Ignite Creation Date:
2025-12-24 @ 12:47 PM
Ignite Modification Date:
2025-12-30 @ 6:15 AM
Study NCT ID:
NCT01606761
Status:
COMPLETED
Last Update Posted:
2018-03-23
First Post:
2012-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of CNTO 136 (Sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Patients With Active Rheumatoid Arthritis Despite Anti-TNF-Alpha Therapy (SIRROUND-T)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Brazil', 'China']}, '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': 'C568922', 'term': 'sirukumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialDisclosure@its.jnj.com', 'title': 'Associate Director', 'organization': 'Janssen Research & Development, LLC'}, 'certainAgreement': {'otherDetails': 'A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to Week 68', 'description': 'For treatment period (up to Week 52), safety population (SP) included all participants who received at least 1 partial or complete dose of study agent. For safety follow-up (SFU) (Week 52-68), SP included participants who decided to enter in safety follow-up period and had at least 1 SFU visit after the discontinuation of study agent (Week 52-68).', 'eventGroups': [{'id': 'EG000', 'title': 'Week (W) 24-Placebo', 'description': 'Participants received matching placebo every 2 week (q2w) until either early escape (EE) at Week 18, or crossover (CO) at Week 24.', 'otherNumAtRisk': 294, 'otherNumAffected': 106, 'seriousNumAtRisk': 294, 'seriousNumAffected': 15}, {'id': 'EG001', 'title': 'W24 to W52-Placebo to 50 mg q4w Due to EE or CO', 'description': 'Participants who received matching placebo in the placebo controlled period and were re-randomized (due to early escape \\[EE\\] at Week 18 or crossed over \\[CO\\] at Week 24) to receive subcutaneous (SC) sirukumab 50 mg q4w dose regimen up to Week 52.', 'otherNumAtRisk': 124, 'otherNumAffected': 50, 'seriousNumAtRisk': 124, 'seriousNumAffected': 8}, {'id': 'EG002', 'title': 'W52-Sirukumab 50 mg q4w', 'description': 'Participants received Sirukumab 50 mg SC at Week 0, 4 and q4w up to Week 52.', 'otherNumAtRisk': 292, 'otherNumAffected': 152, 'seriousNumAtRisk': 292, 'seriousNumAffected': 51}, {'id': 'EG003', 'title': 'W24 to W52-Placebo to 100 mg q2w Due to EE or CO', 'description': 'Participants who received matching placebo in the placebo controlled period and were re-randomized (due to early escape \\[EE\\] at Week 18 or crossed over \\[CO\\] at Week 24) to receive subcutaneous (SC) sirukumab 100 mg q4w dose regimen up to Week 52.', 'otherNumAtRisk': 126, 'otherNumAffected': 63, 'seriousNumAtRisk': 126, 'seriousNumAffected': 18}, {'id': 'EG004', 'title': 'W52-Sirukumab 100 mg q2w', 'description': 'Participants received sirukumab 100 mg SC at Week 0, 2 and q2w up to Week 52.', 'otherNumAtRisk': 292, 'otherNumAffected': 169, 'seriousNumAtRisk': 292, 'seriousNumAffected': 37}, {'id': 'EG005', 'title': 'W52 to W68-Placebo', 'description': 'Participants who discontinued or completed study agent administration up to Week 52 and decided to enter the safety follow-up period were followed up for safety from Week 52 to Week 68.', 'otherNumAtRisk': 28, 'otherNumAffected': 0, 'seriousNumAtRisk': 28, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'W52 to W68-Placebo to 50 mg q4w Due to EE or CO', 'description': 'Participants who discontinued or completed sirukumab 50 mg q4w due to EE or CO administration up to Week 52 and decided to enter the safety follow-up period were followed up for safety from Week 52 to Week 68.', 'otherNumAtRisk': 7, 'otherNumAffected': 1, 'seriousNumAtRisk': 7, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'W52 to W68-Sirukumab 50 mg q4w', 'description': 'Participants who discontinued or completed sirukumab 50 mg q4w administration up to Week 52 and decided to enter the safety follow-up period were followed up for safety from Week 52 to Week 68.', 'otherNumAtRisk': 65, 'otherNumAffected': 2, 'seriousNumAtRisk': 65, 'seriousNumAffected': 1}, {'id': 'EG008', 'title': 'W52 to W68-Placebo to 100 mg q2w Due to EE or CO', 'description': 'Participants who discontinued or completed sirukumab 100 mg q2w due to EE or CO administration up to Week 52 and decided to enter the safety follow-up period were followed up for safety from Week 52 to Week 68.', 'otherNumAtRisk': 19, 'otherNumAffected': 3, 'seriousNumAtRisk': 19, 'seriousNumAffected': 2}, {'id': 'EG009', 'title': 'W52 to W68-Sirukumab 100 mg q2w', 'description': 'Participants who discontinued or completed sirukumab 100 mg q2w administration up to Week 52 and decided to enter the safety follow-up period were followed up for safety from Week 52 to Week 68.', 'otherNumAtRisk': 62, 'otherNumAffected': 4, 'seriousNumAtRisk': 62, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Blepharitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 292, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 292, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 17.0'}, {'term': 'Chronic Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 292, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 292, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 17.