Ignite Creation Date:
2025-12-26 @ 11:48 AM
Ignite Modification Date:
2026-01-28 @ 4:17 PM
Study NCT ID:
NCT01947816
Status:
COMPLETED
Last Update Posted:
2019-05-13
First Post:
2013-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Special Investigation in Patients With Ulcerative Colitis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Japan']}, 'conditionBrowseModule': {'meshes': [{'id': 'D003093', 'term': 'Colitis, Ulcerative'}], 'ancestors': [{'id': 'D003092', 'term': 'Colitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'abbvieclinicaltrials@abbvie.com', 'phone': '800-633-9110', 'title': 'Global Medical Services', 'organization': 'AbbVie'}, 'certainAgreement': {'otherDetails': 'AbbVie 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. AbbVie 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 AbbVie needs to secure patent or proprietary protection.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'up to Week 52', 'eventGroups': [{'id': 'EG000', 'title': 'Humira', 'description': 'Humira 40 mg (marketed product) eow for subcutaneous injection after initial dosage of 160 mg and 2nd dosage of 80 mg in two weeks after the initial administration, for up to 52 weeks.', 'otherNumAtRisk': 1523, 'deathsNumAtRisk': 1523, 'otherNumAffected': 0, 'seriousNumAtRisk': 1523, 'deathsNumAffected': 5, 'seriousNumAffected': 74}], 'seriousEvents': [{'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1523, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Clostridium difficile colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1523, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Cytomegaloviral infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1523, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Disseminated tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1523, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Endotoxic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1523, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Escherichia sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1523, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Gastroenteritis staphylococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1523, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1523, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Liver abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1523, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1523, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1523, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Pneumonia influenzal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1523, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Pneumonia legionella', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1523, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Pulmonary tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1523, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1523, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1523, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Varicella', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1523, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Cytomegalovirus colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1523, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Cytomegalovirus enterocolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1523, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Escherichia bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1523, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Staphylococcal sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1523, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Infective thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1523, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Enteritis infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1523, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Abdominal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1523, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Infective spondylitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1523, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Device related infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1523, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Cytomegalovirus mucocutaneous ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1523, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Pneumocystis jirovecii pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1523, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Aspergillus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1523, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Adenocarcinoma of colon', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1523, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1523, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Breast cancer stage IV', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1523, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Colon cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1523, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Colon cancer stage I', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1523, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Keratoacanthoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1523, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Non-small cell lung cancer stage IIIB', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1523, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Rectal cancer stage II', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1523, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Lung neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1523, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Inflammatory pseudotumour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1523, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Hepatocellular carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1523, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Granulocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1523, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1523, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1523, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Dermatopathic lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1523, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Sarcoidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1523, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1523, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1523, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Sudden hearing loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1523, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1523, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Right ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1523, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Aortic dissection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1523, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': "Takayasu's arteritis", 'stats': [{'groupId': 'EG000', 'numAtRisk': 1523, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Thrombophlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1523, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1523, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1523, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Eosinophilic pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1523, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1523, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Organising pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1523, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1523, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Colitis ulcerative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1523, 'numEvents': 18, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1523, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Gastroenteritis eosinophilic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1523, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Haematochezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1523, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Large intestine perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1523, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Megacolon', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1523, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1523, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1523, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Lower gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1523, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Large intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1523, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Autoimmune pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1523, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1523, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Drug eruption', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1523, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Henoch-Schonlein purpura', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1523, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Pustular psoriasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1523, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1523, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Toxic skin eruption', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1523, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Systemic lupus erythematosus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1523, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Lupus-like syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1523, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Renal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1523, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Stillbirth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1523, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Prostatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1523, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1523, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'C-reactive protein increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1523, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1523, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1523, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'C-reactive protein abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1523, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1523, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Femoral neck fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1523, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Jaw fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1523, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1523, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Post procedural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1523, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Adverse Drug Reactions and Serious Adverse Drug Reactions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1523', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Humira', 'description': 'Humira 40 mg (marketed product) eow for subcutaneous injection after initial dosage of 160 mg and 2nd dosage of 80 mg in two weeks after the initial administration, for up to 52 weeks.'}], 'classes': [{'title': 'Adverse Drug Reactions', 'categories': [{'measurements': [{'value': '276', 'groupId': 'OG000'}]}]}, {'title': 'Serious Adverse Drug Reactions', 'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 52', 'description': 'Adverse drug reactions are defined as adverse events for which the causal relation with Humira cannot be ruled out. Serious adverse drug reactions are adverse drug reaction(s) which have been assessed to be serious based on company criteria.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in CRP Levels Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '882', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Humira', 'description': 'Humira 40 mg (marketed product) eow for subcutaneous injection after initial dosage of 160 mg and 2nd dosage of 80 mg in two weeks after the initial administration, for up to 52 weeks.'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '882', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.64', 'spread': '1.65', 'groupId': 'OG000'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '773', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.53', 'spread': '1.34', 'groupId': 'OG000'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '533', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.38', 'spread': '1.00', 'groupId': 'OG000'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '597', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.29', 'spread': '0.89', 'groupId': 'OG000'}]}]}, {'title': 'At Discontinuation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '308', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.10', 'spread': '3.68', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 4, 8, 24, 52 of study drug administration, and at study drug discontinuation (up to Week 52)', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with an assessment at given time point'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mayo Score Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Humira', 'description': 'Humira 40 mg (marketed product) eow for subcutaneous injection after initial dosage of 160 mg and 2nd dosage of 80 mg in two weeks after the initial administration, for up to 52 weeks.'}], 'classes': [{'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.4', 'spread': '3.1', 'groupId': 'OG000'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.8', 'spread': '3.1', 'groupId': 'OG000'}]}]}, {'title': 'When Discontinued', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.8', 'spread': '3.5', 'groupId': 'OG000'}]}]}, {'title': 'At Final Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.3', 'spread': '4.0', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000'], 'groupDescription': 'Change from Baseline at Week 24', 'statisticalMethod': 'paired t-test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000'], 'groupDescription': 'Change from Baseline at Week 52', 'statisticalMethod': 'paired t-test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5512', 'groupIds': ['OG000'], 'groupDescription': 'Change from Baseline When Discontinued', 'statisticalMethod': 'paired t-test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000'], 'groupDescription': 'Change from Baseline at Final Assessment', 'statisticalMethod': 'paired t-test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 24, 52, at study drug discontinuation (up to Week 52), and at final assessment (up to Week 52)', 'description': "The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy, and physician's global assessment \\[PGA\\]), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo score indicates improvement.