Ignite Creation Date:
2025-12-24 @ 11:02 PM
Ignite Modification Date:
2026-02-25 @ 5:49 PM
Study NCT ID:
NCT01232569
Status:
COMPLETED
Last Update Posted:
2015-07-29
First Post:
2010-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of RoActemra/Actemra (Tocilizumab) Given Subcutaneously in Combination With Traditional DMARDs in Patients With Moderate to Severe Active Rheumatoid Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Peru']}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C502936', 'term': 'tocilizumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '800 821-8590', 'title': 'Medical Communications', 'organization': 'Hoffmann-La Roche'}, 'certainAgreement': {'otherDetails': "The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'Safety population: All patients who received at least 1 dose of study drug and had at least 1 post-dose safety assessment. One patient who received tocilizumab had no post-baseline safety data and was excluded from the safety population.\n\nDue to the study design, some participants received tocilizumab throughout the study, others not.', 'eventGroups': [{'id': 'EG000', 'title': 'Tocilizumab Pre-filled Syringe', 'description': 'Patients received tocilizumab 162 mg sc via a pre-filled syringe every 2 weeks for 24 weeks. In addition, this reporting group includes participants re-randomized at Week 24 to tocilizumab 162 mg sc via a pre-filled syringe every 2 weeks for 72 weeks (Weeks 25-96).', 'otherNumAtRisk': 437, 'otherNumAffected': 212, 'seriousNumAtRisk': 437, 'seriousNumAffected': 36}, {'id': 'EG001', 'title': 'Placebo Pre-filled Syringe', 'description': 'Patients received placebo subcutaneously (sc) via a pre-filled syringe every 2 weeks for 24 weeks.', 'otherNumAtRisk': 218, 'otherNumAffected': 65, 'seriousNumAtRisk': 218, 'seriousNumAffected': 8}, {'id': 'EG002', 'title': 'Tocilizumab Pre-filled Syringe to Tocilizumab Auto-injector', 'description': 'Patients received tocilizumab 162 mg sc via a pre-filled syringe every 2 weeks for 24 weeks followed by tocilizumab162 mg sc via an autoinjector every 2 weeks for 72 weeks.', 'otherNumAtRisk': 168, 'otherNumAffected': 89, 'seriousNumAtRisk': 168, 'seriousNumAffected': 17}, {'id': 'EG003', 'title': 'Placebo Pre-filled Syringe to Tocilizumab Pre-filled Syringe', 'description': 'Patients received placebo sc via a pre-filled syringe every 2 weeks for 24 weeks followed by tocilizumab162 mg sc via a pre-filled syringe every 2 weeks for 72 weeks.', 'otherNumAtRisk': 61, 'otherNumAffected': 35, 'seriousNumAtRisk': 61, 'seriousNumAffected': 2}, {'id': 'EG004', 'title': 'Placebo Pre-filled Syringe to Tocilizumab Autoinjector', 'description': 'Patients received placebo sc via a pre-filled syringe every 2 weeks for 24 weeks followed by tocilizumab162 mg sc via an autoinjector every 2 weeks for 72 weeks.', 'otherNumAtRisk': 59, 'otherNumAffected': 33, 'seriousNumAtRisk': 59, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 67}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 168, 'numAffected': 24}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 10}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 168, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 52}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 168, 'numAffected': 21}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 12}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 168, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 168, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 7}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 168, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 168, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 168, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 168, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 168, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 168, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 168, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 168, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Hypertriglyceridaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 168, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Dyslipidaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 168, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Rheumatoid arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 168, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}], 'seriousEvents': [{'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 168, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 168, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 168, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 168, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Arthritis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 168, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Bronchopneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 168, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Coccidioidomycosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 168, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Erysipelas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 168, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 168, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Postoperative wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 168, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Pulmonary tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 168, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 168, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 168, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 168, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Spinal column stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 168, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Synovial cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 168, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Adenocarcinoma pancreas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 168, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Renal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 168, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Grand mal convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 168, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Lumbar radiculopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 168, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Ovarian cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 168, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 168, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 168, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 168, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Drug hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 168, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Cervical vertebral fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 168, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Bipolar disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 168, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 168, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 168, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Joint abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 168, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Localised infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 168, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Ludwig angina', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 168, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 168, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Abdominal adhesions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 168, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 168, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 168, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Diverticulum intestinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 168, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Haemorrhagic inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 168, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 168, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 168, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 168, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 168, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 168, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Myelodysplastic syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 168, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Ovarian epithelial cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 168, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Rectal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 168, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Schwannoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 168, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 168, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 168, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 168, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Endometrial hypertrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 168, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Ovarian cyst torsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 168, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 168, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 168, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 168, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 168, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Diabetic ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 168, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Calculus ureteric', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 168, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Pyoderma gangrenosum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 168, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Adrenocortical insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 437, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 168, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 59, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Patients With an American College of Rheumatology 20 (ACR20) Response at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '437', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab 162 mg sc', 'description': 'Patients received tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks.'}, {'id': 'OG001', 'title': 'Placebo sc', 'description': 'Patients received placebo subcutaneously (sc) every 2 weeks for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '60.9', 'groupId': 'OG000', 'lowerLimit': '56.3', 'upperLimit': '65.4'}, {'value': '31.5', 'groupId': 'OG001', 'lowerLimit': '25.4', 'upperLimit': '37.7'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '29.5', 'ciLowerLimit': '22.0', 'ciUpperLimit': '37.0', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Analysis adjusted for the randomization stratification factors applied at Baseline (region and weight category).', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 24', 'description': 'A patient had an ACR20 response if there was at least a 20% improvement, ie, reduction from baseline, in tender and swollen joint counts (28 assessed joints) and in at least 3 of the following 5 parameters: Separate patient and physician assessments of patient disease activity in the previous 24 hours on a visual analog scale (VAS, left end=no disease activity \\[symptom-free and no arthritis symptoms\\], right end=maximum disease activity; patient assessment of pain in previous 24 hours on a VAS (left end=no pain and right end=unbearable pain); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and acute-phase reactant (either C-reactive protein or erythrocyte sedimentation rate).', 'unitOfMeasure': 'Percentage of patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. Patients were assigned to the ITT population as randomized, irrespective of the treatment actually received. Only patients with available data were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With ACR50 and ACR70 Responses at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '437', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab 162 mg sc', 'description': 'Patients received tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks.'}, {'id': 'OG001', 'title': 'Placebo sc', 'description': 'Patients received placebo subcutaneously (sc) every 2 weeks for 24 weeks.'}], 'classes': [{'title': 'ACR50', 'categories': [{'measurements': [{'value': '39.8', 'groupId': 'OG000', 'lowerLimit': '35.2', 'upperLimit': '44.4'}, {'value': '12.3', 'groupId': 'OG001', 'lowerLimit': '8.0', 'upperLimit': '16.7'}]}]}, {'title': 'ACR70', 'categories': [{'measurements': [{'value': '19.7', 'groupId': 'OG000', 'lowerLimit': '16.0', 'upperLimit': '23.4'}, {'value': '5.0', 'groupId': 'OG001', 'lowerLimit': '2.1', 'upperLimit': '7.