Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2026-03-02 @ 8:37 PM
Study NCT ID:
NCT02373202
Status:
COMPLETED
Last Update Posted:
2018-01-30
First Post:
2015-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study Assessing the Safety and Efficacy of Sarilumab Added to Non-MTX DMARDs or as Monotherapy in Japanese Patients With Active Rheumatoid Arthritis (SARIL-RA-HARUKA)
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': 'C000592401', 'term': 'sarilumab'}, {'id': 'D012460', 'term': 'Sulfasalazine'}, {'id': 'D000077339', 'term': 'Leflunomide'}, {'id': 'C026535', 'term': 'bucillamine'}, {'id': 'D016559', 'term': 'Tacrolimus'}, {'id': 'C010052', 'term': 'mizoribine'}], 'ancestors': [{'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D007555', 'term': 'Isoxazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Contact-US@sanofi.com', 'title': 'Trial Transparency Team', 'organization': 'Sanofi'}, 'certainAgreement': {'otherDetails': 'If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All AEs were collected from signature of the informed consent form until the end of the study (Week 58) regardless of seriousness or relationship to IMP.', 'description': "Reported AEs are treatment-emergent AEs that developed/worsened during the 'on treatment period' (from the first IMP administration up to the 6 week after last IMP administration \\[up to Week 58\\]).", 'eventGroups': [{'id': 'EG000', 'title': 'Sarilumab 150 mg q2w + DMARDs', 'description': 'Participants received sarilumab 150 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 14, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Sarilumab 200 mg q2w + DMARDs', 'description': 'Participants received sarilumab 200 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 13, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'Sarilumab 150 mg q2w Monotherapy', 'description': 'Participants received sarilumab 150 mg, SC injection, q2w for up to 52 weeks.', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 22, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Sarilumab 200 mg q2w Monotherapy', 'description': 'Participants received sarilumab 200 mg, SC injection, q2w for up to 52 weeks.', 'otherNumAtRisk': 31, 'deathsNumAtRisk': 31, 'otherNumAffected': 23, 'seriousNumAtRisk': 31, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Conjunctivitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Glossodynia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Injection site haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Injection site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Injection site rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Hepatic function abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 4}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Chronic sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Enteritis infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Gingivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Periodontitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Accidental overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Foot fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Heat stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Scratch', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Protein urine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Hypercholesterolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Hyperlipidaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Musculoskeletal stiffness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Osteoporosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Rheumatoid arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Synovitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Breast cancer female', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Gastric cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Dysarthria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Renal impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Rhinitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Dermatitis contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Eczema nummular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Haemorrhage subcutaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Onycholysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Psoriasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}], 'seriousEvents': [{'term': 'Chronic sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Herpes zoster oticus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Periorbital abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Pneumonia bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Breast cancer female', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Gastric cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Abortion induced', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sarilumab 150 mg q2w + DMARDs', 'description': 'Participants received sarilumab 150 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.'}, {'id': 'OG001', 'title': 'Sarilumab 200 mg q2w + DMARDs', 'description': 'Participants received sarilumab 200 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.'}, {'id': 'OG002', 'title': 'Sarilumab 150 mg q2w', 'description': 'Participants received sarilumab 150 mg, SC injection, q2w for up to 52 weeks.'}, {'id': 'OG003', 'title': 'Sarilumab 200 mg q2w', 'description': 'Participants received sarilumab 200 mg, SC injection, q2w for up to 52 weeks.'}], 'classes': [{'title': 'Any TEAE', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}]}, {'title': 'SAE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Week 58', 'description': 'Adverse event (AE) was defined as any untoward medical occurrence in a participant who received IMP and did not necessary have to had a causal relationship with treatment. All AEs that occurred from the first dose of the IMP administration up to 6 weeks after last dose of treatment (up to Week 58) were considered as TEAEs. SAEs were AEs resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly or a medically important event. TEAEs included both SAEs and non-SAEs.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all randomized participants who actually received at least one dose or a partial dose of IMP analyzed according to the treatment actually received.