Ignite Creation Date:
2025-12-24 @ 9:37 PM
Ignite Modification Date:
2025-12-30 @ 12:40 PM
Study NCT ID:
NCT00445432
Status:
COMPLETED
Last Update Posted:
2012-02-02
First Post:
2007-03-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Adalimumab for the Maintenance of Clinical Remission in Japanese Subjects With Crohn's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003424', 'term': 'Crohn Disease'}], 'ancestors': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068879', 'term': 'Adalimumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '800-633-9110', 'title': 'Global Medical Services', 'organization': 'Abbott'}, 'certainAgreement': {'otherDetails': 'Abbott requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Abbott requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Abbott needs to secure patent or proprietary protection.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '52 weeks for the double-blind (DB) treatments (adalimumab and placebo) and for the open-label adalimumab treatment. Overall study (maximum adalimumab treatment of 184 weeks plus 70-day follow-up period) for the Any Adalimumab group.', 'eventGroups': [{'id': 'EG000', 'title': 'DB Adalimumab 40 mg Eow', 'description': 'Double-blind adalimumab 40 mg every other week', 'otherNumAtRisk': 25, 'otherNumAffected': 17, 'seriousNumAtRisk': 25, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Placebo Eow', 'description': 'Double-blind adalimumab placebo every other week', 'otherNumAtRisk': 25, 'otherNumAffected': 13, 'seriousNumAtRisk': 25, 'seriousNumAffected': 6}, {'id': 'EG002', 'title': 'OL Adalimumab 40 mg Eow', 'description': 'Open-label adalimumab 40 mg every other week', 'otherNumAtRisk': 32, 'otherNumAffected': 28, 'seriousNumAtRisk': 32, 'seriousNumAffected': 13}, {'id': 'EG003', 'title': 'Any Adalimumab', 'description': 'All participants in this study who received at least 1 dose of adalimumab 40 mg every other week (double-blind or open-label).', 'otherNumAtRisk': 79, 'otherNumAffected': 73, 'seriousNumAtRisk': 79, 'seriousNumAffected': 49}], 'otherEvents': [{'term': "Crohn's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Dental caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Adverse drug reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 22}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 17}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 23}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 60}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Tinea pedis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Antinuclear antibody increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 16}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 12}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Ocular hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Periproctitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Herpes simplex', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Malnutrition', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Pharyngolaryngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 11}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 8}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Hepatic function abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 4}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Enteritis infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'C-reactive protein increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'DNA antibody positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Lymphocyte morphology abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 10}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Rhinitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 8}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Seborrhoeic dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}], 'seriousEvents': [{'term': "Crohn's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 26}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Intestinal perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Subileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Abdominal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Liver abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Perianal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Duodenal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Intestinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Enterocolitis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Malnutrition', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Cardiac disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Anal fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Anal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Large intestinal stricture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Small intestinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Systemic inflammatory response syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Bile duct stone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Cholangitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Subdiaphragmatic abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Anaemia postoperative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Blood phorphorus decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Depressed level of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Ovarian cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Acute respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Dyspnoea exertional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Pharyngolaryngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 79, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Who Had Clinical Remission at Week 52 of Double-blind Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DB Adalimumab 40 mg Eow', 'description': 'Double-blind adalimumab 40 mg every other week'}, {'id': 'OG001', 'title': 'Placebo Eow', 'description': 'Double-blind adalimumab placebo every other week'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 52 of double-blind treatment', 'description': "Clinical remission=Crohn's Disease (CD) Activity Index (CDAI) \\<150; number of soft stools, abdominal pain, general well-being, presence of 6 signs (arthritis/arthralgia; iritis/uveitis; erythema nodosum/pyoderma gangrenosum/aphthous stomatitis; fissure, abscess, anal fistula; other cutaneous fistula; fever over 100 degrees), taking medication for diarrhea, abdominal mass, hematocrit, and weight loss are documented during 1-week assessment period. CDAI total score is \\>= 0 and without upper limit. Low score=less severe CD activity. Decrease indicates improvement.