Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 10:14 PM
Study NCT ID:
NCT01313858
Status:
COMPLETED
Last Update Posted:
2016-11-01
First Post:
2011-03-10
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study to Investigate the Use of Golimumab (Simponi®) in Participants With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis (P06554)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Germany']}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D015535', 'term': 'Arthritis, Psoriatic'}, {'id': 'D013167', 'term': 'Spondylitis, Ankylosing'}], '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'}, {'id': 'D025242', 'term': 'Spondylarthropathies'}, {'id': 'D025241', 'term': 'Spondylarthritis'}, {'id': 'D013166', 'term': 'Spondylitis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D011565', 'term': 'Psoriasis'}, {'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D000089183', 'term': 'Axial Spondyloarthritis'}, {'id': 'D000844', 'term': 'Ankylosis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C529000', 'term': 'golimumab'}, {'id': 'D008727', 'term': 'Methotrexate'}], 'ancestors': [{'id': 'D000630', 'term': 'Aminopterin'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Up to 24 months', 'description': 'Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.', 'eventGroups': [{'id': 'EG000', 'title': 'All Participants', 'description': 'Simponi®-naïve participants with rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis given Simponi® 50 mg once a month as a subcutaneous injection.', 'otherNumAtRisk': 1613, 'otherNumAffected': 315, 'seriousNumAtRisk': 1613, 'seriousNumAffected': 204}], 'otherEvents': [{'term': 'DRUG INEFFECTIVE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 315, 'numAffected': 315}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}], 'seriousEvents': [{'term': 'ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'LEUKOPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'NORMOCHROMIC NORMOCYTIC ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'THROMBOCYTOPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'ACUTE MYOCARDIAL INFARCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'ANGINA PECTORIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'ANGINA UNSTABLE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'ATRIAL FIBRILLATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'CARDIOVASCULAR INSUFFICIENCY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'CORONARY ARTERY DISEASE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'MYOCARDIAL INFARCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'MYOCARDIAL ISCHAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'SINOATRIAL BLOCK', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'TACHYARRHYTHMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'ACUTE VESTIBULAR SYNDROME', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'EXOSTOSIS OF EXTERNAL EAR CANAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'HYPOACUSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'EXOPHTHALMOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'EYELID OEDEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'PAROPHTHALMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'RETINAL DETACHMENT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'ABDOMINAL ADHESIONS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'ABDOMINAL DISCOMFORT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'ABDOMINAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'ABDOMINAL PAIN UPPER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'COLITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'CONSTIPATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'DYSPHAGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'ENTERITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'GASTROOESOPHAGEAL REFLUX DISEASE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'ILEUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'INGUINAL HERNIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'MELAENA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'OESOPHAGEAL VARICES HAEMORRHAGE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'SUBILEUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'SWOLLEN TONGUE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'CHEST DISCOMFORT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'CHILLS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'CONDITION AGGRAVATED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'DEATH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'DRUG INEFFECTIVE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'FACIAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'FATIGUE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'MASS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'PYREXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'HEPATIC CYST', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'HYPERSENSITIVITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'ATYPICAL PNEUMONIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'BRONCHITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'BRONCHOPNEUMONIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'CELLULITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'CHLAMYDIAL INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'DIVERTICULITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'ENCEPHALITIC INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'ERYSIPELAS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'FEBRILE INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'GASTROENTERITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'KIDNEY INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'LOBAR PNEUMONIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'PERITONITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'PNEUMONIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'PULMONARY SEPSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'PULMONARY TUBERCULOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'PYELONEPHRITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'RESPIRATORY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'SALPINGO-OOPHORITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'SEPSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'SINOBRONCHITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'SUBCUTANEOUS ABSCESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'URINARY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'ANKLE FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'CLAVICLE FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'CRANIOCEREBRAL INJURY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'FALL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'FEMORAL NECK FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'FEMUR FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'JOINT DISLOCATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'JOINT