Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2025-12-29 @ 9:13 AM
Study NCT ID:
NCT01350804
Status:
COMPLETED
Last Update Posted:
2016-05-23
First Post:
2011-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy at 24 Weeks and Safety, Tolerability and Long Term Efficacy of Secukinumab (AIN457) in Patients With Active Rheumatoid Arthritis (RA) and an Inadequate Response to Anti-Tumor Necrosis Factor α (Anti-TNFα) Agents (CAIN457F2309 and CAIN457F2309E1)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C555450', 'term': 'secukinumab'}, {'id': 'D000069594', 'term': 'Abatacept'}], 'ancestors': [{'id': 'D018796', 'term': 'Immunoconjugates'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '862-778-8300', 'title': 'Study Director', 'organization': 'Novartis'}, 'certainAgreement': {'otherDetails': "The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Any AIN457 75 mg', 'description': 'Any AIN457 75 mg', 'otherNumAtRisk': 218, 'otherNumAffected': 144, 'seriousNumAtRisk': 218, 'seriousNumAffected': 30}, {'id': 'EG001', 'title': 'Any AIN457 150 mg', 'description': 'Any AIN457 150 mg', 'otherNumAtRisk': 215, 'otherNumAffected': 146, 'seriousNumAtRisk': 215, 'seriousNumAffected': 28}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (\\>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24.', 'otherNumAtRisk': 139, 'otherNumAffected': 51, 'seriousNumAtRisk': 139, 'seriousNumAffected': 7}, {'id': 'EG003', 'title': 'Abatacept', 'description': 'Participants received abatacept (from 500 to 1000 mg i.v. based on weight). Participants who did not respond to abatacept at Week 16 were re-randomized 1:1 to AIN457 75mg or 150mg at week 24 (after an 8 week washout period).', 'otherNumAtRisk': 137, 'otherNumAffected': 78, 'seriousNumAtRisk': 137, 'seriousNumAffected': 9}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Neutrophilia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Oral candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Tracheobronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Lipoprotein (a) increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Dyslipidaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Hypercholesterolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 10}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Hyperlipidaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Hypertriglyceridaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Bursitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Rheumatoid arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Rheumatoid nodule', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 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'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Intervertebral disc disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Osteoporotic fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Rheumatoid arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Fibroadenoma of breast', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Lipoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Papillary thyroid cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Cerebral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Cerebrospinal fluid leakage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Formication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Lumbar radiculopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Meningorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Perineurial cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Vertebrobasilar insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Cystocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Metrorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Rectocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Acute pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Pulmonary hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Angioedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Venous thrombosis limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 218, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 139, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 137, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Achieving an American College of Rheumatology Response 20 (ACR20).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}, {'value': '138', 'groupId': 'OG002'}, {'value': '138', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'AIN457 10mg/kg - 75 mg', 'description': 'Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks.'}, {'id': 'OG001', 'title': 'AIN457 10mg/kg - 150 mg', 'description': 'Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (\\>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24.'}, {'id': 'OG003', 'title': 'Abatacept', 'description': 'Participants received abatacept (from 500 to 1000 mg i.v. based on weight). Participants who did not respond to abatacept at Week 16 were re-randomized 1:1 to AIN457 75mg or 150mg at week 24 (after an 8 week washout period).'}], 'classes': [{'categories': [{'measurements': [{'value': '28.3', 'groupId': 'OG000'}, {'value': '30.7', 'groupId': 'OG001'}, {'value': '18.1', 'groupId': 'OG002'}, {'value': '42.8', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.0458', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.79', 'ciLowerLimit': '1.0', 'ciUpperLimit': '3.2', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0152', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.02', 'ciLowerLimit': '1.1', 'ciUpperLimit': '3.5', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'week 24', 'description': "ACR20 response was defined as having a positive clinical response to treatment (individual improvement) in disease activity if the participant had at least 20% improvement in tender 68-joint count, swollen 66-joint count and at least 3 of the following 5 measures: patient's assessment of RA pain, patient's global assessment of disease activity, physician's global assessment of disease activity, subject self-assessed disability (Health Assessment Questionnaire \\[HAQ-DI\\] score), and/or acute phase reactant (high sensitivity c-reactive protein (hsCRP) or erythrocyte sedimentation rate (ESR). The ACR20 response results at week 24 used non-responder imputation.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set: the full analysis set was comprised of all randomized participants (excluding mis-randomized participants) who were assigned to study treatment.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Disease Activity Score Utilizing CRP (DAS28-CRP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '84', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'AIN457 10mg/kg - 75 mg', 'description': 'Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks.'}, {'id': 'OG001', 'title': 'AIN457 10mg/kg - 150 mg', 'description': 'Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (\\>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24.'}, {'id': 'OG003', 'title': 'Abatacept', 'description': 'Participants received abatacept (from 500 to 1000 mg i.v. based on weight). Participants who did not respond to abatacept at Week 16 were re-randomized 1:1 to AIN457 75mg or 150mg at week 24 (after an 8 week washout period).'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.47', 'spread': '0.115', 'groupId': 'OG000'}, {'value': '-1.47', 'spread': '0.119', 'groupId': 'OG001'}, {'value': '-1.02', 'spread': '0.163', 'groupId': 'OG002'}, {'value': '-2.07', 'spread': '0.128', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline, week 24', 'description': "The DAS28 is a measure of disease activity in RA based on Swollen and Tender Joint Counts (out of a total of 28), hsCRP and the Patient's Global Assessment of Disease Activity. A DAS28 score greater than 5.1 implies active disease, equal to or less than 3.2 low disease activity, and less than 2.6 remission. A negative change from baseline indicates improvement.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the full analysis set were considered for the analysis. Participants with measurements at both baseline and week 24 were analyzed. The full analysis set was comprised of all randomized participants (excluding mis-randomized participants) who were assigned to study treatment.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Stanford Health Assessment Questionnaire Disability Index (HAQ-DI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '86', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'AIN457 10mg/kg - 75 mg', 'description': 'Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks.'}, {'id': 'OG001', 'title': 'AIN457 10mg/kg - 150 mg', 'description': 'Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (\\>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24.'}, {'id': 'OG003', 'title': 'Abatacept', 'description': 'Participants received abatacept (from 500 to 1000 mg i.v. based on weight). Participants who did not respond to abatacept at Week 16 were re-randomized 1:1 to AIN457 75mg or 150mg at week 24 (after an 8 week washout period).'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.30', 'spread': '0.049', 'groupId': 'OG000'}, {'value': '-0.39', 'spread': '0.051', 'groupId': 'OG001'}, {'value': '-0.26', 'spread': '0.065', 'groupId': 'OG002'}, {'value': '-0.61', 'spread': '0.053', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline, week 24', 'description': 'The HAQ-DI assesses a subject\'s level of functional ability and includes questions of fine movements of the upper extremity, locomotor activities of the lower extremity, and activities that involve both upper and lower extremities. There are 20 questions in 8 categories of functioning including dressing, rising, eating, walking, hygiene, reach, grip and usual activities. The stem of each item asks \'Over the past week, "are you able to..." perform a particular task\'. Each item is scored on a 4 point scale from 0 - 3, representing normal, no difficulty (0), some difficulty (1), much difficulty (2) and unable to do (3). The disability index score is calculated as the mean of the available category scores, ranging from 0 to 3. A negative change from baseline indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the full analysis set were considered for the analysis. Participants with measurements at both baseline and week 24 were analyzed. The full analysis set was comprised of all randomized participants (excluding mis-randomized participants) who were assigned to study treatment.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving ACR50', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}, {'value': '138', 'groupId': 'OG002'}, {'value': '138', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'AIN457 10mg/kg - 75 mg', 'description': 'Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks.'}, {'id': 'OG001', 'title': 'AIN457 10mg/kg - 150 mg', 'description': 'Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (\\>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24.'}, {'id': 'OG003', 'title': 'Abatacept', 'description': 'Participants received abatacept (from 500 to 1000 mg i.v. based on weight). Participants who did not respond to abatacept at Week 16 were re-randomized 1:1 to AIN457 75mg or 150mg at week 24 (after an 8 week washout period).'}], 'classes': [{'categories': [{'measurements': [{'value': '11.6', 'groupId': 'OG000'}, {'value': '16.8', 'groupId': 'OG001'}, {'value': '9.4', 'groupId': 'OG002'}, {'value': '27.5', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'week 24', 'description': "ACR50 response was defined as having a positive clinical response to treatment (individual improvement) in disease activity if the participant had at least 50% improvement in tender 68-joint count, swollen 66-joint count and at least 3 of the following 5 measures: patient's assessment of RA pain, patient's global assessment of disease activity, physician's global assessment of disease activity, subject self-assessed disability (Health Assessment Questionnaire \\[HAQ-DI\\] score), and/or acute phase reactant (high sensitivity c-reactive protein (hsCRP) or erythrocyte sedimentation rate (ESR). The ACR50 response results at week 24 used non-responder imputation.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set: the full analysis set was comprised of all randomized participants (excluding mis-randomized participants) who were assigned to study treatment.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving ACR20, ACR 50 and ACR 70 - Using Non-responder Imputation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}, {'value': '138', 'groupId': 'OG002'}, {'value': '138', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'AIN457 10mg/kg - 75 mg', 'description': 'Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks.'}, {'id': 'OG001', 'title': 'AIN457 10mg/kg - 150 mg', 'description': 'Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (\\>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24.'}, {'id': 'OG003', 'title': 'Abatacept', 'description': 'Participants received abatacept (from 500 to 1000 mg i.v. based on weight). Participants who did not respond to abatacept at Week 16 were re-randomized 1:1 to AIN457 75mg or 150mg at week 24 (after an 8 week washout period).'}], 'classes': [{'title': 'ACR20, week 1', 'categories': [{'measurements': [{'value': '21.0', 'groupId': 'OG000'}, {'value': '17.5', 'groupId': 'OG001'}, {'value': '7.2', 'groupId': 'OG002'}, {'value': '10.9', 'groupId': 'OG003'}]}]}, {'title': 'ACR20, week 2', 'categories': [{'measurements': [{'value': '24.6', 'groupId': 'OG000'}, {'value': '21.2', 'groupId': 'OG001'}, {'value': '12.3', 'groupId': 'OG002'}, {'value': '23.9', 'groupId': 'OG003'}]}]}, {'title': 'ACR20, week 4', 'categories': [{'measurements': [{'value': '34.1', 'groupId': 'OG000'}, {'value': '27.0', 'groupId': 'OG001'}, {'value': '21.7', 'groupId': 'OG002'}, {'value': '31.2', 'groupId': 'OG003'}]}]}, {'title': 'ACR20, week 8', 'categories': [{'measurements': [{'value': '35.5', 'groupId': 'OG000'}, {'value': '41.6', 'groupId': 'OG001'}, {'value': '21.0', 'groupId': 'OG002'}, {'value': '49.3', 'groupId': 'OG003'}]}]}, {'title': 'ACR20, week 12', 'categories': [{'measurements': [{'value': '28.3', 'groupId': 'OG000'}, {'value': '33.6', 'groupId': 'OG001'}, {'value': '24.6', 'groupId': 'OG002'}, {'value': '47.1', 'groupId': 'OG003'}]}]}, {'title': 'ACR20, week 16', 'categories': [{'measurements': [{'value': '34.1', 'groupId': 'OG000'}, {'value': '39.4', 'groupId': 'OG001'}, {'value': '23.2', 'groupId': 'OG002'}, {'value': '51.4', 'groupId': 'OG003'}]}]}, {'title': 'ACR20, week 20', 'categories': [{'measurements': [{'value': '26.8', 'groupId': 'OG000'}, {'value': '38.0', 'groupId': 'OG001'}, {'value': '18.1', 'groupId': 'OG002'}, {'value': '47.8', 'groupId': 'OG003'}]}]}, {'title': 'ACR20, week 24', 'categories': [{'measurements': [{'value': '28.3', 'groupId': 'OG000'}, {'value': '30.7', 'groupId': 'OG001'}, {'value': '18.1', 'groupId': 'OG002'}, {'value': '42.8', 'groupId': 'OG003'}]}]}, {'title': 'ACR50, week 1', 'categories': [{'measurements': [{'value': '6.5', 'groupId': 'OG000'}, {'value': '2.9', 'groupId': 'OG001'}, {'value': '0.7', 'groupId': 'OG002'}, {'value': '1.4', 'groupId': 'OG003'}]}]}, {'title': 'ACR50, week 2', 'categories': [{'measurements': [{'value': '5.1', 'groupId': 'OG000'}, {'value': '8.8', 'groupId': 'OG001'}, {'value': '2.9', 'groupId': 'OG002'}, {'value': '2.9', 'groupId': 'OG003'}]}]}, {'title': 'ACR50, week 4', 'categories': [{'measurements': [{'value': '9.4', 'groupId': 'OG000'}, {'value': '10.2', 'groupId': 'OG001'}, {'value': '2.9', 'groupId': 'OG002'}, {'value': '7.2', 'groupId': 'OG003'}]}]}, {'title': 'ACR50, week 8', 'categories': [{'measurements': [{'value': '7.2', 'groupId': 'OG000'}, {'value': '15.3', 'groupId': 'OG001'}, {'value': '10.1', 'groupId': 'OG002'}, {'value': '18.8', 'groupId': 'OG003'}]}]}, {'title': 'ACR50, week 12', 'categories': [{'measurements': [{'value': '8.7', 'groupId': 'OG000'}, {'value': '13.1', 'groupId': 'OG001'}, {'value': '10.1', 'groupId': 'OG002'}, {'value': '22.5', 'groupId': 'OG003'}]}]}, {'title': 'ACR50, week 16', 'categories': [{'measurements': [{'value': '13.8', 'groupId': 'OG000'}, {'value': '20.4', 'groupId': 'OG001'}, {'value': '9.4', 'groupId': 'OG002'}, {'value': '23.9', 'groupId': 'OG003'}]}]}, {'title': 'ACR50, week 20', 'categories': [{'measurements': [{'value': '12.3', 'groupId': 'OG000'}, {'value': '18.2', 'groupId': 'OG001'}, {'value': '8.0', 'groupId': 'OG002'}, {'value': '26.8', 'groupId': 'OG003'}]}]}, {'title': 'ACR50, week 24', 'categories': [{'measurements': [{'value': '11.6', 'groupId': 'OG000'}, {'value': '16.8', 'groupId': 'OG001'}, {'value': '9.4', 'groupId': 'OG002'}, {'value': '27.5', 'groupId': 'OG003'}]}]}, {'title': 'ACR70, week 1', 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000'}, {'value': '0.7', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.7', 'groupId': 'OG003'}]}]}, {'title': 'ACR70, week 2', 'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000'}, {'value': '0.7', 'groupId': 'OG001'}, {'value': '1.4', 'groupId': 'OG002'}, {'value': '0.7', 'groupId': 'OG003'}]}]}, {'title': 'ACR70, week 4', 'categories': [{'measurements': [{'value': '4.3', 'groupId': 'OG000'}, {'value': '2.9', 'groupId': 'OG001'}, {'value': '1.4', 'groupId': 'OG002'}, {'value': '1.4', 'groupId': 'OG003'}]}]}, {'title': 'ACR70, week 8', 'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000'}, {'value': '4.4', 'groupId': 'OG001'}, {'value': '2.9', 'groupId': 'OG002'}, {'value': '5.8', 'groupId': 'OG003'}]}]}, {'title': 'ACR70, week 12', 'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000'}, {'value': '2.9', 'groupId': 'OG001'}, {'value': '2.9', 'groupId': 'OG002'}, {'value': '9.4', 'groupId': 'OG003'}]}]}, {'title': 'ACR70, week 16', 'categories': [{'measurements': [{'value': '5.1', 'groupId': 'OG000'}, {'value': '8.0', 'groupId': 'OG001'}, {'value': '2.9', 'groupId': 'OG002'}, {'value': '9.4', 'groupId': 'OG003'}]}]}, {'title': 'ACR70, week 20', 'categories': [{'measurements': [{'value': '4.3', 'groupId': 'OG000'}, {'value': '7.3', 'groupId': 'OG001'}, {'value': '5.8', 'groupId': 'OG002'}, {'value': '10.1', 'groupId': 'OG003'}]}]}, {'title': 'ACR70, week 24', 'categories': [{'measurements': [{'value': '5.1', 'groupId': 'OG000'}, {'value': '10.2', 'groupId': 'OG001'}, {'value': '5.1', 'groupId': 'OG002'}, {'value': '12.3', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'baseline, weeks 1, 2, 4, 8, 12, 16, 20 and 24', 'description': "ACR20, ACR 50 and ACR 70 response was defined as having a positive clinical response to treatment (individual improvement) in disease activity if the participant had at least 20%, 50% and/or 70% improvement, respectively, in tender 68-joint count, swollen 66-joint count and at least 3 of the following 5 measures: patient's assessment of RA pain, patient's global assessment of disease activity, physician's global assessment of disease activity, subject self-assessed disability (Health Assessment Questionnaire \\[HAQ-DI\\] score), and/or acute phase reactant (high sensitivity c-reactive protein (hsCRP) or erythrocyte sedimentation rate (ESR).", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the full analysis set were considered for the analysis. Participants with missing data were considered non-responders at the respective time point. Placebo and Abatacept participants were considered non-responders from the time of treatment switch.