001'}, {'value': '17.5', 'groupId': 'OG002'}]}]}, {'title': 'At home (n=55,204,137)', 'categories': [{'measurements': [{'value': '5.5', 'groupId': 'OG000'}, {'value': '11.8', 'groupId': 'OG001'}, {'value': '21.9', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.982', 'groupIds': ['OG001', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Mean at the site', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.012', 'groupIds': ['OG001', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Mean at home', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Week 48', 'description': 'The percentage of participants who were treated at interferon application centers and at home and who discontinued treatment is presented. Participants who did not have viral load assessment at Week 12 were considered treatment failures, except in the specific case where the lack of assessment was not due to treatment shortening in function of response guided therapy.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population consisted of participants who fulfilled all inclusion/ exclusion criteria. The analysis excluded participants treated at an unknown location (7/62, 10/312, and 23/286 respectively)'}, {'type': 'SECONDARY', 'title': 'Mean Percentage Reduction of Hemoglobin in Treatment Responders and Treatment Non-Responders', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional Interferon Plus Ribavirin', 'description': 'Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).'}, {'id': 'OG001', 'title': 'Peginterferon Alfa-2a Plus Ribavirin', 'description': 'Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).'}, {'id': 'OG002', 'title': 'Peginterferon Alfa-2b Plus Ribavirin', 'description': 'Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).'}], 'classes': [{'title': 'Responders (n=0,19,15)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'No participants were available for analysis in this arm.', 'groupId': 'OG000'}, {'value': '14.4', 'spread': '8.5', 'groupId': 'OG001'}, {'value': '15.8', 'spread': '10.3', 'groupId': 'OG002'}]}]}, {'title': 'Non-responders (n=10,54,48)', 'categories': [{'measurements': [{'value': '18.3', 'spread': '9.5', 'groupId': 'OG000'}, {'value': '9.8', 'spread': '27.7', 'groupId': 'OG001'}, {'value': '12.6', 'spread': '11.1', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.476', 'groupIds': ['OG001'], 'groupDescription': 'Responders vs Non-responders', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.320', 'groupIds': ['OG002'], 'groupDescription': 'Responders vs Non-Responders', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Up to Week 72', 'description': 'The average percentage reduction of hemoglobin (Hb) in treatment responders and treatment non-responders between the conventional group, peginterferon alfa-2a plus and peginterferon alfa-2b is presented. Participants with undetectable HCV RNA at specified time points (Weeks 4/12/18/24/48) were considered as treatment responders. Participants with positive viral load (detectable HCV RNA) at end of treatment regardless of the treatment duration were considered as treatment non-responders.', 'unitOfMeasure': 'mean percentage reduction of hemoglobin', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population consisted of participants who fulfilled all inclusion/ exclusion criteria. Treatment responders and non-responders for whom data was available were considered for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Rapid Virologic Response at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '312', 'groupId': 'OG001'}, {'value': '286', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional Interferon Plus Ribavirin', 'description': 'Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).'}, {'id': 'OG001', 'title': 'Peginterferon Alfa-2a Plus Ribavirin', 'description': 'Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).'}, {'id': 'OG002', 'title': 'Peginterferon Alfa-2b Plus Ribavirin', 'description': 'Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).'}], 'classes': [{'categories': [{'measurements': [{'value': '6.5', 'groupId': 'OG000'}, {'value': '21.2', 'groupId': 'OG001'}, {'value': '20.3', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.792', 'groupIds': ['OG001', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 4', 'description': 'Rapid virologic response was defined as qualitative or quantitative HCV-RNA (viral load) undetectable (below the lower limit of detection) at Week 4 of treatment period.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population consisted of participants who fulfilled all inclusion/ exclusion criteria.