INJURY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'LACERATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'LIGAMENT RUPTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'LOWER LIMB FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'LUMBAR VERTEBRAL FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'PERIPROSTHETIC FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'RIB FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'ROAD TRAFFIC ACCIDENT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'SKULL FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'SPLENIC RUPTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'ANTI-CYCLIC CITRULLINATED PEPTIDE ANTIBODY POSITIVE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'COLONOSCOPY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'GAMMA-GLUTAMYLTRANSFERASE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'HAEMOGLOBIN DECREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'INVESTIGATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'PLATELET COUNT INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'DECREASED APPETITE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'DIABETES MELLITUS INADEQUATE CONTROL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'HYPOKALAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'ANKYLOSING SPONDYLITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'ARTHRITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'ARTHROFIBROSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'BACK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'FACET JOINT SYNDROME', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'HAND DEFORMITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'INTERVERTEBRAL DISC PROTRUSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'JAW CYST', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'JOINT EFFUSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'JOINT SWELLING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'MYALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'OSTEOARTHRITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'PSORIATIC ARTHROPATHY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'RHEUMATOID ARTHRITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'ROTATOR CUFF SYNDROME', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'SYNOVITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'VERTEBRAL FORAMINAL STENOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'BRAIN NEOPLASM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'BREAST CANCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'CHOLESTEATOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'CHRONIC MYELOID LEUKAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'FIBROMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'GASTROINTESTINAL STROMAL TUMOUR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'LIP AND/OR ORAL CAVITY CANCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'MELANOCYTIC NAEVUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'METASTASES TO BONE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': "NON-HODGKIN'S LYMPHOMA", 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'OESOPHAGEAL CARCINOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'PROSTATE CANCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'PROSTATIC ADENOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'RENAL CELL CARCINOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'SALIVARY GLAND NEOPLASM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'BURNING SENSATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'CARPAL TUNNEL SYNDROME', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'CEREBELLAR INFARCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'CEREBRAL INFARCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'CEREBRAL ISCHAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'CEREBROVASCULAR ACCIDENT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'CEREBROVASCULAR DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'CUBITAL TUNNEL SYNDROME', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'DEMYELINATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'DIZZINESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'FACIAL PARESIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'MONOPARESIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'SCIATICA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'SYNCOPE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'TRANSIENT ISCHAEMIC ATTACK', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'BURNOUT SYNDROME', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'DEPRESSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'MAJOR DEPRESSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'CALCULUS URETERIC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'NEPHROLITHIASIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'NEUROGENIC BLADDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'RENAL FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'EPIDIDYMITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'MENORRHAGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'VAGINAL EROSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'ALVEOLITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'BRONCHIECTASIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'DYSPNOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'HAEMOPTYSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'PNEUMOTHORAX', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'PULMONARY EMBOLISM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'ECZEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'NIGHT SWEATS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'PSORIASIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'PUSTULAR PSORIASIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'SKIN ULCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'AUTONOMIC GANGLIONECTOMY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'BLADDER OPERATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'BURSA REMOVAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'CARDIAC OPERATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'CHOLECYSTECTOMY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'CHOLESTEATOMA REMOVAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'DRUG THERAPY CHANGED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'ENDOMETRIAL ABLATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'FOOT OPERATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'GALLBLADDER OPERATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'HIP ARTHROPLASTY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'HOSPITALISATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'HYSTERECTOMY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'JOINT ARTHROPLASTY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'KNEE ARTHROPLASTY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'KNEE OPERATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'LAXATIVE SUPPORTIVE CARE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'LIMB OPERATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'POLYPECTOMY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'PROSTHESIS IMPLANTATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'RADIOACTIVE IODINE THERAPY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'SHOULDER ARTHROPLASTY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'SHOULDER OPERATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'SPINAL DECOMPRESSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'SPINAL FUSION SURGERY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'SPINAL OPERATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'SYNOVECTOMY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'TENDON SHEATH INCISION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'TENOTOMY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'TOE OPERATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'VARICOSE VEIN OPERATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'VASCULAR GRAFT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'WRIST SURGERY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'DEEP VEIN THROMBOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'HYPERTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'HYPERTENSIVE CRISIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'LYMPHOEDEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'PERIPHERAL ARTERIAL OCCLUSIVE DISEASE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'VENOUS INSUFFICIENCY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Clinical Global Impression (CGI) Disease Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '474', 'groupId': 'OG000'}, {'value': '501', 'groupId': 'OG001'}, {'value': '483', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants With Rheumatoid Arthritis', 'description': 'Simponi®-naïve participants with rheumatoid arthritis given Simponi® 50 mg once a month as a subcutaneous injection. Combination use with methotrexate was recommended.'}, {'id': 'OG001', 'title': 'Participants With Psoriatic Arthritis', 'description': 'Simponi®-naïve participants with psoriatic arthritis given Simponi® 50 mg once a month as a subcutaneous injection.'}, {'id': 'OG002', 'title': 'Participants With Ankylosing Spondylitis', 'description': 'Simponi®-naïve participants with ankylosing spondylitis given Simponi® 50 mg once a month as a subcutaneous injection.'}], 'classes': [{'title': 'BL', 'categories': [{'measurements': [{'value': '5.7', 'spread': '2.21', 'groupId': 'OG000', 'lowerLimit': '3.69', 'upperLimit': '6.74'}, {'value': '5.5', 'spread': '2.17', 'groupId': 'OG001', 'lowerLimit': '2.77', 'upperLimit': '6.01'}, {'value': '5.7', 'spread': '2.19', 'groupId': 'OG002', 'lowerLimit': '3.69', 'upperLimit': '6.74'}]}]}, {'title': 'Month 3', 'categories': [{'measurements': [{'value': '3.4', 'spread': '2.27', 'groupId': 'OG000', 'lowerLimit': '4.10', 'upperLimit': '7.33'}, {'value': '3.2', 'spread': '2.25', 'groupId': 'OG001', 'lowerLimit': '2.71', 'upperLimit': '6.08'}, {'value': '2.9', 'spread': '2.13', 'groupId': 'OG002', 'lowerLimit': '4.10', 'upperLimit': '7.33'}]}]}, {'title': 'Month 6', 'categories': [{'measurements': [{'value': '3.1', 'spread': '2.25', 'groupId': 'OG000', 'lowerLimit': '4.13', 'upperLimit': '7.58'}, {'value': '2.8', 'spread': '2.19', 'groupId': 'OG001', 'lowerLimit': '3.80', 'upperLimit': '7.44'}, {'value': '2.5', 'spread': '2.09', 'groupId': 'OG002', 'lowerLimit': '4.13', 'upperLimit': '7.58'}]}]}, {'title': 'Month 9', 'categories': [{'measurements': [{'value': '2.7', 'spread': '1.99', 'groupId': 'OG000', 'lowerLimit': '4.50', 'upperLimit': '8.08'}, {'value': '2.6', 'spread': '2.07', 'groupId': 'OG001', 'lowerLimit': '4.97', 'upperLimit': '8.77'}, {'value': '2.4', 'spread': '1.87', 'groupId': 'OG002', 'lowerLimit': '4.50', 'upperLimit': '8.08'}]}]}, {'title': 'Month 12', 'categories': [{'measurements': [{'value': '2.8', 'spread': '2.11', 'groupId': 'OG000', 'lowerLimit': '6.21', 'upperLimit': '9.82'}, {'value': '2.4', 'spread': '2.01', 'groupId': 'OG001', 'lowerLimit': '3.98', 'upperLimit': '7.89'}, {'value': '2.3', 'spread': '1.94', 'groupId': 'OG002', 'lowerLimit': '6.21', 'upperLimit': '9.82'}]}]}, {'title': 'Month 15', 'categories': [{'measurements': [{'value': '2.5', 'spread': '1.89', 'groupId': 'OG000'}, {'value': '2.3', 'spread': '1.96', 'groupId': 'OG001'}, {'value': '2.2', 'spread': '1.85', 'groupId': 'OG002'}]}]}, {'title': 'Month 18', 'categories': [{'measurements': [{'value': '2.4', 'spread': '1.97', 'groupId': 'OG000'}, {'value': '2.2', 'spread': '1.86', 'groupId': 'OG001'}, {'value': '2.2', 'spread': '1.91', 'groupId': 'OG002'}]}]}, {'title': 'Month 21', 'categories': [{'measurements': [{'value': '2.5', 'spread': '1.99', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '1.84', 'groupId': 'OG001'}, {'value': '2.2', 'spread': '1.78', 'groupId': 'OG002'}]}]}, {'title': 'Month 24', 'categories': [{'measurements': [{'value': '2.2', 'spread': '1.84', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '1.95', 'groupId': 'OG001'}, {'value': '2.1', 'spread': '2.01', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (BL; Month 0), Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21, Month 24', 'description': 'The CGI is a non-disease-specific evaluation of participants\' overall health status assessed on a 10 mm visual analogue scale (VAS) ranging from "0" (free of complaints) to "10" (strong discomfort). The closer the score to 0, the better the health status.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The mITT population consists of all participants who were treated with Simponi® and have a baseline assessment and at least one additional visit, regardless of any protocol violations during the study.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in FFbH (Funktionsfragebogen Hannover) Questionnaire Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '474', 'groupId': 'OG000'}, {'value': '501', 'groupId': 'OG001'}, {'value': '483', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants With Rheumatoid Arthritis', 'description': 'Simponi®-naïve participants with rheumatoid arthritis given Simponi® 50 mg once a month as a subcutaneous injection. Combination use with methotrexate was recommended.'}, {'id': 'OG001', 'title': 'Participants With Psoriatic Arthritis', 'description': 'Simponi®-naïve participants with psoriatic arthritis given Simponi® 50 mg once a month as a subcutaneous injection.'}, {'id': 'OG002', 'title': 'Participants With Ankylosing Spondylitis', 'description': 'Simponi®-naïve participants with ankylosing spondylitis given Simponi® 50 mg once a month as a subcutaneous injection.'