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Full Analysis Set (mFAS), defined as participants who had received adalimumab (not placebo) during the adalimumab induction study and who received at least 1 dose of DB study drug during this study. Nonresponder imputation (NRI) (clinical remission not achieved) was used for missing data.'}, {'type': 'SECONDARY', 'title': "Number of Participants Who Had Clinical Response-70 (CR-70; a Decrease in Crohn's Disease Activity Index of at Least 70 Points From Lead-in Study [NCT00445939] Baseline Score) at Week 52 of Double-blind Treatment", 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'DB Adalimumab 40 mg Eow', 'description': 'Double-blind adalimumab 40 mg every other week'}, {'id': 'OG001', 'title': 'Placebo Eow', 'description': 'Double-blind adalimumab placebo every other week'}, {'id': 'OG002', 'title': 'OL Adalimumab 40 mg Eow', 'description': 'Open-label adalimumab 40 mg every other week'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 52 of double-blind treatment', 'description': "Crohn's Disease Activity Index (CDAI) documents number of soft stools, abdominal pain, general well-being, presence of 6 signs (arthritis/arthralgia; iritis/uveitis; erythema nodosum/pyoderma gangrenosum/aphthous stomatitis; fissure, abscess, anal fistula; other cutaneous fistula; fever over 100 degrees), taking medication for diarrhea, abdominal mass, hematocrit, and weight loss during a 1-week assessment period. CDAI has a total score \\>= 0 and without upper limit. Low score=less severe CD activity. Decrease in score indicates improvement.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'OL efficacy set (assigned to OL treatment at Week 0, received \\>= 1 dose of OL study drug) and mFAS (participants who had received adalimumab \\[not placebo\\] during adalimumab induction study and who received \\>= 1 dose of DB study drug during this study). Nonresponder imputation (NRI) (CR-70 not achieved) used for DB treatments; LOCF for OL treatment.'}, {'type': 'SECONDARY', 'title': "Number of Participants Who Had Clinical Response-100 (CR-100; a Decrease in Crohn's Disease Activity Index of at Least 100 Points From Lead-in Study [NCT00445939] Baseline Score) at Week 52 of Double-blind Treatment", 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'DB Adalimumab 40 mg Eow', 'description': 'Double-blind adalimumab 40 mg every other week'}, {'id': 'OG001', 'title': 'Placebo Eow', 'description': 'Double-blind adalimumab placebo every other week'}, {'id': 'OG002', 'title': 'OL Adalimumab 40 mg Eow', 'description': 'Open-label adalimumab 40 mg every other week'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 52 of double-blind treatment', 'description': "Crohn's Disease Activity Index (CDAI) documents number of soft stools, abdominal pain, general well-being, presence of 6 signs (arthritis/arthralgia; iritis/uveitis; erythema nodosum/pyoderma gangrenosum/aphthous stomatitis; fissure, abscess, anal fistula; other cutaneous fistula; fever over 100 degrees), taking medication for diarrhea, abdominal mass, hematocrit, and weight loss during a 1-week assessment period. CDAI has a total score \\>= 0 and without upper limit. Low score=less severe CD activity. Decrease in score indicates improvement.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'OL efficacy set (assigned to OL treatment at Week 0, received \\>= 1 dose of OL study drug) and mFAS (participants who had received adalimumab (not placebo) during adalimumab induction study and who received \\>= 1 dose of DB study drug during this study). NRI (CR-100 not achieved) used for missing data for DB treatments; LOCF for OL treatment.'}, {'type': 'SECONDARY', 'title': "Change in Crohn's Disease Activity Index From Baseline of Lead-in Study (NCT00445939) to Week 52 of Double-blind Treatment", 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DB Adalimumab 40 mg Eow', 'description': 'Double-blind adalimumab 40 mg every other week'}, {'id': 'OG001', 'title': 'Placebo Eow', 'description': 'Double-blind adalimumab placebo every other week'}], 'classes': [{'categories': [{'measurements': [{'value': '-83.7', 'spread': '110.26', 'groupId': 'OG000'}, {'value': '-9.1', 'spread': '110.41', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline of lead-in study (NCT00445939) to Week 52 of double-blind treatment', 'description': "Crohn's Disease Activity Index (CDAI) is a measure of disease severity. Number of soft stools, abdominal pain, general well-being, presence of 6 signs (arthritis/arthralgia; iritis/uveitis; erythema nodosum/pyoderma gangrenosum/aphthous stomatitis; fissure, abscess, anal fistula; other cutaneous fistula; fever over 100 degrees), taking medication for diarrhea, abdominal mass, hematocrit, and weight loss are documented during 1-week assessment period. CDAI has a total score \\>= 0 and without upper limit. Low score=less severe CD activity. Decrease in score indicates improvement.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'modified Full Analysis Set (mFAS), defined as participants who had received adalimumab (not placebo) during the adalimumab induction study and who received at least 1 dose of DB study drug during this study. Last observation carried forward (LOCF) used for missing data.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Had Clinical Remission at Week 52 of Open-label Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'OL Adalimumab 40 mg Eow', 'description': 'Open-label adalimumab 40 mg every other week'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 52 of open-label treatment', 'description': "Clinical remission=Crohn's Disease (CD) Activity Index (CDAI) \\<150; number of soft stools, abdominal pain, general well-being, presence of 6 signs (arthritis/arthralgia; iritis/uveitis; erythema nodosum/pyoderma gangrenosum/aphthous stomatitis; fissure, abscess, anal fistula; other cutaneous fistula; fever over 100 degrees), taking medication for diarrhea, abdominal mass, hematocrit, and weight loss are documented during 1-week assessment period. CDAI total score is \\>= 0 and without upper limit. Low score=less severe CD activity. Decrease in score indicates improvement.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'OL efficacy set (assigned to OL treatment at Week 0, received \\>= 1 dose of OL study drug). Last observation carried forward (LOCF) used for missing data.'