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Virologic Response at End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '312', 'groupId': 'OG001'}, {'value': '286', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional Interferon Plus Ribavirin', 'description': 'Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).'}, {'id': 'OG001', 'title': 'Peginterferon Alfa-2a Plus Ribavirin', 'description': 'Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).'}, {'id': 'OG002', 'title': 'Peginterferon Alfa-2b Plus Ribavirin', 'description': 'Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).'}], 'classes': [{'categories': [{'measurements': [{'value': '25.8', 'groupId': 'OG000'}, {'value': '40.4', 'groupId': 'OG001'}, {'value': '35.3', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.202', 'groupIds': ['OG001', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 48', 'description': 'Virologic response at EOT was defined as undetectable HCV-RNA at EOT (regardless in which week treatment was concluded). EOT = Week 48.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population consisted of participants who fulfilled all inclusion/ exclusion criteria.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Virologic Relapse up to Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}, {'value': '101', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional Interferon Plus Ribavirin', 'description': 'Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).'}, {'id': 'OG001', 'title': 'Peginterferon Alfa-2a Plus Ribavirin', 'description': 'Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).'}, {'id': 'OG002', 'title': 'Peginterferon Alfa-2b Plus Ribavirin', 'description': 'Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).'}], 'classes': [{'categories': [{'measurements': [{'value': '37.5', 'groupId': 'OG000'}, {'value': '22.2', 'groupId': 'OG001'}, {'value': '22.8', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.921', 'groupIds': ['OG001', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Week 72', 'description': 'Virologic relapse was defined as undetectable HCV-RNA at end of treatment and detectable HCV-RNA at the last follow-up assessment available. If the participant was a responder at end of treatment and was not submitted to any viral load assessment during the follow-up period, he was considered a relapser.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population consisted of participants who fulfilled all inclusion/ exclusion criteria. The analysis was performed in participants with virologic response at EOT in each group (16, 126, and 101 respectively).'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Null Response or No Responder at End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '312', 'groupId': 'OG001'}, {'value': '286', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional Interferon Plus Ribavirin', 'description': 'Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).'}, {'id': 'OG001', 'title': 'Peginterferon Alfa-2a Plus Ribavirin', 'description': 'Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).'}, {'id': 'OG002', 'title': 'Peginterferon Alfa-2b Plus Ribavirin', 'description': 'Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).'}], 'classes': [{'categories': [{'measurements': [{'value': '74.2', 'groupId': 'OG000'}, {'value': '59.6', 'groupId': 'OG001'}, {'value': '64.7', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.202', 'groupIds': ['OG001', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 48', 'description': 'Null response or no responders were defined as those participants presenting positive viral load at EOT (regardless of the treatment duration). EOT= Week 48.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population consisted of participants who fulfilled all inclusion/ exclusion criteria.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Discontinued Treatment Due to Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '312', 'groupId': 'OG001'}, {'value': '286', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional Interferon Plus Ribavirin', 'description': 'Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).'}, {'id': 'OG001', 'title': 'Peginterferon Alfa-2a Plus Ribavirin', 'description': 'Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).'}, {'id': 'OG002', 'title': 'Peginterferon Alfa-2b Plus Ribavirin', 'description': 'Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).'