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'participants with an assessment at given time point'}, {'type': 'SECONDARY', 'title': 'Mayo Endoscopic Sub-Score Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Humira', 'description': 'Humira 40 mg (marketed product) eow for subcutaneous injection after initial dosage of 160 mg and 2nd dosage of 80 mg in two weeks after the initial administration, for up to 52 weeks.'}], 'classes': [{'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'categories': [{'title': '0=Normal or Inactive Disease', 'measurements': [{'value': '18', 'groupId': 'OG000'}]}, {'title': '1=Mild Disease', 'measurements': [{'value': '21', 'groupId': 'OG000'}]}, {'title': '2=Moderate Disease', 'measurements': [{'value': '16', 'groupId': 'OG000'}]}, {'title': '3=Severe Disease', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}]}], 'categories': [{'title': '0=Normal or Inactive Disease', 'measurements': [{'value': '35', 'groupId': 'OG000'}]}, {'title': '1=Mild Disease', 'measurements': [{'value': '34', 'groupId': 'OG000'}]}, {'title': '2=Moderate Disease', 'measurements': [{'value': '29', 'groupId': 'OG000'}]}, {'title': '3=Severe Disease', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'When Discontinued', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'categories': [{'title': '0=Normal or Inactive Disease', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': '1=Mild Disease', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': '2=Moderate Disease', 'measurements': [{'value': '21', 'groupId': 'OG000'}]}, {'title': '3=Severe Disease', 'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}, {'title': 'At Final Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}]}], 'categories': [{'title': '0=Normal or Inactive Disease', 'measurements': [{'value': '47', 'groupId': 'OG000'}]}, {'title': '1=Mild Disease', 'measurements': [{'value': '49', 'groupId': 'OG000'}]}, {'title': '2=Moderate Disease', 'measurements': [{'value': '58', 'groupId': 'OG000'}]}, {'title': '3=Severe Disease', 'measurements': [{'value': '25', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Weeks 24, 52, at study drug discontinuation (up to Week 52), and at final assessment (up to Week 52)', 'description': 'The endoscopist evaluated each observed segment of the colon (rectum, sigmoid, descending colon, transverse colon, ascending colon/cecum) by using the classification as follows: 0=Normal or inactive disease; 1=Mild disease (erythema, decreased vascular pattern, mild friability); 2=Moderate disease (marked erythema, absent vascular pattern, friability, erosions); 3=Severe disease (spontaneous bleeding, ulceration).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'participants with an assessment at given time point'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Partial Mayo Score Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1186', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Humira', 'description': 'Humira 40 mg (marketed product) eow for subcutaneous injection after initial dosage of 160 mg and 2nd dosage of 80 mg in two weeks after the initial administration, for up to 52 weeks.'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1068', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.1', 'spread': '2.4', 'groupId': 'OG000'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '935', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.5', 'spread': '2.6', 'groupId': 'OG000'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '765', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.8', 'spread': '2.6', 'groupId': 'OG000'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '697', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.0', 'spread': '2.6', 'groupId': 'OG000'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '724', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.5', 'spread': '2.6', 'groupId': 'OG000'}]}]}, {'title': 'When Discontinued', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.7', 'spread': '2.7', 'groupId': 'OG000'}]}]}, {'title': 'At Final Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1186', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.5', 'spread': '3.0', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000'], 'groupDescription': 'Change from Baseline at Week 4', 'statisticalMethod': 'paired t-test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000'], 'groupDescription': 'Change from Baseline at Week 8', 'statisticalMethod': 'paired t-test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000'], 'groupDescription': 'Change from Baseline at Week 16', 'statisticalMethod': 'paired t-test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000'], 'groupDescription': 'Change from Baseline at Week 24', 'statisticalMethod': 'paired t-test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000'], 'groupDescription': 'Change from Baseline at Week 52', 'statisticalMethod': 'paired t-test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000'], 'groupDescription': 'Change from Baseline when discontinued', 'statisticalMethod': 'paired t-test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000'], 'groupDescription': 'Change from Baseline at Final Assessment', 'statisticalMethod': 'paired t-test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 4, 8, 16, 24, 52, when discontinued (up to Week 52), at final assessment (up to Week 52)', 'description': "The Partial Mayo score (Mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding and physician's global assessment \\[PGA\\]), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Partial Mayo score indicates improvement.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'participants with an assessment at given time point'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Humira', 'description': 'Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 160 mg and 2nd dosage of 80 mg in two weeks after the initial administration, for up to 52 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Number of participants with CRFs attained', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1593'}]}, {'type': 'COMPLETED', 'comment': 'Number of participants not excluded from the safety and/or efficacy analysis sets', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1523'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '70'}]}]}], 'preAssignmentDetails': 'A total of 1621 participants were enrolled. Among the enrolled participants, case report forms were not collected from 28 participants, and there were 1593 participants whose data in case report forms were assessable.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1593', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Humira', 'description': 'Humira 40 mg (marketed product) eow for subcutaneous injection after initial dosage of 160 mg and 2nd dosage of 80 mg in two weeks after the initial administration, for up to 52 weeks.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1593', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '42.0', 'spread': '16.