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving ACR20, ACR 50 and ACR 70 - Observed Data', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}, {'value': '138', 'groupId': 'OG002'}, {'value': '138', 'groupId': 'OG003'}, {'value': '39', 'groupId': 'OG004'}, {'value': '39', 'groupId': 'OG005'}, {'value': '23', 'groupId': 'OG006'}, {'value': '22', 'groupId': 'OG007'}, {'value': '101', 'groupId': 'OG008'}, {'value': '18', 'groupId': 'OG009'}, {'value': '19', 'groupId': 'OG010'}]}], 'groups': [{'id': 'OG000', 'title': 'AIN457 10mg/kg - 75 mg', 'description': 'Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks.'}, {'id': 'OG001', 'title': 'AIN457 10mg/kg - 150 mg', 'description': 'Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (\\>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24.'}, {'id': 'OG003', 'title': 'Abatacept', 'description': 'Participants received abatacept (from 500 to 1000 mg i.v. based on weight). Participants who did not respond to abatacept at Week 16 were re-randomized 1:1 to AIN457 75mg or 150mg at week 24 (after an 8 week washout period).'}, {'id': 'OG004', 'title': 'Placebo Non-responder - AIN457 75 mg', 'description': 'Participants switched from placebo to AIN457 75 mg starting at week 16.'}, {'id': 'OG005', 'title': 'Placebo Non-responder - AIN457 150 mg', 'description': 'Participants switched from placebo to AIN457 150 mg starting at week 16.'}, {'id': 'OG006', 'title': 'Placebo Responder - AIN457 75mg', 'description': 'Participants switched from placebo to AIN457 75 mg starting at week 24.'}, {'id': 'OG007', 'title': 'Placebo Responder - AIN457 150mg', 'description': 'Participants switched from placebo to AIN457 150 mg starting at week 24.'}, {'id': 'OG008', 'title': 'Abatacept Responders', 'description': 'Abatacept responders remained on abatacept (from 500 to 1000 mg iv based on weight).'}, {'id': 'OG009', 'title': 'Abatacept Non-respnders - AIN457 75mg', 'description': 'Participants switched from abatacept to AIN457 75 mg starting at week 24.'}, {'id': 'OG010', 'title': 'Abatacept Non-responders - AIN457 150mg', 'description': 'Participants switched from abatacept to AIN457 150 mg starting at week 24.'}], 'classes': [{'title': 'ACR20,wk 1,n=132,129,130,130,39,35,21,22,96,17,17', 'categories': [{'measurements': [{'value': '22.7', 'groupId': 'OG000'}, {'value': '18.6', 'groupId': 'OG001'}, {'value': '7.7', 'groupId': 'OG002'}, {'value': '11.5', 'groupId': 'OG003'}, {'value': '5.1', 'groupId': 'OG004'}, {'value': '5.7', 'groupId': 'OG005'}, {'value': '14.3', 'groupId': 'OG006'}, {'value': '13.6', 'groupId': 'OG007'}, {'value': '14.6', 'groupId': 'OG008'}, {'value': '0.0', 'groupId': 'OG009'}, {'value': '5.9', 'groupId': 'OG010'}]}]}, {'title': 'ACR20,wk 2,n=131,130,134,134,39,36,23,22,99,17,18', 'categories': [{'measurements': [{'value': '26.7', 'groupId': 'OG000'}, {'value': '22.3', 'groupId': 'OG001'}, {'value': '12.7', 'groupId': 'OG002'}, {'value': '25.4', 'groupId': 'OG003'}, {'value': '2.6', 'groupId': 'OG004'}, {'value': '11.1', 'groupId': 'OG005'}, {'value': '34.8', 'groupId': 'OG006'}, {'value': '13.6', 'groupId': 'OG007'}, {'value': '29.3', 'groupId': 'OG008'}, {'value': '11.8', 'groupId': 'OG009'}, {'value': '16.7', 'groupId': 'OG010'}]}]}, {'title': 'ACR20,wk 4,n=133,132,131,129,39,39,23,21,93,17,19', 'categories': [{'measurements': [{'value': '36.1', 'groupId': 'OG000'}, {'value': '28.0', 'groupId': 'OG001'}, {'value': '22.9', 'groupId': 'OG002'}, {'value': '34.1', 'groupId': 'OG003'}, {'value': '15.4', 'groupId': 'OG004'}, {'value': '12.8', 'groupId': 'OG005'}, {'value': '43.5', 'groupId': 'OG006'}, {'value': '42.9', 'groupId': 'OG007'}, {'value': '41.9', 'groupId': 'OG008'}, {'value': '17.6', 'groupId': 'OG009'}, {'value': '10.5', 'groupId': 'OG010'}]}]}, {'title': 'ACR20,wk 8,n=132,127,131,131,39,39,23,22,95,17,19', 'categories': [{'measurements': [{'value': '38.6', 'groupId': 'OG000'}, {'value': '44.9', 'groupId': 'OG001'}, {'value': '22.1', 'groupId': 'OG002'}, {'value': '52.7', 'groupId': 'OG003'}, {'value': '17.9', 'groupId': 'OG004'}, {'value': '12.8', 'groupId': 'OG005'}, {'value': '39.1', 'groupId': 'OG006'}, {'value': '31.8', 'groupId': 'OG007'}, {'value': '61.1', 'groupId': 'OG008'}, {'value': '29.4', 'groupId': 'OG009'}, {'value': '31.6', 'groupId': 'OG010'}]}]}, {'title': 'ACR20,wk 12,n=130,115,123,129,39,37,23,21,94,17,18', 'categories': [{'measurements': [{'value': '30.8', 'groupId': 'OG000'}, {'value': '40.0', 'groupId': 'OG001'}, {'value': '27.6', 'groupId': 'OG002'}, {'value': '51.2', 'groupId': 'OG003'}, {'value': '15.4', 'groupId': 'OG004'}, {'value': '16.2', 'groupId': 'OG005'}, {'value': '47.8', 'groupId': 'OG006'}, {'value': '52.4', 'groupId': 'OG007'}, {'value': '62.8', 'groupId': 'OG008'}, {'value': '17.6', 'groupId': 'OG009'}, {'value': '22.2', 'groupId': 'OG010'}]}]}, {'title': 'ACR20,wk 16,n=126,118,116,129,36,37,21,22,94,16,19', 'categories': [{'measurements': [{'value': '38.1', 'groupId': 'OG000'}, {'value': '45.8', 'groupId': 'OG001'}, {'value': '27.6', 'groupId': 'OG002'}, {'value': '55.8', 'groupId': 'OG003'}, {'value': '2.8', 'groupId': 'OG004'}, {'value': '2.7', 'groupId': 'OG005'}, {'value': '76.2', 'groupId': 'OG006'}, {'value': '63.6', 'groupId': 'OG007'}, {'value': '76.6', 'groupId': 'OG008'}, {'value': '0.0', 'groupId': 'OG009'}, {'value': '0.0', 'groupId': 'OG010'}]}]}, {'title': 'ACR20,wk 20,n=122,114,119,126,38,37,23,21,91,16,19', 'categories': [{'measurements': [{'value': '39.3', 'groupId': 'OG000'}, {'value': '51.8', 'groupId': 'OG001'}, {'value': '42.9', 'groupId': 'OG002'}, {'value': '57.9', 'groupId': 'OG003'}, {'value': '42.1', 'groupId': 'OG004'}, {'value': '29.7', 'groupId': 'OG005'}, {'value': '60.9', 'groupId': 'OG006'}, {'value': '47.6', 'groupId': 'OG007'}, {'value': '73.6', 'groupId': 'OG008'}, {'value': '6.3', 'groupId': 'OG009'}, {'value': '26.3', 'groupId': 'OG010'}]}]}, {'title': 'ACR20,wk 24,n=117,110,117,121,38,36,21,22,87,16,18', 'categories': [{'measurements': [{'value': '45.3', 'groupId': 'OG000'}, {'value': '48.2', 'groupId': 'OG001'}, {'value': '40.2', 'groupId': 'OG002'}, {'value': '57.9', 'groupId': 'OG003'}, {'value': '26.3', 'groupId': 'OG004'}, {'value': '33.3', 'groupId': 'OG005'}, {'value': '57.1', 'groupId': 'OG006'}, {'value': '59.1', 'groupId': 'OG007'}, {'value': '69.0', 'groupId': 'OG008'}, {'value': '31.3', 'groupId': 'OG009'}, {'value': '27.8', 'groupId': 'OG010'}]}]}, {'title': 'ACR20,wk28,n=115,103,na,na,33,35,21,21,86,17,19', 'categories': [{'measurements': [{'value': '47.8', 'groupId': 'OG000'}, {'value': '65.0', 'groupId': 'OG001'}, {'value': 'NA', 'comment': "After week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only.", 'groupId': 'OG002'}, {'value': 'NA', 'comment': "After week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only.", 'groupId': 'OG003'}, {'value': '33.3', 'groupId': 'OG004'}, {'value': '37.1', 'groupId': 'OG005'}, {'value': '71.4', 'groupId': 'OG006'}, {'value': '90.5', 'groupId': 'OG007'}, {'value': '74.4', 'groupId': 'OG008'}, {'value': '41.2', 'groupId': 'OG009'}, {'value': '42.1', 'groupId': 'OG010'}]}]}, {'title': 'ACR20,wk32,n=104,97,na,na,33,30,21,19,87,17,17', 'categories': [{'measurements': [{'value': '56.7', 'groupId': 'OG000'}, {'value': '61.9', 'groupId': 'OG001'}, {'value': 'NA', 'comment': "After week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only.", 'groupId': 'OG002'}, {'value': 'NA', 'comment': "After week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only.", 'groupId': 'OG003'}, {'value': '51.5', 'groupId': 'OG004'}, {'value': '36.7', 'groupId': 'OG005'}, {'value': '81.0', 'groupId': 'OG006'}, {'value': '68.4', 'groupId': 'OG007'}, {'value': '74.7', 'groupId': 'OG008'}, {'value': '23.5', 'groupId': 'OG009'}, {'value': '47.1', 'groupId': 'OG010'}]}]}, {'title': 'ACR20,wk36,n=102,93,na,na,30,30,21,20,85,18,16', 'categories': [{'measurements': [{'value': '56.9', 'groupId': 'OG000'}, {'value': '53.8', 'groupId': 'OG001'}, {'value': 'NA', 'comment': "After week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only.", 'groupId': 'OG002'}, {'value': 'NA', 'comment': "After week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only.", 'groupId': 'OG003'}, {'value': '46.7', 'groupId': 'OG004'}, {'value': '56.7', 'groupId': 'OG005'}, {'value': '85.7', 'groupId': 'OG006'}, {'value': '65.0', 'groupId': 'OG007'}, {'value': '77.6', 'groupId': 'OG008'}, {'value': '27.8', 'groupId': 'OG009'}, {'value': '56.3', 'groupId': 'OG010'}]}]}, {'title': 'ACR20,wk40,n=96,90,na,na,28,28,21,19,85,15,17', 'categories': [{'measurements': [{'value': '53.1', 'groupId': 'OG000'}, {'value': '61.1', 'groupId': 'OG001'}, {'value': 'NA', 'comment': "After week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only.", 'groupId': 'OG002'}, {'value': 'NA', 'comment': "After week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only.", 'groupId': 'OG003'}, {'value': '53.6', 'groupId': 'OG004'}, {'value': '53.6', 'groupId': 'OG005'}, {'value': '85.7', 'groupId': 'OG006'}, {'value': '73.7', 'groupId': 'OG007'}, {'value': '71.8', 'groupId': 'OG008'}, {'value': '40.0', 'groupId': 'OG009'}, {'value': '58.8', 'groupId': 'OG010'}]}]}, {'title': 'ACR20,wk44,n=97,90,na,na,28,27,20,18,84,15,16', 'categories': [{'measurements': [{'value': '56.7', 'groupId': 'OG000'}, {'value': '61.1', 'groupId': 'OG001'}, {'value': 'NA', 'comment': "After week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only.", 'groupId': 'OG002'}, {'value': 'NA', 'comment': "After week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only.", 'groupId': 'OG003'}, {'value': '50.0', 'groupId': 'OG004'}, {'value': '55.6', 'groupId': 'OG005'}, {'value': '85.0', 'groupId': 'OG006'}, {'value': '77.8', 'groupId': 'OG007'}, {'value': '77.4', 'groupId': 'OG008'}, {'value': '33.3', 'groupId': 'OG009'}, {'value': '31.3', 'groupId': 'OG010'}]}]}, {'title': 'ACR20,wk48,n=94,89,na,na,28,26,18,19,77,12,14', 'categories': [{'measurements': [{'value': '57.4', 'groupId': 'OG000'}, {'value': '68.5', 'groupId': 'OG001'}, {'value': 'NA', 'comment': "After week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only.", 'groupId': 'OG002'}, {'value': 'NA', 'comment': "After week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only.", 'groupId': 'OG003'}, {'value': '53.6', 'groupId': 'OG004'}, {'value': '61.5', 'groupId': 'OG005'}, {'value': '72.2', 'groupId': 'OG006'}, {'value': '57.9', 'groupId': 'OG007'}, {'value': '71.4', 'groupId': 'OG008'}, {'value': '25.0', 'groupId': 'OG009'}, {'value': '50.0', 'groupId': 'OG010'}]}]}, {'title': 'ACR20,wk52,n=92,88,na,na,28,26,20,18,79,15,15', 'categories': [{'measurements': [{'value': '56.5', 'groupId': 'OG000'}, {'value': '62.5', 'groupId': 'OG001'}, {'value': 'NA', 'comment': "After week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only.", 'groupId': 'OG002'}, {'value': 'NA', 'comment': "After week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only.", 'groupId': 'OG003'}, {'value': '39.3', 'groupId': 'OG004'}, {'value': '57.7', 'groupId': 'OG005'}, {'value': '75.0', 'groupId': 'OG006'}, {'value': '88.9', 'groupId': 'OG007'}, {'value': '74.7', 'groupId': 'OG008'}, {'value': '40.0', 'groupId': 'OG009'}, {'value': '33.3', 'groupId': 'OG010'}]}]}, {'title': 'ACR50,wk1,n=132,129,130,130,39,35,21,22,96,17,17', 'categories': [{'measurements': [{'value': '6.8', 'groupId': 'OG000'}, {'value': '3.1', 'groupId': 'OG001'}, {'value': '0.8', 'groupId': 'OG002'}, {'value': '1.5', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}, {'value': '0.0', 'groupId': 'OG005'}, {'value': '4.8', 'groupId': 'OG006'}, {'value': '0.0', 'groupId': 'OG007'}, {'value': '1.0', 'groupId': 'OG008'}, {'value': '0.0', 'groupId': 'OG009'}, {'value': '5.9', 'groupId': 'OG010'}]}]}, {'title': 'ACR50,wk2,n=131,130,134,134,39,36,23,22,99,17,18', 'categories': [{'measurements': [{'value': '5.3', 'groupId': 'OG000'}, {'value': '9.2', 'groupId': 'OG001'}, {'value': '3.0', 'groupId': 'OG002'}, {'value': '3.0', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}, {'value': '0.0', 'groupId': 'OG005'}, {'value': '13.0', 'groupId': 'OG006'}, {'value': '4.5', 'groupId': 'OG007'}, {'value': '3.0', 'groupId': 'OG008'}, {'value': '0.0', 'groupId': 'OG009'}, {'value': '5.6', 'groupId': 'OG010'}]}]}, {'title': 'ACR50,wk4,n=133,132,131,129,39,39,23,21,93,17,19', 'categories': [{'measurements': [{'value': '9.8', 'groupId': 'OG000'}, {'value': '10.6', 'groupId': 'OG001'}, {'value': '3.1', 'groupId': 'OG002'}, {'value': '7.8', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}, {'value': '0.0', 'groupId': 'OG005'}, {'value': '8.7', 'groupId': 'OG006'}, {'value': '9.5', 'groupId': 'OG007'}, {'value': '10.8', 'groupId': 'OG008'}, {'value': '0.0', 'groupId': 'OG009'}, {'value': '0.0', 'groupId': 'OG010'}]}]}, {'title': 'ACR50,wk8,n=132,127,131,131,39,39,23,22,95,17,19', 'categories': [{'measurements': [{'value': '9.1', 'groupId': 'OG000'}, {'value': '16.5', 'groupId': 'OG001'}, {'value': '10.7', 'groupId': 'OG002'}, {'value': '20.6', 'groupId': 'OG003'}, {'value': '5.1', 'groupId': 'OG004'}, {'value': '5.1', 'groupId': 'OG005'}, {'value': '34.8', 'groupId': 'OG006'}, {'value': '9.1', 'groupId': 'OG007'}, {'value': '25.3', 'groupId': 'OG008'}, {'value': '11.8', 'groupId': 'OG009'}, {'value': '5.3', 'groupId': 'OG010'}]}]}, {'title': 'ACR50,wk12,n=130,115,123,129,39,37,23,21,94,17,18', 'categories': [{'measurements': [{'value': '10.0', 'groupId': 'OG000'}, {'value': '15.7', 'groupId': 'OG001'}, {'value': '11.4', 'groupId': 'OG002'}, {'value': '24.8', 'groupId': 'OG003'}, {'value': '2.6', 'groupId': 'OG004'}, {'value': '8.1', 'groupId': 'OG005'}, {'value': '21.7', 'groupId': 'OG006'}, {'value': '23.8', 'groupId': 'OG007'}, {'value': '30.9', 'groupId': 'OG008'}, {'value': '5.9', 'groupId': 'OG009'}, {'value': '11.1', 'groupId': 'OG010'}]}]}, {'title': 'ACR50,wk16,n=126,118,116,129,36,37,21,22,94,16,19', 'categories': [{'measurements': [{'value': '15.9', 'groupId': 'OG000'}, {'value': '23.7', 'groupId': 'OG001'}, {'value': '11.2', 'groupId': 'OG002'}, {'value': '26.4', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}, {'value': '0.0', 'groupId': 'OG005'}, {'value': '38.1', 'groupId': 'OG006'}, {'value': '22.7', 'groupId': 'OG007'}, {'value': '36.2', 'groupId': 'OG008'}, {'value': '0.0', 'groupId': 'OG009'}, {'value': '0.0', 'groupId': 'OG010'}]}]}, {'title': 'ACR50,wk20,n=122,114,119,126,38,37,23,21,91,16,19', 'categories': [{'measurements': [{'value': '15.6', 'groupId': 'OG000'}, {'value': '21.9', 'groupId': 'OG001'}, {'value': '12.6', 'groupId': 'OG002'}, {'value': '31.7', 'groupId': 'OG003'}, {'value': '7.9', 'groupId': 'OG004'}, {'value': '2.7', 'groupId': 'OG005'}, {'value': '34.8', 'groupId': 'OG006'}, {'value': '14.3', 'groupId': 'OG007'}, {'value': '40.7', 'groupId': 'OG008'}, {'value': '0.0', 'groupId': 'OG009'}, {'value': '15.8', 'groupId': 'OG010'}]}]}, {'title': 'ACR50,wk24,n=117,110,117,121,38,36,21,22,87,16,18', 'categories': [{'measurements': [{'value': '14.5', 'groupId': 'OG000'}, {'value': '22.7', 'groupId': 'OG001'}, {'value': '14.5', 'groupId': 'OG002'}, {'value': '33.1', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}, {'value': '11.1', 'groupId': 'OG005'}, {'value': '38.1', 'groupId': 'OG006'}, {'value': '22.7', 'groupId': 'OG007'}, {'value': '44.8', 'groupId': 'OG008'}, {'value': '0.0', 'groupId': 'OG009'}, {'value': '5.6', 'groupId': 'OG010'}]}]}, {'title': 'ACR50,wk28,n=115,103,na,na,33,35,21,21,86,17,19', 'categories': [{'measurements': [{'value': '13.9', 'groupId': 'OG000'}, {'value': '31.1', 'groupId': 'OG001'}, {'value': 'NA', 'comment': "After week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only.", 'groupId': 'OG002'}, {'value': 'NA', 'comment': "After week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only.", 'groupId': 'OG003'}, {'value': '6.1', 'groupId': 'OG004'}, {'value': '8.6', 'groupId': 'OG005'}, {'value': '33.3', 'groupId': 'OG006'}, {'value': '33.3', 'groupId': 'OG007'}, {'value': '41.9', 'groupId': 'OG008'}, {'value': '23.5', 'groupId': 'OG009'}, {'value': '0.0', 'groupId': 