Ignite Creation Date:
2025-12-24 @ 2:50 PM
Ignite Modification Date:
2026-03-13 @ 11:01 AM
Study NCT ID:
NCT01076959
Status:
COMPLETED
Last Update Posted:
2012-08-28
First Post:
2010-02-25
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Drug Use Investigation for Humira® - All Patient Investigation for Rheumatoid Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, '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': 'Adverse events were assessed from the time treatment began until treatment ended after 24 weeks.', 'eventGroups': [{'id': 'EG000', 'title': 'Humira', 'description': 'Patients who received Humira for 24 weeks during the PMDA review period.', 'otherNumAtRisk': 7740, 'otherNumAffected': 863, 'seriousNumAtRisk': 7740, 'seriousNumAffected': 469}], 'otherEvents': [{'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 160}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 108}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 99}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hepatic function abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 110}], 'organSystem': 'Hepatobiliary disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 94}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Upper respiratory tract inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 79}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 78}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 255}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA 14.0'}], 'seriousEvents': [{'term': 'Agranulocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Anemia folate deficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Disseminated intravascular coagulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Lymphadenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Bone Marrow Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Atrial tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cardiac failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Right ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Sick sinus syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Deafness neurosensory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Retinal vein occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Scleritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Uveitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Visual impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Colitis ischemic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Duodenal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Enterocolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Gastric ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Gastric ulcer hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Gastric ulcer perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Gastritis atrophic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Gastritis hemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Gastrointestinal hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Gastrointestinal necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Ileitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Ileus paralytic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Intestinal perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Melena', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Esophageal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Small intestine ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Upper gastrointestinal hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Duodenal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pneumatosis intestinalis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Diverticular perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 3}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 4}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Device breakage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Drowning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Gait disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hyperthermia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Local swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 2}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Multiorgan failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 2}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Edema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 13}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hepatic failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hepatic function abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 4}], 'organSystem': 'Hepatobiliary disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hepatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Jaundice', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Liver disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Gallbladder polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Anaphylactic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Anaphylactoid reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Sarcoidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Bronchopneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Bronchopulmonary aspergillosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Disseminated tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Endophthalmitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Erysipelas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hepatitis B', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Lymph node tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Meningitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Meningitis aseptic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Peritonsillar abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 41}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pneumonia chlamydial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pneumonia cytomegaloviral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pneumonia legionella', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pneumonia pneumococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Postoperative wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pseudomembranous colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pulmonary tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pulpitis dental', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pyelonephritis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pyothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Rash pustular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Tooth abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Infections and 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connective tissue disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Rheumatoid arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Bile duct cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Bladder cancer recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Bone neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Breast cancer recurrent', 'stats': [{'groupId': 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'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Meningioma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': "Non-Hodgkin's Lymphoma", 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Rectal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Squamous cell carcinoma of the cervix', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Tongue neoplasm malignant stage unspecified', 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'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cerebellar infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cerebral hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cerebral thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cerebrovascular disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Demyelination', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Nervous system disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Optic neuritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Subarachnoid hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Putamen hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Thrombotic cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Completed suicide', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Calculus ureteric', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Nephrotic syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Renal impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Henoch-Schonlein purpura nephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 40}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Lung disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pleurisy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pulmonary edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Rheumatoid lung', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Diffuse panbronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Organising pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dermatitis acneiform', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dermatitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dermatomyositis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Drug eruption', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Leukocytoclastic vasculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Rash erythematosus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Rash generalized', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Skin necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Stevens-Johnson syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Generalized erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Toxic skin eruption', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dermatitis psoriasiform', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Aortic aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Aortic dissection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Peripheral circulatory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Vasculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Vasculitis necrotizing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Arterial hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7740, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA 14.0'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Total Number of Patients With Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7740', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Humira', 'description': 'Patients who received Humira for 24 weeks during the PMDA review period.'}], 'classes': [{'categories': [{'measurements': [{'value': '27.8', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 24', 'description': 'Adverse events were assessed from the time treatment began until treatment ended after 24 weeks. Details about the adverse events and serious adverse events are presented with the adverse event section of the disclosure. This outcome is measured as a percentage of patients with adverse events.', 'unitOfMeasure': 'Percentage of Patients', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population included all patients who received at least one dose of Humira, had one set of case report forms, and were registered with PMDA during the review period.'}, {'type': 'SECONDARY', 'title': "Physicians' Overall Effectiveness Response Rating", 'denoms': [{'units': 'Participants', 'counts': [{'value': '6802', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Physician Response Rating', 'description': "The full analysis set was used to determine the physicians' overall response rating."