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 292, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 292, 'numAffected': 13}, {'groupId': 'EG005', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 17.0'}, {'term': 'Injection Site Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 292, 'numAffected': 28}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 19}, {'groupId': 'EG004', 'numAtRisk': 292, 'numAffected': 47}, {'groupId': 'EG005', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 17.0'}, {'term': 'Injection Site Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 292, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 10}, {'groupId': 'EG004', 'numAtRisk': 292, 'numAffected': 31}, {'groupId': 'EG005', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 17.0'}, {'term': 'Injection Site Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 292, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 292, 'numAffected': 24}, {'groupId': 'EG005', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 17.0'}, {'term': 'Drug-Induced Liver Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 292, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 292, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 17.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 292, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 292, 'numAffected': 22}, {'groupId': 'EG005', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 17.0'}, {'term': 'Conjunctivitis Bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 292, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 292, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 17.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 292, 'numAffected': 34}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 292, 'numAffected': 26}, {'groupId': 'EG005', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 17.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 292, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 292, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 17.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 292, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 292, 'numAffected': 15}, {'groupId': 'EG005', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 17.0'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 292, 'numAffected': 24}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 292, 'numAffected': 26}, {'groupId': 'EG005', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 17.0'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 292, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 292, 'numAffected': 19}, {'groupId': 'EG005', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 17.0'}, {'term': 'Alanine Aminotransferase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 292, 'numAffected': 27}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 292, 'numAffected': 23}, {'groupId': 'EG005', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 17.0'}, {'term': 'Aspartate Aminotransferase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 292, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 292, 'numAffected': 15}, {'groupId': 'EG005', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 17.0'}, {'term': 'Hepatitis B Dna Assay Positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 292, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 292, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 17.0'}, {'term': 'Lymphocyte Count Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 292, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 292, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 17.0'}, {'term': 'Neutrophil Count Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 292, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 292, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 17.0'}, {'term': 'White Blood Cell Count Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 292, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 292, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 17.0'}, {'term': 'X-Ray with Contrast Upper Gastrointestinal Tract Abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 292, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 292, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 17.