}], 'classes': [{'title': 'Month 3 (n=348;361;375)', 'categories': [{'measurements': [{'value': '5.29', 'spread': '1.56', 'groupId': 'OG000', 'lowerLimit': '2.23', 'upperLimit': '8.34'}, {'value': '5.82', 'spread': '1.54', 'groupId': 'OG001'}, {'value': '8.66', 'spread': '1.31', 'groupId': 'OG002'}]}]}, {'title': 'Month 6 (n=263;310;297)', 'categories': [{'measurements': [{'value': '5.71', 'spread': '1.69', 'groupId': 'OG000', 'lowerLimit': '2.40', 'upperLimit': '9.30'}, {'value': '6.31', 'spread': '1.61', 'groupId': 'OG001'}, {'value': '10.01', 'spread': '1.40', 'groupId': 'OG002'}]}]}, {'title': 'Month 9 (n=226;265;262)', 'categories': [{'measurements': [{'value': '5.78', 'spread': '1.77', 'groupId': 'OG000'}, {'value': '7.07', 'spread': '1.69', 'groupId': 'OG001'}, {'value': '9.67', 'spread': '1.45', 'groupId': 'OG002'}]}]}, {'title': 'Month 12 (n=218;247;247)', 'categories': [{'measurements': [{'value': '5.70', 'spread': '1.79', 'groupId': 'OG000'}, {'value': '7.86', 'spread': '1.73', 'groupId': 'OG001'}, {'value': '8.34', 'spread': '1.48', 'groupId': 'OG002'}]}]}, {'title': 'Month 15 (n=188;222;234)', 'categories': [{'measurements': [{'value': '5.63', 'spread': '1.89', 'groupId': 'OG000'}, {'value': '6.64', 'spread': '1.79', 'groupId': 'OG001'}, {'value': '9.04', 'spread': '1.50', 'groupId': 'OG002'}]}]}, {'title': 'Month 18 (n=168;211;216)', 'categories': [{'measurements': [{'value': '6.98', 'spread': '1.96', 'groupId': 'OG000'}, {'value': '8.99', 'spread': '1.82', 'groupId': 'OG001'}, {'value': '8.79', 'spread': '1.54', 'groupId': 'OG002'}]}]}, {'title': 'Month 21 (n=166;198;200)', 'categories': [{'measurements': [{'value': '5.43', 'spread': '1.97', 'groupId': 'OG000'}, {'value': '9.18', 'spread': '1.86', 'groupId': 'OG001'}, {'value': '7.95', 'spread': '1.59', 'groupId': 'OG002'}]}]}, {'title': 'Month 24 (n=167;198;211)', 'categories': [{'measurements': [{'value': '7.42', 'spread': '1.97', 'groupId': 'OG000'}, {'value': '7.71', 'spread': '1.86', 'groupId': 'OG001'}, {'value': '9.51', 'spread': '1.56', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0007', 'groupIds': ['OG000'], 'groupDescription': 'Least squares mean difference from baseline in FFbH at Month 3 (Month 3 minus BL)', 'statisticalMethod': 'Repeated measures analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0007', 'groupIds': ['OG000'], 'groupDescription': 'Least squares mean difference from baseline in FFbH at Month 6 (Month 6 minus BL)', 'statisticalMethod': 'Repeated measures analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0011', 'groupIds': ['OG000'], 'groupDescription': 'Least squares mean difference from baseline in FFbH at Month 9 (Month 9 minus BL)', 'statisticalMethod': 'Repeated measures analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0015', 'groupIds': ['OG000'], 'groupDescription': 'Least squares mean difference from baseline in FFbH at Month 12 (Month 12 minus BL)', 'statisticalMethod': 'Repeated measures analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0029', 'groupIds': ['OG000'], 'groupDescription': 'Least squares mean difference from baseline in FFbH at Month 15 (Month 15 minus BL)', 'statisticalMethod': 'Repeated measures analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0004', 'groupIds': ['OG000'], 'groupDescription': 'Least squares mean difference from baseline in FFbH at Month 18 (Month 18 minus BL)', 'statisticalMethod': 'Repeated measures analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0059', 'groupIds': ['OG000'], 'groupDescription': 'Least squares mean difference from baseline in FFbH at Month 21 (Month 21 minus BL)', 'statisticalMethod': 'Repeated measures analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0002', 'groupIds': ['OG000'], 'groupDescription': 'Least squares mean difference from baseline in FFbH at Month 24 (Month 24 minus BL)', 'statisticalMethod': 'Repeated measures analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0002', 'groupIds': ['OG001'], 'groupDescription': 'Least squares mean difference from baseline in FFbH at Month 3 (Month 3 minus BL)', 'statisticalMethod': 'Repeated measures analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001'], 'groupDescription': 'Least squares mean difference from baseline in FFbH at Month 6 (Month 6 minus BL)', 'statisticalMethod': 'Repeated measures analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001'], 'groupDescription': 'Least squares mean difference from baseline in FFbH at Month 9 (Month 9 minus BL)', 'statisticalMethod': 'Repeated measures analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001'], 'groupDescription': 'Least squares mean difference from baseline in FFbH at Month 12 (Month 12 minus BL)', 'statisticalMethod': 'Repeated measures analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0002', 'groupIds': ['OG001'], 'groupDescription': 'Least squares mean difference from baseline in FFbH at Month 15 (Month 15 minus BL)', 'statisticalMethod': 'Repeated measures analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001'], 'groupDescription': 'Least squares mean difference from baseline in FFbH at Month 18 (Month 18 minus BL)', 'statisticalMethod': 'Repeated measures analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001'], 'groupDescription': 'Least squares mean difference from baseline in FFbH at Month 21 (Month 21 minus BL)', 'statisticalMethod': 'Repeated measures analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001'], 'groupDescription': 'Least squares mean difference from baseline in FFbH at Month 24 (Month 24 minus BL)', 'statisticalMethod': 'Repeated measures analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG002'], 'groupDescription': 'Least squares mean difference from baseline in FFbH at Month 3 (Month 3 minus BL)', 'statisticalMethod': 'Repeated measures analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG002'], 'groupDescription': 'Least squares mean difference from baseline in FFbH at Month 6 (Month 6 minus BL)', 'statisticalMethod': 'Repeated measures analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG002'], 'groupDescription': 'Least squares mean difference from baseline in FFbH at Month 9 (Month 9 minus BL)', 'statisticalMethod': 'Repeated measures analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG002'], 'groupDescription': 'Least squares mean difference from baseline in FFbH at Month 12 (Month 12 minus BL)', 'statisticalMethod': 'Repeated measures analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG002'], 'groupDescription': 'Least squares mean difference from baseline in FFbH at Month 15 (Month 15 minus BL)', 'statisticalMethod': 'Repeated measures analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG002'], 'groupDescription': 'Least squares mean difference from baseline in FFbH at Month 18 (Month 18 minus BL)', 'statisticalMethod': 'Repeated measures analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG002'], 'groupDescription': 'Least squares mean difference from baseline in FFbH at Month 21 (Month 21 minus BL)', 'statisticalMethod': 'Repeated measures analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG002'], 'groupDescription': 'Least squares mean difference from baseline in FFbH at Month 24 (Month 24 minus BL)', 'statisticalMethod': 'Repeated measures analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Months 3, 6, 9, 12, 15, 18, 21, 24', 'description': 'The FFbH is a participant questionnaire assessing disability/functional impairment. Ability to perform 18 activities of daily living are scored on a 3 point scale (2=Yes, 1=Yes but with effort, and 0=No or with assistance) and summed. Remaining functional capacity is calculated as the percent of the maximum number of score points (FFbH\\[%\\] = (Attained score\\*100)/(2\\*n) where n is the number of completed responses) with range from 0 = total loss of functional capacity to 100 = maximal functional capacity. Increase from baseline in FFbH score signifies improvement. The FFbH is similar to Health Assessment Questionnaire (HAQ) but is more widely used in Germany.