Viewing Study NCT01659567

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Ignite Creation Date: 2025-12-25 @ 12:44 AM
Ignite Modification Date: 2026-02-03 @ 4:18 AM
Study NCT ID: NCT01659567
Status: COMPLETED
Last Update Posted: 2017-10-03
First Post: 2012-07-27
Is Gene Therapy: True
Has Adverse Events: True
Brief Title: A Study of Predictors of the Effectiveness of Pegylated Interferon in a Cohort of Participants With Hepatitis C
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

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': 'D012254', 'term': 'Ribavirin'}], 'ancestors': [{'id': 'D012263', 'term': 'Ribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'genentech@druginfo.com', 'phone': '800-821-8590', 'title': 'Medical Communications', 'organization': 'Hoffmann-La Roche'}, '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': 'Baseline up to 96 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Pegylated Interferon Alfa-2a and Ribavirin', 'description': 'Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, were observed for up to 96 weeks.', 'otherNumAtRisk': 516, 'otherNumAffected': 256, 'seriousNumAtRisk': 516, 'seriousNumAffected': 17}], 'otherEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 10}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bilirubinemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Thyrotoxicosis second degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 16}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Thrombocytopenia second degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Thrombocytopenia third degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Leukopenia second degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Leukopenia third degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 14}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Neutropenia second degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Neutropenia third degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 23}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Liver enzymes incresed (ALT, AST other)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'ST elevation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Paresthesia (numbness in hands)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hemorrhoid varicose veins', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hyperemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Alopecia/hair loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Itching/pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 9}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Anal itching', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Herpes rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Left nostril furuncle', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Sweating - general', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Toxidermia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Sty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 65}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 18}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Muscle weakness in legs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Allergic reactions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 8}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Autoimmune thyroiditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 2}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 31}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Sexual potency impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Flue-like syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 15}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Sour throat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Heartburn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abdominal pain upper/epigastric pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Meteorism (flatulence)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 128}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Adynamy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'General weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 75}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Rigors', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Sweating - general', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Blurred vision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Earache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pollakiuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Scalding during urination/urine scald', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Sexual potency impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Weight decrease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Loss of appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 10}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 10}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 11}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Emotional liability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Anemia fourth degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Thrombocytopenia fourth degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Neutropenia fourth degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypoalbuminemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Rectal bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lingual bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Tachyarrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 516, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Achieving Sustained Virological Response (SVR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pegylated Interferon Alfa-2a and Ribavirin', 'description': 'Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, were observed for up to 96 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '79.1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 24 weeks after end of treatment (EOT) (up to 96 weeks), where EOT = up to 72 weeks', 'description': 'SVR was defined as hepatitis C virus (HCV) ribonucleic acid (RNA) level undetectable (less than \\[\\<\\] 15 international units per milliliter \\[IU/mL\\]) 24 weeks after completion of the actual treatment period (measured using the COBAS AmpliPrep \\[CAP\\]/ COBAS TaqMan \\[CTM\\] test). Percentage of participants achieving SVR was reported.