}, {'type': 'SECONDARY', 'title': 'Change in International Organization for the Study of Inflammatory Bowel Disease (IOIBD) Score From Baseline of Lead-in Study (NCT00445939) to Week 52 of Double-blind Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DB Adalimumab 40 mg Eow', 'description': 'Double-blind adalimumab 40 mg every other week'}, {'id': 'OG001', 'title': 'Placebo Eow', 'description': 'Double-blind adalimumab placebo every other week'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.8', 'spread': '1.89', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '1.34', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline of lead-in study (NCT00445939) to Week 52 of double-blind treatment', 'description': "The International Organization for the Study of Inflammatory Bowel Disease (IOIBD) score is an indicator of the activity of Crohn's disease. It measures absence (score of 0) or presence (score of 1) of abdominal pain, diarrhea or bloody stools more than 6 times per day, anal lesion, anal fistula, other complication, abdominal mass, weight loss, fever above 38 degrees Centigrade, abdominal tenderness, and blood pigment below 10 g/dL. Total possible score=0 to 10; low score=less disease activity. Decrease in score indicates alleviation of the disease; increase indicates aggravation of disease.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Full Analysis Set (mFAS), defined as participants who had received adalimumab (not placebo) during the adalimumab induction study and who received at least 1 dose of DB study drug during this study. Last observation carried forward (LOCF) used for missing data.'}, {'type': 'SECONDARY', 'title': 'Change in Inflammatory Bowel Disease Questionnaire (IBDQ) From Baseline of Lead-in Study (NCT00445939) to Week 52 of Double-blind Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DB Adalimumab 40 mg Eow', 'description': 'Double-blind adalimumab 40 mg every other week'}, {'id': 'OG001', 'title': 'Placebo Eow', 'description': 'Double-blind adalimumab placebo every other week'}], 'classes': [{'categories': [{'measurements': [{'value': '27.8', 'spread': '32.44', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '35.42', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline of lead-in study (NCT00445939) to Week 52 of double-blind treatment', 'description': 'IBDQ is a validated disease-specific instrument that assesses the impact of IBD on patient quality of life during a 2-week recall period. It has 32 questions about bowel function and related symptoms, and their social and emotional impact. For each item, participants select 1 of 7 responses. 1=poor quality of life (e.g., feeling of fatigue "all of the time") and 7=good quality (e.g., feeling of fatigue "none of the time"). Scoring range = 32 to 224. Higher scores indicate better quality of life; increases in IBDQ = improved overall quality of life.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Full Analysis Set (mFAS), defined as participants who had received adalimumab (not placebo) during the adalimumab induction study and who received at least 1 dose of DB study drug during this study. Last observation carried forward (LOCF) used for missing data.'}, {'type': 'SECONDARY', 'title': 'Change in Physical Component of the Short Form-36 Health Survey From Baseline of the Lead-in Study (NCT00445939) to Week 52 of Double-blind Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DB Adalimumab 40 mg Eow', 'description': 'Double-blind adalimumab 40 mg every other week'}, {'id': 'OG001', 'title': 'Placebo Eow', 'description': 'Double-blind adalimumab placebo every other week'}], 'classes': [{'categories': [{'measurements': [{'value': '4.4', 'spread': '9.09', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '6.31', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline of lead-in study (NCT00445939) to Week 52 of double-blind treatment', 'description': "The Short-Form-36 (SF-36) Health Survey is a comprehensive quality of life scale. An increase in SF-36 score indicates alleviation of the disease and a decrease in score indicates aggravation of disease. The physical component reflects activity level, activity limitations, pain, and rating of one's health. Score on the physical component ranges from 0 (Poorest Health) to 100 (Best Health).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Full Analysis Set (mFAS), defined as participants who had received adalimumab (not placebo) during the adalimumab induction study and who received at least 1 dose of DB study drug during this study. Last observation carried forward (LOCF) used for missing data.'}, {'type': 'SECONDARY', 'title': 'Change in Mental Component of the Short Form-36 Health Survey From Baseline of the Lead-in Study (NCT00445939) to Week 52 of Double-blind Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DB Adalimumab 40 mg Eow', 'description': 'Double-blind adalimumab 40 mg every other week'}, {'id': 'OG001', 'title': 'Placebo Eow', 'description': 'Double-blind adalimumab placebo every other week'}], 'classes': [{'categories': [{'measurements': [{'value': '9.6', 'spread': '8.37', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '14.15', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline of lead-in study (NCT00445939) to Week 52 of double-blind treatment', 'description': "The Short-Form-36 (SF-36) Health Survey is a comprehensive quality of life scale. An increase in SF-36 score indicates alleviation of the disease and a decrease in score indicates aggravation. The mental component reflects energy/vitality, social functioning, limitations, and ratings of one's mental health. Score on mental component ranges from 0 (worst score) to 100 (best score).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Full Analysis Set (mFAS), defined as participants who had received adalimumab (not placebo) during the adalimumab induction study and who received at least 1 dose of DB study drug during this study. Last observation carried forward (LOCF) used for missing data.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants Who Had Clinical Remission at Week 148', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Any Adalimumab', 'description': 'All participants in this study who received at least 1 dose of adalimumab 40 mg every other week (double-blind or open-label).'}], 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 148 relative to the first dose of adalimumab in NCT00445432 (Study M06-837)', 'description': "Clinical remission = Crohn's Disease (CD) Activity Index (CDAI) \\<150; number of soft stools, abdominal pain, general well-being, presence of 6 signs (arthritis/arthralgia; iritis/uveitis; erythema nodosum/pyoderma gangrenosum/aphthous stomatitis; fissure, abscess, anal fistula; other cutaneous fistula; fever over 100 degrees), taking medication for diarrhea, abdominal mass, hematocrit, and weight loss are documented during 1-week assessment period. CDAI total score is \\>= 0 and without upper limit. Low score=less severe CD activity. Decrease indicates improvement.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data is reported as observed cases. No imputation technique was used.