Viewing Study NCT00265395

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Ignite Creation Date: 2025-12-24 @ 2:07 PM
Ignite Modification Date: 2025-12-27 @ 9:16 PM
Study NCT ID: NCT00265395
Status: COMPLETED
Last Update Posted: 2017-04-05
First Post: 2005-12-13
Is Gene Therapy: True
Has Adverse Events: True
Brief Title: Extended Treatment With PEG-Intron® and Rebetol® in Patients With Genotype 1 Chronic Hepatitis C and Slow Virologic Response (Study P03685)
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Canada', 'Czechia', 'Finland', 'France', 'Germany', 'Israel', 'Poland', 'Portugal', 'Russia', 'Spain', 'Sweden', 'Switzerland']}, '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': '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': 'ClinicalTrialsDisclosure@merck.com', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp.'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Standard Therapy (48-week Treatment)', 'otherNumAtRisk': 1427, 'otherNumAffected': 1337, 'seriousNumAtRisk': 1427, 'seriousNumAffected': 93}], 'otherEvents': [{'term': 'ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 260, 'numAffected': 197}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'ERYTHROPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 96, 'numAffected': 74}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'LEUKOPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 268, 'numAffected': 183}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'NEUTROPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 464, 'numAffected': 281}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'ABDOMINAL PAIN UPPER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 112, 'numAffected': 94}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 152, 'numAffected': 129}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'DRY MOUTH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 75, 'numAffected': 75}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 301, 'numAffected': 254}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'ASTHENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 458, 'numAffected': 402}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'CHILLS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 204, 'numAffected': 153}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'FATIGUE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 412, 'numAffected': 338}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'INFLUENZA LIKE ILLNESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 843, 'numAffected': 599}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'INJECTION SITE ERYTHEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 152, 'numAffected': 143}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'IRRITABILITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 169, 'numAffected': 157}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'PYREXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 834, 'numAffected': 421}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'HAEMOGLOBIN DECREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 215, 'numAffected': 161}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'NEUTROPHIL COUNT DECREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 171, 'numAffected': 106}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'WEIGHT DECREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 169, 'numAffected': 150}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'WHITE BLOOD CELL COUNT DECREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 112, 'numAffected': 77}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'ANOREXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 160, 'numAffected': 156}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'DECREASED APPETITE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 107, 'numAffected': 103}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'ARTHRALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 235, 'numAffected': 195}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'BACK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 106, 'numAffected': 91}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'MYALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 417, 'numAffected': 274}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'DISTURBANCE IN ATTENTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 81, 'numAffected': 77}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'DIZZINESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 128, 'numAffected': 115}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 569, 'numAffected': 408}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'DEPRESSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 156, 'numAffected': 139}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'INSOMNIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 194, 'numAffected': 178}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'COUGH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 213, 'numAffected': 195}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'DYSPNOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 124, 'numAffected': 111}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'ALOPECIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 328, 'numAffected': 318}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'DRY SKIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 199, 'numAffected': 188}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'PRURITUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 290, 'numAffected': 267}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'RASH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 211, 'numAffected': 177}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'seriousEvents': [{'term': 'ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'FEBRILE NEUTROPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'PANCYTOPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'ATRIOVENTRICULAR BLOCK COMPLETE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'ATRIOVENTRICULAR BLOCK SECOND DEGREE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'BRADYCARDIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'MYOCARDIAL INFARCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'PALPITATIONS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'PERICARDIAL EFFUSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'SINUS BRADYCARDIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'VERTIGO', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'AUTOIMMUNE THYROIDITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'HYPERTHYROIDISM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'HYPOTHYROIDISM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'THYROIDITIS SUBACUTE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'RETINAL DETACHMENT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'RETINAL TEAR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'VISUAL DISTURBANCE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'ABDOMINAL PAIN LOWER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'COLITIS ULCERATIVE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'CONSTIPATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'GASTRITIS EROSIVE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'INTESTINAL OBSTRUCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'INTUSSUSCEPTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'PANCREATITIS NECROTISING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'SMALL INTESTINAL OBSTRUCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'VOLVULUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'VOMITING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'ASTHENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'PYREXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'CHOLECYSTITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'CHOLECYSTITIS ACUTE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'CHOLELITHIASIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'JAUNDICE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'HYPERSENSITIVITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'ABSCESS LIMB', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'ABSCESS ORAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'APPENDICITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'CELLULITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'CYTOMEGALOVIRUS INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'INFLUENZA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'INJECTION SITE ABSCESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'INJECTION SITE CELLULITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'LOBAR PNEUMONIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'ORCHITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'PNEUMONIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'PULMONARY TUBERCULOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'PYELONEPHRITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'SALMONELLOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'SEPTIC SHOCK', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'SYPHILIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'URINARY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'ALCOHOL POISONING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'CLAVICLE FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'CONCUSSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'CONTUSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'DISLOCATION OF VERTEBRA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'DRUG TOXICITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'INJURY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'MULTIPLE DRUG OVERDOSE INTENTIONAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'ROAD TRAFFIC ACCIDENT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'SCAPULA FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'UPPER LIMB FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'ARTERIOGRAM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'HEART RATE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'PLATELET COUNT DECREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'WHITE BLOOD CELL COUNT DECREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'DIABETES MELLITUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'HYPERCALCAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'HYPOGLYCAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'HYPONATRAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'ARTHRALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'ARTHRITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'BACK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'UNEQUAL LIMB LENGTH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'CERVIX CARCINOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'HEPATIC NEOPLASM MALIGNANT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'PARATHYROID TUMOUR BENIGN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'UTERINE LEIOMYOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'CAROTID ARTERY DISSECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'CAROTID ARTERY OCCLUSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'CEREBRAL INFARCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'CONVULSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'EPILEPSY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'GRAND MAL CONVULSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'MEMORY IMPAIRMENT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'MIGRAINE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'NERVOUS SYSTEM DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'PARKINSONISM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'SYNCOPE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'SYNCOPE VASOVAGAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'TREMOR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'ABORTION SPONTANEOUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'ALCOHOLISM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'ANXIETY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'BIPOLAR DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'COMPLETED SUICIDE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'DELIRIUM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'DEPRESSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'HALLUCINATION, AUDITORY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'HALLUCINATION, VISUAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'HOMICIDAL IDEATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'PANIC ATTACK', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'PARANOIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'PSYCHOTIC DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'SUICIDAL IDEATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'SUICIDE ATTEMPT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'OLIGURIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'METRORRHAGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'BRONCHITIS CHRONIC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'DYSPNOEA EXERTIONAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'HAEMOPNEUMOTHORAX', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'HAEMOPTYSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'INTERSTITIAL LUNG DISEASE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'OBLITERATIVE BRONCHIOLITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'ECZEMA NUMMULAR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'SKIN LESION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'ANAL FISSURE EXCISION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'THROMBOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1427, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Sustained Virologic Response, Defined as a Plasma HCV-RNA (Hepatitis C Ribonucleic Acid) Level Below the LLQ (Lower Level of Quantitation) at 24 Weeks Post-treatment.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Therapy (48-week Treatment)', 'description': 'Slow responders (defined as being polymerase chain reaction \\[PCR\\] positive at Week 12 with at least 2 log reduction in viral load and PCR negative at Week 24) who are randomized at Week 48 to stop treatment at Week 48.'}, {'id': 'OG001', 'title': 'Extended Therapy (72-week Treatment)', 'description': 'Slow responders (defined as being PCR positive at Week 12 with at least 2 log reduction in viral load and PCR negative at Week 24) who are randomized at Week 48 to continue treatment to Week 72.'}], 'classes': [{'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.6445', 'groupIds': ['OG000', 'OG001'], 'paramType': 'SVR Rate Difference', 'ciPctValue': '95', 'paramValue': '-4.9', 'ciLowerLimit': '-20.4', 'ciUpperLimit': '10.6', 'statisticalMethod': 'Asymptotic Z-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '48 or 72 weeks of treatment plus 24 weeks of follow-up.', 'description': 'LLQ = 30 IU/mL by reverse transcription polymerase chain reaction (RT-PCR) (Taqman Roche)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'According to the protocol, the efficacy analysis was carried out on all slow responders (ie, patients who had at least 2 log drop in HCV-RNA level at treatment week 12, and undetectable HCV-RNA at treatment week 24).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Standard Therapy (48-week Treatment)', 'description': 'Slow responders (defined as being polymerase chain reaction \\[PCR\\] positive at Week 12 with at least 2 log reduction in viral load and PCR negative at Week 24) who are randomized at Week 48 to stop treatment at Week 48.'}, {'id': 'FG001', 'title': 'Extended Therapy (72-week Treatment)', 'description': 'Slow responders (defined as being PCR positive at Week 12 with at least 2 log reduction in viral load and PCR negative at Week 24) who are randomized at Week 48 to continue treatment to Week 72.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '86'}, {'groupId': 'FG001', 'numSubjects': '73'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '78'}, {'groupId': 'FG001', 'numSubjects': '56'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '17'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Administrative', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': '1428 patients enrolled; 159 patients qualified as slow responders per treatment week 12 and 24 protocol-specified eligibility criteria; 159 patients were randomized'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '159', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Standard Therapy (48-week Treatment)', 'description': 'Slow responders (defined as being polymerase chain reaction \\[PCR\\] positive at Week 12 with at least 2 log reduction in viral load and PCR negative at Week 24) who are randomized at Week 48 to stop treatment at Week 48.'}, {'id': 'BG001', 'title': 'Extended Therapy (72-week Treatment)', 'description': 'Slow responders (defined as being PCR positive at Week 12 with at least 2 log reduction in viral load and PCR negative at Week 24) who are randomized at Week 48 to continue treatment to Week 72.