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis population included all treated participants. Here, 'Number of Participants Analyzed' = participants evaluable for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Positive Predictive Value (PPV) of Rapid Viral Response (RVR) on SVR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pegylated Interferon Alfa-2a and Ribavirin', 'description': 'Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, were observed for up to 96 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '93.1', 'groupId': 'OG000', 'lowerLimit': '89.3', 'upperLimit': '96.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 24 weeks after EOT (up to 96 weeks), where EOT = up to 72 weeks', 'description': 'RVR was defined as HCV RNA less than or equal to (\\<=) 25 IU/mL at Week 4 using CAP/CTM test. The percentage of participants with probability that the participant who develops RVR would achieve SVR was termed as PPV of RVR on SVR. SVR was defined as HCV RNA level undetectable (\\<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis population included all treated participants. Here, 'Number of Participants Analyzed' = participants evaluable for this outcome measure."}, {'type': 'PRIMARY', 'title': 'PPV of Complete Early Viral Response (cEVR) on SVR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pegylated Interferon Alfa-2a and Ribavirin', 'description': 'Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, were observed for up to 96 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '60.3', 'groupId': 'OG000', 'lowerLimit': '48.3', 'upperLimit': '72.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 24 weeks after EOT (up to 96 weeks), where EOT = up to 72 weeks', 'description': 'cEVR was defined as HCV RNA \\<=25 IU/mL at Week 12, but not at Week 4 using CAP/CTM test. The percentage of participants with probability that the participant who develops cEVR would achieve SVR was termed as PPV of cEVR on SVR. SVR was defined as HCV RNA level undetectable (\\<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis population included all treated participants. Here, 'Number of Participants Analyzed' = participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Odds Ratio (OR) for Impact of Age on SVR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pegylated Interferon Alfa-2a and Ribavirin', 'description': 'Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, were observed for up to 96 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.21', 'groupId': 'OG000', 'lowerLimit': '0.10', 'upperLimit': '0.47'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)', 'description': 'The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of age (greater than \\[\\>\\] 42 years versus \\<=42 years) on SVR. SVR was defined as HCV RNA level undetectable (\\<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).', 'unitOfMeasure': 'odds ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis population included all treated participants. Here, 'Number of Participants Analyzed' = participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'OR for Impact of Gender on SVR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pegylated Interferon Alfa-2a and Ribavirin', 'description': 'Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, were observed for up to 96 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.48', 'groupId': 'OG000', 'lowerLimit': '0.13', 'upperLimit': '1.69'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)', 'description': 'The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of gender (male versus female) on SVR. SVR was defined as HCV RNA level undetectable (\\<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).', 'unitOfMeasure': 'odds ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis population included all treated participants. Here, 'Number of Participants Analyzed' = participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'OR for Impact of Body Weight on SVR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '516', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pegylated Interferon Alfa-2a and Ribavirin', 'description': 'Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, were observed for up to 96 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.01', 'groupId': 'OG000', 'lowerLimit': '0.99', 'upperLimit': '1.02'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)', 'description': 'The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of body weight on SVR. SVR was defined as HCV RNA level undetectable (\\<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).', 'unitOfMeasure': 'odds ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all treated participants.'