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 24', 'description': 'A patient had an ACR50 response if there was at least a 50% improvement in the ACR scores. A patient had an ACR70 response if there was at least a 70% improvement in the ACR scores.', 'unitOfMeasure': 'Percentage of patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. Patients were assigned to the ITT population as randomized, irrespective of the treatment actually received. Only patients with available data were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Time to Onset of ACR20, ACR50, and ACR70 Responses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '437', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab 162 mg sc', 'description': 'Patients received tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks.'}, {'id': 'OG001', 'title': 'Placebo sc', 'description': 'Patients received placebo subcutaneously (sc) every 2 weeks for 24 weeks.'}], 'classes': [{'title': 'ACR20', 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000', 'lowerLimit': '57', 'upperLimit': '58'}, {'value': '86', 'groupId': 'OG001', 'lowerLimit': '85', 'upperLimit': '113'}]}]}, {'title': 'ACR50', 'categories': [{'measurements': [{'value': '115', 'groupId': 'OG000', 'lowerLimit': '113', 'upperLimit': '141'}, {'value': 'NA', 'comment': 'Not calculable due to too few events.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'ACR70', 'categories': [{'measurements': [{'value': '174', 'comment': 'Not calculable due to too few events.', 'groupId': 'OG000', 'lowerLimit': '172', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not calculable due to too few events.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to Week 24', 'description': 'Time to first ACR response was calculated as the number of days between the date of the first ACR response minus the date of the first dose of study drug. Median days are reported.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. Patients were assigned to the ITT population as randomized, irrespective of the treatment actually received. Only patients with available data were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Tender Joint Count (TJC) and Swollen Joint Count (SJC) at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '432', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab 162 mg sc', 'description': 'Patients received tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks.'}, {'id': 'OG001', 'title': 'Placebo sc', 'description': 'Patients received placebo subcutaneously (sc) every 2 weeks for 24 weeks.'}], 'classes': [{'title': 'Tender Joint Count', 'categories': [{'measurements': [{'value': '-14.8', 'spread': '15.0', 'groupId': 'OG000'}, {'value': '-8.1', 'spread': '14.2', 'groupId': 'OG001'}]}]}, {'title': 'Swollen Joint Count', 'categories': [{'measurements': [{'value': '-9.6', 'spread': '9.7', 'groupId': 'OG000'}, {'value': '-5.9', 'spread': '10.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 24', 'description': 'Joints (28 joints) will be assessed and classified as swollen/not swollen and tender/not tender by pressure and joint manipulation on physical examination.', 'unitOfMeasure': 'Joint count', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. Patients were assigned to the ITT population as randomized, irrespective of the treatment actually received. Only patients with available data were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in C-reactive Protein at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '345', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab 162 mg sc', 'description': 'Patients received tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks.'}, {'id': 'OG001', 'title': 'Placebo sc', 'description': 'Patients received placebo subcutaneously (sc) every 2 weeks for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.7', 'spread': '2.6', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '1.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 24', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. Patients were assigned to the ITT population as randomized, irrespective of the treatment actually received. Only patients with available data were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Erythrocyte Sedimentation Rate at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '347', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab 162 mg sc', 'description': 'Patients received tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks.'}, {'id': 'OG001', 'title': 'Placebo sc', 'description': 'Patients received placebo subcutaneously (sc) every 2 weeks for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-36.4', 'spread': '23.6', 'groupId': 'OG000'}, {'value': '-9.5', 'spread': '22.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 24', 'unitOfMeasure': 'mm/hr', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. Patients were assigned to the ITT population as randomized, irrespective of the treatment actually received. Only patients with available data were included in the analysis.'}, {'type': 'SECONDARY', 'title': "Change From Baseline in the Patient's and the Physician's Global Assessment of Disease Activity Visual Analog (VAS) Score", 'denoms': [{'units': 'Participants', 'counts': [{'value': '348', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab 162 mg sc', 'description': 'Patients received tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks.'}, {'id': 'OG001', 'title': 'Placebo sc', 'description': 'Patients received placebo subcutaneously (sc) every 2 weeks for 24 weeks.'}], 'classes': [{'title': "Patient's Global Assessment VAS, N=346, 123", 'categories': [{'measurements': [{'value': '-32.0', 'spread': '27.6', 'groupId': 'OG000'}, {'value': '-20.9', 'spread': '25.2', 'groupId': 'OG001'}]}]}, {'title': "Physician's Global Assessment VAS, N=348, 124", 'categories': [{'measurements': [{'value': '-36.9', 'spread': '22.5', 'groupId': 'OG000'}, {'value': '-30.7', 'spread': '25.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 24', 'description': 'Patients and physicians assessed the patient\'s disease activity in the previous 24 hours on a 100 mm visual analog scale, where the extreme left end of the line represented "no disease activity" (symptom-free and no arthritis symptoms) and the extreme right end represented "maximum disease activity". Scores ranged from 0 to 100 with a higher score indicating more disease activity. A negative change score indicated less disease activity.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. Patients were assigned to the ITT population as randomized, irrespective of the treatment actually received. Only patients with available data were included in the analysis.'