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 292, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG004', 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292, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 17.0'}, {'term': 'Calculus Urinary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 292, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 292, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 17.0'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 292, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 292, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 17.0'}, {'term': 'Nephrotic Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 292, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 292, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 17.0'}, {'term': 'Renal Colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 292, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 292, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 17.0'}, {'term': 'Cervical Dysplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 292, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 292, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 17.0'}, {'term': 'Acute Respiratory Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 292, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 292, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 17.0'}, {'term': 'Interstitial Lung Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 292, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 292, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 17.0'}, {'term': 'Laryngeal Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 292, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 292, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 17.0'}, {'term': 'Oropharyngeal Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 292, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 292, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 17.0'}, {'term': 'Pleural Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 292, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 292, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 17.0'}, {'term': 'Pulmonary Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 292, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 292, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 17.0'}, {'term': 'Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 292, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 292, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 17.0'}, {'term': 'Drug Eruption', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 292, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 292, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 17.0'}, {'term': 'Skin Ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 292, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 292, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 17.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 292, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 292, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 17.0'}, {'term': 'Intermittent Claudication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 292, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 292, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 17.0'}, {'term': 'Phlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 292, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 292, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 17.0'}, {'term': 'Thrombosed Varicose Vein', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 292, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 292, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 17.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '294', 'groupId': 'OG000'}, {'value': '292', 'groupId': 'OG001'}, {'value': '292', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching placebo every 2 week (q2w) until either early escape (EE) at Week 18, or crossed over (CO) at Week 24. Participants who met EE criteria at Week 18 or crossover (CO) at Week 24 re-randomized and received subcutaneous (SC) sirukumab 50 mg dose regimen q4w up to Week 52.'}, {'id': 'OG001', 'title': 'Sirukumab 50 mg', 'description': 'Participants received Sirukumab 50 mg SC at Week 0, 4 and q4w up to Week 52.'}, {'id': 'OG002', 'title': 'Sirukumab 100 mg', 'description': 'Participants received Sirukumab 100 mg SC at Week 0, 2 and q2w up to Week 24. Participants who received matching placebo in the placebo controlled period and met EE criteria at Week 18 or crossover (CO) at Week 24 re-randomized and received subcutaneous (SC) sirukumab 100 mg dose regimen q2w up to Week 52.'}], 'classes': [{'categories': [{'measurements': [{'value': '24.1', 'groupId': 'OG000'}, {'value': '40.1', 'groupId': 'OG001'}, {'value': '45.2', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Percentage Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '15.9', 'ciLowerLimit': '8.5', 'ciUpperLimit': '23.2', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '< 0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Percentage Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '21.0', 'ciLowerLimit': '13.6', 'ciUpperLimit': '28.5', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 16', 'description': "The ACR 20 Response is defined as greater than or equal to (\\>=) 20 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and \\>=20 percent improvement in 3 of following 5 assessments: patient's assessment of pain using Visual Analog Scale (VAS; 0-10 scale, 0 =no pain and 10 =worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 to 10, \\[0 =no pain to 10 =worst possible pain\\]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by Health Assessment Questionnaire-Disability Index (HAQ-DI, defined as a 20-question instrument assessing 8 functional areas. The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and serum C-Reactive Protein (CRP).", 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy full analysis set included all participants who were randomized into the study.