}, {'type': 'SECONDARY', 'title': 'OR for Impact of Baseline Level of Fibrosis (kPa) on SVR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pegylated Interferon Alfa-2a and Ribavirin', 'description': 'Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, were observed for up to 96 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.53', 'groupId': 'OG000', 'lowerLimit': '0.38', 'upperLimit': '0.74'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)', 'description': 'The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of baseline level of fibrosis on SVR. Level of fibrosis was measured in terms of kilopascals (kPa) using elastography. kPa score was categorized in 4 groups: 0 to 6.0; 6.1 to 9.9; 10.0 to 14.5; and 14.6 and above. SVR was defined as HCV RNA level undetectable (\\<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).', 'unitOfMeasure': 'odds ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis population included all treated participants. Here, 'Number of Participants Analyzed' = participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'OR for Impact of Baseline Alanine Transaminase (ALT) Level on SVR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pegylated Interferon Alfa-2a and Ribavirin', 'description': 'Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, were observed for up to 96 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.12', 'groupId': 'OG000', 'lowerLimit': '0.02', 'upperLimit': '0.92'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)', 'description': 'The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of baseline ALT level (\\>40 international units per liter \\[IU/L\\] versus \\<=40 IU/L) on SVR. SVR was defined as HCV RNA level undetectable (\\<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).', 'unitOfMeasure': 'odds ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis population included all treated participants. Here, 'Number of Participants Analyzed' = participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'OR for Impact of Baseline Viral Load Count on SVR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pegylated Interferon Alfa-2a and Ribavirin', 'description': 'Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, were observed for up to 96 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.07', 'groupId': 'OG000', 'lowerLimit': '0.56', 'upperLimit': '2.03'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)', 'description': 'The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of baseline viral load count (\\>800000 IU/mL versus \\<=800000 IU/mL) on SVR. SVR was defined as HCV RNA level undetectable (\\<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).', 'unitOfMeasure': 'odds ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Analysis population included all treated participants. Here, 'Number of Participants Analyzed' = participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'OR for Impact of Overall Duration of Treatment on SVR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '516', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pegylated Interferon Alfa-2a and Ribavirin', 'description': 'Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, were observed for up to 96 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.05', 'groupId': 'OG000', 'lowerLimit': '0.59', 'upperLimit': '1.86'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 96 weeks (assessed at Baseline, EOT, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)', 'description': 'The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of overall duration of treatment on SVR. SVR was defined as HCV RNA level undetectable (\\<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).', 'unitOfMeasure': 'odds ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all treated participants.'}, {'type': 'SECONDARY', 'title': 'OR for Impact of Duration of Treatment After Achieving RVR on SVR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '516', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pegylated Interferon Alfa-2a and Ribavirin', 'description': 'Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, were observed for up to 96 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.04', 'groupId': 'OG000', 'lowerLimit': '0.92', 'upperLimit': '1.18'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 96 weeks (assessed at Baseline, Week 4, EOT, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)', 'description': 'The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of duration of treatment after achieving RVR (\\>18 weeks versus \\<=18 weeks) on SVR. RVR was defined as HCV RNA \\<=25 IU/mL at Week 4 using CAP/CTM test. SVR was defined as HCV RNA level undetectable (\\<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).', 'unitOfMeasure': 'odds ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all treated participants.'}, {'type': 'SECONDARY', 'title': 'OR for Impact of Duration of Treatment After Achieving cEVR on SVR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '516', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pegylated Interferon Alfa-2a and Ribavirin', 'description': 'Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, were observed for up to 96 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.77', 'groupId': 'OG000', 'lowerLimit': '1.14', 'upperLimit': '6.72'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 96 weeks (assessed at Baseline, Weeks 4, 12, EOT, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)', 'description': 'The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of duration of treatment after achieving cEVR (\\>11 weeks versus \\<=11 weeks) on SVR. cEVR was defined as HCV RNA \\<=25 IU/mL at Week 12, but not at Week 4 using CAP/CTM test. SVR was defined as HCV RNA level undetectable (\\<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).', 'unitOfMeasure': 'odds ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all treated participants.'}, {'type': 'SECONDARY', 'title': 'OR for Impact of Cumulative Doses of Pegylated Interferon Alfa-2a on SVR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '516', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pegylated Interferon Alfa-2a and Ribavirin', 'description': 'Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, were observed for up to 96 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.99', 'groupId': 'OG000', 'lowerLimit': '0.99', 'upperLimit': '1.00'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 24 weeks after EOT (up to 96 weeks), where EOT = up to 72 weeks', 'description': 'The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of cumulative doses of pegylated interferon alfa-2a on SVR. SVR was defined as HCV RNA level undetectable (\\<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).', 'unitOfMeasure': 'odds ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all treated participants.'