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': "Number of Participants Who Had Clinical Response-70 (CR-70; a Decrease in Crohn's Disease Activity Index of at Least 70 Points From Lead-in Study [NCT00445939] Baseline Score) at Week 148", 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Any Adalimumab', 'description': 'All participants in this study who received at least 1 dose of adalimumab 40 mg every other week (double-blind or open-label).'}], 'classes': [{'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 148 relative to the first dose of adalimumab in NCT00445432 (Study M06-837)', 'description': "Crohn's Disease Activity Index (CDAI) documents number of soft stools, abdominal pain, general well-being, presence of 6 signs (arthritis/arthralgia; iritis/uveitis; erythema nodosum/pyoderma gangrenosum/aphthous stomatitis; fissure, abscess, anal fistula; other cutaneous fistula; fever over 100 degrees), taking medication for diarrhea, abdominal mass, hematocrit, and weight loss during a 1-week assessment period. CDAI has a total score \\>= 0 and without upper limit. Low score=less severe CD activity. Decrease in score indicates improvement.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data is reported as observed cases. No imputation technique was used.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': "Number of Participants Who Had Clinical Response-100 (CR-100; a Decrease in Crohn's Disease Activity Index of at Least 100 Points From Lead-in Study [NCT00445939] Baseline Score) at Week 148", 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Any Adalimumab', 'description': 'All participants in this study who received at least 1 dose of adalimumab 40 mg every other week (double-blind or open-label).'}], 'classes': [{'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 148 relative to the first dose of adalimumab in NCT00445432 (Study M06-837)', 'description': "Crohn's Disease Activity Index (CDAI) documents number of soft stools, abdominal pain, general well-being, presence of 6 signs (arthritis/arthralgia; iritis/uveitis; erythema nodosum/pyoderma gangrenosum/aphthous stomatitis; fissure, abscess, anal fistula; other cutaneous fistula; fever over 100 degrees), taking medication for diarrhea, abdominal mass, hematocrit, and weight loss during a 1-week assessment period. CDAI has a total score \\>= 0 and without upper limit. Low score=less severe CD activity. Decrease in score indicates improvement.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data is reported as observed cases. No imputation technique was used.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': "Change in Crohn's Disease Activity Index From Baseline of Lead-in Study (NCT00445939) to Week 148", 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Any Adalimumab', 'description': 'All participants in this study who received at least 1 dose of adalimumab 40 mg every other week (double-blind or open-label).'}], 'classes': [{'categories': [{'measurements': [{'value': '-143.0', 'spread': '102.49', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline of lead-in study (NCT00445939) to Week 148 relative to the first dose of adalimumab in NCT00445432 (Study M06-837)', 'description': "Crohn's Disease Activity Index (CDAI) is a measure of disease severity. Number of soft stools, abdominal pain, general well-being, presence of 6 signs (arthritis/arthralgia; iritis/uveitis; erythema nodosum/pyoderma gangrenosum/apthous stomatitis; fissure, abscess, anal fistula; other cutaneous fistula; fever over 100 degrees), taking medication for diarrhea, abdominal mass, hematocrit, and weight loss are documented during 1-week assessment period. CDAI has a total score \\>=0 and without upper limit. Low score=less severe CD activity. Decrease in score indicates improvement.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data is reported as observed cases. No imputation technique was used.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in International Organization for the Study of Inflammatory Bowel Disease (IOIBD) Score From Baseline of Lead-in Study (NCT00445939) to Week 148', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Any Adalimumab', 'description': 'All participants in this study who received at least 1 dose of adalimumab 40 mg every other week (double-blind or open-label).'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.7', 'spread': '1.41', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline of lead-in study (NCT00445939) to Week 148 relative to the first dose of adalimumab in NCT00445432 (Study M06-837)', 'description': "The International Organization for the Study of Inflammatory Bowel Disease (IOIBD) score is an indicator of the activity of Crohn's disease. It measures absence (score of 0) or presence (score of 1) of abdominal pain, diarrhea or bloody stools more than 6 times per day, anal lesion, anal fistula, other complication, abdominal mass, weight loss, fever above 38 degrees Centigrade, abdominal tenderness, and blood pigment below 10 g/dL. Total possible score=0 to 10; low score=less disease activity. Decrease in score indicates alleviation of the disease; increase indicates aggravation of disease.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data is reported as observed cases. No imputation technique was used.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Inflammatory Bowel Disease Questionnaire (IBDQ) From Baseline of Lead-in Study (NCT00445939) to Week 148', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Any Adalimumab', 'description': 'All participants in this study who received at least 1 dose of adalimumab 40 mg every other week (double-blind or open-label).'}], 'classes': [{'categories': [{'measurements': [{'value': '27.2', 'spread': '31.22', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline of lead-in study (NCT00445939) to Week 148 relative to the first dose of adalimumab in NCT00445432 (Study M06-837)', 'description': 'IBDQ is a validated disease-specific instrument that assesses the impact of IBD on patient quality of life during a 2-week recall period with 32 questions about bowel function and related symptoms \\& their social/emotional impact. Per item, participants select 1 of 7 responses (1=poor quality of life \\[e.g., feeling of fatigue "all of the time"\\]; 7=good quality \\[e.g., feeling of fatigue "none of the time"\\]). Scoring range=32 to 224. Higher scores indicate better quality of life; increases in IBDQ=improved overall quality of life.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data is reported as observed cases. No imputation technique was used.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Physical Component of the Short Form-36 Health Survey From Baseline of the Lead-in Study (NCT00445939) to Week 148', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Any Adalimumab', 'description': 'All participants in this study who received at least 1 dose of adalimumab 40 mg every other week (double-blind or open-label).'