}, {'type': 'SECONDARY', 'title': "Change From Baseline in the Patient's Pain Visual Analog Score", 'denoms': [{'units': 'Participants', 'counts': [{'value': '346', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab 162 mg sc', 'description': 'Patients received tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks.'}, {'id': 'OG001', 'title': 'Placebo sc', 'description': 'Patients received placebo subcutaneously (sc) every 2 weeks for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-28.1', 'spread': '27.2', 'groupId': 'OG000'}, {'value': '-15.0', 'spread': '28.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 24', 'description': 'Patients assessed their pain in the previous 24 hours on a visual analog scale, where the extreme left end of the line represented "no pain" and the extreme right end represented "unbearable pain". Scores ranged from 0 to 100 with a higher score indicating more pain. A negative change score indicated less pain.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. Patients were assigned to the ITT population as randomized, irrespective of the treatment actually received. Only patients with available data were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '348', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab 162 mg sc', 'description': 'Patients received tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks.'}, {'id': 'OG001', 'title': 'Placebo sc', 'description': 'Patients received placebo subcutaneously (sc) every 2 weeks for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.5', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '0.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 24', 'description': 'The HAQ-DI is a questionnaire specific for rheumatoid arthritis and consists of 20 questions referring to 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Patients completed the questionnaire by answering the 20 questions on a scale of 0 (without difficulty) to 3 (unable to do). The total score ranges from 0 (no disability) to 3 (completely disabled). A negative change score indicates improvement.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. Patients were assigned to the ITT population as randomized, irrespective of the treatment actually received. Only patients with available data were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With an Improvement of ≥ 0.3 Units From Baseline in the HAQ-DI Score at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '348', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab 162 mg sc', 'description': 'Patients received tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks.'}, {'id': 'OG001', 'title': 'Placebo sc', 'description': 'Patients received placebo subcutaneously (sc) every 2 weeks for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '58.0', 'groupId': 'OG000', 'lowerLimit': '52.9', 'upperLimit': '63.2'}, {'value': '46.8', 'groupId': 'OG001', 'lowerLimit': '38.0', 'upperLimit': '55.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 24', 'description': 'The HAQ-DI is a questionnaire specific for rheumatoid arthritis and consists of 20 questions referring to 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Patients completed the questionnaire by answering the 20 questions on a scale of 0 (without difficulty) to 3 (unable to do). The total score ranges from 0 (no disability) to 3 (completely disabled). A negative change score indicates improvement.', 'unitOfMeasure': 'Percentage of patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. Patients were assigned to the ITT population as randomized, irrespective of the treatment actually received. Only patients with available data were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Disease Activity Score 28 (DAS28) at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '344', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab 162 mg sc', 'description': 'Patients received tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks.'}, {'id': 'OG001', 'title': 'Placebo sc', 'description': 'Patients received placebo subcutaneously (sc) every 2 weeks for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.3', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '-1.8', 'spread': '1.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 24', 'description': "The DAS28 is a combined index for measuring disease activity in rheumatic arthritis (RA) and includes swollen and tender joint counts, erythrocyte sedimentation rate (ESR), and general health (GH) status. The index is calculated with the following formula: DAS28 = (0.56 × √(TJC28)) + (0.28 × √(SJC28)) + (0.7 × log(ESR)) + (0.014 × GH), where TJC28 = tender joint count and SJC28 = swollen joint count, each on 28 joints. GH = a patient's global assessment of disease activity in the previous 24 hours on a 100 mm visual analog scale (left end = no disease activity \\[symptom-free and no arthritis symptoms\\], right end = maximum disease activity \\[maximum arthritis disease activity\\]). When ESR equaled 0 mm/hr, it was set to 1 mm/hr. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A negative change score indicates improvement.", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. Patients were assigned to the ITT population as randomized, irrespective of the treatment actually received. Only patients with available data were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With a DAS28 Score ≤ 3.2 (DAS28 Low Disease Activity) at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '347', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab 162 mg sc', 'description': 'Patients received tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks.'}, {'id': 'OG001', 'title': 'Placebo sc', 'description': 'Patients received placebo subcutaneously (sc) every 2 weeks for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '45.2', 'groupId': 'OG000', 'lowerLimit': '40.0', 'upperLimit': '50.5'}, {'value': '15.3', 'groupId': 'OG001', 'lowerLimit': '9.0', 'upperLimit': '21.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 24', 'description': "The DAS28 is a combined index for measuring disease activity in rheumatic arthritis (RA) and includes swollen and tender joint counts, erythrocyte sedimentation rate (ESR), and general health (GH) status. The index is calculated with the following formula: DAS28 = (0.56 × √(TJC28)) + (0.28 × √(SJC28)) + (0.7 × log(ESR)) + (0.014 × GH), where TJC28 = tender joint count and SJC28 = swollen joint count, each on 28 joints. GH = a patient's global assessment of disease activity in the previous 24 hours on a 100 mm visual analog scale (left end = no disease activity \\[symptom-free and no arthritis symptoms\\], right end = maximum disease activity \\[maximum arthritis disease activity\\]). When ESR equaled 0 mm/hr, it was set to 1 mm/hr. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A negative change score indicates improvement.", 'unitOfMeasure': 'Percentage of patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. Patients were assigned to the ITT population as randomized, irrespective of the treatment actually received. Only patients with available data were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With a DAS28 Score < 2.6 (DAS28 Remission) at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '347', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab 162 mg sc', 'description': 'Patients received tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks.'}, {'id': 'OG001', 'title': 'Placebo sc', 'description': 'Patients received placebo subcutaneously (sc) every 2 weeks for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '32.0', 'groupId': 'OG000', 'lowerLimit': '27.1', 'upperLimit': '36.9'}, {'value': '4.0', 'groupId': 'OG001', 'lowerLimit': '0.6', 'upperLimit': '7.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'description': "The DAS28 is a combined index for measuring disease activity in rheumatic arthritis (RA) and includes swollen and tender joint counts, erythrocyte sedimentation rate (ESR), and general health (GH) status. The index is calculated with the following formula: DAS28 = (0.56 × √(TJC28)) + (0.28 × √(SJC28)) + (0.7 × log(ESR)) + (0.014 × GH), where TJC28 = tender joint count and SJC28 = swollen joint count, each on 28 joints. GH = a patient's global assessment of disease activity in the previous 24 hours on a 100 mm visual analog scale (left end = no disease activity \\[symptom-free and no arthritis symptoms\\], right end = maximum disease activity \\[maximum arthritis disease activity\\]). When ESR equaled 0 mm/hr, it was set to 1 mm/hr. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A negative change score indicates improvement.", 'unitOfMeasure': 'Percentage of patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. Patients were assigned to the ITT population as randomized, irrespective of the treatment actually received. Only patients with available data were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With Good, Moderate, or no European League Against Rheumatism (EULAR) Responses at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '374', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab 162 mg sc', 'description': 'Patients received tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks.'}, {'id': 'OG001', 'title': 'Placebo sc', 'description': 'Patients received placebo subcutaneously (sc) every 2 weeks for 24 weeks.'}], 'classes': [{'title': 'Good Response', 'categories': [{'measurements': [{'value': '41.7', 'groupId': 'OG000'}, {'value': '13.8', 'groupId': 'OG001'}]}]}, {'title': 'Moderate Response', 'categories': [{'measurements': [{'value': '44.9', 'groupId': 'OG000'}, {'value': '54.3', 'groupId': 'OG001'}]}]}, {'title': 'No Response', 'categories': [{'measurements': [{'value': '13.4', 'groupId': 'OG000'}, {'value': '31.9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 24', 'description': 'Change of the Disease Activity Score 28 score from baseline was used to determine EULAR responses of good, moderate, or no response. For a post-baseline score ≤ 3.2, a change from baseline of \\< -1.2 was a good response, \\< -0.6 to ≥ -1.2 was a moderate response, and ≥ -0.6 was no response. For a post-baseline score \\> 3.2 to ≤ 5.1, a change from baseline of \\< -0.6 was a moderate response and ≥ -0.6 was no response. For a post-baseline score \\> 5.1, a change from baseline \\< -1.2 was a moderate response and ≥ -1.2 was no response. A good response could not be achieved for post-baseline scores \\> 3.2.', 'unitOfMeasure': 'Percentage of patients', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. Patients were assigned to the ITT population as randomized, irrespective of the treatment actually received. Only patients with available data were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Van Der Heijde Modified Sharp Radiographic Score at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '391', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab 162 mg sc', 'description': 'Patients received tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks.'}, {'id': 'OG001', 'title': 'Placebo sc', 'description': 'Patients received placebo subcutaneously (sc) every 2 weeks for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.62', 'spread': '2.692', 'groupId': 'OG000'}, {'value': '1.23', 'spread': '2.816', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 24', 'description': 'The degree of joint damage was assessed using the van der Heijde modified total Sharp score (mTSS). The methodology quantifies the extent of bone erosions for 44 joints and joint space narrowing (JSN) for 42 joints, with higher scores representing greater damage. The independent read of X-ray images was performed by 2 primary readers. In case of discrepancy between the 2 primary readers, an adjudicator was involved. The mTSS can range from 0 to 448 with a higher score indicating more joint damage. A negative change score indicates improvement.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. Patients were assigned to the ITT population as randomized, irrespective of the treatment actually received. Only patients with available data were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Physical and Mental Component Scores of the Short Form 36 (SF-36) Health Survey at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '347', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab 162 mg sc', 'description': 'Patients received tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks.'}, {'id': 'OG001', 'title': 'Placebo sc', 'description': 'Patients received placebo subcutaneously (sc) every 2 weeks for 24 weeks.'}], 'classes': [{'title': 'Physical Component', 'categories': [{'measurements': [{'value': '7.2', 'spread': '8.0', 'groupId': 'OG000'}, {'value': '4.3', 'spread': '5.9', 'groupId': 'OG001'}]}]}, {'title': 'Mental Component', 'categories': [{'measurements': [{'value': '6.1', 'spread': '10.8', 'groupId': 'OG000'}, {'value': '3.0', 'spread': '9.