'OG010'}]}]}, {'title': 'ACR50,wk32,n=104,97,na,na,33,30,21,19,87,17,17', 'categories': [{'measurements': [{'value': '21.2', 'groupId': 'OG000'}, {'value': '32.0', 'groupId': 'OG001'}, {'value': 'NA', 'comment': "After week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only.", 'groupId': 'OG002'}, {'value': 'NA', 'comment': "After week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only.", 'groupId': 'OG003'}, {'value': '6.1', 'groupId': 'OG004'}, {'value': '13.3', 'groupId': 'OG005'}, {'value': '42.9', 'groupId': 'OG006'}, {'value': '31.6', 'groupId': 'OG007'}, {'value': '47.1', 'groupId': 'OG008'}, {'value': '5.9', 'groupId': 'OG009'}, {'value': '0.0', 'groupId': 'OG010'}]}]}, {'title': 'ACR50,wk36,n=102,93,na,na,30,30,21,20,85,18,16', 'categories': [{'measurements': [{'value': '23.5', 'groupId': 'OG000'}, {'value': '24.7', 'groupId': 'OG001'}, {'value': 'NA', 'comment': "After week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only.", 'groupId': 'OG002'}, {'value': 'NA', 'comment': "After week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only.", 'groupId': 'OG003'}, {'value': '16.7', 'groupId': 'OG004'}, {'value': '16.7', 'groupId': 'OG005'}, {'value': '28.6', 'groupId': 'OG006'}, {'value': '20.0', 'groupId': 'OG007'}, {'value': '47.1', 'groupId': 'OG008'}, {'value': '16.7', 'groupId': 'OG009'}, {'value': '18.8', 'groupId': 'OG010'}]}]}, {'title': 'ACR50,wk40,n=96,90,na,na,28,28,21,19,85,15,17', 'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000'}, {'value': '25.6', 'groupId': 'OG001'}, {'value': 'NA', 'comment': "After week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only.", 'groupId': 'OG002'}, {'value': 'NA', 'comment': "After week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only.", 'groupId': 'OG003'}, {'value': '14.3', 'groupId': 'OG004'}, {'value': '28.6', 'groupId': 'OG005'}, {'value': '38.1', 'groupId': 'OG006'}, {'value': '26.3', 'groupId': 'OG007'}, {'value': '45.9', 'groupId': 'OG008'}, {'value': '20.0', 'groupId': 'OG009'}, {'value': '5.9', 'groupId': 'OG010'}]}]}, {'title': 'ACR50,wk44,n=97,90,na,na,28,27,20,18,84,15,16', 'categories': [{'measurements': [{'value': '27.8', 'groupId': 'OG000'}, {'value': '30.0', 'groupId': 'OG001'}, {'value': 'NA', 'comment': "After week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only.", 'groupId': 'OG002'}, {'value': 'NA', 'comment': "After week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only.", 'groupId': 'OG003'}, {'value': '7.1', 'groupId': 'OG004'}, {'value': '29.6', 'groupId': 'OG005'}, {'value': '35.0', 'groupId': 'OG006'}, {'value': '33.3', 'groupId': 'OG007'}, {'value': '50.0', 'groupId': 'OG008'}, {'value': '13.3', 'groupId': 'OG009'}, {'value': '6.3', 'groupId': 'OG010'}]}]}, {'title': 'ACR50,wk48,n=94,89,na,na,28,26,18,19,77,12,14', 'categories': [{'measurements': [{'value': '25.5', 'groupId': 'OG000'}, {'value': '42.7', 'groupId': 'OG001'}, {'value': 'NA', 'comment': "After week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only.", 'groupId': 'OG002'}, {'value': 'NA', 'comment': "After week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only.", 'groupId': 'OG003'}, {'value': '14.3', 'groupId': 'OG004'}, {'value': '23.1', 'groupId': 'OG005'}, {'value': '38.9', 'groupId': 'OG006'}, {'value': '26.3', 'groupId': 'OG007'}, {'value': '48.1', 'groupId': 'OG008'}, {'value': '0.0', 'groupId': 'OG009'}, {'value': '0.0', 'groupId': 'OG010'}]}]}, {'title': 'ACR50,wk52,n=92,88,na,na,28,26,20,18,79,15,15', 'categories': [{'measurements': [{'value': '26.1', 'groupId': 'OG000'}, {'value': '45.5', 'groupId': 'OG001'}, {'value': 'NA', 'comment': "After week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only.", 'groupId': 'OG002'}, {'value': 'NA', 'comment': "After week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only.", 'groupId': 'OG003'}, {'value': '10.7', 'groupId': 'OG004'}, {'value': '26.9', 'groupId': 'OG005'}, {'value': '40.0', 'groupId': 'OG006'}, {'value': '44.4', 'groupId': 'OG007'}, {'value': '51.9', 'groupId': 'OG008'}, {'value': '20.0', 'groupId': 'OG009'}, {'value': '13.3', 'groupId': 'OG010'}]}]}, {'title': 'ACR70,wk1,n=132,129,130,130,39,35,21,22,96,17,17', 'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000'}, {'value': '0.8', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.8', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}, {'value': '0.0', 'groupId': 'OG005'}, {'value': '0.0', 'groupId': 'OG006'}, {'value': '0.0', 'groupId': 'OG007'}, {'value': '1.0', 'groupId': 'OG008'}, {'value': '0.0', 'groupId': 'OG009'}, {'value': '0.0', 'groupId': 'OG010'}]}]}, {'title': 'ACR70,wk2,n=131,130,134,134,39,36,23,22,99,17,18', 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000'}, {'value': '0.8', 'groupId': 'OG001'}, {'value': '1.5', 'groupId': 'OG002'}, {'value': '0.7', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}, {'value': '0.0', 'groupId': 'OG005'}, {'value': '4.3', 'groupId': 'OG006'}, {'value': '4.5', 'groupId': 'OG007'}, {'value': '1.0', 'groupId': 'OG008'}, {'value': '0.0', 'groupId': 'OG009'}, {'value': '0.0', 'groupId': 'OG010'}]}]}, {'title': 'ACR70,wk4,n=133,132,131,129,39,39,23,21,93,17,19', 'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000'}, {'value': '3.0', 'groupId': 'OG001'}, {'value': '1.5', 'groupId': 'OG002'}, {'value': '1.6', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}, {'value': '0.0', 'groupId': 'OG005'}, {'value': '4.3', 'groupId': 'OG006'}, {'value': '4.8', 'groupId': 'OG007'}, {'value': '2.2', 'groupId': 'OG008'}, {'value': '0.0', 'groupId': 'OG009'}, {'value': '0.0', 'groupId': 'OG010'}]}]}, {'title': 'ACR70,wk8,n=132,127,131,131,39,39,23,22,95,17,19', 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000'}, {'value': '4.7', 'groupId': 'OG001'}, {'value': '3.1', 'groupId': 'OG002'}, {'value': '6.1', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}, {'value': '2.6', 'groupId': 'OG005'}, {'value': '13.0', 'groupId': 'OG006'}, {'value': '0.0', 'groupId': 'OG007'}, {'value': '7.4', 'groupId': 'OG008'}, {'value': '5.9', 'groupId': 'OG009'}, {'value': '0.0', 'groupId': 'OG010'}]}]}, {'title': 'ACR70,wk12,n=130,115,123,129,39,37,23,21,94,17,18', 'categories': [{'measurements': [{'value': '3.1', 'groupId': 'OG000'}, {'value': '3.5', 'groupId': 'OG001'}, {'value': '3.3', 'groupId': 'OG002'}, {'value': '10.9', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}, {'value': '0.0', 'groupId': 'OG005'}, {'value': '13.0', 'groupId': 'OG006'}, {'value': '4.8', 'groupId': 'OG007'}, {'value': '14.9', 'groupId': 'OG008'}, {'value': '0.0', 'groupId': 'OG009'}, {'value': '0.0', 'groupId': 'OG010'}]}]}, {'title': 'ACR70,wk16,n=126,118,116,129,36,37,21,22,94,16,19', 'categories': [{'measurements': [{'value': '6.3', 'groupId': 'OG000'}, {'value': '9.3', 'groupId': 'OG001'}, {'value': '3.4', 'groupId': 'OG002'}, {'value': '10.0', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}, {'value': '0.0', 'groupId': 'OG005'}, {'value': '14.3', 'groupId': 'OG006'}, {'value': '4.5', 'groupId': 'OG007'}, {'value': '13.8', 'groupId': 'OG008'}, {'value': '0.0', 'groupId': 'OG009'}, {'value': '0.0', 'groupId': 'OG010'}]}]}, {'title': 'ACR70,wk20,n=122,114,119,126,38,37,23,21,91,16,19', 'categories': [{'measurements': [{'value': '6.6', 'groupId': 'OG000'}, {'value': '8.8', 'groupId': 'OG001'}, {'value': '6.7', 'groupId': 'OG002'}, {'value': '11.1', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}, {'value': '0.0', 'groupId': 'OG005'}, {'value': '21.7', 'groupId': 'OG006'}, {'value': '14.3', 'groupId': 'OG007'}, {'value': '15.4', 'groupId': 'OG008'}, {'value': '0.0', 'groupId': 'OG009'}, {'value': '0.0', 'groupId': 'OG010'}]}]}, {'title': 'ACR70,wk24,n=117,110,117,121,38,36,21,22,87,16,18', 'categories': [{'measurements': [{'value': '6.0', 'groupId': 'OG000'}, {'value': '12.7', 'groupId': 'OG001'}, {'value': '8.5', 'groupId': 'OG002'}, {'value': '14.9', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}, {'value': '8.3', 'groupId': 'OG005'}, {'value': '23.8', 'groupId': 'OG006'}, {'value': '9.1', 'groupId': 'OG007'}, {'value': '19.5', 'groupId': 'OG008'}, {'value': '0.0', 'groupId': 'OG009'}, {'value': '5.6', 'groupId': 'OG010'}]}]}, {'title': 'ACR70,wk28,n=115,103,na,na,33,35,21,21,86,17,19', 'categories': [{'measurements': [{'value': '6.1', 'groupId': 'OG000'}, {'value': '17.5', 'groupId': 'OG001'}, {'value': 'NA', 'comment': "After week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only.", 'groupId': 'OG002'}, {'value': 'NA', 'comment': "After week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only.", 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}, {'value': '2.9', 'groupId': 'OG005'}, {'value': '14.3', 'groupId': 'OG006'}, {'value': '14.3', 'groupId': 'OG007'}, {'value': '17.4', 'groupId': 'OG008'}, {'value': '5.9', 'groupId': 'OG009'}, {'value': '0.0', 'groupId': 'OG010'}]}]}, {'title': 'ACR70,wk32,n=104,97,na,na,33,30,21,19,87,17,17', 'categories': [{'measurements': [{'value': '4.8', 'groupId': 'OG000'}, {'value': '10.0', 'groupId': 'OG001'}, {'value': 'NA', 'comment': "After week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only.", 'groupId': 'OG002'}, {'value': 'NA', 'comment': "After week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only.", 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}, {'value': '3.3', 'groupId': 'OG005'}, {'value': '19.0', 'groupId': 'OG006'}, {'value': '0.0', 'groupId': 'OG007'}, {'value': '21.8', 'groupId': 'OG008'}, {'value': '0.0', 'groupId': 'OG009'}, {'value': '0.0', 'groupId': 'OG010'}]}]}, {'title': 'ACR70,wk36,n=102,93,na,na,30,30,21,20,85,18,16', 'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000'}, {'value': '11.8', 'groupId': 'OG001'}, {'value': 'NA', 'comment': "After week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only.", 'groupId': 'OG002'}, {'value': 'NA', 'comment': "After week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only.", 'groupId': 'OG003'}, {'value': '3.3', 'groupId': 'OG004'}, {'value': '0.0', 'groupId': 'OG005'}, {'value': '23.8', 'groupId': 'OG006'}, {'value': '0.0', 'groupId': 'OG007'}, {'value': '23.5', 'groupId': 'OG008'}, {'value': '11.1', 'groupId': 'OG009'}, {'value': '0.0', 'groupId': 'OG010'}]}]}, {'title': 'ACR70,wk40,n=96,90,na,na,28,28,21,19,85,15,17', 'categories': [{'measurements': [{'value': '8.3', 'groupId': 'OG000'}, {'value': '11.1', 'groupId': 'OG001'}, {'value': 'NA', 'comment': "After week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only.", 'groupId': 'OG002'}, {'value': 'NA', 'comment': "After week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only.", 'groupId': 'OG003'}, {'value': '7.1', 'groupId': 'OG004'}, {'value': '10.7', 'groupId': 'OG005'}, {'value': '19.0', 'groupId': 'OG006'}, {'value': '10.5', 'groupId': 'OG007'}, {'value': '21.2', 'groupId': 'OG008'}, {'value': '13.3', 'groupId': 'OG009'}, {'value': '0.0', 'groupId': 'OG010'}]}]}, {'title': 'ACR70,wk44,n=97,90,na,na,28,27,20,18,84,15,16', 'categories': [{'measurements': [{'value': '12.4', 'groupId': 'OG000'}, {'value': '18.9', 'groupId': 'OG001'}, {'value': 'NA', 'comment': "After week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only.", 'groupId': 'OG002'}, {'value': 'NA', 'comment': "After week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only.", 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}, {'value': '11.1', 'groupId': 'OG005'}, {'value': '25.0', 'groupId': 'OG006'}, {'value': '11.1', 'groupId': 'OG007'}, {'value': '26.2', 'groupId': 'OG008'}, {'value': '6.7', 'groupId': 'OG009'}, {'value': '0.0', 'groupId': 'OG010'}]}]}, {'title': 'ACR70,wk48,n=94,89,na,na,28,26,18,19,77,12,14', 'categories': [{'measurements': [{'value': '9.6', 'groupId': 'OG000'}, {'value': '20.2', 'groupId': 'OG001'}, {'value': 'NA', 'comment': "After week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only.", 'groupId': 'OG002'}, {'value': 'NA', 'comment': "After week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only.", 'groupId': 'OG003'}, {'value': '3.6', 'groupId': 'OG004'}, {'value': '15.4', 'groupId': 'OG005'}, {'value': '33.3', 'groupId': 'OG006'}, {'value': '10.5', 'groupId': 'OG007'}, {'value': '27.3', 'groupId': 'OG008'}, {'value': '0.0', 'groupId': 'OG009'}, {'value': '0.0', 'groupId': 'OG010'}]}]}, {'title': 'ACR70,wk52,n=92,88,na,na,28,26,20,18,79,15,15', 'categories': [{'measurements': [{'value': '6.5', 'groupId': 'OG000'}, {'value': '19.3', 'groupId': 'OG001'}, {'value': 'NA', 'comment': "After week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only.", 'groupId': 'OG002'}, {'value': 'NA', 'comment': "After week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only.", 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}, {'value': '7.7', 'groupId': 'OG005'}, {'value': '30.0', 'groupId': 'OG006'}, {'value': '16.7', 'groupId': 'OG007'}, {'value': '22.8', 'groupId': 'OG008'}, {'value': '13.3', 'groupId': 'OG009'}, {'value': '0.0', 'groupId': 'OG010'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'baseline, weeks 1, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52', 'description': "ACR20, ACR 50 and ACR 70 response was defined as having a positive clinical response to treatment (individual improvement) in disease activity if the participant had at least 20%, 50% and/or 70% improvement, respectively, in tender 68-joint count, swollen 66-joint count and at least 3 of the following 5 measures: patient's assessment of RA pain, patient's global assessment of disease activity, physician's global assessment of disease activity, subject self-assessed disability (Health Assessment Questionnaire \\[HAQ-DI\\] score), and/or acute phase reactant (high sensitivity c-reactive protein (hsCRP) or erythrocyte sedimentation rate (ESR). The ACR20, ACR50 and ACR70 response results from baseline up to week 52 were based on observed data, i.e. without imputation.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the full analysis set were considered for the analysis. Participants with measurements at both baseline and each post-baseline time point were analyzed for that post-baseline time point. The full analysis set was comprised of all randomized participants (excluding mis-randomized participants) who were assigned to study treatment.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in HAQ-DI - Using Mixed Model Repeated Measures (MMRM)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}, {'value': '138', 'groupId': 'OG002'}, {'value': '138', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'AIN457 10mg/kg - 75 mg', 'description': 'Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks.'}, {'id': 'OG001', 'title': 'AIN457 10mg/kg - 150 mg', 'description': 'Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (\\>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24.'}, {'id': 'OG003', 'title': 'Abatacept', 'description': 'Participants received abatacept (from 500 to 1000 mg i.v. based on weight). Participants who did not respond to abatacept at Week 16 were re-randomized 1:1 to AIN457 75mg or 150mg at week 24 (after an 8 week washout period).'}], 'classes': [{'title': 'week 1, n=132,129,130,129', 'categories': [{'measurements': [{'value': '-0.22', 'spread': '0.032', 'groupId': 'OG000'}, {'value': '-0.21', 'spread': '0.032', 'groupId': 'OG001'}, {'value': '-0.08', 'spread': '0.032', 'groupId': 'OG002'}, {'value': '-0.19', 'spread': '0.032', 'groupId': 'OG003'}]}]}, {'title': 'week 2, n=131,130,134,133', 'categories': [{'measurements': [{'value': '-0.22', 'spread': '0.036', 'groupId': 'OG000'}, {'value': '-0.25', 'spread': '0.036', 'groupId': 'OG001'}, {'value': '-0.16', 'spread': '0.036', 'groupId': 'OG002'}, {'value': '-0.26', 'spread': '0.036', 'groupId': 'OG003'}]}]}, {'title': 'week 4, n=133,133,131,130', 'categories': [{'measurements': [{'value': '-0.30', 'spread': '0.039', 'groupId': 'OG000'}, {'value': '-0.31', 'spread': '0.040', 'groupId': 'OG001'}, {'value': '-0.17', 'spread': '0.040', 'groupId': 'OG002'}, {'value': '-0.36', 'spread': '0.040', 'groupId': 'OG003'}]}]}, {'title': 'week 8, n=132,127,131,130', 'categories': [{'measurements': [{'value': '-0.29', 'spread': '0.042', 'groupId': 'OG000'}, {'value': '-0.32', 'spread': '0.043', 'groupId': 'OG001'}, {'value': '-0.17', 'spread': '0.043', 'groupId': 'OG002'}, {'value': '-0.46', 'spread': '0.043', 'groupId': 'OG003'}]}]}, {'title': 'week 12, n=130,114,123,129', 'categories': [{'measurements': [{'value': '-0.31', 'spread': '0.046', 'groupId': 'OG000'}, {'value': '-0.33', 'spread': '0.047', 'groupId': 'OG001'}, {'value': '-0.18', 'spread': '0.047', 'groupId': 'OG002'}, {'value': '-0.51', 'spread': '0.046', 'groupId': 'OG003'}]}]}, {'title': 'week 16, n=127,118,116,129', 'categories': [{'measurements': [{'value': '-0.30', 'spread': '0.048', 'groupId': 'OG000'}, {'value': '-0.37', 'spread': '0.049', 'groupId': 'OG001'}, {'value': '-0.22', 'spread': '0.049', 'groupId': 'OG002'}, {'value': '-0.52', 'spread': '0.048', 'groupId': 'OG003'}]}]}, {'title': 'week 20, n=122,114,47,92', 'categories': [{'measurements': [{'value': '-0.36', 'spread': '0.051', 'groupId': 'OG000'}, {'value': '-0.42', 'spread': '0.052', 'groupId': 'OG001'}, {'value': '-0.21', 'spread': '0.066', 'groupId': 'OG002'}, {'value': '-0.57', 'spread': '0.054', 'groupId': 'OG003'}]}]}, {'title': 'week 24, n=117,110,44,86', 'categories': [{'measurements': [{'value': '-0.30', 'spread': '0.049', 'groupId': 'OG000'}, {'value': '-0.39', 'spread': '0.051', 'groupId': 'OG001'}, {'value': '-0.26', 'spread': '0.065', 'groupId': 'OG002'}, {'value': '-0.61', 'spread': '0.053', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline, weeks 1, 2, 4, 8, 12, 16, 20 and 24', 'description': 'The HAQ-DI, assesses a subject\'s level of functional ability and includes questions of fine movements of the upper extremity, locomotor activities of the lower extremity, and activities that involve both upper and lower extremities. There are 20 questions in 8 categories of functioning including dressing, rising, eating, walking, hygiene, reach, grip and usual activities. The stem of each item asks \'Over the past week, "are you able to..." perform a particular task\'. Each item is scored on a 4 point scale from 0 - 3, representing normal, no difficulty (0), some difficulty (1), much difficulty (2) and unable to do (3). The disability index score is calculated as the mean of the available category scores, ranging from 0 to 3. A negative change from baseline indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the full analysis set were considered for this analysis. For Placebo and Abatacept participants, data collected after treatment switch was treated as missing, as were missing values for all treatment groups.