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sarilumab 150 mg q2w + DMARDs', 'description': 'Participants received sarilumab 150 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.'}, {'id': 'OG001', 'title': 'Sarilumab 200 mg q2w + DMARDs', 'description': 'Participants received sarilumab 200 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.'}, {'id': 'OG002', 'title': 'Sarilumab 150 mg q2w', 'description': 'Participants received sarilumab 150 mg, SC injection, q2w for up to 52 weeks.'}, {'id': 'OG003', 'title': 'Sarilumab 200 mg q2w', 'description': 'Participants received sarilumab 200 mg, SC injection, q2w for up to 52 weeks.'}], 'classes': [{'title': 'SBP (supine) <=95 mmHg and DFB >=20 mmHg', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'SBP (supine) >=160 mmHg and IFB >=20 mmHg', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'DBP (supine) <=45 mmHg and DFB >=10 mmHg', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'DBP (supine) >=110 mmHg and IFB >=10 mmHg', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'SBP (orthostatic) <=-20 mmHg', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}, {'title': 'DBP (orthostatic) <=-10 mmHg', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}]}, {'title': 'HR (supine) <=50 bpm and DFB >= 20 bpm', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'HR (supine) >=120 bpm and IFB >=20 bpm', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Weight >=5% DFB', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Weight >=5% IFB', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Week 58', 'description': 'Criteria for potentially clinically significant vital sign abnormalities:\n\n* Systolic blood pressure (SBP) supine: \\<=95 mmHg and decrease from baseline (DFB) \\>=20 mmHg; \\>=160 mmHg and increase from baseline (IFB) \\>=20 mmHg\n* Diastolic blood pressure (DBP) supine: \\<=45 mmHg and DFB \\>=10 mmHg; \\>=110 mmHg and IFB ≥10 mmHg\n* SBP (Orthostatic): \\<=-20 mmHg\n* DBP (Orthostatic): \\<=-10 mmHg\n* Heart rate (HR) supine: \\<=50 beats per minute (bpm) and DFB \\>=20 bpm; \\>=120 bpm and IFB \\>=20 bpm\n* Weight: \\>=5% DFB; \\>=5% IFB', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all randomized participants who actually received at least one dose or a partial dose of IMP analyzed according to the treatment actually received.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sarilumab 150 mg q2w + DMARDs', 'description': 'Participants received sarilumab 150 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.'}, {'id': 'OG001', 'title': 'Sarilumab 200 mg q2w + DMARDs', 'description': 'Participants received sarilumab 200 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.'}, {'id': 'OG002', 'title': 'Sarilumab 150 mg q2w', 'description': 'Participants received sarilumab 150 mg, SC injection, q2w for up to 52 weeks.'}, {'id': 'OG003', 'title': 'Sarilumab 200 mg q2w', 'description': 'Participants received sarilumab 200 mg, SC injection, q2w for up to 52 weeks.'}], 'classes': [{'title': 'PR >200 ms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'PR >200 ms and IFB >=25%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'PR >220 ms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'PR >220 ms and IFB >=25%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'PR >240 ms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'PR >240 ms and IFB >=25%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'QRS >110 ms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'QRS >110 ms and IFB >=25%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'QRS >120 ms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'QRS >120 ms and IFB >=25%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'QT >500 ms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'QTc B >450 ms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}]}, {'title': 'QTc B >480 ms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'QTc B >500 ms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'QTc B IFB >30 and <=60 ms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'QTc B IFB >60 ms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'QTc F >450 ms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}, {'title': 'QTc F >480 ms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'QTc F >500 ms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'QTc F IFB >30 and <=60 ms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'QTc F IFB >60 ms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Week 58', 'description': 'Criteria for potentially clinically significant ECG abnormalities:\n\n* PR Interval: \\>200 milliseconds (ms); \\>200 ms and IFB \\>=25%; \\>220 ms; \\>220 ms and IFB \\>=25%; \\>240 ms; \\>240 ms and IFB \\>=25%\n* QRS Interval: \\>110 ms; \\>110 ms and IFB \\>=25%; \\>120 ms; \\>120 ms and IFB \\>=25%\n* QT Interval: \\>500 ms\n* QTc Bazett (QTc B): \\>450 ms; \\>480 ms; \\>500 ms; IFB \\>30 and \\<=60 ms, IFB \\>60 ms\n* QTc Fridericia (QTc F): \\>450 ms; \\>480 ms; \\>500 ms; IFB \\>30 and \\<=60 ms; IFB \\>60 ms', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all randomized participants who actually received at least one dose or a partial dose of IMP analyzed according to the treatment actually received.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sarilumab 150 mg q2w + DMARDs', 'description': 'Participants received sarilumab 150 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.'}, {'id': 'OG001', 'title': 'Sarilumab 200 mg q2w + DMARDs', 'description': 'Participants received sarilumab 200 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.'}, {'id': 'OG002', 'title': 'Sarilumab 150 mg q2w', 'description': 'Participants received sarilumab 150 mg, SC injection, q2w for up to 52 weeks.'}, {'id': 'OG003', 'title': 'Sarilumab 200 mg q2w', 'description': 'Participants received sarilumab 200 mg, SC injection, q2w for up to 52 weeks.'