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 24', 'description': 'The SF-36 Health Survey uses patient-reported symptoms on 8 subscales to assess health-related quality of life (HRQoL). The Physical Component Summary (PCS) score summarizes the subscales Physical Functioning, Role-Physical, Bodily Pain, and General Health. The Mental Component Summary (MCS) score summarizes the subscales Vitality, Social Functioning, Role-Emotional, and Mental Health. Each score was scaled from 0 to 100 with a higher score indicating better HRQoL. A positive change score indicates an improvement in HRQoL.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. Patients were assigned to the ITT population as randomized, irrespective of the treatment actually received. Only patients with available data were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Hemoglobin at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '343', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tocilizumab 162 mg sc', 'description': 'Patients received tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks.'}, {'id': 'OG001', 'title': 'Placebo sc', 'description': 'Patients received placebo subcutaneously (sc) every 2 weeks for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.0', 'spread': '12.6', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '7.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 24', 'unitOfMeasure': 'g/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. Patients were assigned to the ITT population as randomized, irrespective of the treatment actually received. Only patients with available data were included in the analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tocilizumab 162 mg sc - Double-blind Treatment Period', 'description': 'Patients received tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks.'}, {'id': 'FG001', 'title': 'Placebo sc - Double-blind Treatment Period', 'description': 'Patients received placebo sc every 2 weeks for 24 weeks.'}, {'id': 'FG002', 'title': 'Tocilizumab Pre-filled Syringe - Open-label Extension Period', 'description': 'Patients received tocilizumab 162 mg sc via a pre-filled syringe every 2 weeks for 72 weeks.'}, {'id': 'FG003', 'title': 'Tocilizumab Auto-injector - Open-label Extension Period', 'description': 'Patients received tocilizumab 162 mg sc via auto-injector every 2 weeks for 72 weeks.'}], 'periods': [{'title': 'Double-blind Treatment Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '438'}, {'groupId': 'FG001', 'numSubjects': '218'}, {'comment': 'There were no participants in this reporting group in this period.', 'groupId': 'FG002', 'numSubjects': '0'}, {'comment': 'There were no participants in this reporting group in this period.', 'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '410'}, {'groupId': 'FG001', 'numSubjects': '209'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Escape', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Adverse Event (Except Anaphylaxis)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Open-label Extension Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'There were no participants in this reporting group in this period.', 'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'There were no participants in this reporting group in this period.', 'groupId': 'FG001', 'numSubjects': '0'}, {'comment': 'Some participants who completed the double-blind period did not enter the open-label period.', 'groupId': 'FG002', 'numSubjects': '230'}, {'comment': 'Some participants who completed the double-blind period did not enter the open-label period.', 'groupId': 'FG003', 'numSubjects': '227'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '203'}, {'groupId': 'FG003', 'numSubjects': '200'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '27'}, {'groupId': 'FG003', 'numSubjects': '27'}]}]}], 'preAssignmentDetails': 'Of the 656 patients randomized into the study (437 to the tocilizumab arm and 219 to the placebo arm), 438 patients received tocilizumab as their first dose and 218 received placebo as their first dose because of a dose administration error with 1 patient.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '437', 'groupId': 'BG000'}, {'value': '218', 'groupId': 'BG001'}, {'value': '655', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Tocilizumab 162 mg sc', 'description': 'Patients received tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks.'}, {'id': 'BG001', 'title': 'Placebo sc', 'description': 'Patients received placebo subcutaneously (sc) every 2 weeks for 24 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52.1', 'spread': '11.49', 'groupId': 'BG000'}, {'value': '52.0', 'spread': '11.67', 'groupId': 'BG001'}, {'value': '52.1', 'spread': '11.54', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '375', 'groupId': 'BG000'}, {'value': '180', 'groupId': 'BG001'}, {'value': '555', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Baseline Characteristics are reported for the safety population which included all patients who received at least 1 dose of study drug and had at least 1 post-dose safety assessment. One patient who received tocilizumab had no post-baseline safety data and was excluded from the safety population.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 656}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-07', 'studyFirstSubmitDate': '2010-11-01', 'resultsFirstSubmitDate': '2013-04-18', 'studyFirstSubmitQcDate': '2010-11-01', 'lastUpdatePostDateStruct': {'date': '2015-07-29', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-08-20', 'studyFirstPostDateStruct': {'date': '2010-11-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-10-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Patients With an American College of Rheumatology 20 (ACR20) Response at Week 24', 'timeFrame': 'Baseline to Week 24', 'description': 'A patient had an ACR20 response if there was at least a 20% improvement, ie, reduction from baseline, in tender and swollen joint counts (28 assessed joints) and in at least 3 of the following 5 parameters: Separate patient and physician assessments of patient disease activity in the previous 24 hours on a visual analog scale (VAS, left end=no disease activity \\[symptom-free and no arthritis symptoms\\], right end=maximum disease activity; patient assessment of pain in previous 24 hours on a VAS (left end=no pain and right end=unbearable pain); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and acute-phase reactant (either C-reactive protein or erythrocyte sedimentation rate).'}], 'secondaryOutcomes': [{'measure': 'Percentage of Patients With ACR50 and ACR70 Responses at Week 24', 'timeFrame': 'Baseline to Week 24', 'description': 'A patient had an ACR50 response if there was at least a 50% improvement in the ACR scores. A patient had an ACR70 response if there was at least a 70% improvement in the ACR scores.'