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in HAQ-DI - Observed Data', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}, {'value': '138', 'groupId': 'OG002'}, {'value': '138', 'groupId': 'OG003'}, {'value': '39', 'groupId': 'OG004'}, {'value': '39', 'groupId': 'OG005'}, {'value': '23', 'groupId': 'OG006'}, {'value': '22', 'groupId': 'OG007'}, {'value': '101', 'groupId': 'OG008'}, {'value': '18', 'groupId': 'OG009'}, {'value': '19', 'groupId': 'OG010'}]}], 'groups': [{'id': 'OG000', 'title': 'AIN457 10mg/kg - 75 mg', 'description': 'Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks.'}, {'id': 'OG001', 'title': 'AIN457 10mg/kg - 150 mg', 'description': 'Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (\\>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24.'}, {'id': 'OG003', 'title': 'Abatacept', 'description': 'Participants received abatacept (from 500 to 1000 mg i.v. based on weight). Participants who did not respond to abatacept at Week 16 were re-randomized 1:1 to AIN457 75mg or 150mg at week 24 (after an 8 week washout period).'}, {'id': 'OG004', 'title': 'Placebo Non-responder - AIN457 75mg', 'description': 'Participants switched from placebo to AIN457 75 mg starting at week 16.'}, {'id': 'OG005', 'title': 'Placebo Non-responder - AIN457 150mg', 'description': 'Participants switched from placebo to AIN457 150 mg starting at week 16.'}, {'id': 'OG006', 'title': 'Placebo Responder - AIN457 75mg', 'description': 'Participants switched from placebo to AIN457 75 mg starting at week 24.'}, {'id': 'OG007', 'title': 'Placebo Responder - AIN457 150mg', 'description': 'Participants switched from placebo to AIN457 150 mg starting at week 24.'}, {'id': 'OG008', 'title': 'Abatacept Responders', 'description': 'Abatacept responders remained on abatacept (from 500 to 1000 mg iv based on weight).'}, {'id': 'OG009', 'title': 'Abatacept Non-responders - AIN457 75mg', 'description': 'Participants switched from placebo to AIN457 75 mg starting at week 24.'}, {'id': 'OG010', 'title': 'Abatacept Non-responders - AIN457 150mg', 'description': 'Participants switched from abatacept to AIN457 150 mg starting at week 24.'}], 'classes': [{'title': 'wk1,n=132,129,130,129,39,35,21,22,95,17,17', 'categories': [{'measurements': [{'value': '-0.225', 'spread': '0.3766', 'groupId': 'OG000'}, {'value': '-0.215', 'spread': '0.4095', 'groupId': 'OG001'}, {'value': '-0.101', 'spread': '0.3186', 'groupId': 'OG002'}, {'value': '-0.194', 'spread': '0.4290', 'groupId': 'OG003'}, {'value': '-0.119', 'spread': '0.2896', 'groupId': 'OG004'}, {'value': '-0.079', 'spread': '0.3093', 'groupId': 'OG005'}, {'value': '-0.125', 'spread': '0.4257', 'groupId': 'OG006'}, {'value': '-0.153', 'spread': '0.2468', 'groupId': 'OG007'}, {'value': '-0.232', 'spread': '0.4551', 'groupId': 'OG008'}, {'value': '-0.081', 'spread': '0.3616', 'groupId': 'OG009'}, {'value': '-0.096', 'spread': '0.3047', 'groupId': 'OG010'}]}]}, {'title': 'Wk2,n=131,130,134,133,39,36,23,22,133,98,17,18', 'categories': [{'measurements': [{'value': '-0.215', 'spread': '0.3877', 'groupId': 'OG000'}, {'value': '-0.239', 'spread': '0.4885', 'groupId': 'OG001'}, {'value': '-0.191', 'spread': '0.4340', 'groupId': 'OG002'}, {'value': '-0.254', 'spread': '0.4520', 'groupId': 'OG003'}, {'value': '-0.122', 'spread': '0.2605', 'groupId': 'OG004'}, {'value': '-0.176', 'spread': '0.4631', 'groupId': 'OG005'}, {'value': '-0.380', 'spread': '0.5063', 'groupId': 'OG006'}, {'value': '-0.250', 'spread': '0.5015', 'groupId': 'OG007'}, {'value': '-0.300', 'spread': '0.4693', 'groupId': 'OG008'}, {'value': '-0.132', 'spread': '0.3630', 'groupId': 'OG009'}, {'value': '-0.118', 'spread': '0.3987', 'groupId': 'OG010'}]}]}, {'title': 'Wk4,n=133,133,131,130,39,39,23,21,94,17,19', 'categories': [{'measurements': [{'value': '-0.299', 'spread': '0.4551', 'groupId': 'OG000'}, {'value': '-0.300', 'spread': '0.5184', 'groupId': 'OG001'}, {'value': '-0.214', 'spread': '0.4492', 'groupId': 'OG002'}, {'value': '-0.368', 'spread': '0.5130', 'groupId': 'OG003'}, {'value': '-0.077', 'spread': '0.3634', 'groupId': 'OG004'}, {'value': '-0.224', 'spread': '0.4968', 'groupId': 'OG005'}, {'value': '-0.364', 'spread': '0.5627', 'groupId': 'OG006'}, {'value': '-0.310', 'spread': '0.3103', 'groupId': 'OG007'}, {'value': '-0.445', 'spread': '0.5245', 'groupId': 'OG008'}, {'value': '-0.110', 'spread': '0.3505', 'groupId': 'OG009'}, {'value': '-0.217', 'spread': '0.4874', 'groupId': 'OG010'}]}]}, {'title': 'Wk8,n=132,127,131,130,39,39,23,22,94,17,19', 'categories': [{'measurements': [{'value': '-0.277', 'spread': '0.5062', 'groupId': 'OG000'}, {'value': '-0.309', 'spread': '0.5175', 'groupId': 'OG001'}, {'value': '-0.217', 'spread': '0.5457', 'groupId': 'OG002'}, {'value': '-0.463', 'spread': '0.5182', 'groupId': 'OG003'}, {'value': '-0.186', 'spread': '0.5097', 'groupId': 'OG004'}, {'value': '-0.128', 'spread': '0.5077', 'groupId': 'OG005'}, {'value': '-0.543', 'spread': '0.6313', 'groupId': 'OG006'}, {'value': '-0.176', 'spread': '0.4782', 'groupId': 'OG007'}, {'value': '-0.543', 'spread': '0.5289', 'groupId': 'OG008'}, {'value': '-0.206', 'spread': '0.4900', 'groupId': 'OG009'}, {'value': '-0.303', 'spread': '0.3780', 'groupId': 'OG010'}]}]}, {'title': 'wk12,n=130,114,123,129,39,37,23,21,94,17,18', 'categories': [{'measurements': [{'value': '-0.287', 'spread': '0.5384', 'groupId': 'OG000'}, {'value': '-0.307', 'spread': '0.5488', 'groupId': 'OG001'}, {'value': '-0.241', 'spread': '0.5152', 'groupId': 'OG002'}, {'value': '-0.508', 'spread': '0.6369', 'groupId': 'OG003'}, {'value': '-0.109', 'spread': '0.4783', 'groupId': 'OG004'}, {'value': '-0.179', 'spread': '0.5133', 'groupId': 'OG005'}, {'value': '-0.451', 'spread': '0.6167', 'groupId': 'OG006'}, {'value': '-0.381', 'spread': '0.3982', 'groupId': 'OG007'}, {'value': '-0.622', 'spread': '0.6520', 'groupId': 'OG008'}, {'value': '-0.221', 'spread': '0.4274', 'groupId': 'OG009'}, {'value': '-0.181', 'spread': '0.5376', 'groupId': 'OG010'}]}]}, {'title': 'Wk16,n=127,118,116,129,36,37,21,22,94,16,19', 'categories': [{'measurements': [{'value': '-0.294', 'spread': '0.5236', 'groupId': 'OG000'}, {'value': '-0.355', 'spread': '0.6217', 'groupId': 'OG001'}, {'value': '-0.279', 'spread': '0.5493', 'groupId': 'OG002'}, {'value': '-0.535', 'spread': '0.6418', 'groupId': 'OG003'}, {'value': '-0.167', 'spread': '0.5295', 'groupId': 'OG004'}, {'value': '-0.111', 'spread': '0.4591', 'groupId': 'OG005'}, {'value': '-0.565', 'spread': '0.5356', 'groupId': 'OG006'}, {'value': '-0.472', 'spread': '0.5988', 'groupId': 'OG007'}, {'value': '-0.660', 'spread': '0.6590', 'groupId': 'OG008'}, {'value': '-0.195', 'spread': '0.4281', 'groupId': 'OG009'}, {'value': '-0.204', 'spread': '0.4827', 'groupId': 'OG010'}]}]}, {'title': 'Wk20,n=122,114,119,125,38,37,23,21,90,16,19', 'categories': [{'measurements': [{'value': '-0.333', 'spread': '0.5111', 'groupId': 'OG000'}, {'value': '-0.402', 'spread': '0.6429', 'groupId': 'OG001'}, {'value': '-0.319', 'spread': '0.5637', 'groupId': 'OG002'}, {'value': '-0.583', 'spread': '0.6654', 'groupId': 'OG003'}, {'value': '-0.237', 'spread': '0.4756', 'groupId': 'OG004'}, {'value': '-0.179', 'spread': '0.5158', 'groupId': 'OG005'}, {'value': '-0.543', 'spread': '0.5325', 'groupId': 'OG006'}, {'value': '-0.470', 'spread': '0.7309', 'groupId': 'OG007'}, {'value': '-0.699', 'spread': '0.6849', 'groupId': 'OG008'}, {'value': '-0.086', 'spread': '0.3972', 'groupId': 'OG009'}, {'value': '-0.454', 'spread': '0.5436', 'groupId': 'OG010'}]}]}, {'title': 'Wk24,n=117,110,117,120,38,36,21,22,86,16,18', 'categories': [{'measurements': [{'value': '-0.268', 'spread': '0.4930', 'groupId': 'OG000'}, {'value': '-0.405', 'spread': '0.5767', 'groupId': 'OG001'}, {'value': '0.346', 'spread': '0.5941', 'groupId': 'OG002'}, {'value': '-0.590', 'spread': '0.6872', 'groupId': 'OG003'}, {'value': '-0.257', 'spread': '0.4730', 'groupId': 'OG004'}, {'value': '-0.253', 'spread': '0.6502', 'groupId': 'OG005'}, {'value': '-0.589', 'spread': '0.5648', 'groupId': 'OG006'}, {'value': '-0.420', 'spread': '0.6732', 'groupId': 'OG007'}, {'value': '-0.744', 'spread': '0.6787', 'groupId': 'OG008'}, {'value': '-0.180', 'spread': '0.4257', 'groupId': 'OG009'}, {'value': '-0.215', 'spread': '0.6443', 'groupId': 'OG010'}]}]}, {'title': 'Wk28,n=115,102,na,na,33,35,21,21,86,17,19', 'categories': [{'measurements': [{'value': '-0.304', 'spread': '0.5342', 'groupId': 'OG000'}, {'value': '-0.439', 'spread': '0.5780', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': "After week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only.", 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': "After week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only.", 'groupId': 'OG003'}, {'value': '-0.345', 'spread': '0.5880', 'groupId': 'OG004'}, {'value': '-0.336', 'spread': '0.5846', 'groupId': 'OG005'}, {'value': '-0.625', 'spread': '0.4809', 'groupId': 'OG006'}, {'value': '-0.601', 'spread': '0.5571', 'groupId': 'OG007'}, {'value': '-0.689', 'spread': '0.6428', 'groupId': 'OG008'}, {'value': '-0.309', 'spread': '0.5522', 'groupId': 'OG009'}, {'value': '-0.303', 'spread': '0.5882', 'groupId': 'OG010'}]}]}, {'title': 'Wk32,n=104,97,na,na,33,30,21,19,87,17,17', 'categories': [{'measurements': [{'value': '-0.358', 'spread': '0.4964', 'groupId': 'OG000'}, {'value': '-0.505', 'spread': '0.5759', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': "After week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only.", 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': "After week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only.", 'groupId': 'OG003'}, {'value': '-0.284', 'spread': '0.4627', 'groupId': 'OG004'}, {'value': '-0.300', 'spread': '0.5039', 'groupId': 'OG005'}, {'value': '-0.679', 'spread': '0.5414', 'groupId': 'OG006'}, {'value': '-0.546', 'spread': '0.5998', 'groupId': 'OG007'}, {'value': '-0.741', 'spread': '0.6909', 'groupId': 'OG008'}, {'value': '-0.228', 'spread': '0.5612', 'groupId': 'OG009'}, {'value': '-0.375', 'spread': '0.7315', 'groupId': 'OG010'}]}]}, {'title': 'Wk36,n=102,93,na,na,30,30,21,19,84,18,16,', 'categories': [{'measurements': [{'value': '-0.339', 'spread': '0.5687', 'groupId': 'OG000'}, {'value': '-0.430', 'spread': '0.5573', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': "After week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only.", 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': "After week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only.", 'groupId': 'OG003'}, {'value': '-0.368', 'spread': '0.5397', 'groupId': 'OG004'}, {'value': '-0.383', 'spread': '0.4500', 'groupId': 'OG005'}, {'value': '-0.607', 'spread': '0.5538', 'groupId': 'OG006'}, {'value': '-0.474', 'spread': '0.6032', 'groupId': 'OG007'}, {'value': '-0.756', 'spread': '0.6844', 'groupId': 'OG008'}, {'value': '-0.285', 'spread': '0.5891', 'groupId': 'OG009'}, {'value': '-0.430', 'spread': '0.6723', 'groupId': 'OG010'}]}]}, {'title': 'Wk40,n=96,89,na,na,28,28,21,19,84,15,17', 'categories': [{'measurements': [{'value': '-0.424', 'spread': '0.5967', 'groupId': 'OG000'}, {'value': '-0.440', 'spread': '0.5416', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': "After week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only.", 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': "After week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only.", 'groupId': 'OG003'}, {'value': '-0.522', 'spread': '0.6805', 'groupId': 'OG004'}, {'value': '-0.391', 'spread': '0.5446', 'groupId': 'OG005'}, {'value': '-0.571', 'spread': '0.5736', 'groupId': 'OG006'}, {'value': '-0.539', 'spread': '0.6998', 'groupId': 'OG007'}, {'value': '-0.763', 'spread': '0.6750', 'groupId': 'OG008'}, {'value': '-0.242', 'spread': '0.6312', 'groupId': 'OG009'}, {'value': '-0.390', 'spread': '0.6523', 'groupId': 'OG010'}]}]}, {'title': 'Wk44,n=97,90,na,na,28,27,20,18,84,15,16', 'categories': [{'measurements': [{'value': '-0.331', 'spread': '0.5871', 'groupId': 'OG000'}, {'value': '-0.449', 'spread': '0.5427', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': "After week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only.", 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': "After week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only.", 'groupId': 'OG003'}, {'value': '-0.277', 'spread': '0.6377', 'groupId': 'OG004'}, {'value': '-0.523', 'spread': '0.6587', 'groupId': 'OG005'}, {'value': '-0.638', 'spread': '0.5144', 'groupId': 'OG006'}, {'value': '-0.514', 'spread': '0.7752', 'groupId': 'OG007'}, {'value': '-0.781', 'spread': '0.7252', 'groupId': 'OG008'}, {'value': '-0.308', 'spread': '0.6319', 'groupId': 'OG009'}, {'value': '-0.203', 'spread': '0.7917', 'groupId': 'OG010'}]}]}, {'title': 'Wk48,n-94,89,na,na,28,26,19,19,76,12,14', 'categories': [{'measurements': [{'value': '-0.303', 'spread': '0.5062', 'groupId': 'OG000'}, {'value': '-0.483', 'spread': '0.5459', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': "After week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only.", 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': "After week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only.", 'groupId': 'OG003'}, {'value': '-0.348', 'spread': '0.5886', 'groupId': 'OG004'}, {'value': '-0.413', 'spread': '0.5698', 'groupId': 'OG005'}, {'value': '-0.605', 'spread': '0.6113', 'groupId': 'OG006'}, {'value': '-0.454', 'spread': '0.5547', 'groupId': 'OG007'}, {'value': '-0.798', 'spread': '0.6481', 'groupId': 'OG008'}, {'value': '-0.229', 'spread': '0.6546', 'groupId': 'OG009'}, {'value': '-0.286', 'spread': '0.7618', 'groupId': 'OG010'}]}]}, {'title': 'Wk52,n=92,87,na,na,28,26,20,18,79,15,15', 'categories': [{'measurements': [{'value': '-0.341', 'spread': '0.5428', 'groupId': 'OG000'}, {'value': '-0.516', 'spread': '0.6036', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': "After week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only.", 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': "After week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only.", 'groupId': 'OG003'}, {'value': '-0.402', 'spread': '0.5436', 'groupId': 'OG004'}, {'value': '-0.351', 'spread': '0.6335', 'groupId': 'OG005'}, {'value': '-0.606', 'spread': '0.6492', 'groupId': 'OG006'}, {'value': '-0.569', 'spread': '0.7126', 'groupId': 'OG007'}, {'value': '-0.788', 'spread': '0.6853', 'groupId': 'OG008'}, {'value': '-0.392', 'spread': '0.5216', 'groupId': 'OG009'}, {'value': '-0.258', 'spread': '0.8298', 'groupId': 'OG010'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, weeks 1, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52', 'description': 'The HAQ-DI assesses a subject\'s level of functional ability and includes questions of fine movements of the upper extremity, locomotor activities of the lower extremity, and activities that involve both upper and lower extremities. There are 20 questions in 8 categories of functioning including dressing, rising, eating, walking, hygiene, reach, grip and usual activities. The stem of each item asks \'Over the past week, "are you able to..." perform a particular task\'. Each item is scored on a 4 point scale from 0 - 3, representing normal, no difficulty (0), some difficulty (1), much difficulty (2) and unable to do (3). The disability index score is calculated as the mean of the available category scores, ranging from 0 to 3. A negative change from baseline indicates improvement. The HAQ-DI results from baseline up to week 52 were based on observed data, i.e. without imputation.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the full analysis set were considered for the analysis. Participants with measurements at both baseline and each post-baseline time point were analyzed for that post-baseline time point. The full analysis set was comprised of all randomized participants (excluding mis-randomized participants) who were assigned to study treatment.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Disease Activity Score Utilizing CRP (DAS28-CRP) - Using MMRM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}, {'value': '138', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'AIN457 10mg/kg - 75 mg', 'description': 'Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks.'}, {'id': 'OG001', 'title': 'AIN457 10mg/kg - 150 mg', 'description': 'Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (\\>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24.'}, {'id': 'OG003', 'title': 'Abatacept', 'description': 'Participants received abatacept (from 500 to 1000 mg i.v. based on weight). Participants who did not respond to abatacept at Week 16 were re-randomized 1:1 to AIN457 75mg or 150mg at week 24 (after an 8 week washout period).'