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '294', 'groupId': 'OG000'}, {'value': '291', 'groupId': 'OG001'}, {'value': '292', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching placebo every 2 week (q2w) until either early escape (EE) at Week 18, or crossed over (CO) at Week 24. Participants who met EE criteria at Week 18 or crossover (CO) at Week 24 re-randomized and received subcutaneous (SC) sirukumab 50 mg dose regimen q4w up to Week 52.'}, {'id': 'OG001', 'title': 'Sirukumab 50 mg', 'description': 'Participants received Sirukumab 50 mg SC at Week 0, 4 and q4w up to Week 52.'}, {'id': 'OG002', 'title': 'Sirukumab 100 mg', 'description': 'Participants received Sirukumab 100 mg SC at Week 0, 2 and q2w up to Week 24. Participants who received matching placebo in the placebo controlled period and met EE criteria at Week 18 or crossover (CO) at Week 24 re-randomized and received subcutaneous (SC) sirukumab 100 mg dose regimen q2w up to Week 52.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '1.5663', 'spread': '0.65223', 'groupId': 'OG000'}, {'value': '1.6499', 'spread': '0.59743', 'groupId': 'OG001'}, {'value': '1.6122', 'spread': '0.61320', 'groupId': 'OG002'}]}]}, {'title': 'Change at Week 24', 'categories': [{'measurements': [{'value': '-0.12', 'spread': '0.491', 'groupId': 'OG000'}, {'value': '-0.31', 'spread': '0.543', 'groupId': 'OG001'}, {'value': '-0.33', 'spread': '0.526', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Square (LS) mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.17', 'ciLowerLimit': '-0.251', 'ciUpperLimit': '-0.088', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '< 0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.194', 'ciLowerLimit': '-0.275', 'ciUpperLimit': '-0.112', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 24', 'description': 'The HAQ-DI is a 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping and activities of daily living). Responses in each functional area are scored from 0 to 3 (0=no difficulty and 3=inability to perform a task in that area). Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Efficacy full analysis set included all participants who were randomized into the study. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this endpoint."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving American College of Rheumatology (ACR) 50 Response at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '294', 'groupId': 'OG000'}, {'value': '292', 'groupId': 'OG001'}, {'value': '292', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching placebo every 2 week (q2w) until either early escape (EE) at Week 18, or crossed over (CO) at Week 24. Participants who met EE criteria at Week 18 or crossover (CO) at Week 24 re-randomized and received subcutaneous (SC) sirukumab 50 mg dose regimen q4w up to Week 52.'}, {'id': 'OG001', 'title': 'Sirukumab 50 mg', 'description': 'Participants received Sirukumab 50 mg SC at Week 0, 4 and q4w up to Week 52.'}, {'id': 'OG002', 'title': 'Sirukumab 100 mg', 'description': 'Participants received Sirukumab 100 mg SC at Week 0, 2 and q2w up to Week 24. Participants who received matching placebo in the placebo controlled period and met EE criteria at Week 18 or crossover (CO) at Week 24 re-randomized and received subcutaneous (SC) sirukumab 100 mg dose regimen q2w up to Week 52.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.8', 'groupId': 'OG000'}, {'value': '20.9', 'groupId': 'OG001'}, {'value': '21.6', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Percentage Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.0', 'ciLowerLimit': '6.4', 'ciUpperLimit': '17.7', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '< 0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Percentage Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.7', 'ciLowerLimit': '7.0', 'ciUpperLimit': '18.4', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'description': "The ACR 50 Response is defined as \\>= 50 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and \\>=50 percent improvement in 3 of following 5 assessments: patient's assessment of pain using VAS ( 0-10 scale, 0 =no pain and 10 =worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 to 10, \\[0 =no pain to 10 =worst possible pain\\]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by HAQ-DI (defined as a 20-question instrument assessing 8 functional areas. The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and serum C-Reactive Protein (CRP).", 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy full analysis set included all participants who were randomized into the study.