}], 'classes': [{'title': 'Hemoglobin <=115 g/L (M) or <=95 g/L (F)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Hemoglobin >=185 g/L (M) or >=165 g/L (F)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Hemoglobin DFB >=20 g/L', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Hematocrit <=0.37 v/v (M) or <=0.32 v/v (F)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}, {'title': 'Hematocrit >0.55 v/v (M) or >=0.5 v/v (F)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'RBC >=6 Tera/L', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Platelets <50 Giga/L', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Platelets >=50 and <100 Giga/L', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Platelets >=700 Giga/L', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'WBC <3.0 Giga/L (NB) or <2.0 Giga/L (B)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}, {'title': 'WBC >=16.0 Giga/L', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Neutrophils <1.5 Giga/L (NB) or <1.0 Giga/L (B)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}]}, {'title': 'Neutrophils <1.0 Giga/L', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'Lymphocytes <0.5 Giga/L', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Lymphocytes >=0.5 Giga/L and <LLN', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}]}, {'title': 'Lymphocytes >4.0 Giga/L', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Monocytes >0.7 Giga/L', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Basophils >0.1 Giga/L', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}, {'title': 'Eosinophils >0.5 Giga/L or >ULN (ULN >=0.5 Giga/L)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Week 58', 'description': 'Criteria for potentially clinically significant abnormalities:\n\n* Hemoglobin: \\<=115 g/L (Male\\[M\\]) or \\<=95 g/L (Female\\[F\\]); \\>=185 g/L (M) or \\>=165 g/L (F); DFB \\>=20 g/L\n* Hematocrit: \\<=0.37 v/v (M) or \\<=0.32 v/v (F); \\>=0.55 v/v (M) or \\>=0.5 v/v (F)\n* Red blood cells (RBC): \\>=6 Tera/L\n* Platelets: \\<50 Giga/L; \\>=50 and \\<100 Giga/L; \\>=700 Giga/L\n* White blood cells (WBC): \\<3.0 Giga/L (Non-Black \\[NB\\]) or \\<2.0 Giga/L (Black \\[B\\]); \\>=16.0 Giga/L\n* Neutrophils: \\<1.5 Giga/L (NB) or \\<1.0 Giga/L (B); \\<1.0 Giga/L\n* Lymphocytes: \\<0.5 Giga/L; \\>=0.5 Giga/L and \\<lower limit of normal (LLN); \\>4.0 Giga/L\n* Monocytes: \\>0.7 Giga/L\n* Basophils: \\>0.1 Giga/L\n* Eosinophils: \\>0.5 Giga/L or \\>upper limit of normal (ULN) (if ULN \\>=0.5 Giga/L)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all randomized participants who actually received at least one dose or a partial dose of IMP analyzed according to the treatment actually received.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving American College of Rheumatology (ACR) 20, 50 and 70 Responses at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sarilumab 150 mg q2w + DMARDs', 'description': 'Participants received sarilumab 150 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.'}, {'id': 'OG001', 'title': 'Sarilumab 200 mg q2w + DMARDs', 'description': 'Participants received sarilumab 200 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.'}, {'id': 'OG002', 'title': 'Sarilumab 150 mg q2w', 'description': 'Participants received sarilumab 150 mg, SC injection, q2w for up to 52 weeks.'}, {'id': 'OG003', 'title': 'Sarilumab 200 mg q2w', 'description': 'Participants received sarilumab 200 mg, SC injection, q2w for up to 52 weeks.'}], 'classes': [{'title': 'ACR20', 'categories': [{'measurements': [{'value': '73.3', 'groupId': 'OG000'}, {'value': '40.0', 'groupId': 'OG001'}, {'value': '76.7', 'groupId': 'OG002'}, {'value': '74.2', 'groupId': 'OG003'}]}]}, {'title': 'ACR50', 'categories': [{'measurements': [{'value': '60.0', 'groupId': 'OG000'}, {'value': '33.3', 'groupId': 'OG001'}, {'value': '56.7', 'groupId': 'OG002'}, {'value': '54.8', 'groupId': 'OG003'}]}]}, {'title': 'ACR70', 'categories': [{'measurements': [{'value': '53.3', 'groupId': 'OG000'}, {'value': '26.7', 'groupId': 'OG001'}, {'value': '26.7', 'groupId': 'OG002'}, {'value': '25.8', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 52', 'description': "ACR response is a composite rating scale that includes 7 variables: tender joints count (TJC \\[68 joints\\]); swollen joints count (SJC \\[66 joints\\]); levels of an acute phase reactant (high sensitivity C-reactive protein \\[hs-CRP level\\]); participant's assessment of pain (measured on 0 \\[no pain\\]-100 mm \\[worst pain\\] visual analog scale \\[VAS\\]); participant's global assessment of disease activity (measured on 0 \\[no arthritis activity\\]-100 mm \\[maximal arthritis activity\\] VAS); physician's global assessment of disease activity (measured on 0 \\[no arthritis activity\\]-100 mm \\[maximal arthritis activity\\] VAS); participant's assessment of physical function (measured by Health Assessment Question-Disability Index \\[HAQ-DI\\], with scoring range of 0 \\[better health\\] - 3 \\[worst health\\]). ACR20/50/70 response is defined as at least 20/50/70% improvement in both TJC and SJC, and at least 20/50/70% improvement in at least 3 of the 5 other assessments, respectively.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population included all randomized participants who received at least one dose of IMP, irrespective of compliance with the study protocol and procedures.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline at Week 52 in Disease Activity Score for 28 Joints Based on C-Reactive Protein (DAS28-CRP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sarilumab 150 mg q2w + DMARDs', 'description': 'Participants received sarilumab 150 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.'}, {'id': 'OG001', 'title': 'Sarilumab 200 mg q2w + DMARDs', 'description': 'Participants received sarilumab 200 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.'}, {'id': 'OG002', 'title': 'Sarilumab 150 mg q2w', 'description': 'Participants received sarilumab 150 mg, SC injection, q2w for up to 52 weeks.'}, {'id': 'OG003', 'title': 'Sarilumab 200 mg q2w', 'description': 'Participants received sarilumab 200 mg, SC injection, q2w for up to 52 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.90', 'spread': '1.06', 'groupId': 'OG000'}, {'value': '-2.47', 'spread': '0.84', 'groupId': 'OG001'}, {'value': '-2.62', 'spread': '1.12', 'groupId': 'OG002'}, {'value': '-2.64', 'spread': '1.35', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 52', 'description': "DAS28-CRP is a composite score that contains 4 variables: TJC (based on 28 joints), SJC (based on 28 joints), participant's assessment of general health on VAS (range 0 \\[very well\\] to 100 mm \\[extremely bad\\]) and CRP (mg/L). DAS28-CRP total score ranges from 2-10 with a lower score indicating less disease activity. A DAS28-CRP above 5.1 indicates high disease activity, whereas below 3.2 indicates low disease activity and below 2.6 as disease remission.