}, {'type': 'SECONDARY', 'title': 'OR for Impact of Cumulative Doses of Ribavirin on SVR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '516', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pegylated Interferon Alfa-2a and Ribavirin', 'description': 'Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, were observed for up to 96 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.99', 'groupId': 'OG000', 'lowerLimit': '0.99', 'upperLimit': '1.00'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 24 weeks after EOT (up to 96 weeks), where EOT = up to 72 weeks', 'description': 'The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of cumulative doses of ribavirin on SVR. SVR was defined as HCV RNA level undetectable (\\<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).', 'unitOfMeasure': 'odds ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all treated participants.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pegylated Interferon Alfa-2a and Ribavirin', 'description': 'Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, were observed for up to 96 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '516'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '393'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '123'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '22'}]}, {'type': 'Switched to Pegferon', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'Good result at early stage of treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '64'}]}, {'type': 'Progression of the main disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '516', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Pegylated Interferon Alfa-2a and Ribavirin', 'description': 'Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, were observed for up to 96 weeks.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '42.12', 'spread': '10.01', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '62', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '454', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Analysis population included all treated participants.'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 516}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2015-10-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-05', 'studyFirstSubmitDate': '2012-07-27', 'resultsFirstSubmitDate': '2017-05-05', 'studyFirstSubmitQcDate': '2012-08-07', 'lastUpdatePostDateStruct': {'date': '2017-10-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-05-05', 'studyFirstPostDateStruct': {'date': '2012-08-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-10-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-10-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Achieving Sustained Virological Response (SVR)', 'timeFrame': 'At 24 weeks after end of treatment (EOT) (up to 96 weeks), where EOT = up to 72 weeks', 'description': 'SVR was defined as hepatitis C virus (HCV) ribonucleic acid (RNA) level undetectable (less than \\[\\<\\] 15 international units per milliliter \\[IU/mL\\]) 24 weeks after completion of the actual treatment period (measured using the COBAS AmpliPrep \\[CAP\\]/ COBAS TaqMan \\[CTM\\] test). Percentage of participants achieving SVR was reported.'}, {'measure': 'Positive Predictive Value (PPV) of Rapid Viral Response (RVR) on SVR', 'timeFrame': 'At 24 weeks after EOT (up to 96 weeks), where EOT = up to 72 weeks', 'description': 'RVR was defined as HCV RNA less than or equal to (\\<=) 25 IU/mL at Week 4 using CAP/CTM test. The percentage of participants with probability that the participant who develops RVR would achieve SVR was termed as PPV of RVR on SVR. SVR was defined as HCV RNA level undetectable (\\<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).'}, {'measure': 'PPV of Complete Early Viral Response (cEVR) on SVR', 'timeFrame': 'At 24 weeks after EOT (up to 96 weeks), where EOT = up to 72 weeks', 'description': 'cEVR was defined as HCV RNA \\<=25 IU/mL at Week 12, but not at Week 4 using CAP/CTM test. The percentage of participants with probability that the participant who develops cEVR would achieve SVR was termed as PPV of cEVR on SVR. SVR was defined as HCV RNA level undetectable (\\<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).'}], 'secondaryOutcomes': [{'measure': 'Odds Ratio (OR) for Impact of Age on SVR', 'timeFrame': 'Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)', 'description': 'The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of age (greater than \\[\\>\\] 42 years versus \\<=42 years) on SVR. SVR was defined as HCV RNA level undetectable (\\<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).'}, {'measure': 'OR for Impact of Gender on SVR', 'timeFrame': 'Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)', 'description': 'The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of gender (male versus female) on SVR. SVR was defined as HCV RNA level undetectable (\\<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).'}, {'measure': 'OR for Impact of Body Weight on SVR', 'timeFrame': 'Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)', 'description': 'The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of body weight on SVR. SVR was defined as HCV RNA level undetectable (\\<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).'}, {'measure': 'OR for Impact of Baseline Level of Fibrosis (kPa) on SVR', 'timeFrame': 'Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)', 'description': 'The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of baseline level of fibrosis on SVR. Level of fibrosis was measured in terms of kilopascals (kPa) using elastography. kPa score was categorized in 4 groups: 0 to 6.0; 6.1 to 9.9; 10.0 to 14.5; and 14.6 and above. SVR was defined as HCV RNA level undetectable (\\<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).'