}], 'classes': [{'categories': [{'measurements': [{'value': '5.44', 'spread': '7.245', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline of lead-in study (NCT00445939) to Week 148 relative to the first dose of adalimumab in NCT00445432 (Study M06-837)', 'description': "The Short Form-36 (SF-36) Health Survey is a comprehensive quality of life scale. An increase in SF-36 score indicates alleviation of the disease and a decrease in score indicates aggravation of disease. The physical component reflects activity level, activity limitations, pain, and rating of one's health. Score on the physical component ranges from 0 to 100, with 0=Poorest Health and 100=Best Health.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data is reported as observed cases. No imputation technique was used.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Mental Component of the Short Form-36 Health Survey From Baseline of the Lead-in Study (NCT00445939) to Week 148', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Any Adalimumab', 'description': 'All participants in this study who received at least 1 dose of adalimumab 40 mg every other week (double-blind or open-label).'}], 'classes': [{'categories': [{'measurements': [{'value': '6.44', 'spread': '11.173', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline of lead-in study (NCT00445939) to Week 148 relative to the first dose of adalimumab in NCT00445432 (Study M06-837)', 'description': "The Short Form-36 (SF-36) Health Survey is a comprehensive quality of life scale. An increase in SF-36 indicates alleviation of the disease and a decrease in score indicates aggravation. The mental component reflects energy/vitality, social functioning, limitations, and ratings of one's mental health. Score on mental component ranges from 0 (worst score) to 100 (best score).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data is reported as observed cases. No imputation technique was used.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'DB Adalimumab 40 mg Eow', 'description': 'Double-blind adalimumab 40 mg every other week'}, {'id': 'FG001', 'title': 'Placebo Eow', 'description': 'Double-blind adalimumab placebo every other week'}, {'id': 'FG002', 'title': 'OL Adalimumab 40 mg Eow', 'description': 'Open-label adalimumab 40 mg every other week'}, {'id': 'FG003', 'title': 'Any Adalimumab', 'description': 'All participants in NCT00445432 (Study M06-837) who received at least 1 dose of adalimumab 40 mg every other week (double-blind or open-label).'}], 'periods': [{'title': 'Through Week 52 of NCT00445432 (M06-837)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '32'}, {'comment': 'This treatment group is not applicable for this period.', 'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '21'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '23'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Moved to open-label', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': '148 Weeks of Adalimumab Treatment', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'This group is not applicable for this period.', 'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'This group is not applicable for this period.', 'groupId': 'FG001', 'numSubjects': '0'}, {'comment': 'This group is not applicable for this period.', 'groupId': 'FG002', 'numSubjects': '0'}, {'comment': '3 participants discontinued while receiving double-blind placebo and never received any adalimumab', 'groupId': 'FG003', 'numSubjects': '79'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '35'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '44'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '32'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '9'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '82', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'DB Adalimumab 40 mg Eow', 'description': 'Double-blind adalimumab 40 mg every other week'}, {'id': 'BG001', 'title': 'Placebo Eow', 'description': 'Double-blind adalimumab placebo every other week'}, {'id': 'BG002', 'title': 'OL Adalimumab 40 mg Eow', 'description': 'Open-label adalimumab 40 mg every other week'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '77', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '31.60', 'spread': '7.171', 'groupId': 'BG000'}, {'value': '30.80', 'spread': '10.939', 'groupId': 'BG001'}, {'value': '30.75', 'spread': '8.359', 'groupId': 'BG002'}, {'value': '31.02', 'spread': '8.808', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '49', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Japan', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '82', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 82}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-02-01', 'studyFirstSubmitDate': '2007-03-07', 'resultsFirstSubmitDate': '2010-03-31', 'studyFirstSubmitQcDate': '2007-03-07', 'lastUpdatePostDateStruct': {'date': '2012-02-02', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-05-17', 'studyFirstPostDateStruct': {'date': '2007-03-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-06-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Participants Who Had Clinical Remission at Week 148', 'timeFrame': 'Week 148 relative to the first dose of adalimumab in NCT00445432 (Study M06-837)', 'description': "Clinical remission = Crohn's Disease (CD) Activity Index (CDAI) \\<150; number of soft stools, abdominal pain, general well-being, presence of 6 signs (arthritis/arthralgia; iritis/uveitis; erythema nodosum/pyoderma gangrenosum/aphthous stomatitis; fissure, abscess, anal fistula; other cutaneous fistula; fever over 100 degrees), taking medication for diarrhea, abdominal mass, hematocrit, and weight loss are documented during 1-week assessment period. CDAI total score is \\>= 0 and without upper limit. Low score=less severe CD activity. Decrease indicates improvement."}, {'measure': "Number of Participants Who Had Clinical Response-70 (CR-70; a Decrease in Crohn's Disease Activity Index of at Least 70 Points From Lead-in Study [NCT00445939] Baseline Score) at Week 148", 'timeFrame': 'Week 148 relative to the first dose of adalimumab in NCT00445432 (Study M06-837)', 'description': "Crohn's Disease Activity Index (CDAI) documents number of soft stools, abdominal pain, general well-being, presence of 6 signs (arthritis/arthralgia; iritis/uveitis; erythema nodosum/pyoderma gangrenosum/aphthous stomatitis; fissure, abscess, anal fistula; other cutaneous fistula; fever over 100 degrees), taking medication for diarrhea, abdominal mass, hematocrit, and weight loss during a 1-week assessment period. CDAI has a total score \\>= 0 and without upper limit. Low score=less severe CD activity. Decrease in score indicates improvement."