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "mITT population included all randomized participants who received at least one dose of IMP, irrespective of compliance with the study protocol and procedures. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sarilumab 150 mg q2w + DMARDs', 'description': 'Participants received sarilumab 150 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.'}, {'id': 'OG001', 'title': 'Sarilumab 200 mg q2w + DMARDs', 'description': 'Participants received sarilumab 200 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.'}, {'id': 'OG002', 'title': 'Sarilumab 150 mg q2w', 'description': 'Participants received sarilumab 150 mg, SC injection, q2w for up to 52 weeks.'}, {'id': 'OG003', 'title': 'Sarilumab 200 mg q2w', 'description': 'Participants received sarilumab 200 mg, SC injection, q2w for up to 52 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.52', 'spread': '0.45', 'groupId': 'OG000'}, {'value': '-0.34', 'spread': '0.60', 'groupId': 'OG001'}, {'value': '-0.48', 'spread': '0.58', 'groupId': 'OG002'}, {'value': '-0.38', 'spread': '0.34', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 52', 'description': "HAQ-DI assessed the degree of difficulty participants experienced in 8 daily living activity domains during a week: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consisted of 2-3 items. Each items's difficulty was scored from 0-3 (0=no difficulty, 1=some difficulty, 2=much difficulty, 3=unable to do). Overall HAQ-DI score was computed as the sum of domain scores divided by the number of domains answered, providing a score from 0-3. Low scores denoted improvement of disability/lower degree of domain difficulty.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "mITT population included all randomized participants who received at least one dose of IMP, irrespective of compliance with the study protocol and procedures. Here 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Metabolic Parameters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sarilumab 150 mg q2w + DMARDs', 'description': 'Participants received sarilumab 150 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.'}, {'id': 'OG001', 'title': 'Sarilumab 200 mg q2w + DMARDs', 'description': 'Participants received sarilumab 200 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.'}, {'id': 'OG002', 'title': 'Sarilumab 150 mg q2w', 'description': 'Participants received sarilumab 150 mg, SC injection, q2w for up to 52 weeks.'}, {'id': 'OG003', 'title': 'Sarilumab 200 mg q2w', 'description': 'Participants received sarilumab 200 mg, SC injection, q2w for up to 52 weeks.'}], 'classes': [{'title': 'Glucose <=3.9 mmol/L and <LLN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Glucose >=11.1 mmol/L (unfas) or >=7 mmol/L (fas)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'HbA1c >8%', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Total Cholesterol >=6.2 mmol/L', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}]}, {'title': 'Total Cholesterol >=7.74 mmol/L', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'LDL Cholesterol >=4.1 mmol/L', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'LDL Cholesterol >=4.9 mmol/L', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Triglycerides >=4.6 mmol/L', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Triglycerides >=5.6 mmol/L', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Week 58', 'description': 'Criteria for potentially clinically significant abnormalities:\n\n* Glucose: \\<=3.9 mmol/L and \\<LLN; \\>=11.1 mmol/L (unfasted \\[unfas\\]) or \\>=7 mmol/L (fasted \\[fas\\])\n* Hemoglobin A1c (HbA1c): \\>8%\n* Total cholesterol: \\>=6.2 mmol/L; \\>=7.74 mmol/L\n* LDL cholesterol: \\>=4.1 mmol/L; \\>=4.9 mmol/L\n* Triglycerides: \\>=4.6 mmol/L; \\>=5.6 mmol/L', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all randomized participants who actually received at least one dose or a partial dose of IMP analyzed according to the treatment actually received.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Electrolytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sarilumab 150 mg q2w + DMARDs', 'description': 'Participants received sarilumab 150 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.'}, {'id': 'OG001', 'title': 'Sarilumab 200 mg q2w + DMARDs', 'description': 'Participants received sarilumab 200 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.'}, {'id': 'OG002', 'title': 'Sarilumab 150 mg q2w', 'description': 'Participants received sarilumab 150 mg, SC injection, q2w for up to 52 weeks.'}, {'id': 'OG003', 'title': 'Sarilumab 200 mg q2w', 'description': 'Participants received sarilumab 200 mg, SC injection, q2w for up to 52 weeks.'}], 'classes': [{'title': 'Sodium <=129 mmol/L', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Sodium >=160 mmol/L', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Potassium <3 mmol/L', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Potassium >=5.5 mmol/L', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Chloride <80 mmol/L', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Chloride >115 mmol/L', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Week 58', 'description': 'Criteria for potentially clinically significant abnormalities:\n\n* Sodium: \\<=129 mmol/L; \\>=160 mmol/L\n* Potassium: \\<3 mmol/L; \\>=5.5 mmol/L\n* Chloride: \\<80 mmol/L; \\>115 mmol/L', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all randomized participants who actually received at least one dose or a partial dose of IMP analyzed according to the treatment actually received.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Renal Function Parameters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sarilumab 150 mg q2w + DMARDs', 'description': 'Participants received sarilumab 150 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.'}, {'id': 'OG001', 'title': 'Sarilumab 200 mg q2w + DMARDs', 'description': 'Participants received sarilumab 200 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.'}, {'id': 'OG002', 'title': 'Sarilumab 150 mg q2w', 'description': 'Participants received sarilumab 150 mg, SC injection, q2w for up to 52 weeks.'