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44.5', 'spread': '9.9', 'groupId': 'BG000'}, {'value': '46.5', 'spread': '11.6', 'groupId': 'BG001'}, {'value': '45.35', 'spread': '10.79', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1428}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-08', 'studyFirstSubmitDate': '2005-12-13', 'resultsFirstSubmitDate': '2009-05-15', 'studyFirstSubmitQcDate': '2005-12-13', 'lastUpdatePostDateStruct': {'date': '2017-04-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2009-05-15', 'studyFirstPostDateStruct': {'date': '2005-12-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-07-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sustained Virologic Response, Defined as a Plasma HCV-RNA (Hepatitis C Ribonucleic Acid) Level Below the LLQ (Lower Level of Quantitation) at 24 Weeks Post-treatment.', 'timeFrame': '48 or 72 weeks of treatment plus 24 weeks of follow-up.', 'description': 'LLQ = 30 IU/mL by reverse transcription polymerase chain reaction (RT-PCR) (Taqman Roche)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hepatitis C, Chronic']}, 'referencesModule': {'references': [{'pmid': '20683847', 'type': 'RESULT', 'citation': 'Buti M, Lurie Y, Zakharova NG, Blokhina NP, Horban A, Teuber G, Sarrazin C, Balciuniene L, Feinman SV, Faruqi R, Pedicone LD, Esteban R; SUCCESS Study Investigators. Randomized trial of peginterferon alfa-2b and ribavirin for 48 or 72 weeks in patients with hepatitis C virus genotype 1 and slow virologic response. Hepatology. 2010 Oct;52(4):1201-7. doi: 10.1002/hep.23816.'}]}, 'descriptionModule': {'briefSummary': 'This is a controlled, randomized, parallel-groups, open-label, multinational study designed to evaluate the efficacy and safety of PEG-Intron® (pegylated interferon alfa-2b) plus Rebetol® (ribavirin) in subjects with chronic hepatitis C. It is designed to evaluate whether 72 weeks of treatment with PEG-Intron plus Rebetol is more effective than 48 weeks of treatment in subjects with Genotype 1 chronic hepatitis C who exhibit a slow response to treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adult subjects aged 18 to 70 years, of either sex.\n* Genotype-1 hepatitis C virus (HCV)-ribonucleic acid (RNA)-positive subjects.\n* Subjects must be willing to give written informed consent and able to adhere to dosing and visit schedules.\n* Confirmation of liver biopsy availability: Availability of a liver biopsy performed within 18 months prior to the Screen visit, with a pathology report confirming the histological diagnosis of chronic hepatitis or liver cirrhosis.\n* Compensated liver disease with the following minimum hematological, biochemical, and serological criteria at the screen visit (WNL = within normal limits, ULN = Upper Limit Normal):\n\n * Hemoglobin values of equal or more than 12 g/dL for females and 13 g/dL for males.\n * White blood cells (WBCs) equal to or more than 3,000/mm\\^3\n * Neutrophil count equal to or more than 1,500/mm\\^3\n * Platelet count equal to or more than 80,000/mm\\^3\n * Direct bilirubin up to 10% above ULN is acceptable.\n * Indirect bilirubin up to 10% above ULN is acceptable (unless non-hepatitis related factors such as Gilbert's disease explain an indirect bilirubin rise). In such cases indirect bilirubin should be less than or equal to 3.0 mg/dL (less than or equal to 51.3 µmol/L)\n * Albumin up to 10% above ULN is acceptable.\n * Serum creatinine up to 10% above ULN is acceptable.\n * Alanine aminotransferase (ALT) level above ULN at Screen.\n* At the Screen Visit, fasting glucose must be 70-140 mg/dL. Results between 116-140 mg/dL require repeat fasting glucose to be less than 140 mg/dL and HbA1C less than or equal to 8.5%. HbA1C must be less than or equal to 8.5% in diabetic subjects (whether on medication or diet controlled).\n* Antinuclear antibodies (ANA) must be less than or equal to 1:320.\n* Thyroid Stimulating Hormone (TSH) WNL whether in euthyroid subjects or subjects requiring medical treatment. (subjects requiring medication to maintain TSH levels within normal limits are eligible if all other inclusion/exclusion criteria are met).\n* Confirmation by the principal investigator or a sub-investigator that sexually active females of childbearing potential are practicing adequate contraception.\n* Female subjects cannot be pregnant or breastfeeding and must be either postmenopausal, surgically sterile or using 2 methods of birth control. While abstinence from sexual activity is the only certain method to prevent pregnancy, female patients of childbearing potential who are or who anticipate the possibility of becoming sexually active with a male partner must use a combination of the following 2 methods :\n\n * Contraceptive pill or intrauterine device (IUD) or depot hormonal preparation (ring, injection implant) and\n * A barrier method of contraception such as diaphragm, sponge with spermicide, condom, or a method of birth control considered acceptable by the study physician. Contraceptive measures will be reviewed with female subjects at each visit. Dual methods of contraception must be used for 1 month prior to the start of treatment and 6 months after treatment discontinuation.\n* A serum pregnancy test obtained at Screen Visit prior to the initiation of treatment must be negative.\n* Confirmation by the principal investigator or a sub-investigator that sexually active male subjects are practicing a method of contraception considered acceptable (vasectomy, condom plus spermicide, plus relationship with a female partner who practices an acceptable method of contraception). Contraception must be used during the treatment period and for seven months (or 6 months, according to local label) after the completion of therapy, including condom use by male subjects with pregnant partners.\n* For subjects with a history of hypertension or diabetes, written clearance from an ophthalmologist has to be obtained prior to treatment start.\n\nExclusion Criteria:\n\n* Pregnant women, women who plan to become pregnant, male subjects whose partner wants to become pregnant, and breastfeeding women.\n* Previous treatment for chronic hepatitis C with an antiviral or immunomodulating agent or with some interferon or ribavirin product, whether alone or in combination.