}], 'classes': [{'title': 'week 1, n=131,129,130,129', 'categories': [{'measurements': [{'value': '-0.89', 'spread': '0.069', 'groupId': 'OG000'}, {'value': '-0.73', 'spread': '0.069', 'groupId': 'OG001'}, {'value': '-0.22', 'spread': '0.069', 'groupId': 'OG002'}, {'value': '-0.50', 'spread': '0.069', 'groupId': 'OG003'}]}]}, {'title': 'week 2, n=131,127,132,133', 'categories': [{'measurements': [{'value': '-0.96', 'spread': '0.080', 'groupId': 'OG000'}, {'value': '-0.90', 'spread': '0.081', 'groupId': 'OG001'}, {'value': '-0.35', 'spread': '0.080', 'groupId': 'OG002'}, {'value': '-0.78', 'spread': '0.080', 'groupId': 'OG003'}]}]}, {'title': 'week 4, n=130,131,138,138', 'categories': [{'measurements': [{'value': '-1.20', 'spread': '0.090', 'groupId': 'OG000'}, {'value': '-1.11', 'spread': '0.090', 'groupId': 'OG001'}, {'value': '-0.48', 'spread': '0.090', 'groupId': 'OG002'}, {'value': '-1.11', 'spread': '0.091', 'groupId': 'OG003'}]}]}, {'title': 'week 8, n=130,126,130,130', 'categories': [{'measurements': [{'value': '-1.21', 'spread': '0.093', 'groupId': 'OG000'}, {'value': '-1.23', 'spread': '0.094', 'groupId': 'OG001'}, {'value': '-0.61', 'spread': '0.093', 'groupId': 'OG002'}, {'value': '-1.55', 'spread': '0.093', 'groupId': 'OG003'}]}]}, {'title': 'week 12, n=130,114,123,128', 'categories': [{'measurements': [{'value': '-1.23', 'spread': '0.097', 'groupId': 'OG000'}, {'value': '-1.36', 'spread': '0.102', 'groupId': 'OG001'}, {'value': '-0.73', 'spread': '0.100', 'groupId': 'OG002'}, {'value': '-1.78', 'spread': '0.098', 'groupId': 'OG003'}]}]}, {'title': 'week 16, n=126,116,114,127', 'categories': [{'measurements': [{'value': '-1.23', 'spread': '0.108', 'groupId': 'OG000'}, {'value': '-1.40', 'spread': '0.112', 'groupId': 'OG001'}, {'value': '-0.57', 'spread': '0.112', 'groupId': 'OG002'}, {'value': '-1.71', 'spread': '0.108', 'groupId': 'OG003'}]}]}, {'title': 'week 20, n=121,114,47,92', 'categories': [{'measurements': [{'value': '-1.44', 'spread': '0.108', 'groupId': 'OG000'}, {'value': '-1.49', 'spread': '0.111', 'groupId': 'OG001'}, {'value': '-0.89', 'spread': '0.146', 'groupId': 'OG002'}, {'value': '-1.96', 'spread': '0.117', 'groupId': 'OG003'}]}]}, {'title': 'week 24, n=116,108,44,84', 'categories': [{'measurements': [{'value': '-1.47', 'spread': '0.115', 'groupId': 'OG000'}, {'value': '-1.47', 'spread': '0.119', 'groupId': 'OG001'}, {'value': '-1.02', 'spread': '0.163', 'groupId': 'OG002'}, {'value': '-2.07', 'spread': '0.128', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline, weeks 1, 2, 4, 8, 12, 16, 20 and 24', 'description': "The DAS28 is a measure of disease activity in RA based on Swollen and Tender Joint Counts (out of a total of 28), hsCRP and the Patient's Global Assessment of Disease Activity. A DAS28 score greater than 5.1 implies active disease, equal to or less than 3.2 low disease activity, and less than 2.6 remission. A negative change from baseline indicates improvement.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the full analysis set were considered for the analysis. For Placebo and Abatacept participants, data collected after treatment switch was treated as missing, as were missing values for all treatment groups'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Disease Activity Score Utilizing CRP (DAS28-CRP) - Observed Data', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}, {'value': '138', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '39', 'groupId': 'OG004'}, {'value': '23', 'groupId': 'OG005'}, {'value': '22', 'groupId': 'OG006'}, {'value': '138', 'groupId': 'OG007'}, {'value': '101', 'groupId': 'OG008'}, {'value': '18', 'groupId': 'OG009'}, {'value': '19', 'groupId': 'OG010'}]}], 'groups': [{'id': 'OG000', 'title': 'AIN457 10mg/kg - 75 mg', 'description': 'Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks.'}, {'id': 'OG001', 'title': 'AIN457 10mg/kg - 150 mg', 'description': 'Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (\\>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24.'}, {'id': 'OG003', 'title': 'Abatacept', 'description': 'Participants received abatacept (from 500 to 1000 mg i.v. based on weight). Participants who did not respond to abatacept at Week 16 were re-randomized 1:1 to AIN457 75mg or 150mg at week 24 (after an 8 week washout period).'}, {'id': 'OG004', 'title': 'Placebo Non-responder - AIN457 75mg', 'description': 'Participants switched from placebo to AIN457 75 mg starting at week 16.'}, {'id': 'OG005', 'title': 'Placebo Non-responder - AIN457 150mg', 'description': 'Participants switched from placebo to AIN457 150 mg starting at week 16.'}, {'id': 'OG006', 'title': 'Placebo Responder - AIN457 75mg', 'description': 'Participants switched from placebo to AIN457 75 mg starting at week 24.'}, {'id': 'OG007', 'title': 'Placebo Responder - AIN457 150mg', 'description': 'Participants switched from placebo to AIN457 150 mg starting at week 24.'}, {'id': 'OG008', 'title': 'Abatacept Responders', 'description': 'Abatacept responders remained on abatacept (from 500 to 1000 mg iv based on weight).'}, {'id': 'OG009', 'title': 'Abatacept Non-responders - AIN457 75mg', 'description': 'Participants switched from placebo to AIN457 75 mg starting at week 24.'}, {'id': 'OG010', 'title': 'Abatacept Non-responders - AIN457 150mg', 'description': 'Participants switched from abatacept to AIN457 150 mg starting at week 24.'}], 'classes': [{'title': 'Wk1,n=131,129,130,129,39,35,21,22, 95,17,17', 'categories': [{'measurements': [{'value': '-0.886', 'spread': '0.9784', 'groupId': 'OG000'}, {'value': '-0.759', 'spread': '0.8654', 'groupId': 'OG001'}, {'value': '-0.211', 'spread': '0.6877', 'groupId': 'OG002'}, {'value': '-0.502', 'spread': '0.7539', 'groupId': 'OG003'}, {'value': '-0.147', 'spread': '0.5527', 'groupId': 'OG004'}, {'value': '-0.141', 'spread': '0.7095', 'groupId': 'OG005'}, {'value': '-0.572', 'spread': '0.7856', 'groupId': 'OG006'}, {'value': '-0.235', 'spread': '0.7699', 'groupId': 'OG007'}, {'value': '-0.577', 'spread': '0.7924', 'groupId': 'OG008'}, {'value': '-0.361', 'spread': '0.3578', 'groupId': 'OG009'}, {'value': '-0.222', 'spread': '0.7695', 'groupId': 'OG010'}]}]}, {'title': 'Wk2,n=131,127,132,133,39,36,23,21,98,17,18', 'categories': [{'measurements': [{'value': '-0.909', 'spread': '1.0331', 'groupId': 'OG000'}, {'value': '-0.900', 'spread': '1.0284', 'groupId': 'OG001'}, {'value': '-0.363', 'spread': '0.8388', 'groupId': 'OG002'}, {'value': '-0.755', 'spread': '0.9234', 'groupId': 'OG003'}, {'value': '-0.191', 'spread': '0.7331', 'groupId': 'OG004'}, {'value': '-0.368', 'spread': '0.7170', 'groupId': 'OG005'}, {'value': '-0.835', 'spread': '0.9466', 'groupId': 'OG006'}, {'value': '-0.292', 'spread': '0.7448', 'groupId': 'OG007'}, {'value': '-0.755', 'spread': '0.9234', 'groupId': 'OG008'}, {'value': '-0.882', 'spread': '0.9526', 'groupId': 'OG009'}, {'value': '-0.359', 'spread': '0.8980', 'groupId': 'OG010'}]}]}, {'title': 'Wk4,n=130,131,129,128,39,38,23,21,92,17,19', 'categories': [{'measurements': [{'value': '-1.163', 'spread': '1.1656', 'groupId': 'OG000'}, {'value': '-1.150', 'spread': '1.1942', 'groupId': 'OG001'}, {'value': '-0.492', 'spread': '0.8876', 'groupId': 'OG002'}, {'value': '-1.095', 'spread': '1.0483', 'groupId': 'OG003'}, {'value': '-0.252', 'spread': '0.8116', 'groupId': 'OG004'}, {'value': '-0.352', 'spread': '0.7471', 'groupId': 'OG005'}, {'value': '-1.034', 'spread': '0.9119', 'groupId': 'OG006'}, {'value': '-0.767', 'spread': '0.9661', 'groupId': 'OG007'}, {'value': '-1.268', 'spread': '1.0533', 'groupId': 'OG008'}, {'value': '-0.595', 'spread': '1.1160', 'groupId': 'OG009'}, {'value': '-0.706', 'spread': '0.6999', 'groupId': 'OG010'}]}]}, {'title': 'Wk8,n=130,126,130,130,39,39,23,22,94,17,19', 'categories': [{'measurements': [{'value': '-1.181', 'spread': '1.1821', 'groupId': 'OG000'}, {'value': '-1.283', 'spread': '1.1678', 'groupId': 'OG001'}, {'value': '-0.644', 'spread': '1.1356', 'groupId': 'OG002'}, {'value': '-1.541', 'spread': '1.1172', 'groupId': 'OG003'}, {'value': '-0.546', 'spread': '1.1597', 'groupId': 'OG004'}, {'value': '-0.312', 'spread': '0.9151', 'groupId': 'OG005'}, {'value': '-1.403', 'spread': '1.2060', 'groupId': 'OG006'}, {'value': '-0.613', 'spread': '0.9772', 'groupId': 'OG007'}, {'value': '-1.816', 'spread': '1.0708', 'groupId': 'OG008'}, {'value': '-0.834', 'spread': '1.1469', 'groupId': 'OG009'}, {'value': '-0.808', 'spread': '0.6444', 'groupId': 'OG010'}]}]}, {'title': 'Wk12,n=130,114,123,128,39,37,23,21,93,17,18', 'categories': [{'measurements': [{'value': '-1.229', 'spread': '1.1782', 'groupId': 'OG000'}, {'value': '-1.402', 'spread': '1.2182', 'groupId': 'OG001'}, {'value': '-0.742', 'spread': '1.2330', 'groupId': 'OG002'}, {'value': '-1.790', 'spread': '1.2356', 'groupId': 'OG003'}, {'value': '-0.311', 'spread': '0.9514', 'groupId': 'OG004'}, {'value': '-0.383', 'spread': '1.1765', 'groupId': 'OG005'}, {'value': '-1.588', 'spread': '0.9714', 'groupId': 'OG006'}, {'value': '-1.330', 'spread': '1.4721', 'groupId': 'OG007'}, {'value': '-2.144', 'spread': '1.1028', 'groupId': 'OG008'}, {'value': '-0.749', 'spread': '1.0757', 'groupId': 'OG009'}, {'value': '-0.945', 'spread': '1.1008', 'groupId': 'OG010'}]}]}, {'title': 'Wk16,n=126,116,114,128,36,36,21,21,94,15,19', 'categories': [{'measurements': [{'value': '-1.225', 'spread': '1.2866', 'groupId': 'OG000'}, {'value': '-1.455', 'spread': '1.3489', 'groupId': 'OG001'}, {'value': '-0.592', 'spread': '1.2557', 'groupId': 'OG002'}, {'value': '-1.691', 'spread': '1.2979', 'groupId': 'OG003'}, {'value': '0.128', 'spread': '0.8579', 'groupId': 'OG004'}, {'value': '0.045', 'spread': '0.9145', 'groupId': 'OG005'}, {'value': '-2.008', 'spread': '0.8675', 'groupId': 'OG006'}, {'value': '-1.503', 'spread': '0.8746', 'groupId': 'OG007'}, {'value': '-2.159', 'spread': '1.0767', 'groupId': 'OG008'}, {'value': '-0.490', 'spread': '0.8170', 'groupId': 'OG009'}, {'value': '-0.322', 'spread': '1.0262', 'groupId': 'OG010'}]}]}, {'title': 'Wk20,n=121,114,,119,125,38,37,23,21,90,16,19', 'categories': [{'measurements': [{'value': '-1.427', 'spread': '1.3266', 'groupId': 'OG000'}, {'value': '-1.569', 'spread': '1.2361', 'groupId': 'OG001'}, {'value': '-1.164', 'spread': '1.2087', 'groupId': 'OG002'}, {'value': '-1.840', 'spread': '1.4144', 'groupId': 'OG003'}, {'value': '-0.683', 'spread': '1.1231', 'groupId': 'OG004'}, {'value': '-0.937', 'spread': '1.0966', 'groupId': 'OG005'}, {'value': '-2.108', 'spread': '1.0368', 'groupId': 'OG006'}, {'value': '-1.399', 'spread': '1.1487', 'groupId': 'OG007'}, {'value': '-2.317', 'spread': '1.2549', 'groupId': 'OG008'}, {'value': '-0.402', 'spread': '0.9820', 'groupId': 'OG009'}, {'value': '-0.792', 'spread': '1.0272', 'groupId': 'OG010'}]}]}, {'title': 'Wk24,n=116,108,116,117,37,36,21,22,84,15,18', 'categories': [{'measurements': [{'value': '-1.467', 'spread': '1.3116', 'groupId': 'OG000'}, {'value': '-1.579', 'spread': '1.3221', 'groupId': 'OG001'}, {'value': '-1.248', 'spread': '1.2915', 'groupId': 'OG002'}, {'value': '-1.989', 'spread': '1.4717', 'groupId': 'OG003'}, {'value': '-0.666', 'spread': '0.9983', 'groupId': 'OG004'}, {'value': '-1.140', 'spread': '1.1954', 'groupId': 'OG005'}, {'value': '-2.343', 'spread': '1.2649', 'groupId': 'OG006'}, {'value': '-1.362', 'spread': '1.2999', 'groupId': 'OG007'}, {'value': '-2.435', 'spread': '1.3266', 'groupId': 'OG008'}, {'value': '-0.772', 'spread': '1.1656', 'groupId': 'OG009'}, {'value': '-0.923', 'spread': '1.2560', 'groupId': 'OG010'}]}]}, {'title': 'Wk28,n=115,103,na,na,33,35,21,21,86,17,18', 'categories': [{'measurements': [{'value': '-1.484', 'spread': '1.3216', 'groupId': 'OG000'}, {'value': '-1.819', 'spread': '1.3434', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': "After week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only.", 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': "After week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only.", 'groupId': 'OG003'}, {'value': '-1.172', 'spread': '1.1602', 'groupId': 'OG004'}, {'value': '-1.244', 'spread': '1.2433', 'groupId': 'OG005'}, {'value': '-2.117', 'spread': '0.8573', 'groupId': 'OG006'}, {'value': '-1.782', 'spread': '1.0655', 'groupId': 'OG007'}, {'value': '-2.470', 'spread': '1.2153', 'groupId': 'OG008'}, {'value': '-1.137', 'spread': '1.2050', 'groupId': 'OG009'}, {'value': '-0.973', 'spread': '1.1034', 'groupId': 'OG010'}]}]}, {'title': 'Wk32,n=103,97,na,na,33,39,23,22,87,17,16', 'categories': [{'measurements': [{'value': '-1.738', 'spread': '1.2783', 'groupId': 'OG000'}, {'value': '-1.966', 'spread': '1.1770', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': "After week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only.", 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': "After week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only.", 'groupId': 'OG003'}, {'value': '-1.408', 'spread': '1.3855', 'groupId': 'OG004'}, {'value': '-1.475', 'spread': '1.1846', 'groupId': 'OG005'}, {'value': '-2.363', 'spread': '1.0711', 'groupId': 'OG006'}, {'value': '-1.875', 'spread': '0.9807', 'groupId': 'OG007'}, {'value': '-2.629', 'spread': '1.3104', 'groupId': 'OG008'}, {'value': '-0.961', 'spread': '1.0043', 'groupId': 'OG009'}, {'value': '-1.464', 'spread': '1.2025', 'groupId': 'OG010'}]}]}, {'title': 'Wk36,n=101,92,na,na,30,30,21,20,84,18,15', 'categories': [{'measurements': [{'value': '-1.737', 'spread': '1.4592', 'groupId': 'OG000'}, {'value': '-1.820', 'spread': '1.2500', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': "After week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only.", 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': "After week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only.", 'groupId': 'OG003'}, {'value': '-1.271', 'spread': '1.4949', 'groupId': 'OG004'}, {'value': '-1.444', 'spread': '1.1949', 'groupId': 'OG005'}, {'value': '-2.269', 'spread': '1.0688', 'groupId': 'OG006'}, {'value': '-1.784', 'spread': '0.9029', 'groupId': 'OG007'}, {'value': '-2.642', 'spread': '1.4305', 'groupId': 'OG008'}, {'value': '-1.200', 'spread': '1.3228', 'groupId': 'OG009'}, {'value': '-1.425', 'spread': '0.9247', 'groupId': 'OG010'}]}]}, {'title': 'Wk40,n=96,90,na,na,28,28,21,19,84,15,17', 'categories': [{'measurements': [{'value': '-1.742', 'spread': '1.3259', 'groupId': 'OG000'}, {'value': '-1.788', 'spread': '1.1333', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': "After week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only.", 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': "After week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only.", 'groupId': 'OG003'}, {'value': '-1.354', 'spread': '1.3590', 'groupId': 'OG004'}, {'value': '-1.494', 'spread': '1.3243', 'groupId': 'OG005'}, {'value': '-2.315', 'spread': '1.0773', 'groupId': 'OG006'}, {'value': '-2.134', 'spread': '1.0405', 'groupId': 'OG007'}, {'value': '-2.549', 'spread': '1.3305', 'groupId': 'OG008'}, {'value': '-1.201', 'spread': '1.5293', 'groupId': 'OG009'}, {'value': '-1.612', 'spread': '1.1839', 'groupId': 'OG010'}]}]}, {'title': 'Wk44,n=96,88,na,na,28,27,20,18,84,15,16', 'categories': [{'measurements': [{'value': '-1.764', 'spread': '1.3227', 'groupId': 'OG000'}, {'value': '-1.932', 'spread': '1.2850', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': "After week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only.", 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': "After week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only.", 'groupId': 'OG003'}, {'value': '-1.168', 'spread': '1.2638', 'groupId': 'OG004'}, {'value': '-1.858', 'spread': '1.2373', 'groupId': 'OG005'}, {'value': '-2.155', 'spread': '0.9488', 'groupId': 'OG006'}, {'value': '-2.121', 'spread': '1.1347', 'groupId': 'OG007'}, {'value': '-2.697', 'spread': '1.2117', 'groupId': 'OG008'}, {'value': '-0.881', 'spread': '1.3337', 'groupId': 'OG009'}, {'value': '-1.528', 'spread': '1.2973', 'groupId': 'OG010'}]}]}, {'title': 'Wk48,n=94,88,na,na,28,26,18,19,76,12,14', 'categories': [{'measurements': [{'value': '-1.761', 'spread': '1.3152', 'groupId': 'OG000'}, {'value': '-2.200', 'spread': '1.3293', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': "After week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only.", 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': "After week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only.", 'groupId': 'OG003'}, {'value': '-1.516', 'spread': '1.0635', 'groupId': 'OG004'}, {'value': '-1.660', 'spread': '1.1805', 'groupId': 'OG005'}, {'value': '-2.259', 'spread': '1.1813', 'groupId': 'OG006'}, {'value': '-1.964', 'spread': '1.3404', 'groupId': 'OG007'}, {'value': '-2.634', 'spread': '1.2189', 'groupId': 'OG008'}, {'value': '-1.013', 'spread': '1.1738', 'groupId': 'OG009'}, {'value': '-1.400', 'spread': '1.1985', 'groupId': 'OG010'}]}]}, {'title': 'Wk52,n=92,86,na,na,28,26,20,18,79,15,15', 'categories': [{'measurements': [{'value': '-1.839', 'spread': '1.3755', 'groupId': 'OG000'}, {'value': '-2.109', 'spread': '1.4000', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': "After week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only.", 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': "After week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only.", 'groupId': 'OG003'}, {'value': '-1.487', 'spread': '1.0729', 'groupId': 'OG004'}, {'value': '-1.690', 'spread': '1.2093', 'groupId': 'OG005'}, {'value': '-2.070', 'spread': '0.9984', 'groupId': 'OG006'}, {'value': '-2.334', 'spread': '1.1428', 'groupId': 'OG007'}, {'value': '-2.676', 'spread': '1.3593', 'groupId': 'OG008'}, {'value': '-1.390', 'spread': '1.1884', 'groupId': 'OG009'}, {'value': '-0.982', 'spread': '1.1943', 'groupId': 'OG010'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, weeks 1, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52', 'description': "The DAS28 is a measure of disease activity in RA based on Swollen and Tender Joint Counts (out of a total of 28), hsCRP and the Patient's Global Assessment of Disease Activity. A DAS28 score greater than 5.1 implies active disease, equal to or less than 3.2 low disease activity, and less than 2.6 remission. A negative change from baseline indicates improvement. The DAS28-CRP results from baseline up to week 52 were based on observed data, i.e. without imputation.