}, {'id': 'OG003', 'title': 'Sarilumab 200 mg q2w', 'description': 'Participants received sarilumab 200 mg, SC injection, q2w for up to 52 weeks.'}], 'classes': [{'title': 'Creatinine >=150 micromol/L (Adults)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Creatinine >=30% change from baseline', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}, {'title': 'Creatinine >=100% change from baseline', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Creatinine Clearance <15 mL/min', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Creatinine clearance >=15 to <30 mL/min', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Creatinine clearance >=30 to <60 mL/min', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}, {'title': 'Creatinine clearance >=60 to <90 mL/min', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}]}, {'title': 'Blood Urea Nitrogen >=17 mmol/L', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Uric acid <120 micromol/L', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Uric acid >408 micromol/L', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Week 58', 'description': 'Criteria for potentially clinically significant abnormalities:\n\n* Creatinine: \\>=150 micromol/L (adults); \\>=30% change from baseline, \\>=100% change from baseline\n* Creatinine clearance: \\<15 mL/min; \\>=15 to \\<30 mL/min; \\>=30 to \\<60 mL/min; \\>=60 to \\<90 mL/min\n* Blood urea nitrogen: \\>=17 mmol/L\n* Uric acid: \\<120 micromol/L; \\>408 micromol/L', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all randomized participants who actually received at least one dose or a partial dose of IMP analyzed according to the treatment actually received.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Liver Function Parameters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sarilumab 150 mg q2w + DMARDs', 'description': 'Participants received sarilumab 150 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.'}, {'id': 'OG001', 'title': 'Sarilumab 200 mg q2w + DMARDs', 'description': 'Participants received sarilumab 200 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.'}, {'id': 'OG002', 'title': 'Sarilumab 150 mg q2w', 'description': 'Participants received sarilumab 150 mg, SC injection, q2w for up to 52 weeks.'}, {'id': 'OG003', 'title': 'Sarilumab 200 mg q2w', 'description': 'Participants received sarilumab 200 mg, SC injection, q2w for up to 52 weeks.'}], 'classes': [{'title': 'ALT >1 ULN and <=1.5 ULN', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}, {'title': 'ALT >1.5 ULN and <=3 ULN', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'ALT >3 ULN and <=5 ULN', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'ALT >5 ULN and <=10 ULN', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'ALT >10 ULN and <=20 ULN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'ALT >20 ULN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'AST >1 ULN and <=1.5 ULN', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'AST >1.5 ULN and <=3 ULN', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'AST >3 ULN and <=5 ULN', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'AST >5 ULN and <=10 ULN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'AST >10 ULN and <=20 ULN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'AST >20 ULN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Alkaline Phosphatase >1.5 ULN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'TBILI >1.5 ULN', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'TBILI >2 ULN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'CBILI >1.5 ULN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Unconjugated Bilirubin >1.5 ULN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'ALT> 3 ULN and TBILI >2ULN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'CBILI >35% TBILI and TBILI >1.5 ULN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Albumin <=25 g/L', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Week 58', 'description': 'Criteria for potentially clinically significant abnormalities:\n\n* Alanine Aminotransferase (ALT): \\>1 ULN and \\<=1.5 ULN; \\>1.5 ULN and \\<=3 ULN; \\>3 ULN and \\<=5 ULN; \\>5 ULN and \\<=10 ULN; \\>10 ULN and \\<=20 ULN; \\>20 ULN\n* Aspartate aminotransferase (AST): \\>1 ULN and \\<=1.5 ULN; \\>1.5 ULN and \\<=3 ULN; \\>3 ULN and \\<=5 ULN; \\>5 ULN and \\<=10 ULN; \\>10 ULN and \\<=20 ULN; \\>20 ULN\n* Alkaline phosphatase: \\>1.5 ULN\n* Total bilirubin (TBILI): \\>1.5 ULN; \\>2 ULN\n* Conjugated bilirubin(CBILI): \\>1.5 ULN\n* Unconjugated bilirubin: \\>1.5 ULN\n* ALT \\>3 ULN and TBILI \\>2 ULN\n* CBILI \\>35% TBILI and TBILI \\>1.5 ULN\n* Albumin: \\<=25 g/L', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all randomized participants who actually received at least one dose or a partial dose of IMP analyzed according to the treatment actually received.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sarilumab 150 mg q2w + DMARDs', 'description': 'Participants received sarilumab 150 mg, subcutaneous (SC) injection, q2w along with non-MTX DMARDs for up to 52 weeks.'}, {'id': 'FG001', 'title': 'Sarilumab 200 mg q2w + DMARDs', 'description': 'Participants received sarilumab 200 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.'}, {'id': 'FG002', 'title': 'Sarilumab 150 mg q2w', 'description': 'Participants received sarilumab 150 mg, SC injection, q2w for up to 52 weeks.'}, {'id': 'FG003', 'title': 'Sarilumab 200 mg q2w', 'description': 'Participants received sarilumab 200 mg, SC injection, q2w for up to 52 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '30'}, {'groupId': 'FG003', 'numSubjects': '31'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '27'}, {'groupId': 'FG003', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This study was conducted at 40 centers in Japan. A total of 117 participants were screened between 23 February 2015 and 9 September 2015, 26 of whom were screen failures.', 'preAssignmentDetails': 'A total of 91 participants were randomized to receive monotherapy stratum (in a ratio of 1:1 to sarilumab 150 mg, once in every two weeks \\[q2w\\] or sarilumab 200 mg, q2w) or combination stratum (background non-methotrexate disease modifying anti-rheumatic drugs \\[Non-MTX DMARDs\\] along with sarilumab 150/ 200 mg q2w in 1:1 ratio).