}, {'measure': 'OR for Impact of Baseline Alanine Transaminase (ALT) Level on SVR', 'timeFrame': 'Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)', 'description': 'The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of baseline ALT level (\\>40 international units per liter \\[IU/L\\] versus \\<=40 IU/L) on SVR. SVR was defined as HCV RNA level undetectable (\\<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).'}, {'measure': 'OR for Impact of Baseline Viral Load Count on SVR', 'timeFrame': 'Baseline up to 96 weeks (assessed at Baseline, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)', 'description': 'The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of baseline viral load count (\\>800000 IU/mL versus \\<=800000 IU/mL) on SVR. SVR was defined as HCV RNA level undetectable (\\<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).'}, {'measure': 'OR for Impact of Overall Duration of Treatment on SVR', 'timeFrame': 'Baseline up to 96 weeks (assessed at Baseline, EOT, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)', 'description': 'The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of overall duration of treatment on SVR. SVR was defined as HCV RNA level undetectable (\\<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).'}, {'measure': 'OR for Impact of Duration of Treatment After Achieving RVR on SVR', 'timeFrame': 'Baseline up to 96 weeks (assessed at Baseline, Week 4, EOT, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)', 'description': 'The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of duration of treatment after achieving RVR (\\>18 weeks versus \\<=18 weeks) on SVR. RVR was defined as HCV RNA \\<=25 IU/mL at Week 4 using CAP/CTM test. SVR was defined as HCV RNA level undetectable (\\<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).'}, {'measure': 'OR for Impact of Duration of Treatment After Achieving cEVR on SVR', 'timeFrame': 'Baseline up to 96 weeks (assessed at Baseline, Weeks 4, 12, EOT, 24 weeks after EOT [up to 96 weeks], where EOT = up to 72 weeks)', 'description': 'The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of duration of treatment after achieving cEVR (\\>11 weeks versus \\<=11 weeks) on SVR. cEVR was defined as HCV RNA \\<=25 IU/mL at Week 12, but not at Week 4 using CAP/CTM test. SVR was defined as HCV RNA level undetectable (\\<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).'}, {'measure': 'OR for Impact of Cumulative Doses of Pegylated Interferon Alfa-2a on SVR', 'timeFrame': 'At 24 weeks after EOT (up to 96 weeks), where EOT = up to 72 weeks', 'description': 'The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of cumulative doses of pegylated interferon alfa-2a on SVR. SVR was defined as HCV RNA level undetectable (\\<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).'}, {'measure': 'OR for Impact of Cumulative Doses of Ribavirin on SVR', 'timeFrame': 'At 24 weeks after EOT (up to 96 weeks), where EOT = up to 72 weeks', 'description': 'The viral response development was assessed using univariate analysis with logistic regression model to calculate OR for impact of cumulative doses of ribavirin on SVR. SVR was defined as HCV RNA level undetectable (\\<15 IU/mL) 24 weeks after completion of the actual treatment period (measured using CAP/ CTM test).'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hepatitis C, Chronic']}, 'descriptionModule': {'briefSummary': 'This prospective observational study will investigate predictive values of virological response in pegylated interferon alfa-2a (Pegasys)/ribavirin (Copegus) treatment-naive participants with chronic hepatitis C. Participants will be treated with pegylated interferon alfa-2a and ribavirin as prescribed by the physician. Data will be collected for a maximum of 96 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult participants with chronic hepatitis C infection and naive to peginterferon/ribavirin treatment', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Diagnosis of chronic hepatitis C infection\n\nExclusion Criteria:\n\n* Co-infection with human immunodeficiency virus (HIV) and/or hepatitis B\n* Participants previously treated with pegylated interferon alfa-2a/ribavirin\n* Participation in another clinical study within 30 days prior to study start of ML25544'}, 'identificationModule': {'nctId': 'NCT01659567', 'briefTitle': 'A Study of Predictors of the Effectiveness of Pegylated Interferon in a Cohort of Participants With Hepatitis C', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'Prospective, Observational Study of Predictors of the Effectiveness of Pegylated Interferon in a Cohort of Patients With Hepatitis C in Georgia', 'orgStudyIdInfo': {'id': 'ML25544'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Chronic Hepatitis C', 'description': 'Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (Copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, will be observed for up to 96 weeks.', 'interventionNames': ['Drug: Pegylated Interferon Alfa-2a', 'Drug: Ribavirin']}], 'interventions': [{'name': 'Pegylated Interferon Alfa-2a', 'type': 'DRUG', 'otherNames': ['Pegasys'], 'description': 'Pegylated interferon alfa-2a will be administered according to the current standard of care and in line with current summaries of product characteristics/local labelling.', 'armGroupLabels': ['Chronic Hepatitis C']}, {'name': 'Ribavirin', 'type': 'DRUG', 'otherNames': ['Copegus'], 'description': 'Ribavirin will be administered according to the current standard of care and in line with current summaries of product characteristics/local labelling.', 'armGroupLabels': ['Chronic Hepatitis C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0159', 'city': 'Tbilisi', 'country': 'Georgia', 'facility': 'Hepatology Clinic Hepa', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'zip': '0160', 'city': 'Tbilisi', 'country': 'Georgia', 'facility': 'Infectious Diseases, AIDS and Clinical Immunology Research Center', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'zip': '0160', 'city': 'Tbilisi', 'country': 'Georgia', 'facility': 'Ltd Mrcheveli', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}