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The mITT population consists of all participants who were treated with Simponi® and have a baseline assessment and at least one additional visit, regardless of any protocol violations during the study.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '474', 'groupId': 'OG000'}, {'value': '501', 'groupId': 'OG001'}, {'value': '483', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants With Rheumatoid Arthritis', 'description': 'Simponi®-naïve participants with rheumatoid arthritis given Simponi® 50 mg once a month as a subcutaneous injection. Combination use with methotrexate was recommended.'}, {'id': 'OG001', 'title': 'Participants With Psoriatic Arthritis', 'description': 'Simponi®-naïve participants with psoriatic arthritis given Simponi® 50 mg once a month as a subcutaneous injection.'}, {'id': 'OG002', 'title': 'Participants With Ankylosing Spondylitis', 'description': 'Simponi®-naïve participants with ankylosing spondylitis given Simponi® 50 mg once a month as a subcutaneous injection.'}], 'classes': [{'title': 'Month 3 (n=344;356;368)', 'categories': [{'measurements': [{'value': '2.85', 'spread': '0.79', 'groupId': 'OG000', 'lowerLimit': '3.69', 'upperLimit': '6.74'}, {'value': '4.39', 'spread': '0.83', 'groupId': 'OG001', 'lowerLimit': '2.77', 'upperLimit': '6.01'}, {'value': '5.21', 'spread': '0.78', 'groupId': 'OG002', 'lowerLimit': '3.69', 'upperLimit': '6.74'}]}]}, {'title': 'Month 6 (n=264;311;300)', 'categories': [{'measurements': [{'value': '3.71', 'spread': '0.85', 'groupId': 'OG000', 'lowerLimit': '4.10', 'upperLimit': '7.33'}, {'value': '4.40', 'spread': '0.86', 'groupId': 'OG001', 'lowerLimit': '2.71', 'upperLimit': '6.08'}, {'value': '5.71', 'spread': '0.82', 'groupId': 'OG002', 'lowerLimit': '4.10', 'upperLimit': '7.33'}]}]}, {'title': 'Month 12 (n=215;242;243)', 'categories': [{'measurements': [{'value': '4.81', 'spread': '0.91', 'groupId': 'OG000', 'lowerLimit': '4.13', 'upperLimit': '7.58'}, {'value': '5.62', 'spread': '0.93', 'groupId': 'OG001', 'lowerLimit': '3.80', 'upperLimit': '7.44'}, {'value': '5.86', 'spread': '0.88', 'groupId': 'OG002', 'lowerLimit': '4.13', 'upperLimit': '7.58'}]}]}, {'title': 'Month 18 (n=167;212;216)', 'categories': [{'measurements': [{'value': '5.05', 'spread': '0.99', 'groupId': 'OG000', 'lowerLimit': '4.50', 'upperLimit': '8.08'}, {'value': '6.87', 'spread': '0.97', 'groupId': 'OG001', 'lowerLimit': '4.97', 'upperLimit': '8.77'}, {'value': '6.29', 'spread': '0.91', 'groupId': 'OG002', 'lowerLimit': '4.50', 'upperLimit': '8.08'}]}]}, {'title': 'Month 24 (n=162;196;211)', 'categories': [{'measurements': [{'value': '5.99', 'spread': '1.00', 'groupId': 'OG000', 'lowerLimit': '6.21', 'upperLimit': '9.82'}, {'value': '5.94', 'spread': '1.00', 'groupId': 'OG001', 'lowerLimit': '3.98', 'upperLimit': '7.89'}, {'value': '8.01', 'spread': '0.92', 'groupId': 'OG002', 'lowerLimit': '6.21', 'upperLimit': '9.82'}]}]}], 'analyses': [{'pValue': '0.0003', 'groupIds': ['OG000'], 'groupDescription': 'Least squares mean difference from baseline in FACIT-F at Month 3 (Month 3 minus BL)', 'statisticalMethod': 'Repeated measures analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'groupDescription': 'Least squares mean difference from baseline in FACIT-F at Month 6 (Month 6 minus BL)', 'statisticalMethod': 'Repeated measures analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'groupDescription': 'Least squares mean difference from baseline in FACIT-F at Month 12 (Month 12 minus BL)', 'statisticalMethod': 'Repeated measures analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'groupDescription': 'Least squares mean difference from baseline in FACIT-F at Month 18 (Month 18 minus BL)', 'statisticalMethod': 'Repeated measures analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'groupDescription': 'Least squares mean difference from baseline in FACIT-F at Month 24 (Month 24 minus BL)', 'statisticalMethod': 'Repeated measures analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001'], 'groupDescription': 'Least squares mean difference from baseline in FACIT-F at Month 3 (Month 3 minus BL)', 'statisticalMethod': 'Repeated measures analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001'], 'groupDescription': 'Least squares mean difference from baseline in FACIT-F at Month 6 (Month 6 minus BL)', 'statisticalMethod': 'Repeated measures analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001'], 'groupDescription': 'Least squares mean difference from baseline in FACIT-F at Month 12 (Month 12 minus BL)', 'statisticalMethod': 'Repeated measures analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001'], 'groupDescription': 'Least squares mean difference from baseline in FACIT-F at Month 18 (Month 18 minus BL)', 'statisticalMethod': 'Repeated measures analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001'], 'groupDescription': 'Least squares mean difference from baseline in FACIT-F at Month 24 (Month 24 minus BL)', 'statisticalMethod': 'Repeated measures analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG002'], 'groupDescription': 'Least squares mean difference from baseline in FACIT-F at Month 3 (Month 3 minus BL)', 'statisticalMethod': 'Repeated measures analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG002'], 'groupDescription': 'Least squares mean difference from baseline in FACIT-F at Month 6 (Month 6 minus BL)', 'statisticalMethod': 'Repeated measures analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG002'], 'groupDescription': 'Least squares mean difference from baseline in FACIT-F at Month 12 (Month 12 minus BL)', 'statisticalMethod': 'Repeated measures analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG002'], 'groupDescription': 'Least squares mean difference from baseline in FACIT-F at Month 18 (Month 18 minus BL)', 'statisticalMethod': 'Repeated measures analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG002'], 'groupDescription': 'Least squares mean difference from baseline in FACIT-F at Month 24 (Month 24 minus BL)', 'statisticalMethod': 'Repeated measures analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Months 3, 6, 12, 18, 24', 'description': 'The FACIT-F scale assesses self-reported fatigue and its impact upon daily activities and function. 