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}, {'value': '91', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Sarilumab 150 mg q2w + DMARDs', 'description': 'Participants received sarilumab 150 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.'}, {'id': 'BG001', 'title': 'Sarilumab 200 mg q2w + DMARDs', 'description': 'Participants received sarilumab 200 mg, SC injection, q2w along with non-MTX DMARDs for up to 52 weeks.'}, {'id': 'BG002', 'title': 'Sarilumab 150 mg q2w', 'description': 'Participants received sarilumab 150 mg, SC injection, q2w for up to 52 weeks.'}, {'id': 'BG003', 'title': 'Sarilumab 200 mg q2w', 'description': 'Participants received sarilumab 200 mg, SC injection, q2w for up to 52 weeks.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.3', 'spread': '10.9', 'groupId': 'BG000'}, {'value': '63.3', 'spread': '10.6', 'groupId': 'BG001'}, {'value': '54.4', 'spread': '13.8', 'groupId': 'BG002'}, {'value': '52.5', 'spread': '10.3', 'groupId': 'BG003'}, {'value': '55.6', 'spread': '12.1', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}, {'value': '78', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Modified intent-to-treat (mITT) population included all randomized participants who received at least one dose of investigational medicinal product (IMP), irrespective of compliance with the study protocol and procedures.'}}, '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': 91}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-05', 'studyFirstSubmitDate': '2015-02-12', 'resultsFirstSubmitDate': '2017-11-02', 'studyFirstSubmitQcDate': '2015-02-20', 'lastUpdatePostDateStruct': {'date': '2018-01-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-01-05', 'studyFirstPostDateStruct': {'date': '2015-02-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'Baseline up to Week 58', 'description': 'Adverse event (AE) was defined as any untoward medical occurrence in a participant who received IMP and did not necessary have to had a causal relationship with treatment. All AEs that occurred from the first dose of the IMP administration up to 6 weeks after last dose of treatment (up to Week 58) were considered as TEAEs. SAEs were AEs resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly or a medically important event. TEAEs included both SAEs and non-SAEs.'}, {'measure': 'Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities', 'timeFrame': 'Baseline up to Week 58', 'description': 'Criteria for potentially clinically significant vital sign abnormalities:\n\n* Systolic blood pressure (SBP) supine: \\<=95 mmHg and decrease from baseline (DFB) \\>=20 mmHg; \\>=160 mmHg and increase from baseline (IFB) \\>=20 mmHg\n* Diastolic blood pressure (DBP) supine: \\<=45 mmHg and DFB \\>=10 mmHg; \\>=110 mmHg and IFB ≥10 mmHg\n* SBP (Orthostatic): \\<=-20 mmHg\n* DBP (Orthostatic): \\<=-10 mmHg\n* Heart rate (HR) supine: \\<=50 beats per minute (bpm) and DFB \\>=20 bpm; \\>=120 bpm and IFB \\>=20 bpm\n* Weight: \\>=5% DFB; \\>=5% IFB'}, {'measure': 'Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities', 'timeFrame': 'Baseline up to Week 58', 'description': 'Criteria for potentially clinically significant ECG abnormalities:\n\n* PR Interval: \\>200 milliseconds (ms); \\>200 ms and IFB \\>=25%; \\>220 ms; \\>220 ms and IFB \\>=25%; \\>240 ms; \\>240 ms and IFB \\>=25%\n* QRS Interval: \\>110 ms; \\>110 ms and IFB \\>=25%; \\>120 ms; \\>120 ms and IFB \\>=25%\n* QT Interval: \\>500 ms\n* QTc Bazett (QTc B): \\>450 ms; \\>480 ms; \\>500 ms; IFB \\>30 and \\<=60 ms, IFB \\>60 ms\n* QTc Fridericia (QTc F): \\>450 ms; \\>480 ms; \\>500 ms; IFB \\>30 and \\<=60 ms; IFB \\>60 ms'}, {'measure': 'Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters', 'timeFrame': 'Baseline up to Week 58', 'description': 'Criteria for potentially clinically significant abnormalities:\n\n* Hemoglobin: \\<=115 g/L (Male\\[M\\]) or \\<=95 g/L (Female\\[F\\]); \\>=185 g/L (M) or \\>=165 g/L (F); DFB \\>=20 g/L\n* Hematocrit: \\<=0.37 v/v (M) or \\<=0.32 v/v (F); \\>=0.55 v/v (M) or \\>=0.5 v/v (F)\n* Red blood cells (RBC): \\>=6 Tera/L\n* Platelets: \\<50 Giga/L; \\>=50 and \\<100 Giga/L; \\>=700 Giga/L\n* White blood cells (WBC): \\<3.0 Giga/L (Non-Black \\[NB\\]) or \\<2.0 Giga/L (Black \\[B\\]); \\>=16.0 Giga/L\n* Neutrophils: \\<1.5 Giga/L (NB) or \\<1.0 Giga/L (B); \\<1.0 Giga/L\n* Lymphocytes: \\<0.5 Giga/L; \\>=0.5 Giga/L and \\<lower limit of normal (LLN); \\>4.0 Giga/L\n* Monocytes: \\>0.7 Giga/L\n* Basophils: \\>0.1 Giga/L\n* Eosinophils: \\>0.5 Giga/L or \\>upper limit of normal (ULN) (if ULN \\>=0.5 Giga/L)'}, {'measure': 'Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Metabolic Parameters', 'timeFrame': 'Baseline up to Week 58', 'description': 'Criteria for potentially clinically significant abnormalities:\n\n* Glucose: \\<=3.9 mmol/L and \\<LLN; \\>=11.1 mmol/L (unfasted \\[unfas\\]) or \\>=7 mmol/L (fasted \\[fas\\])\n* Hemoglobin A1c (HbA1c): \\>8%\n* Total cholesterol: \\>=6.2 mmol/L; \\>=7.74 mmol/L\n* LDL cholesterol: \\>=4.1 mmol/L; \\>=4.9 mmol/L\n* Triglycerides: \\>=4.6 mmol/L; \\>=5.6 mmol/L'}, {'measure': 'Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Electrolytes', 'timeFrame': 'Baseline up to Week 58', 'description': 'Criteria for potentially clinically significant abnormalities:\n\n* Sodium: \\<=129 mmol/L; \\>=160 mmol/L\n* Potassium: \\<3 mmol/L; \\>=5.5 mmol/L\n* Chloride: \\<80 mmol/L; \\>115 mmol/L'}, {'measure': 'Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Renal Function Parameters', 'timeFrame': 'Baseline up to Week 58', 'description': 'Criteria for potentially clinically significant abnormalities:\n\n* Creatinine: \\>=150 micromol/L (adults); \\>=30% change from baseline, \\>=100% change from baseline\n* Creatinine clearance: \\<15 mL/min; \\>=15 to \\<30 mL/min; \\>=30 to \\<60 mL/min; \\>=60 to \\<90 mL/min\n* Blood urea nitrogen: \\>=17 mmol/L\n* Uric acid: \\<120 micromol/L; \\>408 micromol/L'}, {'measure': 'Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Liver Function Parameters', 'timeFrame': 'Baseline up to Week 58', 'description': 'Criteria for potentially clinically significant abnormalities:\n\n* Alanine Aminotransferase (ALT): \\>1 ULN and \\<=1.5 ULN; \\>1.5 ULN and \\<=3 ULN; \\>3 ULN and \\<=5 ULN; \\>5 ULN and \\<=10 ULN; \\>10 ULN and \\<=20 ULN; \\>20 ULN\n* Aspartate aminotransferase (AST): \\>1 ULN and \\<=1.5 ULN; \\>1.5 ULN and \\<=3 ULN; \\>3 ULN and \\<=5 ULN; \\>5 