}, {'measure': "Number of Participants Who Had Clinical Response-100 (CR-100; a Decrease in Crohn's Disease Activity Index of at Least 100 Points From Lead-in Study [NCT00445939] Baseline Score) at Week 148", 'timeFrame': 'Week 148 relative to the first dose of adalimumab in NCT00445432 (Study M06-837)', 'description': "Crohn's Disease Activity Index (CDAI) documents number of soft stools, abdominal pain, general well-being, presence of 6 signs (arthritis/arthralgia; iritis/uveitis; erythema nodosum/pyoderma gangrenosum/aphthous stomatitis; fissure, abscess, anal fistula; other cutaneous fistula; fever over 100 degrees), taking medication for diarrhea, abdominal mass, hematocrit, and weight loss during a 1-week assessment period. CDAI has a total score \\>= 0 and without upper limit. Low score=less severe CD activity. Decrease in score indicates improvement."}, {'measure': "Change in Crohn's Disease Activity Index From Baseline of Lead-in Study (NCT00445939) to Week 148", 'timeFrame': 'Baseline of lead-in study (NCT00445939) to Week 148 relative to the first dose of adalimumab in NCT00445432 (Study M06-837)', 'description': "Crohn's Disease Activity Index (CDAI) is a measure of disease severity. Number of soft stools, abdominal pain, general well-being, presence of 6 signs (arthritis/arthralgia; iritis/uveitis; erythema nodosum/pyoderma gangrenosum/apthous stomatitis; fissure, abscess, anal fistula; other cutaneous fistula; fever over 100 degrees), taking medication for diarrhea, abdominal mass, hematocrit, and weight loss are documented during 1-week assessment period. CDAI has a total score \\>=0 and without upper limit. Low score=less severe CD activity. Decrease in score indicates improvement."}, {'measure': 'Change in International Organization for the Study of Inflammatory Bowel Disease (IOIBD) Score From Baseline of Lead-in Study (NCT00445939) to Week 148', 'timeFrame': 'Baseline of lead-in study (NCT00445939) to Week 148 relative to the first dose of adalimumab in NCT00445432 (Study M06-837)', 'description': "The International Organization for the Study of Inflammatory Bowel Disease (IOIBD) score is an indicator of the activity of Crohn's disease. It measures absence (score of 0) or presence (score of 1) of abdominal pain, diarrhea or bloody stools more than 6 times per day, anal lesion, anal fistula, other complication, abdominal mass, weight loss, fever above 38 degrees Centigrade, abdominal tenderness, and blood pigment below 10 g/dL. Total possible score=0 to 10; low score=less disease activity. Decrease in score indicates alleviation of the disease; increase indicates aggravation of disease."}, {'measure': 'Change in Inflammatory Bowel Disease Questionnaire (IBDQ) From Baseline of Lead-in Study (NCT00445939) to Week 148', 'timeFrame': 'Baseline of lead-in study (NCT00445939) to Week 148 relative to the first dose of adalimumab in NCT00445432 (Study M06-837)', 'description': 'IBDQ is a validated disease-specific instrument that assesses the impact of IBD on patient quality of life during a 2-week recall period with 32 questions about bowel function and related symptoms \\& their social/emotional impact. Per item, participants select 1 of 7 responses (1=poor quality of life \\[e.g., feeling of fatigue "all of the time"\\]; 7=good quality \\[e.g., feeling of fatigue "none of the time"\\]). Scoring range=32 to 224. Higher scores indicate better quality of life; increases in IBDQ=improved overall quality of life.'}, {'measure': 'Change in Physical Component of the Short Form-36 Health Survey From Baseline of the Lead-in Study (NCT00445939) to Week 148', 'timeFrame': 'Baseline of lead-in study (NCT00445939) to Week 148 relative to the first dose of adalimumab in NCT00445432 (Study M06-837)', 'description': "The Short Form-36 (SF-36) Health Survey is a comprehensive quality of life scale. An increase in SF-36 score indicates alleviation of the disease and a decrease in score indicates aggravation of disease. The physical component reflects activity level, activity limitations, pain, and rating of one's health. Score on the physical component ranges from 0 to 100, with 0=Poorest Health and 100=Best Health."}, {'measure': 'Change in Mental Component of the Short Form-36 Health Survey From Baseline of the Lead-in Study (NCT00445939) to Week 148', 'timeFrame': 'Baseline of lead-in study (NCT00445939) to Week 148 relative to the first dose of adalimumab in NCT00445432 (Study M06-837)', 'description': "The Short Form-36 (SF-36) Health Survey is a comprehensive quality of life scale. An increase in SF-36 indicates alleviation of the disease and a decrease in score indicates aggravation. The mental component reflects energy/vitality, social functioning, limitations, and ratings of one's mental health. Score on mental component ranges from 0 (worst score) to 100 (best score)."}], 'primaryOutcomes': [{'measure': 'Number of Participants Who Had Clinical Remission at Week 52 of Double-blind Treatment', 'timeFrame': 'Week 52 of double-blind treatment', 'description': "Clinical remission=Crohn's Disease (CD) Activity Index (CDAI) \\<150; number of soft stools, abdominal pain, general well-being, presence of 6 signs (arthritis/arthralgia; iritis/uveitis; erythema nodosum/pyoderma gangrenosum/aphthous stomatitis; fissure, abscess, anal fistula; other cutaneous fistula; fever over 100 degrees), taking medication for diarrhea, abdominal mass, hematocrit, and weight loss are documented during 1-week assessment period. CDAI total score is \\>= 0 and without upper limit. Low score=less severe CD activity. Decrease indicates improvement."}], 'secondaryOutcomes': [{'measure': "Number of Participants Who Had Clinical Response-70 (CR-70; a Decrease in Crohn's Disease Activity Index of at Least 70 Points From Lead-in Study [NCT00445939] Baseline Score) at Week 52 of Double-blind Treatment", 'timeFrame': 'Week 52 of double-blind treatment', 'description': "Crohn's Disease Activity Index (CDAI) documents number of soft stools, abdominal pain, general well-being, presence of 6 signs (arthritis/arthralgia; iritis/uveitis; erythema nodosum/pyoderma gangrenosum/aphthous stomatitis; fissure, abscess, anal fistula; other cutaneous fistula; fever over 100 degrees), taking medication for diarrhea, abdominal mass, hematocrit, and weight loss during a 1-week assessment period. CDAI has a total score \\>= 0 and without upper limit. Low score=less severe CD activity. Decrease in score indicates improvement."}, {'measure': "Number of Participants Who Had Clinical Response-100 (CR-100; a Decrease in Crohn's Disease Activity Index of at Least 100 Points From Lead-in Study [NCT00445939] Baseline Score) at Week 52 of Double-blind Treatment", 'timeFrame': 'Week 52 of double-blind treatment', 'description': "Crohn's Disease Activity Index (CDAI) documents number of soft stools, abdominal pain, general well-being, presence of 6 signs (arthritis/arthralgia; iritis/uveitis; erythema nodosum/pyoderma gangrenosum/aphthous stomatitis; fissure, abscess, anal fistula; other cutaneous fistula; fever over 100 degrees), taking medication for diarrhea, abdominal mass, hematocrit, and weight loss during a 1-week assessment period. CDAI has a total score \\>= 0 and without upper limit. Low score=less severe CD activity. Decrease in score indicates improvement."