}, {'measure': 'Time to Onset of ACR20, ACR50, and ACR70 Responses', 'timeFrame': 'Baseline to Week 24', 'description': 'Time to first ACR response was calculated as the number of days between the date of the first ACR response minus the date of the first dose of study drug. Median days are reported.'}, {'measure': 'Change From Baseline in Tender Joint Count (TJC) and Swollen Joint Count (SJC) at Week 24', 'timeFrame': 'Baseline to Week 24', 'description': 'Joints (28 joints) will be assessed and classified as swollen/not swollen and tender/not tender by pressure and joint manipulation on physical examination.'}, {'measure': 'Change From Baseline in C-reactive Protein at Week 24', 'timeFrame': 'Baseline to Week 24'}, {'measure': 'Change From Baseline in Erythrocyte Sedimentation Rate at Week 24', 'timeFrame': 'Baseline to Week 24'}, {'measure': "Change From Baseline in the Patient's and the Physician's Global Assessment of Disease Activity Visual Analog (VAS) Score", 'timeFrame': 'Baseline to Week 24', 'description': 'Patients and physicians assessed the patient\'s disease activity in the previous 24 hours on a 100 mm visual analog scale, where the extreme left end of the line represented "no disease activity" (symptom-free and no arthritis symptoms) and the extreme right end represented "maximum disease activity". Scores ranged from 0 to 100 with a higher score indicating more disease activity. A negative change score indicated less disease activity.'}, {'measure': "Change From Baseline in the Patient's Pain Visual Analog Score", 'timeFrame': 'Baseline to Week 24', 'description': 'Patients assessed their pain in the previous 24 hours on a visual analog scale, where the extreme left end of the line represented "no pain" and the extreme right end represented "unbearable pain". Scores ranged from 0 to 100 with a higher score indicating more pain. A negative change score indicated less pain.'}, {'measure': 'Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24', 'timeFrame': 'Baseline to Week 24', 'description': 'The HAQ-DI is a questionnaire specific for rheumatoid arthritis and consists of 20 questions referring to 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Patients completed the questionnaire by answering the 20 questions on a scale of 0 (without difficulty) to 3 (unable to do). The total score ranges from 0 (no disability) to 3 (completely disabled). A negative change score indicates improvement.'}, {'measure': 'Percentage of Patients With an Improvement of ≥ 0.3 Units From Baseline in the HAQ-DI Score at Week 24', 'timeFrame': 'Baseline to Week 24', 'description': 'The HAQ-DI is a questionnaire specific for rheumatoid arthritis and consists of 20 questions referring to 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Patients completed the questionnaire by answering the 20 questions on a scale of 0 (without difficulty) to 3 (unable to do). The total score ranges from 0 (no disability) to 3 (completely disabled). A negative change score indicates improvement.'}, {'measure': 'Change From Baseline in Disease Activity Score 28 (DAS28) at Week 24', 'timeFrame': 'Baseline to Week 24', 'description': "The DAS28 is a combined index for measuring disease activity in rheumatic arthritis (RA) and includes swollen and tender joint counts, erythrocyte sedimentation rate (ESR), and general health (GH) status. The index is calculated with the following formula: DAS28 = (0.56 × √(TJC28)) + (0.28 × √(SJC28)) + (0.7 × log(ESR)) + (0.014 × GH), where TJC28 = tender joint count and SJC28 = swollen joint count, each on 28 joints. GH = a patient's global assessment of disease activity in the previous 24 hours on a 100 mm visual analog scale (left end = no disease activity \\[symptom-free and no arthritis symptoms\\], right end = maximum disease activity \\[maximum arthritis disease activity\\]). When ESR equaled 0 mm/hr, it was set to 1 mm/hr. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A negative change score indicates improvement."}, {'measure': 'Percentage of Patients With a DAS28 Score ≤ 3.2 (DAS28 Low Disease Activity) at Week 24', 'timeFrame': 'Baseline to Week 24', 'description': "The DAS28 is a combined index for measuring disease activity in rheumatic arthritis (RA) and includes swollen and tender joint counts, erythrocyte sedimentation rate (ESR), and general health (GH) status. The index is calculated with the following formula: DAS28 = (0.56 × √(TJC28)) + (0.28 × √(SJC28)) + (0.7 × log(ESR)) + (0.014 × GH), where TJC28 = tender joint count and SJC28 = swollen joint count, each on 28 joints. GH = a patient's global assessment of disease activity in the previous 24 hours on a 100 mm visual analog scale (left end = no disease activity \\[symptom-free and no arthritis symptoms\\], right end = maximum disease activity \\[maximum arthritis disease activity\\]). When ESR equaled 0 mm/hr, it was set to 1 mm/hr. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A negative change score indicates improvement."}, {'measure': 'Percentage of Patients With a DAS28 Score < 2.6 (DAS28 Remission) at Week 24', 'timeFrame': 'Week 24', 'description': "The DAS28 is a combined index for measuring disease activity in rheumatic arthritis (RA) and includes swollen and tender joint counts, erythrocyte sedimentation rate (ESR), and general health (GH) status. The index is calculated with the following formula: DAS28 = (0.56 × √(TJC28)) + (0.28 × √(SJC28)) + (0.7 × log(ESR)) + (0.014 × GH), where TJC28 = tender joint count and SJC28 = swollen joint count, each on 28 joints. GH = a patient's global assessment of disease activity in the previous 24 hours on a 100 mm visual analog scale (left end = no disease activity \\[symptom-free and no arthritis symptoms\\], right end = maximum disease activity \\[maximum arthritis disease activity\\]). When ESR equaled 0 mm/hr, it was set to 1 mm/hr. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A negative change score indicates improvement."}, {'measure': 'Percentage of Patients With Good, Moderate, or no European League Against Rheumatism (EULAR) Responses at Week 24', 'timeFrame': 'Baseline to Week 24', 'description': 'Change of the Disease Activity Score 28 score from baseline was used to determine EULAR responses of good, moderate, or no response. For a post-baseline score ≤ 3.2, a change from baseline of \\< -1.2 was a good response, \\< -0.6 to ≥ -1.2 was a moderate response, and ≥ -0.6 was no response. For a post-baseline score \\> 3.2 to ≤ 5.1, a change from baseline of \\< -0.6 was a moderate response and ≥ -0.6 was no response. For a post-baseline score \\> 5.1, a change from baseline \\< -1.2 was a moderate response and ≥ -1.2 was no response. A good response could not be achieved for post-baseline scores \\> 3.2.'