}], 'classes': [{'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000'}, {'value': '4.5', 'groupId': 'OG001'}, {'value': '4.6', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.973', 'groupIds': ['OG001', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Total', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Week 48', 'description': 'The percentage of participants with treatment discontinuation rates due to adverse events (AE) between conventional group, peginterferon alfa-2a and peginterferon alfa-2b is presented.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population consisted of participants who fulfilled all inclusion/ exclusion criteria.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Any Adverse Events and Any Serious Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '312', 'groupId': 'OG001'}, {'value': '286', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional Interferon Plus Ribavirin', 'description': 'Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).'}, {'id': 'OG001', 'title': 'Peginterferon Alfa-2a Plus Ribavirin', 'description': 'Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).'}, {'id': 'OG002', 'title': 'Peginterferon Alfa-2b Plus Ribavirin', 'description': 'Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).'}], 'classes': [{'title': 'any AE', 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '285', 'groupId': 'OG001'}, {'value': '264', 'groupId': 'OG002'}]}]}, {'title': 'any SAE', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Week 72', 'description': "An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event in the investigator's judgment or requires intervention to prevent one or other of these outcomes.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population consisted of participants who fulfilled all inclusion/ exclusion criteria.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Conventional Interferon Plus Ribavirin', 'description': 'Eligible participants who received conventional interferon plus ribavirin for Chronic Hepatitis C (CHC) according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).'}, {'id': 'FG001', 'title': 'Peginterferon Alfa-2a Plus Ribavirin', 'description': 'Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).'}, {'id': 'FG002', 'title': 'Peginterferon Alfa-2b Plus Ribavirin', 'description': 'Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '62'}, {'groupId': 'FG001', 'numSubjects': '312'}, {'groupId': 'FG002', 'numSubjects': '286'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}, {'groupId': 'FG001', 'numSubjects': '265'}, {'groupId': 'FG002', 'numSubjects': '223'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '47'}, {'groupId': 'FG002', 'numSubjects': '63'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '13'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '22'}, {'groupId': 'FG002', 'numSubjects': '38'}]}, {'type': 'Treatment shortening (RGT)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '7'}]}]}], 'recruitmentDetails': 'A total of 660 participants were enrolled from 39 centers in Brazil. The study was conducted from January 2010 to June 2013.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'BG000'}, {'value': '312', 'groupId': 'BG001'}, {'value': '286', 'groupId': 'BG002'}, {'value': '660', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Conventional Interferon Plus Ribavirin', 'description': 'Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).'}, {'id': 'BG001', 'title': 'Peginterferon Alfa-2a Plus Ribavirin', 'description': 'Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).'}, {'id': 'BG002', 'title': 'Peginterferon Alfa-2b Plus Ribavirin', 'description': 'Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50.4', 'spread': '8.6', 'groupId': 'BG000'}, {'value': '49.2', 'spread': '10.7', 'groupId': 'BG001'}, {'value': '49.5', 'spread': '9.5', 'groupId': 'BG002'}, {'value': '49.5', 'spread': '10.0', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '188', 'groupId': 'BG001'}, {'value': '147', 'groupId': 'BG002'}, {'value': '357', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '124', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}, {'value': '303', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 660}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-06', 'studyFirstSubmitDate': '2011-01-20', 'resultsFirstSubmitDate': '2016-08-02', 'studyFirstSubmitQcDate': '2011-01-20', 'lastUpdatePostDateStruct': {'date': '2016-11-29', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-08-02', 'studyFirstPostDateStruct': {'date': '2011-01-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-09-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Sustained Virologic Response at 12 Weeks After End of Treatment', 'timeFrame': 'At Week 60', 'description': "Sustained