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the full analysis set were considered for the analysis. Participants with measurements at both baseline and each post-baseline time point were analyzed for that post-baseline time point. The full analysis set was comprised of all randomized participants (excluding mis-randomized participants) who were assigned to study treatment.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in hsCRP - Observed Data', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}, {'value': '138', 'groupId': 'OG002'}, {'value': '138', 'groupId': 'OG003'}, {'value': '39', 'groupId': 'OG004'}, {'value': '39', 'groupId': 'OG005'}, {'value': '23', 'groupId': 'OG006'}, {'value': '22', 'groupId': 'OG007'}, {'value': '101', 'groupId': 'OG008'}, {'value': '18', 'groupId': 'OG009'}, {'value': '19', 'groupId': 'OG010'}]}], 'groups': [{'id': 'OG000', 'title': 'AIN457 10mg/kg - 75 mg', 'description': 'Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks.'}, {'id': 'OG001', 'title': 'AIN457 10mg/kg - 150 mg', 'description': 'Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (\\>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24.'}, {'id': 'OG003', 'title': 'Abatacept', 'description': 'Participants received abatacept (from 500 to 1000 mg i.v. based on weight). Participants who did not respond to abatacept at Week 16 were re-randomized 1:1 to AIN457 75mg or 150mg at week 24 (after an 8 week washout period).'}, {'id': 'OG004', 'title': 'Placebo Non-responder - AIN457 75mg', 'description': 'Participants switched from placebo to AIN457 75 mg starting at week 16.'}, {'id': 'OG005', 'title': 'Placebo Non-responder - AIN457 150mg', 'description': 'Participants switched from placebo to AIN457 150 mg starting at week 16.'}, {'id': 'OG006', 'title': 'Placebo Responder - AIN457 75mg', 'description': 'Participants switched from placebo to AIN457 75 mg starting at week 24.'}, {'id': 'OG007', 'title': 'Placebo Responder - AIN457 150mg', 'description': 'Participants switched from placebo to AIN457 150 mg starting at week 24.'}, {'id': 'OG008', 'title': 'Abatacept Responders', 'description': 'Abatacept responders remained on abatacept (from 500 to 1000 mg iv based on weight).'}, {'id': 'OG009', 'title': 'Abatacept Non-responders - AIN457 75mg', 'description': 'Participants switched from placebo to AIN457 75 mg starting at week 24.'}, {'id': 'OG010', 'title': 'Abatacept Non-responders - AIN457 150mg', 'description': 'Participants switched from abatacept to AIN457 150 mg starting at week 24.'}], 'classes': [{'title': 'Wk1,n=134,130,131,131,39,36,21,22,97,17,17', 'categories': [{'measurements': [{'value': '-10.91', 'spread': '30.815', 'groupId': 'OG000'}, {'value': '-10.31', 'spread': '27.754', 'groupId': 'OG001'}, {'value': '-0.69', 'spread': '15.521', 'groupId': 'OG002'}, {'value': '-5.64', 'spread': '18.550', 'groupId': 'OG003'}, {'value': '-0.33', 'spread': '10.430', 'groupId': 'OG004'}, {'value': '-0.84', 'spread': '24.777', 'groupId': 'OG005'}, {'value': '-0.40', 'spread': '12.244', 'groupId': 'OG006'}, {'value': '-1.50', 'spread': '7.541', 'groupId': 'OG007'}, {'value': '-6.40', 'spread': '20.458', 'groupId': 'OG008'}, {'value': '-2.92', 'spread': '12.405', 'groupId': 'OG009'}, {'value': '-4.07', 'spread': '10.811', 'groupId': 'OG010'}]}]}, {'title': 'Wk2,n=133,129,133,135,39,36,23,21,100,17,18', 'categories': [{'measurements': [{'value': '-10.24', 'spread': '33.209', 'groupId': 'OG000'}, {'value': '-11.51', 'spread': '32.139', 'groupId': 'OG001'}, {'value': '-2.21', 'spread': '14.501', 'groupId': 'OG002'}, {'value': '-6.36', 'spread': '19.416', 'groupId': 'OG003'}, {'value': '0.43', 'spread': '15.333', 'groupId': 'OG004'}, {'value': '-5.48', 'spread': '17.301', 'groupId': 'OG005'}, {'value': '-1.70', 'spread': '11.170', 'groupId': 'OG006'}, {'value': '-4.78', 'spread': '10.515', 'groupId': 'OG007'}, {'value': '-7.52', 'spread': '20.301', 'groupId': 'OG008'}, {'value': '-3.84', 'spread': '13.737', 'groupId': 'OG009'}, {'value': '-2.30', 'spread': '19.035', 'groupId': 'OG010'}]}]}, {'title': 'Wk4,n=131,134,129,133,39,38,23,21,97,17,19', 'categories': [{'measurements': [{'value': '-9.10', 'spread': '20.514', 'groupId': 'OG000'}, {'value': '-10.76', 'spread': '33.376', 'groupId': 'OG001'}, {'value': '-1.53', 'spread': '19.311', 'groupId': 'OG002'}, {'value': '-6.70', 'spread': '20.732', 'groupId': 'OG003'}, {'value': '2.23', 'spread': '23.317', 'groupId': 'OG004'}, {'value': '-1.94', 'spread': '21.927', 'groupId': 'OG005'}, {'value': '-6.47', 'spread': '12.458', 'groupId': 'OG006'}, {'value': '-1.95', 'spread': '12.090', 'groupId': 'OG007'}, {'value': '-7.53', 'spread': '22.982', 'groupId': 'OG008'}, {'value': '-4.42', 'spread': '14.991', 'groupId': 'OG009'}, {'value': '-4.50', 'spread': '11.029', 'groupId': 'OG010'}]}]}, {'title': 'Wk8,n=134,128,130,132,39,39,23,22,96,17,19', 'categories': [{'measurements': [{'value': '-10.18', 'spread': '33.400', 'groupId': 'OG000'}, {'value': '-12.94', 'spread': '30.854', 'groupId': 'OG001'}, {'value': '-2.94', 'spread': '20.601', 'groupId': 'OG002'}, {'value': '-8.48', 'spread': '21.134', 'groupId': 'OG003'}, {'value': '-4.72', 'spread': '18.766', 'groupId': 'OG004'}, {'value': '-3.28', 'spread': '25.501', 'groupId': 'OG005'}, {'value': '0.13', 'spread': '18.061', 'groupId': 'OG006'}, {'value': '-1.50', 'spread': '12.839', 'groupId': 'OG007'}, {'value': '-10.13', 'spread': '22.724', 'groupId': 'OG008'}, {'value': '-.54', 'spread': '14.849', 'groupId': 'OG009'}, {'value': '-4.59', 'spread': '16.603', 'groupId': 'OG010'}]}]}, {'title': 'Wk12,n=133,119,128,131,39,39,23,22,96,17,18', 'categories': [{'measurements': [{'value': '-9.41', 'spread': '31.859', 'groupId': 'OG000'}, {'value': '-9.66', 'spread': '24.298', 'groupId': 'OG001'}, {'value': '-0.69', 'spread': '18.908', 'groupId': 'OG002'}, {'value': '-9.72', 'spread': '25.787', 'groupId': 'OG003'}, {'value': '2.11', 'spread': '18.312', 'groupId': 'OG004'}, {'value': '-2.89', 'spread': '20.763', 'groupId': 'OG005'}, {'value': '-2.74', 'spread': '12.899', 'groupId': 'OG006'}, {'value': '2.10', 'spread': '22.545', 'groupId': 'OG007'}, {'value': '-12.17', 'spread': '25.813', 'groupId': 'OG008'}, {'value': '-4.18', 'spread': '16.024', 'groupId': 'OG009'}, {'value': '-1.94', 'spread': '31.483', 'groupId': 'OG010'}]}]}, {'title': 'Wk16,n=129,120,121,131,36,38,21,21,96,16,19', 'categories': [{'measurements': [{'value': '-9.97', 'spread': '33.291', 'groupId': 'OG000'}, {'value': '-5.78', 'spread': '25.418', 'groupId': 'OG001'}, {'value': '-1.82', 'spread': '20.849', 'groupId': 'OG002'}, {'value': '-8.37', 'spread': '22.571', 'groupId': 'OG003'}, {'value': '3.92', 'spread': '23.403', 'groupId': 'OG004'}, {'value': '-2.13', 'spread': '24.422', 'groupId': 'OG005'}, {'value': '-5.67', 'spread': '9.583', 'groupId': 'OG006'}, {'value': '-4.29', 'spread': '13.497', 'groupId': 'OG007'}, {'value': '-11.25', 'spread': '23.692', 'groupId': 'OG008'}, {'value': '-1.41', 'spread': '8.810', 'groupId': 'OG009'}, {'value': '0.32', 'spread': '22.024', 'groupId': 'OG010'}]}]}, {'title': 'Wk20,n=124,116,120,127,38,37,23,21,91,17,19', 'categories': [{'measurements': [{'value': '-9.19', 'spread': '32.876', 'groupId': 'OG000'}, {'value': '-8.05', 'spread': '22.394', 'groupId': 'OG001'}, {'value': '-3.75', 'spread': '29.301', 'groupId': 'OG002'}, {'value': '-9.43', 'spread': '23.212', 'groupId': 'OG003'}, {'value': '-5.33', 'spread': '20.645', 'groupId': 'OG004'}, {'value': '-7.77', 'spread': '27.581', 'groupId': 'OG005'}, {'value': '3.23', 'spread': '48.634', 'groupId': 'OG006'}, {'value': '-1.06', 'spread': '15.737', 'groupId': 'OG007'}, {'value': '-11.59', 'spread': '24.271', 'groupId': 'OG008'}, {'value': '-3.94', 'spread': '15.716', 'groupId': 'OG009'}, {'value': '-3.99', 'spread': '32.871', 'groupId': 'OG010'}]}]}, {'title': 'Wk24,n=121,113,116,120,37,36,21,22,86,16,18', 'categories': [{'measurements': [{'value': '-6.90', 'spread': '22.098', 'groupId': 'OG000'}, {'value': '-4.92', 'spread': '23.075', 'groupId': 'OG001'}, {'value': '-6.88', 'spread': '21.014', 'groupId': 'OG002'}, {'value': '-8.66', 'spread': '21.574', 'groupId': 'OG003'}, {'value': '-7.06', 'spread': '20.298', 'groupId': 'OG004'}, {'value': '-11.46', 'spread': '26.373', 'groupId': 'OG005'}, {'value': '-6.40', 'spread': '11.562', 'groupId': 'OG006'}, {'value': '0.45', 'spread': '18.244', 'groupId': 'OG007'}, {'value': '-11.72', 'spread': '22.198', 'groupId': 'OG008'}, {'value': '-4.94', 'spread': '13.605', 'groupId': 'OG009'}, {'value': '2.63', 'spread': '20.875', 'groupId': 'OG010'}]}]}, {'title': 'Wk28,n=119,110,na,na,34,35,21,21,89,17,18', 'categories': [{'measurements': [{'value': '-4.94', 'spread': '23.155', 'groupId': 'OG000'}, {'value': '-5.87', 'spread': '25.885', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': "After week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only.", 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': "After week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only.", 'groupId': 'OG003'}, {'value': '-4.43', 'spread': '21.777', 'groupId': 'OG004'}, {'value': '-11.10', 'spread': '27.186', 'groupId': 'OG005'}, {'value': '-7.97', 'spread': '18.018', 'groupId': 'OG006'}, {'value': '0.09', 'spread': '24.933', 'groupId': 'OG007'}, {'value': '-12.08', 'spread': '22.791', 'groupId': 'OG008'}, {'value': '-4.51', 'spread': '14.144', 'groupId': 'OG009'}, {'value': '-1.70', 'spread': '22.671', 'groupId': 'OG010'}]}]}, {'title': 'Wk32,n=107,101,na,na,34,32,20,21,87,17,16', 'categories': [{'measurements': [{'value': '-8.57', 'spread': '20.826', 'groupId': 'OG000'}, {'value': '7.37', 'spread': '24.564', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': "After week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only.", 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': "After week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only.", 'groupId': 'OG003'}, {'value': '-4.34', 'spread': '23.742', 'groupId': 'OG004'}, {'value': '-9.08', 'spread': '25.867', 'groupId': 'OG005'}, {'value': '-5.02', 'spread': '10.300', 'groupId': 'OG006'}, {'value': '-5.51', 'spread': '14.279', 'groupId': 'OG007'}, {'value': '-12.83', 'spread': '23.330', 'groupId': 'OG008'}, {'value': '-4.26', 'spread': '15.329', 'groupId': 'OG009'}, {'value': '-7.14', 'spread': '17.446', 'groupId': 'OG010'}]}]}, {'title': 'Wk36,n=107,98,na,na,32,31,21,20,85,18,15', 'categories': [{'measurements': [{'value': '-6.60', 'spread': '25.895', 'groupId': 'OG000'}, {'value': '-6.36', 'spread': '22.571', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': "After week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only.", 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': "After week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only.", 'groupId': 'OG003'}, {'value': '-4.21', 'spread': '27.424', 'groupId': 'OG004'}, {'value': '-2.35', 'spread': '37.226', 'groupId': 'OG005'}, {'value': '-2.73', 'spread': '21.272', 'groupId': 'OG006'}, {'value': '-6.78', 'spread': '13.940', 'groupId': 'OG007'}, {'value': '-12.19', 'spread': '24.535', 'groupId': 'OG008'}, {'value': '-4.38', 'spread': '14.479', 'groupId': 'OG009'}, {'value': '-0.47', 'spread': '27.932', 'groupId': 'OG010'}]}]}, {'title': 'WK40,n=101,96,na,na,29,29,22,20,86,15,17', 'categories': [{'measurements': [{'value': '-8.74', 'spread': '22.257', 'groupId': 'OG000'}, {'value': '-7.09', 'spread': '24.325', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': "After week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only.", 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': "After week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only.", 'groupId': 'OG003'}, {'value': '-7.07', 'spread': '26.156', 'groupId': 'OG004'}, {'value': '2.39', 'spread': '32.966', 'groupId': 'OG005'}, {'value': '-4.46', 'spread': '22.808', 'groupId': 'OG006'}, {'value': '-4.73', 'spread': '13.502', 'groupId': 'OG007'}, {'value': '-12.63', 'spread': '23.788', 'groupId': 'OG008'}, {'value': '-2.75', 'spread': '17.297', 'groupId': 'OG009'}, {'value': '-7.95', 'spread': '18.343', 'groupId': 'OG010'}]}]}, {'title': 'Wk44,n=97,92,na,na,,28,28,20,19,85,15,16', 'categories': [{'measurements': [{'value': '-6.59', 'spread': '20.975', 'groupId': 'OG000'}, {'value': '-7.25', 'spread': '24.681', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': "After week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only.", 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': "After week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only.", 'groupId': 'OG003'}, {'value': '-6.66', 'spread': '23.396', 'groupId': 'OG004'}, {'value': '-8.53', 'spread': '19.970', 'groupId': 'OG005'}, {'value': '-6.50', 'spread': '19.968', 'groupId': 'OG006'}, {'value': '-7.27', 'spread': '13.887', 'groupId': 'OG007'}, {'value': '-12.32', 'spread': '25.470', 'groupId': 'OG008'}, {'value': '-1.33', 'spread': '4.846', 'groupId': 'OG009'}, {'value': '-3.69', 'spread': '24.389', 'groupId': 'OG010'}]}]}, {'title': 'Wk48,n=97,91,na,na,28,29,20,19,79,13,14', 'categories': [{'measurements': [{'value': '-6.19', 'spread': '18.912', 'groupId': 'OG000'}, {'value': '-7.63', 'spread': '21.682', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': "After week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only.", 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': "After week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only.", 'groupId': 'OG003'}, {'value': '-10.49', 'spread': '25.564', 'groupId': 'OG004'}, {'value': '-4.76', 'spread': '15.784', 'groupId': 'OG005'}, {'value': '-1.43', 'spread': '33.122', 'groupId': 'OG006'}, {'value': '-6.97', 'spread': '13.680', 'groupId': 'OG007'}, {'value': '-13.90', 'spread': '25.636', 'groupId': 'OG008'}, {'value': '-3.50', 'spread': '21.343', 'groupId': 'OG009'}, {'value': '-4.48', 'spread': '16.918', 'groupId': 'OG010'}]}]}, {'title': 'Wk52,n=95,92,na,na,29,28,20,18,83,16,16', 'categories': [{'measurements': [{'value': '-6.68', 'spread': '26.240', 'groupId': 'OG000'}, {'value': '-8.14', 'spread': '22.149', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': "After week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only.", 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': "After week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only.", 'groupId': 'OG003'}, {'value': '-4.63', 'spread': '25.795', 'groupId': 'OG004'}, {'value': '-4.79', 'spread': '22.882', 'groupId': 'OG005'}, {'value': '2.95', 'spread': '9.880', 'groupId': 'OG006'}, {'value': '-4.88', 'spread': '11.707', 'groupId': 'OG007'}, {'value': '-11.19', 'spread': '27.768', 'groupId': 'OG008'}, {'value': '-6.73', 'spread': '14.972', 'groupId': 'OG009'}, {'value': '-5.78', 'spread': '18.534', 'groupId': 'OG010'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, weeks 1, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52', 'description': 'Blood samples were obtained to identify the presence of inflammation, to determine its severity and to monitor response to treatment. A negative change from baseline indicates improvement. The hsCRP results from baseline up to week 52 were based on observed data, i.e. without imputation.', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the full analysis set were considered for the analysis. Participants with measurements at both baseline and each post-baseline time point were analyzed for that post-baseline time point. The full analysis set was comprised of all randomized participants (excluding mis-randomized participants) who were assigned to study treatment.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Erythrocyte Sedimentation Rate (ESR) - Observed Data', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}, {'value': '138', 'groupId': 'OG002'}, {'value': '138', 'groupId': 'OG003'}, {'value': '39', 'groupId': 'OG004'}, {'value': '39', 'groupId': 'OG005'}, {'value': '23', 'groupId': 'OG006'}, {'value': '22', 'groupId': 'OG007'}, {'value': '101', 'groupId': 'OG008'}, {'value': '18', 'groupId': 'OG009'}, {'value': '19', 'groupId': 'OG010'}]}], 'groups': [{'id': 'OG000', 'title': 'AIN457 10mg/kg - 75 mg', 'description': 'Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks.'}, {'id': 'OG001', 'title': 'AIN457 10mg/kg - 150 mg', 'description': 'Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (\\>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24.'}, {'id': 'OG003', 'title': 'Abatacept', 'description': 'Participants received abatacept (from 500 to 1000 mg i.v. based on weight). Participants who did not respond to abatacept at Week 16 were re-randomized 1:1 to AIN457 75mg or 150mg at week 24 (after an 8 week washout period).'}, {'id': 'OG004', 'title': 'Placebo Non-responder - AIN457 75mg', 'description': 'Participants switched from placebo to AIN457 75 mg starting at week 16.'}, {'id': 'OG005', 'title': 'Placebo Non-responder - AIN457 150mg', 'description': 'Participants switched from placebo to AIN457 150 mg starting at week 16.'}, {'id': 'OG006', 'title': 'Placebo Responder - AIN457 75mg', 'description': 'Participants switched from placebo to AIN457 75 mg starting at week 24.'}, {'id': 'OG007', 'title': 'Placebo Responder - AIN457 150mg', 'description': 'Participants switched from placebo to AIN457 150 mg starting at week 24.'}, {'id': 'OG008', 'title': 'Abatacept Responders', 'description': 'Abatacept responders remained on abatacept (from 500 to 1000 mg iv based on weight).'