}, {'measure': "Change in Crohn's Disease Activity Index From Baseline of Lead-in Study (NCT00445939) to Week 52 of Double-blind Treatment", 'timeFrame': 'Baseline of lead-in study (NCT00445939) to Week 52 of double-blind treatment', 'description': "Crohn's Disease Activity Index (CDAI) is a measure of disease severity. Number of soft stools, abdominal pain, general well-being, presence of 6 signs (arthritis/arthralgia; iritis/uveitis; erythema nodosum/pyoderma gangrenosum/aphthous stomatitis; fissure, abscess, anal fistula; other cutaneous fistula; fever over 100 degrees), taking medication for diarrhea, abdominal mass, hematocrit, and weight loss are documented during 1-week assessment period. CDAI has a total score \\>= 0 and without upper limit. Low score=less severe CD activity. Decrease in score indicates improvement."}, {'measure': 'Number of Participants Who Had Clinical Remission at Week 52 of Open-label Treatment', 'timeFrame': 'Week 52 of open-label treatment', 'description': "Clinical remission=Crohn's Disease (CD) Activity Index (CDAI) \\<150; number of soft stools, abdominal pain, general well-being, presence of 6 signs (arthritis/arthralgia; iritis/uveitis; erythema nodosum/pyoderma gangrenosum/aphthous stomatitis; fissure, abscess, anal fistula; other cutaneous fistula; fever over 100 degrees), taking medication for diarrhea, abdominal mass, hematocrit, and weight loss are documented during 1-week assessment period. CDAI total score is \\>= 0 and without upper limit. Low score=less severe CD activity. Decrease in score indicates improvement."}, {'measure': 'Change in International Organization for the Study of Inflammatory Bowel Disease (IOIBD) Score From Baseline of Lead-in Study (NCT00445939) to Week 52 of Double-blind Treatment', 'timeFrame': 'Baseline of lead-in study (NCT00445939) to Week 52 of double-blind treatment', 'description': "The International Organization for the Study of Inflammatory Bowel Disease (IOIBD) score is an indicator of the activity of Crohn's disease. It measures absence (score of 0) or presence (score of 1) of abdominal pain, diarrhea or bloody stools more than 6 times per day, anal lesion, anal fistula, other complication, abdominal mass, weight loss, fever above 38 degrees Centigrade, abdominal tenderness, and blood pigment below 10 g/dL. Total possible score=0 to 10; low score=less disease activity. Decrease in score indicates alleviation of the disease; increase indicates aggravation of disease."}, {'measure': 'Change in Inflammatory Bowel Disease Questionnaire (IBDQ) From Baseline of Lead-in Study (NCT00445939) to Week 52 of Double-blind Treatment', 'timeFrame': 'Baseline of lead-in study (NCT00445939) to Week 52 of double-blind treatment', 'description': 'IBDQ is a validated disease-specific instrument that assesses the impact of IBD on patient quality of life during a 2-week recall period. It has 32 questions about bowel function and related symptoms, and their social and emotional impact. For each item, participants select 1 of 7 responses. 1=poor quality of life (e.g., feeling of fatigue "all of the time") and 7=good quality (e.g., feeling of fatigue "none of the time"). Scoring range = 32 to 224. Higher scores indicate better quality of life; increases in IBDQ = improved overall quality of life.'}, {'measure': 'Change in Physical Component of the Short Form-36 Health Survey From Baseline of the Lead-in Study (NCT00445939) to Week 52 of Double-blind Treatment', 'timeFrame': 'Baseline of lead-in study (NCT00445939) to Week 52 of double-blind treatment', 'description': "The Short-Form-36 (SF-36) Health Survey is a comprehensive quality of life scale. An increase in SF-36 score indicates alleviation of the disease and a decrease in score indicates aggravation of disease. The physical component reflects activity level, activity limitations, pain, and rating of one's health. Score on the physical component ranges from 0 (Poorest Health) to 100 (Best Health)."}, {'measure': 'Change in Mental Component of the Short Form-36 Health Survey From Baseline of the Lead-in Study (NCT00445939) to Week 52 of Double-blind Treatment', 'timeFrame': 'Baseline of lead-in study (NCT00445939) to Week 52 of double-blind treatment', 'description': "The Short-Form-36 (SF-36) Health Survey is a comprehensive quality of life scale. An increase in SF-36 score indicates alleviation of the disease and a decrease in score indicates aggravation. The mental component reflects energy/vitality, social functioning, limitations, and ratings of one's mental health. Score on mental component ranges from 0 (worst score) to 100 (best score)."}]}, 'conditionsModule': {'conditions': ["Crohn's Disease"]}, 'referencesModule': {'references': [{'pmid': '24874893', 'type': 'DERIVED', 'citation': "Watanabe M, Hibi T, Mostafa NM, Chao J, Arora V, Camez A, Petersson J, Thakkar R. Long-term safety and efficacy of adalimumab in Japanese patients with moderate to severe Crohn's disease. J Crohns Colitis. 2014 Nov;8(11):1407-16. doi: 10.1016/j.crohns.2014.04.012. Epub 2014 May 27."}, {'pmid': '22325170', 'type': 'DERIVED', 'citation': "Watanabe M, Hibi T, Lomax KG, Paulson SK, Chao J, Alam MS, Camez A; Study Investigators. Adalimumab for the induction and maintenance of clinical remission in Japanese patients with Crohn's disease. J Crohns Colitis. 2012 Mar;6(2):160-73. doi: 10.1016/j.crohns.2011.07.013. Epub 2011 Aug 26."}]}, 'descriptionModule': {'briefSummary': "To demonstrate the efficacy and safety of adalimumab for the maintenance of clinical remission in Japanese subjects with Crohn's disease.", 'detailedDescription': "This was a Phase 2/3, multicenter, randomized, double-blind (DB), placebo-controlled, two-arm, efficacy, safety, and pharmacokinetic study designed to demonstrate the effectiveness of adalimumab in Japanese patients with moderate to severe Crohn's Disease (CD).\n\nAll participants who had completed Study M04-729 (NCT00445939), the lead-in adalimumab induction therapy study, were eligible for this study. Participants who rolled over into this study received either DB treatment (adalimumab or placebo) or open-label (OL) treatment with adalimumab.