}], 'classes': [{'title': 'Markedly Improved', 'categories': [{'measurements': [{'value': '29.1', 'groupId': 'OG000'}]}]}, {'title': 'Improved', 'categories': [{'measurements': [{'value': '45.2', 'groupId': 'OG000'}]}]}, {'title': 'Not Changed', 'categories': [{'measurements': [{'value': '19.6', 'groupId': 'OG000'}]}]}, {'title': 'Not Assessable', 'categories': [{'measurements': [{'value': '6.1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'description': 'Physicians\' rated the level of overall patient improvement as "markedly improved," "improved," "not changed," or "not assessable" by comparing clinical conditions at Week 24 or at discontinuation with baseline conditions.', 'unitOfMeasure': 'Percentage of Patients', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 7740 subjects treated, 938 patients were removed; 16 patients used Humira for another indication label, 812 patients had data missing at baseline or at least 1 other time point, and 254 patients were treated with Humira for less than 2 weeks. Patients may have been in more than 1 category.'}, {'type': 'PRIMARY', 'title': 'Patient Effectiveness Response Rating and Effective Rate of Humira With Disease Activity Score (DAS) 28 at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3341', 'groupId': 'OG000'}, {'value': '3341', 'groupId': 'OG001'}, {'value': '3341', 'groupId': 'OG002'}, {'value': '3341', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Humira - Good Response', 'description': 'Patients who received Humira during the PMDA review period and had a good response according to DAS 28 (improvement \\> 1.2) at Week 4. All variables may not have been tested; therefore, a patient may not have been included.'}, {'id': 'OG001', 'title': 'Humira - Moderate Response', 'description': 'Patients who received Humira during the PMDA review period and had a moderate response according to DAS 28 (improvement 0.6 to 1.2) at Week 4. All variables may not have been tested; therefore, a patient may not have been included.'}, {'id': 'OG002', 'title': 'Humira - No Response', 'description': 'Patients who received Humira during the PMDA review period and had no response according to DAS 28 (improvement \\<0.6) at Week 4. All variables may not have been tested; therefore, a patient may not have been included.'}, {'id': 'OG003', 'title': 'Effective Rate-Sum of Patients With Good or Moderate Response', 'description': 'Patients who received Humira during the PMDA review period and had a moderate or good response to DAS 28 (improvement =\\>0.6) at Week 4. All variables may not have been tested; therefore, a patient may not have been included.'}], 'classes': [{'categories': [{'measurements': [{'value': '20.4', 'groupId': 'OG000'}, {'value': '45.7', 'groupId': 'OG001'}, {'value': '33.9', 'groupId': 'OG002'}, {'value': '66.1', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 4', 'description': 'Effectiveness was assessed according to European League Against Rheumatism (EULAR) response criteria. The investigator rated patient response as good, moderate, or none from baseline to Week 4. The DAS 28 index is a measure of activity derived from the number of swollen or tender joints, laboratory tests of inflammation, and patient assessment of global health (10 cm line ranging from very good to very bad).', 'unitOfMeasure': 'Percentage of patients', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 7740 subjects treated, 938 patients were removed; 16 patients used Humira for another indication, 812 patients had data missing at baseline or at least 1 other time point, and 254 patients were treated with Humira for less than 2 weeks. Patients may have been in more than 1 category.'}, {'type': 'PRIMARY', 'title': 'Patient Effectiveness Response Rating and Effective Rate of Humira With DAS 28 at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3927', 'groupId': 'OG000'}, {'value': '3927', 'groupId': 'OG001'}, {'value': '3927', 'groupId': 'OG002'}, {'value': '3927', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Humira - Good Response', 'description': 'Patients who received Humira during the PMDA review period and had a good response to DAS 28 (improvement \\> 1.2) at Week 12. All variables may not have been tested; therefore, a patient may not have been included.'}, {'id': 'OG001', 'title': 'Humira - Moderate Response', 'description': 'Patients who received Humira during the PMDA review period and had a moderate response to DAS 28 (improvement 0.6 to 1.2) at Week 12. All variables may not have been tested; therefore, a patient may not have been included.'}, {'id': 'OG002', 'title': 'Humira - No Response', 'description': 'Patients who received Humira during the PMDA review period and had no response to DAS 28 (improvement \\< 0.6) at Week 12. All variables may not have been tested; therefore, a patient may not have been included.'}, {'id': 'OG003', 'title': 'Effective Rate-Sum of Patients With Good or Moderate Response', 'description': 'Patients who received Humira during the PMDA review period and had a moderate or good response to DAS 28 (improvement =\\>0.6) at Week 12. All variables may not have been tested; therefore, a patient may not have been included.'}], 'classes': [{'categories': [{'measurements': [{'value': '26.4', 'groupId': 'OG000'}, {'value': '42.6', 'groupId': 'OG001'}, {'value': '31.1', 'groupId': 'OG002'}, {'value': '68.9', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'Effectiveness was assessed according to European League Against Rheumatism (EULAR) response criteria. The investigator rated patient response as good, moderate, or none from baseline to Week 12. The DAS 28 index is a measure of activity derived from the number of swollen or tender joints, laboratory tests of inflammation, and patient assessment of global health (10 cm line ranging from very good to very bad).', 'unitOfMeasure': 'percentage of patients', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 7740 subjects treated, 938 patients were removed; 16 patients used Humira for another indication, 812 patients had data missing at baseline or at least 1 other time point, and 254 patients were treated with Humira for less than 2 weeks. Patients may have been in more than 1 category.'}, {'type': 'PRIMARY', 'title': 'Patient Effectiveness Response Rating and Effective Rate of Humira With DAS 28 at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4410', 'groupId': 'OG000'}, {'value': '4410', 'groupId': 'OG001'}, {'value': '4410', 'groupId': 'OG002'}, {'value': '4410', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Humira - Good Response', 'description': 'Patients who received Humira during the PMDA review period and had a good response to DAS 28 (improvement \\> 1.2) at Week 4.at Week 24. All variables may not have been tested; therefore, a patient may not have been included.'