}, {'id': 'OG009', 'title': 'Abatacept Non-responders - AIN457 75mg', 'description': 'Participants switched from placebo to AIN457 75 mg starting at week 24.'}, {'id': 'OG010', 'title': 'Abatacept Non-responders - AIN457 150mg', 'description': 'Participants switched from abatacept to AIN457 150 mg starting at week 24.'}], 'classes': [{'title': 'Wk1,n=133,130,131,131,39,36,21,22,97,17,17,', 'categories': [{'measurements': [{'value': '-7.5', 'spread': '18.74', 'groupId': 'OG000'}, {'value': '-8.4', 'spread': '19.20', 'groupId': 'OG001'}, {'value': '-5.7', 'spread': '15.68', 'groupId': 'OG002'}, {'value': '-9.5', 'spread': '16.55', 'groupId': 'OG003'}, {'value': '-8.4', 'spread': '12.65', 'groupId': 'OG004'}, {'value': '-1.1', 'spread': '18.88', 'groupId': 'OG005'}, {'value': '-5.7', 'spread': '14.97', 'groupId': 'OG006'}, {'value': '-7.1', 'spread': '13.22', 'groupId': 'OG007'}, {'value': '-10.2', 'spread': '17.11', 'groupId': 'OG008'}, {'value': '-7.7', 'spread': '13.90', 'groupId': 'OG009'}, {'value': '-7.2', 'spread': '16.30', 'groupId': 'OG010'}]}]}, {'title': 'Wk2,n=133,130,135,134,39,36,23,22,99,17,18', 'categories': [{'measurements': [{'value': '-12.2', 'spread': '19.06', 'groupId': 'OG000'}, {'value': '-10.5', 'spread': '19.05', 'groupId': 'OG001'}, {'value': '-5.7', 'spread': '18.22', 'groupId': 'OG002'}, {'value': '-11.0', 'spread': '19.50', 'groupId': 'OG003'}, {'value': '-4.0', 'spread': '12.69', 'groupId': 'OG004'}, {'value': '-5.6', 'spread': '26.44', 'groupId': 'OG005'}, {'value': '-9.7', 'spread': '17.86', 'groupId': 'OG006'}, {'value': '-6.6', 'spread': '14.44', 'groupId': 'OG007'}, {'value': '-10.2', 'spread': '20.33', 'groupId': 'OG008'}, {'value': '-12.5', 'spread': '16.71', 'groupId': 'OG009'}, {'value': '-13.6', 'spread': '17.78', 'groupId': 'OG010'}]}]}, {'title': 'Wk4,n=133,135,131,133,39,39,23,21,97,17,19', 'categories': [{'measurements': [{'value': '-12.7', 'spread': '22.23', 'groupId': 'OG000'}, {'value': '-12.1', 'spread': '21.88', 'groupId': 'OG001'}, {'value': '-6.0', 'spread': '18.90', 'groupId': 'OG002'}, {'value': '-12.6', 'spread': '18.14', 'groupId': 'OG003'}, {'value': '-3.7', 'spread': '14.35', 'groupId': 'OG004'}, {'value': '-3.8', 'spread': '20.50', 'groupId': 'OG005'}, {'value': '-9.3', 'spread': '13.81', 'groupId': 'OG006'}, {'value': '-8.2', 'spread': '23.89', 'groupId': 'OG007'}, {'value': '-12.3', 'spread': '18.66', 'groupId': 'OG008'}, {'value': '-15.8', 'spread': '17.49', 'groupId': 'OG009'}, {'value': '-11.3', 'spread': '16.46', 'groupId': 'OG010'}]}]}, {'title': 'Wk8,n=133,129,131,132,39,39,23,22,96,17,19', 'categories': [{'measurements': [{'value': '-15.4', 'spread': '20.38', 'groupId': 'OG000'}, {'value': '-15.7', 'spread': '21.62', 'groupId': 'OG001'}, {'value': '-6.4', 'spread': '22.72', 'groupId': 'OG002'}, {'value': '-17.6', 'spread': '20.89', 'groupId': 'OG003'}, {'value': '-9.4', 'spread': '19.24', 'groupId': 'OG004'}, {'value': '-0.9', 'spread': '27.25', 'groupId': 'OG005'}, {'value': '-8.2', 'spread': '24.09', 'groupId': 'OG006'}, {'value': '-8.3', 'spread': '14.29', 'groupId': 'OG007'}, {'value': '-18.3', 'spread': '21.56', 'groupId': 'OG008'}, {'value': '-13.9', 'spread': '23.29', 'groupId': 'OG009'}, {'value': '-17.6', 'spread': '15.03', 'groupId': 'OG010'}]}]}, {'title': 'Wk12,n=133,118,127,131,39,39,23,21,96,17,18', 'categories': [{'measurements': [{'value': '-14.7', 'spread': '20.08', 'groupId': 'OG000'}, {'value': '-18.4', 'spread': '21.18', 'groupId': 'OG001'}, {'value': '-5.8', 'spread': '21.02', 'groupId': 'OG002'}, {'value': '-19.4', 'spread': '20.97', 'groupId': 'OG003'}, {'value': '-5.9', 'spread': '17.96', 'groupId': 'OG004'}, {'value': '-1.5', 'spread': '25.62', 'groupId': 'OG005'}, {'value': '-11.2', 'spread': '18.06', 'groupId': 'OG006'}, {'value': '-5.5', 'spread': '20.06', 'groupId': 'OG007'}, {'value': '-19.9', 'spread': '21.08', 'groupId': 'OG008'}, {'value': '-18.4', 'spread': '23.07', 'groupId': 'OG009'}, {'value': '-17.9', 'spread': '19.31', 'groupId': 'OG010'}]}]}, {'title': 'Wk16,n=129,121,122,130,36,38,21,22,95,16,19', 'categories': [{'measurements': [{'value': '-16.2', 'spread': '21.22', 'groupId': 'OG000'}, {'value': '-15.6', 'spread': '19.09', 'groupId': 'OG001'}, {'value': '-6.5', 'spread': '23.48', 'groupId': 'OG002'}, {'value': '-18.5', 'spread': '24.32', 'groupId': 'OG003'}, {'value': '-3.1', 'spread': '19.21', 'groupId': 'OG004'}, {'value': '-1.1', 'spread': '25.47', 'groupId': 'OG005'}, {'value': '-17.6', 'spread': '23.03', 'groupId': 'OG006'}, {'value': '-4.9', 'spread': '20.54', 'groupId': 'OG007'}, {'value': '-21.1', 'spread': '24.73', 'groupId': 'OG008'}, {'value': '-14.9', 'spread': '17.78', 'groupId': 'OG009'}, {'value': '-8.8', 'spread': '25.22', 'groupId': 'OG010'}]}]}, {'title': 'Wk20,n=123,116,120,127,38,37,23,21,91,17,19', 'categories': [{'measurements': [{'value': '-16.3', 'spread': '20.90', 'groupId': 'OG000'}, {'value': '-17.7', 'spread': '19.90', 'groupId': 'OG001'}, {'value': '-9.1', 'spread': '26.29', 'groupId': 'OG002'}, {'value': '-21.1', 'spread': '23.66', 'groupId': 'OG003'}, {'value': '-21.1', 'spread': '23.66', 'groupId': 'OG004'}, {'value': '-10.5', 'spread': '20.08', 'groupId': 'OG005'}, {'value': '-7.4', 'spread': '29.40', 'groupId': 'OG006'}, {'value': '-11.6', 'spread': '34.23', 'groupId': 'OG007'}, {'value': '-7.0', 'spread': '22.32', 'groupId': 'OG008'}, {'value': '-22.0', 'spread': '23.60', 'groupId': 'OG009'}, {'value': '-20.5', 'spread': '22.81', 'groupId': 'OG010'}]}]}, {'title': 'Wk24,n=122,113,117,123,38,36,21,22,88,17,18', 'categories': [{'measurements': [{'value': '-13.9', 'spread': '23.65', 'groupId': 'OG000'}, {'value': '-16.0', 'spread': '20.20', 'groupId': 'OG001'}, {'value': '-12.0', 'spread': '24.31', 'groupId': 'OG002'}, {'value': '-19.6', 'spread': '24.52', 'groupId': 'OG003'}, {'value': '-10.8', 'spread': '20.33', 'groupId': 'OG004'}, {'value': '-14.7', 'spread': '27.77', 'groupId': 'OG005'}, {'value': '-16.1', 'spread': '21.57', 'groupId': 'OG006'}, {'value': '-5.5', 'spread': '27.07', 'groupId': 'OG007'}, {'value': '-21.1', 'spread': '24.62', 'groupId': 'OG008'}, {'value': '-20.7', 'spread': '20.65', 'groupId': 'OG009'}, {'value': '-11.4', 'spread': '26.96', 'groupId': 'OG010'}]}]}, {'title': 'Wk28,n=119,110,na,na,34,35,21,21,89,17,19', 'categories': [{'measurements': [{'value': '-15.4', 'spread': '22.95', 'groupId': 'OG000'}, {'value': '-16.8', 'spread': '23.05', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': "After week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only.", 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': "After week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only.", 'groupId': 'OG003'}, {'value': '-17.9', 'spread': '24.87', 'groupId': 'OG004'}, {'value': '-12.5', 'spread': '30.87', 'groupId': 'OG005'}, {'value': '-12.3', 'spread': '24.10', 'groupId': 'OG006'}, {'value': '-14.6', 'spread': '17.31', 'groupId': 'OG007'}, {'value': '-22.4', 'spread': '22.90', 'groupId': 'OG008'}, {'value': '-26.1', 'spread': '19.83', 'groupId': 'OG009'}, {'value': '-17.4', 'spread': '24.77', 'groupId': 'OG010'}]}]}, {'title': 'Wk32,n=108,101,na,na,34,32,21,21,88,17,16', 'categories': [{'measurements': [{'value': '-18.3', 'spread': '23.51', 'groupId': 'OG000'}, {'value': '-17.4', 'spread': '21.57', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': "After week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only.", 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': "After week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only.", 'groupId': 'OG003'}, {'value': '-17.2', 'spread': '16.70', 'groupId': 'OG004'}, {'value': '-12.8', 'spread': '26.21', 'groupId': 'OG005'}, {'value': '-16.8', 'spread': '24.37', 'groupId': 'OG006'}, {'value': '-14.1', 'spread': '20.72', 'groupId': 'OG007'}, {'value': '-25.5', 'spread': '24.89', 'groupId': 'OG008'}, {'value': '-25.7', 'spread': '21.14', 'groupId': 'OG009'}, {'value': '-23.1', 'spread': '21.46', 'groupId': 'OG010'}]}]}, {'title': 'Wk36,n=107,98,na,na,32,31,21,20,87,18,16', 'categories': [{'measurements': [{'value': '-16.6', 'spread': '25.20', 'groupId': 'OG000'}, {'value': '-18.4', 'spread': '21.51', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': "After week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only.", 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': "After week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only.", 'groupId': 'OG003'}, {'value': '-17.8', 'spread': '21.72', 'groupId': 'OG004'}, {'value': '-13.4', 'spread': '29.49', 'groupId': 'OG005'}, {'value': '-17.3', 'spread': '22.02', 'groupId': 'OG006'}, {'value': '-16.5', 'spread': '17.95', 'groupId': 'OG007'}, {'value': '-21.7', 'spread': '25.40', 'groupId': 'OG008'}, {'value': '-26.0', 'spread': '21.21', 'groupId': 'OG009'}, {'value': '-16.6', 'spread': '23.31', 'groupId': 'OG010'}]}]}, {'title': 'Wk40,n=101,96,na,na,29,29,22,20,85,15,17', 'categories': [{'measurements': [{'value': '-18.1', 'spread': '21.06', 'groupId': 'OG000'}, {'value': '-17.3', 'spread': '21.05', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': "After week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only.", 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': "After week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only.", 'groupId': 'OG003'}, {'value': '-20.6', 'spread': '19.66', 'groupId': 'OG004'}, {'value': '-12.3', 'spread': '26.37', 'groupId': 'OG005'}, {'value': '-13.3', 'spread': '18.78', 'groupId': 'OG006'}, {'value': '-16.4', 'spread': '21.79', 'groupId': 'OG007'}, {'value': '-22.2', 'spread': '26.24', 'groupId': 'OG008'}, {'value': '-23.8', 'spread': '22.96', 'groupId': 'OG009'}, {'value': '-22.9', 'spread': '15.57', 'groupId': 'OG010'}]}]}, {'title': 'Wk44,n=98,93,na,na,28,28,20,19,85,15,16', 'categories': [{'measurements': [{'value': '-18.0', 'spread': '21.08', 'groupId': 'OG000'}, {'value': '-16.7', 'spread': '23.87', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': "After week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only.", 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': "After week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only.", 'groupId': 'OG003'}, {'value': '-20.1', 'spread': '17.61', 'groupId': 'OG004'}, {'value': '-16.0', 'spread': '25.30', 'groupId': 'OG005'}, {'value': '-12.0', 'spread': '29.20', 'groupId': 'OG006'}, {'value': '-19.2', 'spread': '22.57', 'groupId': 'OG007'}, {'value': '-24.9', 'spread': '25.66', 'groupId': 'OG008'}, {'value': '-22.3', 'spread': '23.36', 'groupId': 'OG009'}, {'value': '-18.5', 'spread': '21.00', 'groupId': 'OG010'}]}]}, {'title': 'Wk48,n=97,92,na,na,28,30,20,19,79,13,14', 'categories': [{'measurements': [{'value': '-17.8', 'spread': '23.11', 'groupId': 'OG000'}, {'value': '-19.8', 'spread': '20.30', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': "After week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only.", 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': "After week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only.", 'groupId': 'OG003'}, {'value': '-20.8', 'spread': '18.26', 'groupId': 'OG004'}, {'value': '-7.2', 'spread': '22.58', 'groupId': 'OG005'}, {'value': '-12.2', 'spread': '29.55', 'groupId': 'OG006'}, {'value': '-19.4', 'spread': '20.58', 'groupId': 'OG007'}, {'value': '-23.9', 'spread': '25.56', 'groupId': 'OG008'}, {'value': '-18.9', 'spread': '26.41', 'groupId': 'OG009'}, {'value': '-20.2', 'spread': '18.16', 'groupId': 'OG010'}]}]}, {'title': 'Wk52,n=94,91,na,na,29,28,20,18,83,16,16', 'categories': [{'measurements': [{'value': '-17.7', 'spread': '21.08', 'groupId': 'OG000'}, {'value': '-20.6', 'spread': '23.48', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': "After week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only.", 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': "After week 24, placebo and abatacept analysis was done on 'AIN457 switch' groups only.", 'groupId': 'OG003'}, {'value': '-14.9', 'spread': '20.53', 'groupId': 'OG004'}, {'value': '-15.1', 'spread': '21.50', 'groupId': 'OG005'}, {'value': '-14.4', 'spread': '24.54', 'groupId': 'OG006'}, {'value': '-13.6', 'spread': '27.16', 'groupId': 'OG007'}, {'value': '-25.2', 'spread': '27.88', 'groupId': 'OG008'}, {'value': '-27.4', 'spread': '22.71', 'groupId': 'OG009'}, {'value': '-15.4', 'spread': '22.53', 'groupId': 'OG010'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, weeks 1, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52', 'description': 'Blood samples were obtained to monitor disease activity and response to treatment. A negative change from baseline indicates improvement. The ESR results from baseline up to week 52 were based on observed data, i.e. without imputation.', 'unitOfMeasure': 'mm/hr', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the full analysis set were considered for the analysis. Participants with measurements at both baseline and each post-baseline time point were analyzed for that post-baseline time point. The full analysis set was comprised of all randomized participants (excluding mis-randomized participants) who were assigned to study treatment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'AIN457 10mg/kg - 75 mg', 'description': 'Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks.'}, {'id': 'FG001', 'title': 'AIN457 10mg/kg - 150 mg', 'description': 'Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks.'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (\\>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24.'}, {'id': 'FG003', 'title': 'Abatacept', 'description': 'Participants received abatacept (from 500 to 1000 mg i.v. based on weight). Participants who did not respond to abatacept at Week 16 were re-randomized 1:1 to AIN457 75mg or 150mg at week 24 (after an 8 week washout period).'}], 'periods': [{'title': 'Core Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '138'}, {'groupId': 'FG001', 'numSubjects': '137'}, {'groupId': 'FG002', 'numSubjects': '138'}, {'groupId': 'FG003', 'numSubjects': '138'}]}, {'type': 'Safety Set', 'achievements': [{'comment': '1 participant actually received placebo; participant was reassigned to placebo for safety analysis.', 'groupId': 'FG000', 'numSubjects': '137'}, {'comment': '1 participant did not receive treatment; therefore participant was not counted in safety analysis.', 'groupId': 'FG001', 'numSubjects': '136'}, {'comment': '1 participant actually received placebo; participant was reassigned to placebo for safety analysis.', 'groupId': 'FG002', 'numSubjects': '139'}, {'comment': '1 participant did not receive treatment; therefore participant was not counted in safety analysis.', 'groupId': 'FG003', 'numSubjects': '137'}]}, {'type': 'Tratment Switch to AIN457 at Week 16', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'comment': '15 participantsdiscontinued prior to the treatment switch', 'groupId': 'FG002', 'numSubjects': '78'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Treatment Switch to AIN457 at Week 24', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '45'}, {'groupId': 'FG003', 'numSubjects': '37'}]}, {'type': 'Full Analysis Set', 'achievements': [{'groupId': 'FG000', 'numSubjects': '138'}, {'groupId': 'FG001', 'numSubjects': '137'}, {'groupId': 'FG002', 'numSubjects': '138'}, {'groupId': 'FG003', 'numSubjects': '138'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '97'}, {'groupId': 'FG001', 'numSubjects': '90'}, {'groupId': 'FG002', 'numSubjects': '91'}, {'groupId': 'FG003', 'numSubjects': '112'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '47'}, {'groupId': 'FG002', 'numSubjects': '47'}, {'groupId': 'FG003', 'numSubjects': '26'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '16'}, {'groupId': 'FG003', 'numSubjects': '7'}]}, {'type': 'Study terminated by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Protocol deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '18'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '8'}]}]}, {'title': 'Extension Study, Weeks 52 - 260', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '80'}, {'groupId': 'FG001', 'numSubjects': '79'}, {'comment': 'During the extension, these participants received AIN457.', 'groupId': 'FG002', 'numSubjects': '72'}, {'comment': 'During the extension, these participants received AIN457.', 'groupId': 'FG003', 'numSubjects': '23'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '80'}, {'groupId': 'FG001', 'numSubjects': '79'}, {'groupId': 'FG002', 'numSubjects': '72'}, {'groupId': 'FG003', 'numSubjects': '23'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Study terminated by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '67'}, {'groupId': 'FG001', 'numSubjects': '67'}, {'groupId': 'FG002', 'numSubjects': '64'}, {'groupId': 'FG003', 'numSubjects': '16'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'At baseline, participants were randomized to 1 of 4 treatment groups. Placebo non-responders at week16 were re-randomized to receive AIN457 75mg or AIN457 150mg. Placebo responders at Week16 were re-randomized to receive AIN457 75mg or AIN457 150mg at Week24. Fifteen participants from the placebo group discontinued prior to re-randomization.', 'preAssignmentDetails': 'Abatacept responders at Week16 continued on abatacept and non-responders at Week 16 were re-randomized to begin either AIN457 75mg or AIN457 150mg at Week 24. Of the 551 core study participants, 254 participants entered the extension study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'BG000'}, {'value': '137', 'groupId': 'BG001'}, {'value': '138', 'groupId': 'BG002'}, {'value': '138', 'groupId': 'BG003'}, {'value': '551', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'AIN457 10mg/kg - 75 mg', 'description': 'Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks.'