13 items consisting of fatigue, weakness, listlessness, tiredness, trouble with starting things, trouble with finishing things, energy, activity, sleep, eating, help doing activities, frustration, and social activities are scored on a scale of 0 (not at all) to 4 (very much), except energy and activity which are reversed scored. Individual item scores are then summed to provide the final FACIT-F score with range from 0 (lowest) to 52 (highest quality of life). Increase from baseline in FACIT-F score signifies improvement.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The mITT population consists of all participants who were treated with Simponi® and have a baseline assessment and at least one additional visit, regardless of any protocol violations during the study.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in EuroQol- 5 Dimension 3 Level Version (EQ-5D-3L) Questionnaire Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '474', 'groupId': 'OG000'}, {'value': '501', 'groupId': 'OG001'}, {'value': '483', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants With Rheumatoid Arthritis', 'description': 'Simponi®-naïve participants with rheumatoid arthritis given Simponi® 50 mg once a month as a subcutaneous injection. Combination use with methotrexate was recommended.'}, {'id': 'OG001', 'title': 'Participants With Psoriatic Arthritis', 'description': 'Simponi®-naïve participants with psoriatic arthritis given Simponi® 50 mg once a month as a subcutaneous injection.'}, {'id': 'OG002', 'title': 'Participants With Ankylosing Spondylitis', 'description': 'Simponi®-naïve participants with ankylosing spondylitis given Simponi® 50 mg once a month as a subcutaneous injection.'}], 'classes': [{'title': 'Month 6 (n=254;302;293)', 'categories': [{'measurements': [{'value': '-0.69', 'spread': '0.15', 'groupId': 'OG000', 'lowerLimit': '3.69', 'upperLimit': '6.74'}, {'value': '-1.07', 'spread': '0.14', 'groupId': 'OG001', 'lowerLimit': '2.77', 'upperLimit': '6.01'}, {'value': '-1.18', 'spread': '0.14', 'groupId': 'OG002', 'lowerLimit': '3.69', 'upperLimit': '6.74'}]}]}, {'title': 'Month 12 (n=211;236;242)', 'categories': [{'measurements': [{'value': '-0.97', 'spread': '0.16', 'groupId': 'OG000', 'lowerLimit': '4.10', 'upperLimit': '7.33'}, {'value': '-1.35', 'spread': '0.15', 'groupId': 'OG001', 'lowerLimit': '2.71', 'upperLimit': '6.08'}, {'value': '-1.24', 'spread': '0.14', 'groupId': 'OG002', 'lowerLimit': '4.10', 'upperLimit': '7.33'}]}]}, {'title': 'Month 18 (n=161;206;211)', 'categories': [{'measurements': [{'value': '-1.11', 'spread': '0.17', 'groupId': 'OG000', 'lowerLimit': '4.13', 'upperLimit': '7.58'}, {'value': '-1.35', 'spread': '0.16', 'groupId': 'OG001', 'lowerLimit': '3.80', 'upperLimit': '7.44'}, {'value': '-1.25', 'spread': '0.15', 'groupId': 'OG002', 'lowerLimit': '4.13', 'upperLimit': '7.58'}]}]}, {'title': 'Month 24 (n=162;191;210)', 'categories': [{'measurements': [{'value': '-1.08', 'spread': '0.17', 'groupId': 'OG000', 'lowerLimit': '4.50', 'upperLimit': '8.08'}, {'value': '-1.29', 'spread': '0.17', 'groupId': 'OG001', 'lowerLimit': '4.97', 'upperLimit': '8.77'}, {'value': '-1.51', 'spread': '0.15', 'groupId': 'OG002', 'lowerLimit': '4.50', 'upperLimit': '8.08'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'groupDescription': 'Least squares mean difference from baseline in EQ-5D-3L at Month 6 (Month 6 minus BL)', 'statisticalMethod': 'Repeated measures analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'groupDescription': 'Least squares mean difference from baseline in EQ-5D-3L at Month 12 (Month 12 minus BL)', 'statisticalMethod': 'Repeated measures analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'groupDescription': 'Least squares mean difference from baseline in EQ-5D-3L at Month 18 (Month 18 minus BL)', 'statisticalMethod': 'Repeated measures analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'groupDescription': 'Least squares mean difference from baseline in EQ-5D-3L at Month 24 (Month 24 minus BL)', 'statisticalMethod': 'Repeated measures analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001'], 'groupDescription': 'Least squares mean difference from baseline in EQ-5D-3L at Month 6 (Month 6 minus BL)', 'statisticalMethod': 'Repeated measures analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001'], 'groupDescription': 'Least squares mean difference from baseline in EQ-5D-3L at Month 12 (Month 12 minus BL)', 'statisticalMethod': 'Repeated measures analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001'], 'groupDescription': 'Least squares mean difference from baseline in EQ-5D-3L at Month 18 (Month 18 minus BL)', 'statisticalMethod': 'Repeated measures analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001'], 'groupDescription': 'Least squares mean difference from baseline in EQ-5D-3L at Month 24 (Month 24 minus BL)', 'statisticalMethod': 'Repeated measures analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG002'], 'groupDescription': 'Least squares mean difference from baseline in EQ-5D-3L at Month 6 (Month 6 minus BL)', 'statisticalMethod': 'Repeated measures analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG002'], 'groupDescription': 'Least squares mean difference from baseline in EQ-5D-3L at Month 12 (Month 12 minus BL)', 'statisticalMethod': 'Repeated measures analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG002'], 'groupDescription': 'Least squares mean difference from baseline in EQ-5D-3L at Month 18 (Month 18 minus BL)', 'statisticalMethod': 'Repeated measures analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG002'], 'groupDescription': 'Least squares mean difference from baseline in EQ-5D-3L at Month 24 (Month 24 minus BL)', 'statisticalMethod': 'Repeated measures analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Months 6, 12, 18, 24', 'description': 'The EQ-5D-3L is a health profile questionnaire that assesses quality of life along 5 dimensions. Participants rate 5 aspects of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) by choosing from 3 answering options (1=no problems; 2=some problems; 3=extreme problems). The summed score ranges from 1-15 with "1" corresponding to no problems and "15" corresponding to severe problems in the 5 dimensions. Decrease from baseline in EQ-5D-3L signifies improvement.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The mITT population consists of all participants who were treated with Simponi® and have a baseline assessment and at least one additional visit, regardless of any protocol violations during the study.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Experienced at Least One Adverse Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '524', 'groupId': 'OG000'}, {'value': '546', 'groupId': 'OG001'}, {'value': '543', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants With Rheumatoid Arthritis', 'description': 'Simponi®-naïve participants with rheumatoid arthritis given Simponi® 50 mg once a month as a subcutaneous injection. Combination use with methotrexate was recommended.'