virological response (SVR) was defined as virological response at 12 weeks after end of treatment (EOT). Virologic response was either defined as having undetectable (that is, no hepatitis C virus Ribonucleic acid \\[HCV RNA\\] was detected in the participants' plasma samples) or less than 50 international units/milliliter (IU/mL) HCV RNA (that is, the participants' plasma samples contained traces of HCV RNA at a concentration below the limit of quantification of the viral load assay or no HCV RNA was detected in the samples). EOT= Week 48. Participants who did not have viral load assessment at Week 12 were considered treatment failures, except in the specific case where the lack of assessment was not due to treatment shortening in function of response guided therapy."}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Sustained Virologic Response at 24 Weeks After End of Treatment', 'timeFrame': 'At Week 72', 'description': "SVR was defined as virological response at 24 weeks after EOT, EOT= Week 48. Virologic response was either defined as having undetectable (that is, no hepatitis C virus Ribonucleic acid \\[HCV RNA\\] was detected in the participants' plasma samples) or less than 50 IU/mL HCV RNA (that is, the participants' plasma samples contained traces of HCV RNA at a concentration below the limit of quantification of the viral load assay or no HCV RNA was detected in the samples). Participants who did not have viral load assessment at Week 12 were considered treatment failures, except in the specific case where the lack of assessment was not due to treatment shortening in function of response guided therapy."}, {'measure': 'Number of Participants With Interferon Dose Reduction Rates in Function of the Interferon Type Being Used', 'timeFrame': 'At Week 24', 'description': 'The number of participants with Interferon dose reduction rates in function of the interferon type being used are reported'}, {'measure': 'Percentage of Participants With Early Virologic Response at Week 12', 'timeFrame': 'At Week 12', 'description': 'An early virologic response (EVR) was defined as a HCV-RNA decrease of at least two logarithmic scales (2 Log) or 100 times the pretreatment value or non-detection at Week 12 of treatment period.'}, {'measure': 'Percentage of Participants With Sustained Virologic Response Treated at Interferon Application Centers and Treated at Home', 'timeFrame': 'At Week 60 (SVR 12) and Week 72 (SVR 24)', 'description': 'The percentage of participants with SVR-12 and SVR-24 treated at interferon application centers (IAC) and treated at home are presented.'}, {'measure': 'Percentage of Participants Who Were Treated at Interferon Application Centers and at Home and Discontinued Treatment', 'timeFrame': 'Up to Week 48', 'description': 'The percentage of participants who were treated at interferon application centers and at home and who discontinued treatment is presented. Participants who did not have viral load assessment at Week 12 were considered treatment failures, except in the specific case where the lack of assessment was not due to treatment shortening in function of response guided therapy.'}, {'measure': 'Mean Percentage Reduction of Hemoglobin in Treatment Responders and Treatment Non-Responders', 'timeFrame': 'Up to Week 72', 'description': 'The average percentage reduction of hemoglobin (Hb) in treatment responders and treatment non-responders between the conventional group, peginterferon alfa-2a plus and peginterferon alfa-2b is presented. Participants with undetectable HCV RNA at specified time points (Weeks 4/12/18/24/48) were considered as treatment responders. Participants with positive viral load (detectable HCV RNA) at end of treatment regardless of the treatment duration were considered as treatment non-responders.'}, {'measure': 'Percentage of Participants With Rapid Virologic Response at Week 4', 'timeFrame': 'At Week 4', 'description': 'Rapid virologic response was defined as qualitative or quantitative HCV-RNA (viral load) undetectable (below the lower limit of detection) at Week 4 of treatment period.'}, {'measure': 'Percentage of Participants With Virologic Response at End of Treatment', 'timeFrame': 'At Week 48', 'description': 'Virologic response at EOT was defined as undetectable HCV-RNA at EOT (regardless in which week treatment was concluded). EOT = Week 48.'}, {'measure': 'Percentage of Participants With Virologic Relapse up to Week 72', 'timeFrame': 'Up to Week 72', 'description': 'Virologic relapse was defined as undetectable HCV-RNA at end of treatment and detectable HCV-RNA at the last follow-up assessment available. If the participant was a responder at end of treatment and was not submitted to any viral load assessment during the follow-up period, he was considered a relapser.'