ULN and \\<=10 ULN; \\>10 ULN and \\<=20 ULN; \\>20 ULN\n* Alkaline phosphatase: \\>1.5 ULN\n* Total bilirubin (TBILI): \\>1.5 ULN; \\>2 ULN\n* Conjugated bilirubin(CBILI): \\>1.5 ULN\n* Unconjugated bilirubin: \\>1.5 ULN\n* ALT \\>3 ULN and TBILI \\>2 ULN\n* CBILI \\>35% TBILI and TBILI \\>1.5 ULN\n* Albumin: \\<=25 g/L'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Achieving American College of Rheumatology (ACR) 20, 50 and 70 Responses at Week 52', 'timeFrame': 'Week 52', 'description': "ACR response is a composite rating scale that includes 7 variables: tender joints count (TJC \\[68 joints\\]); swollen joints count (SJC \\[66 joints\\]); levels of an acute phase reactant (high sensitivity C-reactive protein \\[hs-CRP level\\]); participant's assessment of pain (measured on 0 \\[no pain\\]-100 mm \\[worst pain\\] visual analog scale \\[VAS\\]); participant's global assessment of disease activity (measured on 0 \\[no arthritis activity\\]-100 mm \\[maximal arthritis activity\\] VAS); physician's global assessment of disease activity (measured on 0 \\[no arthritis activity\\]-100 mm \\[maximal arthritis activity\\] VAS); participant's assessment of physical function (measured by Health Assessment Question-Disability Index \\[HAQ-DI\\], with scoring range of 0 \\[better health\\] - 3 \\[worst health\\]). ACR20/50/70 response is defined as at least 20/50/70% improvement in both TJC and SJC, and at least 20/50/70% improvement in at least 3 of the 5 other assessments, respectively."}, {'measure': 'Change From Baseline at Week 52 in Disease Activity Score for 28 Joints Based on C-Reactive Protein (DAS28-CRP)', 'timeFrame': 'Baseline, Week 52', 'description': "DAS28-CRP is a composite score that contains 4 variables: TJC (based on 28 joints), SJC (based on 28 joints), participant's assessment of general health on VAS (range 0 \\[very well\\] to 100 mm \\[extremely bad\\]) and CRP (mg/L). DAS28-CRP total score ranges from 2-10 with a lower score indicating less disease activity. A DAS28-CRP above 5.1 indicates high disease activity, whereas below 3.2 indicates low disease activity and below 2.6 as disease remission."}, {'measure': 'Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 52', 'timeFrame': 'Baseline, Week 52', 'description': "HAQ-DI assessed the degree of difficulty participants experienced in 8 daily living activity domains during a week: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consisted of 2-3 items. Each items's difficulty was scored from 0-3 (0=no difficulty, 1=some difficulty, 2=much difficulty, 3=unable to do). Overall HAQ-DI score was computed as the sum of domain scores divided by the number of domains answered, providing a score from 0-3. Low scores denoted improvement of disability/lower degree of domain difficulty."}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': 'Primary Objective:\n\nTo document the long-term safety of sarilumab added to non-methotrexate (non-MTX) disease-modifying antirheumatic drugs (DMARDs) or as monotherapy.\n\nSecondary Objective:\n\nTo document the long term efficacy of sarilumab added to non-MTX DMARDs or as monotherapy.', 'detailedDescription': 'Total study duration was up to 62 weeks: Up to 4-week screening period, 52-week treatment period, and 6-week post-treatment follow-up period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\nDiagnosis of rheumatoid arthritis (RA), according to the American College of Rheumatology/The European League Against Rheumatism (ACR/EULAR) 2010 Rheumatoid Arthritis Classification Criteria with \\>=3 months disease duration.\n\nModerately to severely active RA defined as:\n\n* At least 4 of 68 tender joints and 4 of 66 swollen joints at screening visit.\n* High sensitivity C-Reactive Protein (hs-CRP) \\>=4 mg/L or Erythrocyte Sedimentation Rate (ESR) \\>=28 mm/hr at screening visit.\n\nFor the combination stratum:\n\nParticipants who had continuous treatment with non-biologic DMARDs other than MTX for at least 12 weeks prior to the randomization and on a stable dose for a minimum of 6 weeks prior to screening.\n\nFor the monotherapy stratum:\n\nParticipants who per investigator judgment were any of inappropriate, intolerant or inadequate to MTX treatment.\n\nExclusion criteria:\n\nParticipants \\<20 years of age. Prior treatment with tumor necrosis factor (TNF) antagonists or any other RA-directed biologic agents without the appropriate off-drug period prior to screening.\n\nPrior treatment with anti-interleukin-6 (anti-IL-6) or anti-interleukin-6 receptor (IL-6R) antagonist therapies, including but not limited to tocilizumab or sarilumab.\n\nThe above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT02373202', 'briefTitle': 'A Study Assessing the Safety and Efficacy of Sarilumab Added to Non-MTX DMARDs or as Monotherapy in Japanese Patients With Active Rheumatoid Arthritis (SARIL-RA-HARUKA)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'A Randomized, Double-blind, Multicenter Study Evaluating the Safety and Efficacy of Sarilumab Added to Non-MTX DMARDs or as Monotherapy in Japanese Patients With Active Rheumatoid Arthritis', 'orgStudyIdInfo': {'id': 'LTS13618'}, 'secondaryIdInfos': [{'id': 'U1111-1160-6525', 'type': 'OTHER', 'domain': 'UTN'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sarilumab 150 mg q2w + DMARDs', 'description': 'Participants received sarilumab 150 mg, subcutaneous (SC) injection, once every two weeks (q2w) along with non-MTX DMARDs (sulfasalazine, leflunomide, bucillamine, tacrolimus, and/or mizoribine) for up to 52 weeks.', 'interventionNames': ['Drug: Sarilumab', 'Drug: Sulfasalazine', 'Drug: Leflunomide', 'Drug: Bucillamine', 'Drug: Tacrolimus', 'Drug: Mizoribine']}, {'type': 'EXPERIMENTAL', 'label': 'Sarilumab 200 mg q2w + DMARDs', 'description': 'Participants received sarilumab 200 mg, SC injection, q2w along with non-MTX DMARDs (sulfasalazine, leflunomide, bucillamine, tacrolimus, and/or mizoribine) for up to 52 weeks.', 'interventionNames': ['Drug: Sarilumab', 'Drug: Sulfasalazine', 'Drug: Leflunomide', 'Drug: Bucillamine', 'Drug: Tacrolimus', 'Drug: Mizoribine']}, {'type': 'EXPERIMENTAL', 'label': 'Sarilumab 150 mg q2w', 'description': 'Participants received sarilumab 150 mg, SC injection, q2w for up to 52 weeks.', 'interventionNames': ['Drug: Sarilumab']}, {'type': 'EXPERIMENTAL', 'label': 'Sarilumab 200 mg q2w', 'description': 