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1593', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '680', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '913', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Japanese', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1593', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1568', 'groupId': 'BG000'}]}]}, {'title': 'Other Asians', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1593', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}, {'title': 'Other (Not Specified)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1593', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'C-Reactive Protein (CRP)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1058', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1.20', 'spread': '2.35', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'participants with an assessment at the time of study drug administration start'}, {'title': 'Mayo Score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '7.5', 'spread': '2.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': "The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy, and physician's global assessment \\[PGA\\]), each of which ranges from 0 (normal) to 3 (severe disease).", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'participants with an assessment at the time of study drug administration start'}, {'title': 'Endoscopy Results', 'classes': [{'title': 'Normal or Remission-Phase Mucosa', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'Mild', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}, {'title': 'Moderate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '104', 'groupId': 'BG000'}]}]}, {'title': 'Severe', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '61', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The endoscopist evaluated each observed segment of the colon (rectum, sigmoid, descending colon, transverse colon, ascending colon/cecum) by using the classification as follows: 0=Normal or inactive disease; 1=Mild disease (erythema, decreased vascular pattern, mild friability); 2=Moderate disease (marked erythema, absent vascular pattern, friability, erosions); 3=Severe disease (spontaneous bleeding, ulceration).', 'unitOfMeasure': 'Participants', 'populationDescription': 'participants with an assessment at the time of study drug administration start'}, {'title': 'Partial Mayo Score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1186', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '5.1', 'spread': '2.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': "The Partial Mayo score (Mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding and physician's global assessment \\[PGA\\]), each of which ranges from 0 (normal) to 3 (severe disease).", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'participants with an assessment at the time of study drug administration start'}], 'populationDescription': 'Safety Analysis Set'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-03-12', 'size': 459775, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-12-19T12:23', 'hasProtocol': False}, {'date': '2018-04-01', 'size': 293619, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-05-10T10:48', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1621}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2018-02-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-10', 'studyFirstSubmitDate': '2013-09-18', 'resultsFirstSubmitDate': '2019-01-31', 'studyFirstSubmitQcDate': '2013-09-18', 'lastUpdatePostDateStruct': {'date': '2019-05-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-05-10', 'studyFirstPostDateStruct': {'date': '2013-09-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-05-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Adverse Drug Reactions and Serious Adverse Drug Reactions', 'timeFrame': 'Up to Week 52', 'description': 'Adverse drug reactions are defined as adverse events for which the causal relation with Humira cannot be ruled out. Serious adverse drug reactions are adverse drug reaction(s) which have been assessed to be serious based on company criteria.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in CRP Levels Over Time', 'timeFrame': 'Weeks 4, 8, 24, 52 of study drug administration, and at study drug discontinuation (up to Week 52)'}, {'measure': 'Change From Baseline in Mayo Score Over Time', 'timeFrame': 'Weeks 24, 52, at study drug discontinuation (up to Week 52), and at final assessment (up to Week 52)', 'description': "The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy, and physician's global assessment \\[PGA\\]), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo score indicates improvement."}, {'measure': 'Mayo Endoscopic Sub-Score Over Time', 'timeFrame': 'Weeks 24, 52, at study drug discontinuation (up to Week 52), and at final assessment (up to Week 52)', 'description': 'The endoscopist evaluated each observed segment of the colon (rectum, sigmoid, descending colon, transverse colon, ascending colon/cecum) by using the classification as follows: 0=Normal or inactive disease; 1=Mild disease (erythema, decreased vascular pattern, mild friability); 2=Moderate disease (marked erythema, absent vascular pattern, friability, erosions); 3=Severe disease (spontaneous bleeding, ulceration).'}, {'measure': 'Change From Baseline in Partial Mayo Score Over Time', 'timeFrame': 'Weeks 4, 8, 16, 24, 52, when discontinued (up to Week 52), at final assessment (up to Week 52)', 'description': "The Partial Mayo score (Mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding and physician's global assessment \\[PGA\\]), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Partial Mayo score indicates improvement."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ulcerative Colitis'], 'conditions': ['Ulcerative Colitis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://rxabbvie.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This investigation will be conducted to obtain the following information regarding the use of Humira 40 mg Syringe 0.8 mL for Subcutaneous Injection in patients with Ulcerative Colitis.\n\n1. Unknown adverse reactions (in particular, clinically significant)\n2. Incidence and conditions of occurrence of adverse reactions in clinical practice\n3. Factors likely to affect the safety and effectiveness'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients for the first time receiving Humira for the treatment of Ulcerative Colitis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients receiving Humira for the first time for the treatment of Ulcerative Colitis\n\nExclusion Criteria:\n\nContraindications according to the Package Insert include patients who have any of the following:\n\n* serious infections\n* tuberculosis\n* a history of hypersensitivity to any ingredient of Humira\n* demyelinating disease or a history of demyelinating disease\n* congestive cardiac failure'}, 'identificationModule': {'nctId': 'NCT01947816', 'briefTitle': 'Special Investigation in Patients With Ulcerative Colitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'HUMIRA® 40 mg Syringe 0.8 mL for Subcutaneous Injection Protocol for Special Investigation on Long-Term Administration Ulcerative Colitis', 'orgStudyIdInfo': {'id': 'P14-190'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Humira', 'description': 'Humira 40 mg (marketed product) eow for subcutaneous injection after initial dosage of 160 mg and 2nd dosage of 80 mg in two weeks after the initial administration, for up to 52 weeks.'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'AbbVie Inc.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}