}, {'id': 'OG001', 'title': 'Humira - Moderate Response', 'description': 'Patients who received Humira during the PMDA review period and had a moderate response to DAS 28 (improvement 0.6 to 1.2) at Week 24. All variables may not have been tested; therefore, a patient may not have been included.'}, {'id': 'OG002', 'title': 'Humira - No Response', 'description': 'Patients who received Humira during the PMDA review period and had no response to DAS 28 (improvement \\< 0.6) at Week 24. All variables may not have been tested; therefore, a patient may not have been included.'}, {'id': 'OG003', 'title': 'Effective Rate-Sum of Patients With Good and Moderate Response', 'description': 'Patients who received Humira during the PMDA review period and had a moderate or good response to DAS 28 (improvement =\\>0.6) at Week 24. All variables may not have been tested; therefore, a patient may not have been included.'}], 'classes': [{'categories': [{'measurements': [{'value': '30.7', 'groupId': 'OG000'}, {'value': '39.3', 'groupId': 'OG001'}, {'value': '29.9', 'groupId': 'OG002'}, {'value': '70.1', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'description': 'Effectiveness was assessed according to European League Against Rheumatism (EULAR) response criteria. The investigator rated patient response as good, moderate, or none from baseline to Week 24. The DAS 28 index is a measure of activity derived from the number of swollen or tender joints, laboratory tests of inflammation, and patient assessment of global health (10 cm line ranging from very good to very bad).', 'unitOfMeasure': 'Percentage of Patients', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 7740 subjects treated, 938 patients were removed; 16 patients used Humira for another indication, 812 patients had data missing at baseline or at least 1 other time point, and 254 patients were treated with Humira for less than 2 weeks. Patients may have been in more than 1 category.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Humira', 'description': 'Patients who received Humira for 24 weeks during the PMDA review period.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7740'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5490'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2250'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '767'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '849'}]}, {'type': 'Non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '274'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '241'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '119'}]}]}], 'recruitmentDetails': 'The sponsor was required to include all patients diagnosed with rheumatoid arthritis and who were treated Humira in routine medical practice during the review period by the Pharmaceuticals and Medical Devices Agency (PMDA).', 'preAssignmentDetails': 'The study was completed when the PMDA had completed their review. A total of 7972 patients were registered and case report forms were retrieved for 7891 patients; 151 patients were excluded from the analysis because the case report forms were either duplicated (n=150) or the patient was included in another survey (n=1).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7740', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Humira', 'description': 'Patients who received Humira for 24 weeks during the PMDA review period.'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.1', 'spread': '13.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '<20 years', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}]}]}, {'title': '>=20-<30', 'categories': [{'measurements': [{'value': '165', 'groupId': 'BG000'}]}]}, {'title': '>=30-<40', 'categories': [{'measurements': [{'value': '461', 'groupId': 'BG000'}]}]}, {'title': '>=40-<50', 'categories': [{'measurements': [{'value': '828', 'groupId': 'BG000'}]}]}, {'title': '>=50-<60', 'categories': [{'measurements': [{'value': '1803', 'groupId': 'BG000'}]}]}, {'title': '>=60-<70', 'categories': [{'measurements': [{'value': '2515', 'groupId': 'BG000'}]}]}, {'title': '>=70-<80', 'categories': [{'measurements': [{'value': '1676', 'groupId': 'BG000'}]}]}, {'title': '>=80-<90', 'categories': [{'measurements': [{'value': '261', 'groupId': 'BG000'}]}]}, {'title': '>=90', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}, {'title': 'No data', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6388', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '1352', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Japan', 'categories': [{'measurements': [{'value': '7740', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7972}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-27', 'studyFirstSubmitDate': '2010-02-25', 'resultsFirstSubmitDate': '2012-06-29', 'studyFirstSubmitQcDate': '2010-02-25', 'lastUpdatePostDateStruct': {'date': '2012-08-28', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-06-29', 'studyFirstPostDateStruct': {'date': '2010-02-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-08-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Number of Patients With Adverse Events', 'timeFrame': 'Baseline to Week 24', 'description': 'Adverse events were assessed from the time treatment began until treatment ended after 24 weeks. Details about the adverse events and serious adverse events are presented with the adverse event section of the disclosure. This outcome is measured as a percentage of patients with adverse events.'}, {'measure': 'Patient Effectiveness Response Rating and Effective Rate of Humira With Disease Activity Score (DAS) 28 at Week 4', 'timeFrame': 'Week 4', 'description': 'Effectiveness was assessed according to European League Against Rheumatism (EULAR) response criteria. The investigator rated patient response as good, moderate, or none from baseline to Week 4. The DAS 28 index is a measure of activity derived from the number of swollen or tender joints, laboratory tests of inflammation, and patient assessment of global health (10 cm line ranging from very good to very bad).'