'Participants received sarilumab 200 mg, SC injection, q2w for up to 52 weeks.', 'interventionNames': ['Drug: Sarilumab']}], 'interventions': [{'name': 'Sarilumab', 'type': 'DRUG', 'otherNames': ['SAR153191 (REGN88)'], 'description': 'Pharmaceutical form:solution', 'armGroupLabels': ['Sarilumab 150 mg q2w', 'Sarilumab 150 mg q2w + DMARDs', 'Sarilumab 200 mg q2w', 'Sarilumab 200 mg q2w + DMARDs']}, {'name': 'Sulfasalazine', 'type': 'DRUG', 'description': 'Pharmaceutical form: Tablet Route of administration: Oral', 'armGroupLabels': ['Sarilumab 150 mg q2w + DMARDs', 'Sarilumab 200 mg q2w + DMARDs']}, {'name': 'Leflunomide', 'type': 'DRUG', 'description': 'Pharmaceutical form: Tablet Route of administration: Oral', 'armGroupLabels': ['Sarilumab 150 mg q2w + DMARDs', 'Sarilumab 200 mg q2w + DMARDs']}, {'name': 'Bucillamine', 'type': 'DRUG', 'description': 'Pharmaceutical form: Tablet Route of administration: Oral', 'armGroupLabels': ['Sarilumab 150 mg q2w + DMARDs', 'Sarilumab 200 mg q2w + DMARDs']}, {'name': 'Tacrolimus', 'type': 'DRUG', 'description': 'Pharmaceutical form: Capsule Route of administration: Oral', 'armGroupLabels': ['Sarilumab 150 mg q2w + DMARDs', 'Sarilumab 200 mg q2w + DMARDs']}, {'name': 'Mizoribine', 'type': 'DRUG', 'description': 'Pharmaceutical form: Tablet Route of administration: Oral', 'armGroupLabels': ['Sarilumab 150 mg q2w + DMARDs', 'Sarilumab 200 mg q2w + DMARDs']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Asahi-Shi', 'country': 'Japan', 'facility': 'Investigational Site Number 392010'}, {'city': 'Asahikawa-Shi', 'country': 'Japan', 'facility': 'Investigational Site Number 392001'}, {'city': 'Beppu-Shi', 'country': 'Japan', 'facility': 'Investigational Site Number 392070'}, {'city': 'Chiba', 'country': 'Japan', 'facility': 'Investigational Site Number 392036', 'geoPoint': {'lat': 35.6, 'lon': 140.11667}}, {'city': 'Chūōku', 'country': 'Japan', 'facility': 'Investigational Site Number 392083', 'geoPoint': {'lat': 33.63867, 'lon': 130.67068}}, {'city': 'Fukui-shi', 'country': 'Japan', 'facility': 'Investigational Site Number 392004', 'geoPoint': {'lat': 36.06443, 'lon': 136.22257}}, {'city': 'Fukuoka', 'country': 'Japan', 'facility': 'Investigational Site Number 392039', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'city': 'Ichinomiya-Shi', 'country': 'Japan', 'facility': 'Investigational Site Number 392030'}, {'city': 'Iizuka-Shi', 'country': 'Japan', 'facility': 'Investigational Site Number 392002'}, {'city': 'Kagoshima', 'country': 'Japan', 'facility': 'Investigational Site Number 392019', 'geoPoint': {'lat': 31.56667, 'lon': 130.55}}, {'city': 'Kamakura-Shi', 'country': 'Japan', 'facility': 'Investigational Site Number 392066'}, {'city': 'Kato-Shi', 'country': 'Japan', 'facility': 'Investigational Site Number 392050'}, {'city': 'Kawachi-Nagano-Shi', 'country': 'Japan', 'facility': 'Investigational Site Number 392037'}, {'city': 'Kawasaki-Shi', 'country': 'Japan', 'facility': 'Investigational Site Number 392099'}, {'city': 'Kitakyushu-Shi', 'country': 'Japan', 'facility': 'Investigational Site Number 392013'}, {'city': 'Kochi', 'country': 'Japan', 'facility': 'Investigational Site Number 392097', 'geoPoint': {'lat': 33.55, 'lon': 133.53333}}, {'city': 'Kushiro', 'country': 'Japan', 'facility': 'Investigational Site Number 392065', 'geoPoint': {'lat': 42.975, 'lon': 144.37472}}, {'city': 'Matsuyama', 'country': 'Japan', 'facility': 'Investigational Site Number 392026', 'geoPoint': {'lat': 33.83916, 'lon': 132.76574}}, {'city': 'Miyagi-Gun', 'country': 'Japan', 'facility': 'Investigational Site Number 392034'}, {'city': 'Nagoya', 'country': 'Japan', 'facility': 'Investigational Site Number 392076', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'city': 'Nagoya', 'country': 'Japan', 'facility': 'Investigational Site Number 392080', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'city': 'Narashino-Shi', 'country': 'Japan', 'facility': 'Investigational Site Number 392046'}, {'city': 'Okayama', 'country': 'Japan', 'facility': 'Investigational Site Number 392062', 'geoPoint': {'lat': 34.65, 'lon': 133.93333}}, {'city': 'Osaki-Shi', 'country': 'Japan', 'facility': 'Investigational Site Number 392027'}, {'city': 'Ōita', 'country': 'Japan', 'facility': 'Investigational Site Number 392059', 'geoPoint': {'lat': 33.23333, 'lon': 131.6}}, {'city': 'Sagamihara-Shi', 'country': 'Japan', 'facility': 'Investigational Site Number 392049'}, {'city': 'Sapporo', 'country': 'Japan', 'facility': 'Investigational Site Number 392014', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'city': 'Sapporo', 'country': 'Japan', 'facility': 'Investigational Site Number 392041', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'city': 'Sapporo', 'country': 'Japan', 'facility': 'Investigational Site Number 392073', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'city': 'Sasebo-Shi', 'country': 'Japan', 'facility': 'Investigational Site Number 392006'}, {'city': 'Sendai', 'country': 'Japan', 'facility': 'Investigational Site Number 392021', 'geoPoint': {'lat': 38.26667, 'lon': 140.86667}}, {'city': 'Sendai', 'country': 'Japan', 'facility': 'Investigational Site Number 392022', 'geoPoint': {'lat': 38.26667, 'lon': 140.86667}}, {'city': 'Sendai', 'country': 'Japan', 'facility': 'Investigational Site Number 392033', 'geoPoint': {'lat': 38.26667, 'lon': 140.86667}}, {'city': 'Sendai', 'country': 'Japan', 'facility': 'Investigational Site Number 392071', 'geoPoint': {'lat': 38.26667, 'lon': 140.86667}}, {'city': 'Shizuoka', 'country': 'Japan', 'facility': 'Investigational Site Number 392029', 'geoPoint': {'lat': 34.98333, 'lon': 138.38333}}, {'city': 'Takaoka-Shi', 'country': 'Japan', 'facility': 'Investigational Site Number 392023'}, {'city': 'Tomakomai-Shi', 'country': 'Japan', 'facility': 'Investigational Site Number 392003'}, {'city': 'Urasoe-Shi', 'country': 'Japan', 'facility': 'Investigational Site Number 392074'}, {'city': 'Urayasu-Shi', 'country': 'Japan', 'facility': 'Investigational Site Number 392079'}, {'city': 'Yokohama', 'country': 'Japan', 'facility': 'Investigational Site Number 392048', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}], 'overallOfficials': [{'name': 'Clinical Sciences & Operations', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Regeneron Pharmaceuticals', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}