}, {'id': 'OG001', 'title': 'Participants With Psoriatic Arthritis', 'description': 'Simponi®-naïve participants with psoriatic arthritis given Simponi® 50 mg once a month as a subcutaneous injection.'}, {'id': 'OG002', 'title': 'Participants With Ankylosing Spondylitis', 'description': 'Simponi®-naïve participants with ankylosing spondylitis given Simponi® 50 mg once a month as a subcutaneous injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '320', 'groupId': 'OG000'}, {'value': '309', 'groupId': 'OG001'}, {'value': '281', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 24 months', 'description': 'An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population consists of all participants with at least one injection of Simponi®.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Experienced at Least One Serious Adverse Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '524', 'groupId': 'OG000'}, {'value': '546', 'groupId': 'OG001'}, {'value': '543', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants With Rheumatoid Arthritis', 'description': 'Simponi®-naïve participants with rheumatoid arthritis given Simponi® 50 mg once a month as a subcutaneous injection. Combination use with methotrexate was recommended.'}, {'id': 'OG001', 'title': 'Participants With Psoriatic Arthritis', 'description': 'Simponi®-naïve participants with psoriatic arthritis given Simponi® 50 mg once a month as a subcutaneous injection.'}, {'id': 'OG002', 'title': 'Participants With Ankylosing Spondylitis', 'description': 'Simponi®-naïve participants with ankylosing spondylitis given Simponi® 50 mg once a month as a subcutaneous injection.'}], 'classes': [{'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 24 months', 'description': "A serious adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure that results in death, life-threatening adverse event, permanent or significant disability / unfitness for work, hospital treatment (i.e., admission to hospital) or prolongation of a patient's length of stay, or congenital deformity or birth defect.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population consists of all participants with at least one injection of Simponi®.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Participants With Rheumatoid Arthritis', 'description': 'Simponi®-naïve participants with rheumatoid arthritis given Simponi® 50 mg once a month as a subcutaneous injection. Combination use with methotrexate was recommended.'}, {'id': 'FG001', 'title': 'Participants With Psoriatic Arthritis', 'description': 'Simponi®-naïve participants with psoriatic arthritis given Simponi® 50 mg once a month as a subcutaneous injection.'}, {'id': 'FG002', 'title': 'Participants With Ankylosing Spondylitis', 'description': 'Simponi®-naïve participants with ankylosing spondylitis given Simponi® 50 mg once a month as a subcutaneous injection.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '524'}, {'groupId': 'FG001', 'numSubjects': '546'}, {'groupId': 'FG002', 'numSubjects': '543'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '238'}, {'groupId': 'FG001', 'numSubjects': '276'}, {'groupId': 'FG002', 'numSubjects': '305'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '286'}, {'groupId': 'FG001', 'numSubjects': '270'}, {'groupId': 'FG002', 'numSubjects': '238'}]}], 'dropWithdraws': [{'type': 'Premature Treatment Termination', 'reasons': [{'groupId': 'FG000', 'numSubjects': '251'}, {'groupId': 'FG001', 'numSubjects': '219'}, {'groupId': 'FG002', 'numSubjects': '191'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '51'}, {'groupId': 'FG002', 'numSubjects': '47'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '474', 'groupId': 'BG000'}, {'value': '501', 'groupId': 'BG001'}, {'value': '483', 'groupId': 'BG002'}, {'value': '1458', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Participants With Rheumatoid Arthritis', 'description': 'Simponi®-naïve participants with rheumatoid arthritis given Simponi® 50 mg once a month as a subcutaneous injection. Combination use with methotrexate was recommended.'}, {'id': 'BG001', 'title': 'Participants With Psoriatic Arthritis', 'description': 'Simponi®-naïve participants with psoriatic arthritis given Simponi® 50 mg once a month as a subcutaneous injection.'}, {'id': 'BG002', 'title': 'Participants With Ankylosing Spondylitis', 'description': 'Simponi®-naïve participants with ankylosing spondylitis given Simponi® 50 mg once a month as a subcutaneous injection.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.9', 'spread': '13.38', 'groupId': 'BG000'}, {'value': '50.3', 'spread': '12.07', 'groupId': 'BG001'}, {'value': '43.6', 'spread': '12.29', 'groupId': 'BG002'}, {'value': '49.6', 'spread': '13.39', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'The mITT population consists of all participants who were treated with Simponi® and have a baseline assessment and at least one additional visit, regardless of any protocol violations during the study.', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '345', 'groupId': 'BG000'}, {'value': '271', 'groupId': 'BG001'}, {'value': '162', 'groupId': 'BG002'}, {'value': '778', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '129', 'groupId': 'BG000'}, {'value': '230', 'groupId': 'BG001'}, {'value': '321', 'groupId': 'BG002'}, {'value': '680', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The mITT population consists of all participants who were treated with Simponi® and have a baseline assessment and at least one additional visit, regardless of any protocol violations during the study.', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The Modified Intention to Treat Population (mITT) population consists of all participants who were treated with Simponi® and have a baseline assessment and at least one additional visit, regardless of any protocol violations during the study.'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1613}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-12', 'studyFirstSubmitDate': '2011-03-10', 'resultsFirstSubmitDate': '2016-09-12', 'studyFirstSubmitQcDate': '2011-03-10', 'lastUpdatePostDateStruct': {'date': '2016-11-01', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-09-12', 'studyFirstPostDateStruct': {'date': '2011-03-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-11-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Global Impression (CGI) Disease Status', 'timeFrame': 'Baseline (BL; Month 0), Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21, Month 24', 'description': 'The CGI is a non-disease-specific evaluation of participants\' overall health status assessed on a 10 mm visual analogue scale (VAS) ranging from "0" (free of complaints) to "10" (strong discomfort). The closer the score to 0, the better the health status.'