}, {'measure': 'Patient Effectiveness Response Rating and Effective Rate of Humira With DAS 28 at Week 12', 'timeFrame': 'Week 12', 'description': 'Effectiveness was assessed according to European League Against Rheumatism (EULAR) response criteria. The investigator rated patient response as good, moderate, or none from baseline to Week 12. The DAS 28 index is a measure of activity derived from the number of swollen or tender joints, laboratory tests of inflammation, and patient assessment of global health (10 cm line ranging from very good to very bad).'}, {'measure': 'Patient Effectiveness Response Rating and Effective Rate of Humira With DAS 28 at Week 24', 'timeFrame': 'Week 24', 'description': 'Effectiveness was assessed according to European League Against Rheumatism (EULAR) response criteria. The investigator rated patient response as good, moderate, or none from baseline to Week 24. The DAS 28 index is a measure of activity derived from the number of swollen or tender joints, laboratory tests of inflammation, and patient assessment of global health (10 cm line ranging from very good to very bad).'}], 'secondaryOutcomes': [{'measure': "Physicians' Overall Effectiveness Response Rating", 'timeFrame': 'Week 24', 'description': 'Physicians\' rated the level of overall patient improvement as "markedly improved," "improved," "not changed," or "not assessable" by comparing clinical conditions at Week 24 or at discontinuation with baseline conditions.'}]}, 'conditionsModule': {'keywords': ['Rheumatoid Arthritis'], 'conditions': ['Rheumatoid Arthritis']}, 'referencesModule': {'references': [{'pmid': '27747511', 'type': 'DERIVED', 'citation': 'Koike T, Harigai M, Ishiguro N, Inokuma S, Takei S, Takeuchi T, Yamanaka H, Takasaki Y, Mimori T, Hiramatsu K, Komatsu S, Tanaka Y. Effect of Methotrexate Plus Adalimumab on the Achievement of Rheumatoid Arthritis Therapeutic Goals: Post Hoc Analysis of Japanese Patients (MELODY Study). Rheumatol Ther. 2016 Jun;3(1):129-141. doi: 10.1007/s40744-015-0023-x. Epub 2015 Dec 22.'}, {'pmid': '24252049', 'type': 'DERIVED', 'citation': 'Koike T, Harigai M, Ishiguro N, Inokuma S, Takei S, Takeuchi T, Yamanaka H, Haruna S, Ushida N, Kawana K, Tanaka Y. Safety and effectiveness of adalimumab in Japanese rheumatoid arthritis patients: postmarketing surveillance report of 7740 patients. Mod Rheumatol. 2014 May;24(3):390-8. doi: 10.3109/14397595.2013.843760. Epub 2013 Nov 6.'}]}, 'descriptionModule': {'briefSummary': 'To clarify the following matters:\n\n* Unknown adverse reactions (especially clinically significant adverse reactions)\n* Incidence and conditions of occurrence of adverse reactions in the clinical setting\n* Factors that may affect the safety and effectiveness of Humira'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients prescribed and treated with Humira included in this survey.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients prescribed and treated with Humira are included in this survey.\n\nExclusion Criteria:\n\n* Contraindications according to the Package Insert:\n\n * Patients who have serious infections,\n * Patients who have tuberculosis,\n * Patients with a history of hypersensitivity to any ingredient of Humira,\n * Patients who have demyelinating disease or with a history of demyelinating disease,\n * Patients who have cardiac failure congestive.'}, 'identificationModule': {'nctId': 'NCT01076959', 'briefTitle': 'Drug Use Investigation for Humira® - All Patient Investigation for Rheumatoid Arthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott'}, 'officialTitle': 'Humira 40 mg/0.8 mL for Subcutaneous Injection - Drug Use Investigation (All Patient Investigation) for Rheumatoid Arthritis', 'orgStudyIdInfo': {'id': 'P10-559'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Humira', 'description': 'The sponsor was required to include all patients diagnosed with rheumatoid arthritis and who were treated Humira in routine medical practice during the review period by the PMDA. The safety analysis set included all patients who met all eligibility criteria and received at least one dose of Humira. The full analysis set included all patients who were treated with Humira for at least 2 weeks and had complete DAS 28 assessments at baseline and at least one other time point.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aichi', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 35904', 'geoPoint': {'lat': 32.51879, 'lon': 130.62158}}, {'city': 'Aichi', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 35905', 'geoPoint': {'lat': 32.51879, 'lon': 130.62158}}, {'city': 'Aichi', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 35906', 'geoPoint': {'lat': 32.51879, 'lon': 130.62158}}, {'city': 'Aichi', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 35907', 'geoPoint': {'lat': 32.51879, 'lon': 130.62158}}, {'city': 'Aichi', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 35908', 'geoPoint': {'lat': 32.51879, 'lon': 130.62158}}, {'city': 'Aichi', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 35909', 'geoPoint': {'lat': 32.51879, 'lon': 130.62158}}, {'city': 'Aichi', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 35912', 'geoPoint': {'lat': 32.51879, 'lon': 130.62158}}, {'city': 'Aichi', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 35913', 'geoPoint': {'lat': 32.51879, 'lon': 130.62158}}, {'city': 'Aichi', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 35914', 'geoPoint': {'lat': 32.51879, 'lon': 130.62158}}, {'city': 'Aichi', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 35915', 'geoPoint': {'lat': 32.51879, 'lon': 130.62158}}, {'city': 'Aichi', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 35916', 'geoPoint': {'lat': 32.51879, 'lon': 130.62158}}, {'city': 'Aichi', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 35917', 'geoPoint': {'lat': 32.51879, 'lon': 130.62158}}, {'city': 'Aichi', 'country': 'Japan', 'facility': 'Site Reference 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