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '294', 'groupId': 'OG000'}, {'value': '292', 'groupId': 'OG001'}, {'value': '292', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received matching placebo every 2 week (q2w) until either early escape (EE) at Week 18, or crossed over (CO) at Week 24. Participants who met EE criteria at Week 18 or crossover (CO) at Week 24 re-randomized and received subcutaneous (SC) sirukumab 50 mg dose regimen q4w up to Week 52.'}, {'id': 'OG001', 'title': 'Sirukumab 50 mg', 'description': 'Participants received Sirukumab 50 mg SC at Week 0, 4 and q4w up to Week 52.'}, {'id': 'OG002', 'title': 'Sirukumab 100 mg', 'description': 'Participants received Sirukumab 100 mg SC at Week 0, 2 and q2w up to Week 24. Participants who received matching placebo in the placebo controlled period and met EE criteria at Week 18 or crossover (CO) at Week 24 re-randomized and received subcutaneous (SC) sirukumab 100 mg dose regimen q2w up to Week 52.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.2', 'groupId': 'OG000'}, {'value': '19.2', 'groupId': 'OG001'}, {'value': '21.6', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Percentage Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.0', 'ciLowerLimit': '5.5', 'ciUpperLimit': '16.5', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '< 0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Percentage Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.4', 'ciLowerLimit': '7.8', 'ciUpperLimit': '19.1', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'description': "The Disease Activity Index Score 28 (DAS28) based on C-Reactive Protein (CRP) is a statistically derived index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. The values are 0=best to 10=worst. DAS28 (CRP) remission is defined as a DAS28 (CRP) value of less than (\\<) 2.6 at any study visit.", 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy full analysis set included all participants who were randomized into the study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Participants received matching placebo every 2 week (q2w) until either early escape (EE) at Week 18, or crossed over (CO) at Week 24. Participants who met EE criteria at Week 18 or crossover (CO) at Week 24 re-randomized and received subcutaneous (SC) sirukumab 50 mg dose regimen q4w up to Week 52. Participants who discontinued or completed study agent administration before and up to Week 52 entered the safety follow-up period as well as those who completed through Week 52 were followed up for safety.'}, {'id': 'FG001', 'title': 'Sirukumab 50 mg q4w', 'description': 'All participants received Sirukumab 50 mg SC at Week 0, 4 and q4w up to Week 52. Participants who discontinued or completed study agent administration up to Week 52 and decided to enter the safety follow-up period were followed up for safety from Week 52 to Week 68.'}, {'id': 'FG002', 'title': 'Sirukumab 100 mg q2w', 'description': 'All participants received Sirukumab 100 mg SC at Week 0, 2 and q2w up to Week 24. Participants who received matching placebo in the placebo controlled period and met EE criteria at Week 18 or crossover (CO) at Week 24 re-randomized and received subcutaneous (SC) sirukumab 100 mg dose regimen q2w up to Week 52. Participants who discontinued or completed study agent administration up to Week 52 and decided to enter the safety follow-up period were followed up for safety from Week 52 to Week 68.'}, {'id': 'FG003', 'title': 'Placebo to 50 mg q4w Due to EE or CO', 'description': 'Participants who received matching placebo in the placebo controlled period were re-randomized (due to early escape \\[EE\\] at Week 18 or crossed over \\[CO\\] at Week 24) to receive subcutaneous (SC) sirukumab 50 mg dose regimen q4w up to Week 52. Participants who discontinued or completed study agent administration up to Week 52 and decided to enter the safety follow-up period were followed up for safety from Week 52 to Week 68.'}, {'id': 'FG004', 'title': 'Placebo to 100 mg q2w Due to EE or CO', 'description': 'Participants who received matching placebo in the placebo controlled period were re-randomized (due to EE at Week 18 or CO at Week 24) to receive subcutaneous (SC) sirukumab 100 mg dose regimen q2w up to Week 52. Participants who discontinued or completed study agent administration up to Week 52 and decided to enter the safety follow-up period were followed up for safety from Week 52 to Week 68.'