}, {'id': 'BG001', 'title': 'AIN457 10mg/kg - 150 mg', 'description': 'Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks.'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (\\>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24.'}, {'id': 'BG003', 'title': 'Abatacept', 'description': 'Participants received abatacept (from 500 to 1000 mg i.v. based on weight). Participants who did not respond to abatacept at Week 16 were re-randomized 1:1 to AIN457 75mg or 150mg at week 24 (after an 8 week washout period).'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '111', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}, {'value': '115', 'groupId': 'BG003'}, {'value': '435', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '116', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '119', 'groupId': 'BG000'}, {'value': '109', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}, {'value': '107', 'groupId': 'BG003'}, {'value': '450', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}, {'value': '101', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 551}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-04', 'studyFirstSubmitDate': '2011-05-09', 'resultsFirstSubmitDate': '2016-01-26', 'studyFirstSubmitQcDate': '2011-05-09', 'lastUpdatePostDateStruct': {'date': '2016-05-23', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-05-04', 'studyFirstPostDateStruct': {'date': '2011-05-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-05-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Achieving an American College of Rheumatology Response 20 (ACR20).', 'timeFrame': 'week 24', 'description': "ACR20 response was defined as having a positive clinical response to treatment (individual improvement) in disease activity if the participant had at least 20% improvement in tender 68-joint count, swollen 66-joint count and at least 3 of the following 5 measures: patient's assessment of RA pain, patient's global assessment of disease activity, physician's global assessment of disease activity, subject self-assessed disability (Health Assessment Questionnaire \\[HAQ-DI\\] score), and/or acute phase reactant (high sensitivity c-reactive protein (hsCRP) or erythrocyte sedimentation rate (ESR). The ACR20 response results at week 24 used non-responder imputation."}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Disease Activity Score Utilizing CRP (DAS28-CRP)', 'timeFrame': 'baseline, week 24', 'description': "The DAS28 is a measure of disease activity in RA based on Swollen and Tender Joint Counts (out of a total of 28), hsCRP and the Patient's Global Assessment of Disease Activity. A DAS28 score greater than 5.1 implies active disease, equal to or less than 3.2 low disease activity, and less than 2.6 remission. A negative change from baseline indicates improvement."}, {'measure': 'Change From Baseline in Stanford Health Assessment Questionnaire Disability Index (HAQ-DI)', 'timeFrame': 'baseline, week 24', 'description': 'The HAQ-DI assesses a subject\'s level of functional ability and includes questions of fine movements of the upper extremity, locomotor activities of the lower extremity, and activities that involve both upper and lower extremities. There are 20 questions in 8 categories of functioning including dressing, rising, eating, walking, hygiene, reach, grip and usual activities. The stem of each item asks \'Over the past week, "are you able to..." perform a particular task\'. Each item is scored on a 4 point scale from 0 - 3, representing normal, no difficulty (0), some difficulty (1), much difficulty (2) and unable to do (3). The disability index score is calculated as the mean of the available category scores, ranging from 0 to 3. A negative change from baseline indicates improvement.'}, {'measure': 'Percentage of Participants Achieving ACR50', 'timeFrame': 'week 24', 'description': "ACR50 response was defined as having a positive clinical response to treatment (individual improvement) in disease activity if the participant had at least 50% improvement in tender 68-joint count, swollen 66-joint count and at least 3 of the following 5 measures: patient's assessment of RA pain, patient's global assessment of disease activity, physician's global assessment of disease activity, subject self-assessed disability (Health Assessment Questionnaire \\[HAQ-DI\\] score), and/or acute phase reactant (high sensitivity c-reactive protein (hsCRP) or erythrocyte sedimentation rate (ESR). The ACR50 response results at week 24 used non-responder imputation."}, {'measure': 'Percentage of Participants Achieving ACR20, ACR 50 and ACR 70 - Using Non-responder Imputation', 'timeFrame': 'baseline, weeks 1, 2, 4, 8, 12, 16, 20 and 24', 'description': "ACR20, ACR 50 and ACR 70 response was defined as having a positive clinical response to treatment (individual improvement) in disease activity if the participant had at least 20%, 50% and/or 70% improvement, respectively, in tender 68-joint count, swollen 66-joint count and at least 3 of the following 5 measures: patient's assessment of RA pain, patient's global assessment of disease activity, physician's global assessment of disease activity, subject self-assessed disability (Health Assessment Questionnaire \\[HAQ-DI\\] score), and/or acute phase reactant (high sensitivity c-reactive protein (hsCRP) or erythrocyte sedimentation rate (ESR)."}, {'measure': 'Percentage of Participants Achieving ACR20, ACR 50 and ACR 70 - Observed Data', 'timeFrame': 'baseline, weeks 1, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52', 'description': "ACR20, ACR 50 and ACR 70 response was defined as having a positive clinical response to treatment (individual improvement) in disease activity if the participant had at least 20%, 50% and/or 70% improvement, respectively, in tender 68-joint count, swollen 66-joint count and at least 3 of the following 5 measures: patient's assessment of RA pain, patient's global assessment of disease activity, physician's global assessment of disease activity, subject self-assessed disability (Health Assessment Questionnaire \\[HAQ-DI\\] score), and/or acute phase reactant (high sensitivity c-reactive protein (hsCRP) or erythrocyte sedimentation rate (ESR). The ACR20, ACR50 and ACR70 response results from baseline up to week 52 were based on observed data, i.e. without imputation."}, {'measure': 'Change From Baseline in HAQ-DI - Using Mixed Model Repeated Measures (MMRM)', 'timeFrame': 'baseline, weeks 1, 2, 4, 8, 12, 16, 20 and 24', 'description': 'The HAQ-DI, assesses a subject\'s level of functional ability and includes questions of fine movements of the upper extremity, locomotor activities of the lower extremity, and activities that involve both upper and lower extremities. There are 20 questions in 8 categories of functioning including dressing, rising, eating, walking, hygiene, reach, grip and usual activities. The stem of each item asks \'Over the past week, "are you able to..." perform a particular task\'. Each item is scored on a 4 point scale from 0 - 3, representing normal, no difficulty (0), some difficulty (1), much difficulty (2) and unable to do (3). The disability index score is calculated as the mean of the available category scores, ranging from 0 to 3. A negative change from baseline indicates improvement.'}, {'measure': 'Change From Baseline in HAQ-DI - Observed Data', 'timeFrame': 'baseline, weeks 1, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52', 'description': 'The HAQ-DI assesses a subject\'s level of functional ability and includes questions of fine movements of the upper extremity, locomotor activities of the lower extremity, and activities that involve both upper and lower extremities. There are 20 questions in 8 categories of functioning including dressing, rising, eating, walking, hygiene, reach, grip and usual activities. The stem of each item asks \'Over the past week, "are you able to..." perform a particular task\'. Each item is scored on a 4 point scale from 0 - 3, representing normal, no difficulty (0), some difficulty (1), much difficulty (2) and unable to do (3). The disability index score is calculated as the mean of the available category scores, ranging from 0 to 3. A negative change from baseline indicates improvement. The HAQ-DI results from baseline up to week 52 were based on observed data, i.e. without imputation.'}, {'measure': 'Change From Baseline in Disease Activity Score Utilizing CRP (DAS28-CRP) - Using MMRM', 'timeFrame': 'baseline, weeks 1, 2, 4, 8, 12, 16, 20 and 24', 'description': "The DAS28 is a measure of disease activity in RA based on Swollen and Tender Joint Counts (out of a total of 28), hsCRP and the Patient's Global Assessment of Disease Activity. A DAS28 score greater than 5.1 implies active disease, equal to or less than 3.2 low disease activity, and less than 2.6 remission. A negative change from baseline indicates improvement."}, {'measure': 'Change From Baseline in Disease Activity Score Utilizing CRP (DAS28-CRP) - Observed Data', 'timeFrame': 'baseline, weeks 1, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52', 'description': "The DAS28 is a measure of disease activity in RA based on Swollen and Tender Joint Counts (out of a total of 28), hsCRP and the Patient's Global Assessment of Disease Activity. A DAS28 score greater than 5.1 implies active disease, equal to or less than 3.2 low disease activity, and less than 2.6 remission. A negative change from baseline indicates improvement. The DAS28-CRP results from baseline up to week 52 were based on observed data, i.e. without imputation."}, {'measure': 'Change From Baseline in hsCRP - Observed Data', 'timeFrame': 'baseline, weeks 1, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52', 'description': 'Blood samples were obtained to identify the presence of inflammation, to determine its severity and to monitor response to treatment. A negative change from baseline indicates improvement. The hsCRP results from baseline up to week 52 were based on observed data, i.e. without imputation.'}, {'measure': 'Change From Baseline in Erythrocyte Sedimentation Rate (ESR) - Observed Data', 'timeFrame': 'baseline, weeks 1, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52', 'description': 'Blood samples were obtained to monitor disease activity and response to treatment. A negative change from baseline indicates improvement. The ESR results from baseline up to week 52 were based on observed data, i.e. without imputation.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Rheumatoid Arthritis', 'RA', 'ACR', 'inflammatory joints'], 'conditions': ['Rheumatoid Arthritis']}, 'referencesModule': {'references': [{'pmid': '31087226', 'type': 'DERIVED', 'citation': 'Huang Y, Fan Y, Liu Y, Xie W, Zhang Z. Efficacy and safety of secukinumab in active rheumatoid arthritis with an inadequate response to tumor necrosis factor inhibitors: a meta-analysis of phase III randomized controlled trials. Clin Rheumatol. 2019 Oct;38(10):2765-2776. doi: 10.1007/s10067-019-04595-1. Epub 2019 May 14.'}, {'pmid': '28217871', 'type': 'DERIVED', 'citation': 'Blanco FJ, Moricke R, Dokoupilova E, Codding C, Neal J, Andersson M, Rohrer S, Richards H. Secukinumab in Active Rheumatoid Arthritis: A Phase III Randomized, Double-Blind, Active Comparator- and Placebo-Controlled Study. Arthritis Rheumatol. 2017 Jun;69(6):1144-1153. doi: 10.1002/art.40070. Epub 2017 May 3.'}]}, 'descriptionModule': {'briefSummary': 'The core and extension studies assessed the safety and efficacy of secukinumab when added to a background therapy in patients with active rheumatoid arthritis who are intolerant to or have had an inadequate response to anti-TNF-α agents. Patients received either secukinumab, placebo or abatacept (active comparator). The core study was completed. However, the extension study was prematurely terminated after the primary endpoint analysis of the core study at week 24 had demonstrated numerically higher efficacy for the active comparator abatacept compared to secukinumab.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or non-pregnant, non-lactating female patients\n* Presence of RA classified by ACR 2010 revised criteria for at least 3 months before screening\n* At Baseline: Disease activity criteria defined by \\>= 6 tender joints out of 68 and \\>= 6 swollen joints out of 66\n\nWITH at least 1 of the following at screening:\n\n* Anti-Cyclic Citrullinated Peptide (Anti-CCP) antibodies positive OR\n* Rheumatoid Factor positive\n\nAND WITH at least 1 of the following at screening:\n\n* High sensitivity C-Reactive Protein (hsCRP) \\>= 10 mg/L OR\n* Erythrocyte Sedimentation Rate (ESR) \\>= 28 millimeter (mm)/1st hour\n* Patients must have been taking at least one anti-TNF-α agent given at an approved dose for at least 3 months before randomization and have experienced an inadequate response to treatment or have been intolerant to at least one administration of an anti-TNF-α agent\n* Patients must be taking MTX or any other DMARD (but not more than 1 DMARD) for at least 3 months before randomization and have to be on a stable dose at least 4 weeks before randomization (7.5 to 25 mg/week for MTX or other DMARD at maximum tolerated dose)\n\nExclusion Criteria:\n\n* Chest x-ray with evidence of ongoing infectious or malignant process, obtained within 3 months prior to screening and evaluated by a qualified physician\n* RA patients functional status class IV according to the ACR 1991 revised criteria\n* Patients who have ever received biologic immunomodulating agents except for those targeting TNFα\n* Previous treatment with any cell-depleting therapies\n\nOther protocol-defined inclusion/exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT01350804', 'acronym': 'NURTURE 1', 'briefTitle': 'Efficacy at 24 Weeks and Safety, Tolerability and Long Term Efficacy of Secukinumab (AIN457) in Patients With Active Rheumatoid Arthritis (RA) and an Inadequate Response to Anti-Tumor Necrosis Factor α (Anti-TNFα) Agents (CAIN457F2309 and CAIN457F2309E1)', 'nctIdAliases': ['NCT01640938'], 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Randomized, Double-blind, Placebo- and Active-controlled Study of Secukinumab to Demonstrate the Efficacy at 24 Weeks and to Assess the Safety, Tolerability and Long Term Efficacy up to 1 Year in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Anti-TNFα Agents (CAIN457F2309) and A Four Year Extension Study to Evaluate the Long Term Efficacy, Safety and Tolerability of Secukinumab in Patients With Active Rheumatoid Arthritis (CAIN457F2309E1)', 'orgStudyIdInfo': {'id': 'CAIN457F2309'}, 'secondaryIdInfos': [{'id': '2011-000102-21', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AIN457 10mg/kg - 75 mg', 'description': 'Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks', 'interventionNames': ['Biological: AIN457']}, {'type': 'EXPERIMENTAL', 'label': 'AIN457 10mg/kg - 150 mg', 'description': 'Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks', 'interventionNames': ['Biological: AIN457']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (\\>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24.', 'interventionNames': ['Biological: AIN457', 'Biological: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Abatacept', 'description': 'Participants received abatacept (from 500 to 1000 mg i.v. based on weight). Participants who did not respond to abatacept at Week 16 were re-randomized 1:1 to AIN457 75mg or 150mg at week 24 (after an 8 week washout period).', 'interventionNames': ['Biological: AIN457', 'Biological: Abatacept']}], 'interventions': [{'name': 'AIN457', 'type': 'BIOLOGICAL', 'otherNames': ['Secukinumab'], 'description': 'AIN457 (Secukinumab) is a human monoclonal antibody. Secukinumab binds and reduces the activity of Interleukin 17 (IL-17). AIN457 was given as i.v. (10mg/kg) at baseline, week 2 and week 4, and then s.c. (75 or 150mg) every 4 weeks starting at week 8.', 'armGroupLabels': ['AIN457 10mg/kg - 150 mg', 'AIN457 10mg/kg - 75 mg', 'Abatacept', 'Placebo']}, {'name': 'Placebo', 'type': 'BIOLOGICAL', 'description': 'Placebo was given as i.v. at baseline, week 2 and week 4, and then s.c. every 4 weeks starting at week 8.', 'armGroupLabels': ['Placebo']}, {'name': 'Abatacept', 'type': 'BIOLOGICAL', 'otherNames': ['Orencia'], 'description': 'Abatacept (from 500 to 1000 mg i.v. based on weight) was given as i.v. at baseline, weeks 2 and 4, and then every 4 weeks starting at week 8.', 'armGroupLabels': ['Abatacept']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36207-5710', 'city': 'Anniston', 'state': 'Alabama', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 33.65983, 'lon': -85.83163}}, {'zip': '35216', 'city': 'Vestavia Hills', 'state': 'Alabama', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 33.44872, 'lon': -86.78777}}, {'zip': '94538', 'city': 'Freemont', 'state': 'California', 'country': 'United States', 'facility': 'Novartis Investigative Site'}, {'zip': '91767', 'city': 'Pomona', 'state': 'California', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 34.05529, 'lon': -117.75228}}, {'zip': '91786', 'city': 'Upland', 'state': 'California', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 34.09751, 'lon': -117.64839}}, {'zip': '91405', 'city': 'Van Nuys', 'state': 'California', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 34.18667, 'lon': -118.44897}}, {'zip': '06606', 'city': 'Bridgeport', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 41.17923, 'lon': -73.18945}}, {'zip': '33180', 'city': 'Aventura', 'state': 'Florida', 'country': 'United States', 'facility': 'Novartis 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