}, {'measure': 'Change From Baseline in FFbH (Funktionsfragebogen Hannover) Questionnaire Score', 'timeFrame': 'Baseline and Months 3, 6, 9, 12, 15, 18, 21, 24', 'description': 'The FFbH is a participant questionnaire assessing disability/functional impairment. Ability to perform 18 activities of daily living are scored on a 3 point scale (2=Yes, 1=Yes but with effort, and 0=No or with assistance) and summed. Remaining functional capacity is calculated as the percent of the maximum number of score points (FFbH\\[%\\] = (Attained score\\*100)/(2\\*n) where n is the number of completed responses) with range from 0 = total loss of functional capacity to 100 = maximal functional capacity. Increase from baseline in FFbH score signifies improvement. The FFbH is similar to Health Assessment Questionnaire (HAQ) but is more widely used in Germany.'}, {'measure': 'Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score', 'timeFrame': 'Baseline and Months 3, 6, 12, 18, 24', 'description': 'The FACIT-F scale assesses self-reported fatigue and its impact upon daily activities and function. 13 items consisting of fatigue, weakness, listlessness, tiredness, trouble with starting things, trouble with finishing things, energy, activity, sleep, eating, help doing activities, frustration, and social activities are scored on a scale of 0 (not at all) to 4 (very much), except energy and activity which are reversed scored. Individual item scores are then summed to provide the final FACIT-F score with range from 0 (lowest) to 52 (highest quality of life). Increase from baseline in FACIT-F score signifies improvement.'}, {'measure': 'Change From Baseline in EuroQol- 5 Dimension 3 Level Version (EQ-5D-3L) Questionnaire Score', 'timeFrame': 'Baseline and Months 6, 12, 18, 24', 'description': 'The EQ-5D-3L is a health profile questionnaire that assesses quality of life along 5 dimensions. Participants rate 5 aspects of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) by choosing from 3 answering options (1=no problems; 2=some problems; 3=extreme problems). The summed score ranges from 1-15 with "1" corresponding to no problems and "15" corresponding to severe problems in the 5 dimensions. Decrease from baseline in EQ-5D-3L signifies improvement.'}, {'measure': 'Number of Participants Who Experienced at Least One Adverse Event', 'timeFrame': 'Up to 24 months', 'description': 'An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.'}, {'measure': 'Number of Participants Who Experienced at Least One Serious Adverse Event', 'timeFrame': 'Up to 24 months', 'description': "A serious adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure that results in death, life-threatening adverse event, permanent or significant disability / unfitness for work, hospital treatment (i.e., admission to hospital) or prolongation of a patient's length of stay, or congenital deformity or birth defect."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Arthritis, Rheumatoid', 'Arthritis, Psoriatic', 'Spondylitis, Ankylosing']}, 'referencesModule': {'references': [{'pmid': '32303994', 'type': 'DERIVED', 'citation': 'Kruger K, Burmester GR, Wassenberg S, Thomas MH. Golimumab as the First-, Second-, or at Least Third-Line Biologic Agent in Patients with Rheumatoid Arthritis, Psoriatic Arthritis, or Ankylosing Spondylitis: Post Hoc Analysis of a Noninterventional Study in Germany. Rheumatol Ther. 2020 Jun;7(2):371-382. doi: 10.1007/s40744-020-00204-9. Epub 2020 Apr 17.'}, {'pmid': '30415451', 'type': 'DERIVED', 'citation': 'Kruger K, Burmester GR, Wassenberg S, Bohl-Buhler M, Thomas MH. Patient-reported outcomes with golimumab in patients with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis: non-interventional study GO-NICE in Germany. Rheumatol Int. 2019 Jan;39(1):131-140. doi: 10.1007/s00296-018-4180-4. Epub 2018 Nov 10.'}, {'pmid': '29903793', 'type': 'DERIVED', 'citation': 'Kruger K, Burmester GR, Wassenberg S, Bohl-Buhler M, Thomas MH. Effectiveness and safety of golimumab in patients with rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis under real-life clinical conditions: non-interventional GO-NICE study in Germany. BMJ Open. 2018 Jun 14;8(6):e021082. doi: 10.1136/bmjopen-2017-021082.'}]}, 'descriptionModule': {'briefSummary': 'This is a study to assess the use of golimumab (Simponi®) in participants with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. The study objective is to evaluate the clinical safety of golimumab (Simponi®) under real-life, clinical practice conditions as assessed by the incidence and type of (serious) adverse events and changes in clinical status of participants as assessed by clinical parameters.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants in a primary care clinic or office with rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis for whom the treatment with Simponi® by autoinjector device is to be initiated for the first time', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Has rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis and treatment with Simponi® by autoinjector device is to be initiated for the first time\n\nExclusion Criteria:\n\n* No specific exclusion criteria'}, 'identificationModule': {'nctId': 'NCT01313858', 'acronym': 'GO-NICE', 'briefTitle': 'A Study to Investigate the Use of Golimumab (Simponi®) in Participants With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis (P06554)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'Non-Interventional Study Investigating the Use of Golimumab (Simponi®) in Patients With Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis', 'orgStudyIdInfo': {'id': 'P06554'}, 'secondaryIdInfos': [{'id': 'MK-8259-005', 'type': 'OTHER', 'domain': 'Merck'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Participants with Rheumatoid Arthritis', 'description': 'Simponi®-naïve participants with rheumatoid arthritis given Simponi® 50 mg once a month as a subcutaneous injection. Combination use with methotrexate was recommended.', 'interventionNames': ['Drug: Simponi®', 'Drug: Methotrexate']}, {'label': 'Participants with Psoriatic Arthritis', 'description': 'Simponi®-naïve participants with psoriatic arthritis given Simponi® 50 mg once a month as a subcutaneous injection.', 'interventionNames': ['Drug: Simponi®']}, {'label': 'Participants with Ankylosing Spondylitis', 'description': 'Simponi®-naïve participants with ankylosing spondylitis given Simponi® 50 mg once a month as a subcutaneous injection.', 'interventionNames': ['Drug: Simponi®']}], 'interventions': [{'name': 'Simponi®', 'type': 'DRUG', 'otherNames': ['Golimumab'], 'armGroupLabels': ['Participants with Ankylosing Spondylitis', 'Participants with Psoriatic Arthritis', 'Participants with Rheumatoid Arthritis']}, {'name': 'Methotrexate', 'type': 'DRUG', 'description': 'Given concomitantly with Simponi®', 'armGroupLabels': ['Participants with Rheumatoid Arthritis']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}