}, {'measure': 'Change From Baseline in the Van Der Heijde Modified Sharp Radiographic Score at Week 24', 'timeFrame': 'Baseline to Week 24', 'description': 'The degree of joint damage was assessed using the van der Heijde modified total Sharp score (mTSS). The methodology quantifies the extent of bone erosions for 44 joints and joint space narrowing (JSN) for 42 joints, with higher scores representing greater damage. The independent read of X-ray images was performed by 2 primary readers. In case of discrepancy between the 2 primary readers, an adjudicator was involved. The mTSS can range from 0 to 448 with a higher score indicating more joint damage. A negative change score indicates improvement.'}, {'measure': 'Change From Baseline in the Physical and Mental Component Scores of the Short Form 36 (SF-36) Health Survey at Week 24', 'timeFrame': 'Baseline to Week 24', 'description': 'The SF-36 Health Survey uses patient-reported symptoms on 8 subscales to assess health-related quality of life (HRQoL). The Physical Component Summary (PCS) score summarizes the subscales Physical Functioning, Role-Physical, Bodily Pain, and General Health. The Mental Component Summary (MCS) score summarizes the subscales Vitality, Social Functioning, Role-Emotional, and Mental Health. Each score was scaled from 0 to 100 with a higher score indicating better HRQoL. A positive change score indicates an improvement in HRQoL.'}, {'measure': 'Change From Baseline in Hemoglobin at Week 24', 'timeFrame': 'Baseline to Week 24'}]}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'referencesModule': {'references': [{'pmid': '24942540', 'type': 'DERIVED', 'citation': 'Kivitz A, Olech E, Borofsky M, Zazueta BM, Navarro-Sarabia F, Radominski SC, Merrill JT, Rowell L, Nasmyth-Miller C, Bao M, Wright S, Pope JE. Subcutaneous tocilizumab versus placebo in combination with disease-modifying antirheumatic drugs in patients with rheumatoid arthritis. Arthritis Care Res (Hoboken). 2014 Nov;66(11):1653-61. doi: 10.1002/acr.22384.'}]}, 'descriptionModule': {'briefSummary': 'This randomized, parallel-group, placebo-controlled, multicenter study will evaluate the reduction in disease activity and the safety of tocilizumab (RoActemra/Actemra) in combination with traditional disease-modifying anti-rheumatic drugs (DMARDs) in patients with active, moderate to severe rheumatoid arthritis. In the double-blind part of the study, patients will be randomized to receive either 162 mg tocilizumab or placebo subcutaneously every 2 weeks for 24 weeks using a pre-filled syringe. In the open-label part of the study, patients will be randomized to receive 162 mg tocilizumab subcutaneously every 2 weeks from Week 24 to Week 96 using a pre-filled syringe or an auto-injector.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adult patients, ≥ years of age.\n* Moderate to severe rheumatoid arthritis of ≥ 6 months duration.\n* Receiving treatment on an outpatient basis.\n* Swollen joint count (SJC) ≥ 6 (66 joint count) and tender joint count (TJC)≥ 8 (68 joint count) at screening and study start.\n* On a stable dose of disease-modifying anti-rheumatic drugs for at least 8 weeks prior to study start.\n\nExclusion Criteria:\n\n* Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following randomization.\n* Rheumatic autoimmune disease other than rheumatoid arthritis, Secondary Sjögren's Syndrome with rheumatoid arthritis is allowed.\n* Functional class IV as defined by the American College of Rheumatology (ACR) Classification of Functional Status in Rheumatoid Arthritis.\n* Diagnosis of juvenile idiopathic arthritis or juvenile rheumatoid arthritis and/or rheumatoid arthritis before the age of 16 years.\n* Prior history of or current inflammatory joint disease other than rheumatoid arthritis.\n* History of malignancy, active or recurrent infections, positive to hepatitis B surface antigen or hepatitis C antibody, active tuberculosis, serious allergy to biologics, or a history of diverticular disease or other symptomatic GI conditions that might predispose to perforations.\n\nOther inclusion and exclusion criteria applied to the study."}, 'identificationModule': {'nctId': 'NCT01232569', 'briefTitle': 'A Study of RoActemra/Actemra (Tocilizumab) Given Subcutaneously in Combination With Traditional DMARDs in Patients With Moderate to Severe Active Rheumatoid Arthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Randomized, Double-blind, Parallel Group Study of Safety and the Effect on Clinical Outcome of Tocilizumab Subcutaneous (sc) Versus Placebo sc in Combination With Traditional Disease Modifying Anti-rheumatic Drugs (DMARDs) in Patients With Moderate to Severe Active Rheumatoid Arthritis', 'orgStudyIdInfo': {'id': 'NA25220'}, 'secondaryIdInfos': [{'id': '2010-019912-18', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tocilizumab 162 mg sc', 'description': 'Patients will receive tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks.', 'interventionNames': ['Drug: Tocilizumab 162 mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo sc', 'description': 'Patients will receive placebo subcutaneously (sc) every 2 weeks for 24 weeks.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Tocilizumab 162 mg', 'type': 'DRUG', 'otherNames': ['RoActemra', 'Actemra'], 'description': 'Tocilizumab will be supplied in a ready-to-use, single-use, pre-filled syringe. Patients and/or caregivers will be trained to administer the injection.', 'armGroupLabels': ['Tocilizumab 162 mg sc']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo will be supplied in a ready-to-use, single-use, pre-filled syringe. Patients and/or caregivers will be trained to administer the injection.', 'armGroupLabels': ['Placebo sc']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85381', 'city': 'Peoria', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.5806, 'lon': -112.23738}}, {'zip': '85258', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '85723', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '85724', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '92835', 'city': 'Fullerton', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.87029, 'lon': -117.92534}}, {'zip': '92108', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '94578', 'city': 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