}, {'measure': 'Percentage of Participants With Null Response or No Responder at End of Treatment', 'timeFrame': 'At Week 48', 'description': 'Null response or no responders were defined as those participants presenting positive viral load at EOT (regardless of the treatment duration). EOT= Week 48.'}, {'measure': 'Percentage of Participants Who Discontinued Treatment Due to Adverse Events', 'timeFrame': 'Up to Week 48', 'description': 'The percentage of participants with treatment discontinuation rates due to adverse events (AE) between conventional group, peginterferon alfa-2a and peginterferon alfa-2b is presented.'}, {'measure': 'Number of Participants With Any Adverse Events and Any Serious Adverse Events', 'timeFrame': 'Up to Week 72', 'description': "An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event in the investigator's judgment or requires intervention to prevent one or other of these outcomes."}]}, 'conditionsModule': {'conditions': ['Hepatitis C, Chronic']}, 'descriptionModule': {'briefSummary': 'This retrospective study will assess the sustained virologic response and the safety of two different interferons (pegylated or conventional) in patients with chronic hepatitis C. Data will be collected for 24 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Hepatitis C patients that received interferon (pegylated or conventional) during the period stipulated (from 01-Sep-2007 to 31-Aug-2008)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients, \\>/=18 years and \\<70 years of age\n* Diagnosis of hepatitis C\n* Assessment of viral load prior to treatment (mandatory for genotype 1 only)\n* Liver biopsy\n* Co-morbidities data\n* Use of interferon (pegylated or conventional) and ribavirin to treat hepatitis C infection genotype 2 and 3 and pegylated interferon plus ribavirin to treat hepatitis C infection genotype 1\n* Above mentioned treatment started between 01-Sep-2007 and 31-Aug-2008\n\nExclusion Criteria:\n\n* Co-infection with human immunodeficiency virus\n* Co-infection with hepatitis B virus\n* Presence of hepatocarcinoma\n* Patients submitted to hemodialysis\n* Organ transplant patients'}, 'identificationModule': {'nctId': 'NCT01280656', 'briefTitle': 'A Retrospective Study to Assess the Impact of the Use of Interferon in Patients With Chronic Hepatitis C (DECISION)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'Retrospective Study to Evaluate the Impact of Using Interferon (Pegylated or Not) in the Treatment of Patients With Chronic Hepatitis C in Brazil (DECISION)', 'orgStudyIdInfo': {'id': 'ML22995'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Conventional Interferon Plus Ribavirin', 'description': 'Eligible participants who will receive conventional interferon plus ribavirin for Chronic Hepatitis C (CHC) according to the standard of care and aligned with the local prescription instructions will be observed during treatment period (48 weeks) and follow up period (24 weeks).', 'interventionNames': ['Drug: Conventional Interferon', 'Drug: Ribavirin']}, {'label': 'Peginterferon Alfa-2a Plus Ribavirin', 'description': 'Eligible participants who will receive peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions will be observed during treatment period (48 weeks) and follow up period (24 weeks).', 'interventionNames': ['Drug: Peginterferon Alfa-2a', 'Drug: Ribavirin']}, {'label': 'Peginterferon Alfa-2b Plus Ribavirin', 'description': 'Eligible participants who will receive peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions will be observed during treatment period (48 weeks) and follow up period (24 weeks).', 'interventionNames': ['Drug: Peginterferon Alfa-2b', 'Drug: Ribavirin']}], 'interventions': [{'name': 'Conventional Interferon', 'type': 'DRUG', 'description': 'Conventional interferon according to the standard of care and aligned with the local prescription instructions', 'armGroupLabels': ['Conventional Interferon Plus Ribavirin']}, {'name': 'Peginterferon Alfa-2a', 'type': 'DRUG', 'description': 'Peginterferon alfa-2a according to the standard of care and aligned with the local prescription instructions', 'armGroupLabels': ['Peginterferon Alfa-2a Plus Ribavirin']}, {'name': 'Peginterferon Alfa-2b', 'type': 'DRUG', 'description': 'Peginterferon alfa-2b according to the standard of care and aligned with the local prescription instructions', 'armGroupLabels': ['Peginterferon Alfa-2b Plus Ribavirin']}, {'name': 'Ribavirin', 'type': 'DRUG', 'description': 'Ribavirin