\n\nCrohn's Disease Activity Index (CDAI) was used to determine participants who were responders and participants who were in clinical remission. CDAI documents number of soft stools, abdominal pain, general well-being, presence of 6 signs (arthritis/arthralgia; iritis/uveitis; erythema nodosum/pyoderma gangrenosum/aphthous stomatitis; fissure, abscess, anal fistula; other cutaneous fistula; fever over 100 degrees), taking medication for diarrhea, abdominal mass, hematocrit, and weight loss during a 1-week assessment period. It yields a total score \\>= 0 and without upper limit. Baseline scores in the study ranged from 221 to 448. Low score=less severe CD activity. Decrease in score indicates improvement.\n\nClinical remission is a CDAI score \\< 150.\n\nClinical response-70 (CR-70) = decrease in CDAI ≥ 70 points from lead-in study Baseline score.\n\nClinical response-100 (CR-100) = decrease in CDAI ≥ 100 points from lead-in study Baseline score.\n\nParticipants who had CR-70 response at Week 4 of the induction study were randomized into 1 of 2 treatment groups (double-blind adalimumab 40 mg every other week or adalimumab placebo every other week) using 2 stratification factors - CDAI category (CDAI less than 150 and CDAI 150 or higher) and presence/absence of fistula at Week 0 of this study. The double-blind treatment was to last from Week 0 to Week 52. Any time at or after Week 4 of this study, if a participant's disease flared (defined as a recurrence of very active disease, specifically an increase in CDAI when compared to Week 0 in this study of ≥ 70 points and a CDAI above 220) during the double-blind treatment period, the participant was allowed to move to OL treatment. At Week 52, all participants still receiving DB treatment were to be moved to open-label treatment and could continue in the study until adalimumab is approved for commercial use in Japan.\n\nParticipants who did not respond by Week 4 in the induction study and participants who had disease flare during DB treatment of this study entered OL treatment and received adalimumab 40 mg every other week. At or after Week 4 of this study, if a participant in the open-label treatment group had a disease flare or if the participant was still not responding to treatment, the participant was allowed to dose escalate to adalimumab 80 mg every other week. Participants who entered open-label treatment were to be allowed to continue on open-label adalimumab until adalimumab is approved for commercial use in Japan.\n\nThe study is complete. Results of this study are reported for endpoints at Week 52 (end of the DB treatment period) for subjects who received DB treatment (adalimumab or placebo) or OL adalimumab treatment and for endpoints at Week 148 for all subjects who received at least one dose of adalimumab in this study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects who successfully enrolled in and completed the M04-729, (NCT00445939) study\n\nExclusion Criteria:\n\n* Subject is considered by the investigator, for any reason, to be an unsuitable candidate for the study'}, 'identificationModule': {'nctId': 'NCT00445432', 'briefTitle': "A Study of Adalimumab for the Maintenance of Clinical Remission in Japanese Subjects With Crohn's Disease", 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott'}, 'officialTitle': "A Multi-Center, Randomized, Double-blind, Placebo-controlled Study of Adalimumab for the Maintenance of Clinical Remission in Japanese Subjects With Crohn's Disease", 'orgStudyIdInfo': {'id': 'M06-837'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DB Adalimumab 40 mg eow', 'description': 'Subjects received double-blind (DB) 40 mg adalimumab subcutaneously (SC) every other week (eow) during the DB treatment period lasting 52 weeks.', 'interventionNames': ['Biological: adalimumab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo eow', 'description': 'Subjects received placebo subcutaneously (SC) every other week (eow) during the double-blind treatment period lasting 52 weeks.', 'interventionNames': ['Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'OL Adalimumab 40 mg eow', 'description': 'Subjects received open-label (OL) 40 mg adalimumab subcutaneously (SC) every other week (eow) during the double-blind treatment period lasting 52 weeks.', 'interventionNames': ['Biological: adalimumab']}], 'interventions': [{'name': 'adalimumab', 'type': 'BIOLOGICAL', 'otherNames': ['Humira', 'D2E7'], 'description': 'Subcutaneous injection of 40 mg adalimumab (0.8 mL/injection) every other week (eow)', 'armGroupLabels': ['DB Adalimumab 40 mg eow', 'OL Adalimumab 40 mg eow']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Subcutaneous injection of placebo (0.8 mL/injection) every other week (eow)', 'armGroupLabels': ['Placebo eow']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aichi', 'country': 'Japan', 'facility': 'Site Ref # / Investigator 46965', 'geoPoint': {'lat': 32.51879, 'lon': 130.62158}}, {'city': 'Aichi', 'country': 'Japan', 'facility': 'Site Ref # / Investigator 46977', 'geoPoint': {'lat': 32.51879, 'lon': 130.62158}}, {'city': 'Aichi', 'country': 'Japan', 'facility': 'Site Ref # / Investigator 46978', 'geoPoint': {'lat': 32.51879, 'lon': 130.62158}}, {'city': 'Aichi', 'country': 'Japan', 'facility': 'Site Ref # / Investigator 46979', 'geoPoint': {'lat': 32.51879, 'lon': 130.62158}}, {'city': 'Chiba', 'country': 'Japan', 'facility': 'Site Ref # / Investigator 46922', 'geoPoint': {'lat': 35.6, 'lon': 140.11667}}, {'city': 'Chiba', 'country': 'Japan', 'facility': 'Site Ref # / Investigator 46974', 'geoPoint': {'lat': 35.6, 'lon': 140.11667}}, {'city': 'Ehime', 'country': 'Japan', 'facility': 'Site Ref # / Investigator 46970'}, {'city': 'Fukuoka', 'country': 'Japan', 'facility': 'Site Ref # / Investigator 46971', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'city': 'Fukuoka', 'country': 'Japan', 'facility': 'Site Ref # / Investigator 46985', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'city': 'Fukuoka', 'country': 'Japan', 'facility': 'Site Ref # / Investigator 46986', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'city': 'Fukuoka', 'country': 'Japan', 'facility': 'Site Ref # / Investigator 46987', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'city': 'Hiroshima', 'country': 'Japan', 'facility': 'Site Ref # / Investigator 46968', 'geoPoint': {'lat': 34.4, 'lon': 132.45}}, {'city': 'Hokkaido', 'country': 'Japan', 'facility': 'Site Ref # / Investigator 46973'}, {'city': 'Hokkaido', 'country': 'Japan', 'facility': 'Site Ref # / Investigator 6881'}, {'city': 'Hyōgo', 'country': 'Japan', 'facility': 'Site Ref # / Investigator 46982', 'geoPoint': {'lat': 43.36667, 'lon': 144.43333}}, {'city': 'Kagawa', 'country': 'Japan', 'facility': 'Site Ref # / Investigator 46969', 'geoPoint': {'lat': 34.06667, 'lon': 131.03333}}, {'city': 'Kanagawa', 'country': 'Japan', 'facility': 'Site Ref # / Investigator 46927', 'geoPoint': {'lat': 37.58333, 'lon': 139.91667}}, {'city': 'Kochi', 'country': 'Japan', 'facility': 'Site Ref # 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