\n* Subjects weighing over 125 kg.\n* Suspected hypersensitivity to any interferon or ribavirin product.\n* Participation in other clinical trial within 30 days prior to screen into this study.\n* Coinfection with hepatitis B virus (HBV), human immunodeficiency virus (HIV), or both.\n* Any cause of liver disease other than chronic hepatitis C, including but not limited to:\n\n * Hemochromatosis\n * Alpha-1 antitrypsin deficiency\n * Wilson's disease\n * Autoimmune hepatitis\n * Alcoholic liver disease\n * Non-alcoholic steatohepatitis (NASH)\n * Drug-related liver disease\n* Active malignant disease or suspicion or history of malignant disease within five previous years (except for adequately treated basal cell carcinoma).\n* Known coagulation diseases such as hemophilia; hemoglobin diseases (e.g. thalassemia).\n* Known glucose 6-phosphate dehydrogenase (G6PD) deficiency\n* Evidence of advanced liver disease such as history or presence of ascites, bleeding varices, or hepatic encephalopathy.\n* Subjects with organ transplants, except for corneal or hair transplant.\n* Any known preexisting medical condition that could interfere with the subject's participation in and completion of study, such as:\n\n * Preexisting psychiatric condition, especially moderate to severe depression, or a history of severe psychiatric disorder, such as psychosis, suicidal ideation, or suicide attempts. Severe depression includes the following:\n\n * Hospitalization for depression\n * Electroconvulsive therapy for depression, or\n * Depression causing a prolonged absence from work or significantly altering daily functions.\n * Subjects with mild depression may be considered for entry into the study provided that a pre-treatment assessment demonstrates that the subject's emotional status is clinically stable, in which case a management plan must be formulated for the subject; this management plan will become a part of the subject's medical record.\n * Craniocerebral trauma which is not a concussion, or active seizure disorders requiring medication.\n * Clinically significant electrocardiogram (ECG) abnormalities and/or cardiovascular dysfunction within 6 previous months (e.g., angina, congestive heart failure, recent myocardial infarction, or significant arrhythmia).\n * Chronic lung disease (e.g., chronic obstructive lung disease)\n * Poorly controlled diabetes mellitus\n * Immune-mediated disease (e.g., inflammatory bowel disease \\[Crohn's disease, ulcerative colitis\\], idiopathic thrombocytopenic purpura, systemic lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis)\n * Clinical gout\n* Subject is or was a substance abuser, such as alcohol (80 g/day or more), methadone, intravenous(IV), oral or inhaled drugs. To be considered for inclusion into the protocol, the subject must have abstained and agree to abstain from using any of the above for at least 6 months. Subjects treated with buprenorphine (Subutex) who have been stable for 6 months may be included.\n* Cirrhotic subjects whose ultrasound confirms hepatocellular carcinoma.\n* Any other condition that, in the investigator's opinion, could determine that subject's participation in the study is not indicated or could interfere with the subject's participation in and completion of study.\n* Subjacent disease that potentially would require systematic administration of steroids\n* Insulin dependent diabetes mellitus"}, 'identificationModule': {'nctId': 'NCT00265395', 'briefTitle': 'Extended Treatment With PEG-Intron® and Rebetol® in Patients With Genotype 1 Chronic Hepatitis C and Slow Virologic Response (Study P03685)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Study to Assess Treatment With PEG-Intron® and Rebetol® in Naïve Patients With Genotype 1 Chronic Hepatitis C and Slow Virological Response', 'orgStudyIdInfo': {'id': 'P03685'}, 'secondaryIdInfos': [{'id': 'SUCCESS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard therapy', 'description': 'Slow responders (defined as being polymerase chain reaction \\[PCR\\] positive at Week 12 with at least 2 log reduction in viral load and PCR negative at Week 24) who are randomized at Week 48 to stop treatment at Week 48.', 'interventionNames': ['Drug: Combination of pegylated interferon alfa-2b (PEG-Intron®) and ribavirin (Rebetol®)']}, {'type': 'EXPERIMENTAL', 'label': 'Extended therapy', 'description': 'Slow responders (defined as being PCR positive at Week 12 with at least 2 log reduction in viral load and PCR negative at Week 24) who are randomized at Week 48 to continue treatment to Week 72.', 'interventionNames': ['Drug: Combination of pegylated interferon alfa-2b and ribavirin']}], 'interventions': [{'name': 'Combination of pegylated interferon alfa-2b (PEG-Intron®) and ribavirin (Rebetol®)', 'type': 'DRUG', 'otherNames': ['(a) SCH 54031; PEG-Intron; PegIntron; ViraferonPeg.', '(b) SCH 18908; Rebetol; REBETOL.'], 'description': '1. Powder for injection in vial or Redipen (50, 80, 100, 120, and 150 microgram strengths), subcutaneous, dose of 1.5 micrograms/kg, weekly for 48 weeks\n2. 200 mg capsules, oral, weight based dose of 800-1400 mg, daily for 48 weeks', 'armGroupLabels': ['Standard therapy']}, {'name': 'Combination of pegylated interferon alfa-2b and ribavirin', 'type': 'DRUG', 'otherNames': ['(a) SCH 54031; PEG-Intron; PegIntron; ViraferonPeg.', '(b) SCH 18908; Rebetol; REBETOL.'], 'description': '1. Powder for injection in vial or Redipen (50, 80, 100, 120, and 150 microgram strength), subcutaneous, dose of 1.5 micrograms/kg, weekly for 72 weeks.\n2. 200 mg capsules, oral, weight based dose of 800-1400 mg, daily for 72 weeks', 'armGroupLabels': ['Extended therapy']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\\_Updated%20July\\_9\\_2014.pdf\n\nhttp://engagezone.msd.com/ds\\_documentation.php'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}