according to the standard of care and aligned with the local prescription instructions', 'armGroupLabels': ['Conventional Interferon Plus Ribavirin', 'Peginterferon Alfa-2a Plus Ribavirin', 'Peginterferon Alfa-2b Plus Ribavirin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69908-210', 'city': 'Rio Branco', 'state': 'Acre', 'country': 'Brazil', 'geoPoint': {'lat': -9.97472, 'lon': -67.81}}, {'zip': '69040-000', 'city': 'Manaus', 'state': 'Amazonas', 'country': 'Brazil', 'geoPoint': {'lat': -3.10194, 'lon': -60.025}}, {'zip': '29043-260', 'city': 'Vitória', 'state': 'Espírito Santo', 'country': 'Brazil', 'geoPoint': {'lat': -20.31944, 'lon': -40.33778}}, {'zip': '41110-170', 'city': 'Salvador', 'state': 'Estado de Bahia', 'country': 'Brazil', 'geoPoint': {'lat': -12.97563, 'lon': -38.49096}}, {'zip': '74535170', 'city': 'Goiânia', 'state': 'Goiás', 'country': 'Brazil', 'geoPoint': {'lat': -16.67861, 'lon': -49.25389}}, {'zip': '65020560', 'city': 'São Luís', 'state': 'Maranhão', 'country': 'Brazil', 'geoPoint': {'lat': -2.52972, 'lon': -44.30278}}, {'zip': '79034-000', 'city': 'Campo Grande - MS', 'state': 'Mato Grosso do Sul', 'country': 'Brazil'}, {'zip': '37550-000', 'city': 'Pouso Alegre', 'state': 'Minas Gerais', 'country': 'Brazil', 'geoPoint': {'lat': -22.23, 'lon': -45.93639}}, {'zip': '38025-180', 'city': 'Uberaba', 'state': 'Minas Gerais', 'country': 'Brazil', 'geoPoint': {'lat': -19.74833, 'lon': -47.93194}}, {'zip': '80060-900', 'city': 'Curitiba', 'state': 'Paraná', 'country': 'Brazil', 'geoPoint': {'lat': -25.42778, 'lon': -49.27306}}, {'zip': '80810-040', 'city': 'Curitiba', 'state': 'Paraná', 'country': 'Brazil', 'geoPoint': {'lat': -25.42778, 'lon': -49.27306}}, {'zip': '66050-380', 'city': 'Belém', 'state': 'Pará', 'country': 'Brazil', 'geoPoint': {'lat': -1.45583, 'lon': -48.50444}}, {'zip': '50100-130', 'city': 'Recife', 'state': 'Pernambuco', 'country': 'Brazil', 'geoPoint': {'lat': -8.05389, 'lon': -34.88111}}, {'zip': '50670-420', 'city': 'Recife', 'state': 'Pernambuco', 'country': 'Brazil', 'geoPoint': {'lat': -8.05389, 'lon': -34.88111}}, {'zip': '24033-900', 'city': 'Niterói', 'state': 'Rio de Janeiro', 'country': 'Brazil', 'geoPoint': {'lat': -22.88333, 'lon': -43.10361}}, {'zip': '26030-380', 'city': 'Nova Iguaçu', 'state': 'Rio de Janeiro', 'country': 'Brazil', 'geoPoint': {'lat': -22.75917, 'lon': -43.45111}}, {'zip': '20270-004', 'city': 'Rio de Janeiro', 'state': 'Rio de Janeiro', 'country': 'Brazil', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}, {'zip': '90035-003', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'zip': '90610-000', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'zip': '96200-310', 'city': 'Rio Grande', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'geoPoint': {'lat': -32.035, 'lon': -52.09861}}, {'zip': '78812-329', 'city': 'Porto Velho', 'state': 'Rondônia', 'country': 'Brazil', 'geoPoint': {'lat': -8.76194, 'lon': -63.90389}}, {'zip': '15090-000', 'city': 'Sao Jose Do Rio Preto', 'state': 'Santa Catarina', 'country': 'Brazil'}, {'zip': '49060-100', 'city': 'Aracaju', 'state': 'Sergipe', 'country': 'Brazil', 'geoPoint': {'lat': -10.91111, 'lon': -37.07167}}, {'zip': '18600-400', 'city': 'Botucatu', 'state': 'São Paulo', 'country': 'Brazil', 'geoPoint': {'lat': -22.88583, 'lon': -48.445}}, {'zip': '13060-803', 'city': 'Campinas', 'state': 'São Paulo', 'country': 'Brazil', 'geoPoint': {'lat': -22.90556, 'lon': -47.06083}}, {'zip': '14049-900', 'city': 'Ribeirão Preto', 'state': 'São Paulo', 'country': 'Brazil', 'geoPoint': {'lat': -21.1775, 'lon': -47.81028}}, {'zip': '14085-410', 'city': 'Ribeirão Preto', 'state': 'São Paulo', 'country': 'Brazil', 'geoPoint': {'lat': -21.1775, 'lon': -47.81028}}, {'zip': '09060-650', 'city': 'Santo André', 'state': 'São Paulo', 'country': 'Brazil', 'geoPoint': {'lat': -23.66389, 'lon': -46.53833}}, {'zip': '11015470', 'city': 'Santos', 'state': 'São Paulo', 'country': 'Brazil', 'geoPoint': {'lat': -23.96083, 'lon': -46.33361}}, {'zip': '01246-000', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '01323-020', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '04039-004', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '04040-002', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '04040-003', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '05403-000', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '05403-010', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '18047-600', 'city': 'Sorocaba', 'state': 'São Paulo', 'country': 'Brazil', 'geoPoint': {'lat': -23.50167, 'lon': -47.45806}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}