}], 'periods': [{'title': 'Prior to Week 24', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '294'}, {'groupId': 'FG001', 'numSubjects': '292'}, {'groupId': 'FG002', 'numSubjects': '292'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Participants Re-randomized at Week 18', 'achievements': [{'comment': 'Out of 94, 46 were re-randomized to sirukumab 50 mg and 48 were re-randomized to 100 mg group.', 'groupId': 'FG000', 'numSubjects': '94'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '252'}, {'groupId': 'FG001', 'numSubjects': '237'}, {'groupId': 'FG002', 'numSubjects': '245'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '55'}, {'groupId': 'FG002', 'numSubjects': '47'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '22'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}, {'title': 'Week 24 to Week 52', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '237'}, {'groupId': 'FG002', 'numSubjects': '245'}, {'comment': 'Participants re-randomized at Week 18 (46) and Week 24 (80) were included.', 'groupId': 'FG003', 'numSubjects': '126'}, {'comment': 'Participants re-randomized at Week 18 (48) and Week 24 (78) were included.', 'groupId': 'FG004', 'numSubjects': '126'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '237'}, {'groupId': 'FG002', 'numSubjects': '245'}, {'groupId': 'FG003', 'numSubjects': '124'}, {'groupId': 'FG004', 'numSubjects': '126'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '204'}, {'groupId': 'FG002', 'numSubjects': '212'}, {'groupId': 'FG003', 'numSubjects': '109'}, {'groupId': 'FG004', 'numSubjects': '106'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '33'}, {'groupId': 'FG002', 'numSubjects': '33'}, {'groupId': 'FG003', 'numSubjects': '17'}, {'groupId': 'FG004', 'numSubjects': '20'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '14'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '15'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '10'}, {'groupId': 'FG004', 'numSubjects': '3'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '2'}]}]}, {'title': 'Safety Follow-up Period (Week 52-68)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '65'}, {'groupId': 'FG002', 'numSubjects': '62'}, {'groupId': 'FG003', 'numSubjects': '9'}, {'groupId': 'FG004', 'numSubjects': '19'}]}, {'type': 'Safety Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '65'}, {'groupId': 'FG002', 'numSubjects': '62'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '19'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '55'}, {'groupId': 'FG002', 'numSubjects': '45'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '17'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '3'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '3'}]}]}], 'preAssignmentDetails': 'A total of 878 participants (placebo \\[n=294\\], sirukumab 50 mg every 4 week (q4w) \\[n=292\\], and sirukumab 100 milligram (mg) every 2 week (q2w) \\[n=292\\]) were randomized and included in the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '294', 'groupId': 'BG000'}, {'value': '292', 'groupId': 'BG001'}, {'value': '292', 'groupId': 'BG002'}, {'value': '878', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Participants received matching placebo every 2 week (q2w) until either early escape (EE) at Week 18, or crossed over (CO) at Week 24. Participants who met EE criteria at Week 18 or crossover (CO) at Week 24 re-randomized and received subcutaneous (SC) sirukumab 50 mg dose regimen q4w up to Week 52. Participants who discontinued or completed study agent administration before and up to Week 52 entered the safety follow-up period as well as those who completed through Week 52 were followed up for safety.'}, {'id': 'BG001', 'title': 'Sirukumab 50 mg q4w', 'description': 'All participants received Sirukumab 50 mg SC at Week 0, 4 and q4w up to Week 52. Participants who discontinued or completed study agent administration up to Week 52 and decided to enter the safety follow-up period were followed up for safety from Week 52 to Week 68.'}, {'id': 'BG002', 'title': 'Sirukumab 100 mg q2w', 'description': 'All participants received Sirukumab 100 mg SC at Week 0, 2 and q2w up to Week 24. Participants who received matching placebo in the placebo controlled period and met EE criteria at Week 18 or crossover (CO) at Week 24 re-randomized and received subcutaneous (SC) sirukumab 100 mg dose regimen q2w up to Week 52. Participants who discontinued or completed study agent administration up to Week 52 and decided to enter the safety follow-up period were followed up for safety from Week 52 to Week 68.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'spread': '12.19', 'groupId': 'BG000'}, {'value': '0', 'spread': '11.89', 'groupId': 'BG001'}, {'value': '0', 'spread': '12.28', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '228', 'groupId': 'BG000'}, {'value': '225', 'groupId': 'BG001'}, {'value': '230', 'groupId': 'BG002'}, {'value': '683', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}, {'value': '195', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.4', 'spread': '12.19', 'groupId': 'BG000'}, {'value': '55.8', 'spread': '11.89', 'groupId': 'BG001'}, {'value': '55', 'spread': '12.28', 'groupId': 'BG002'}, {'value': '55.4', 'spread': '12.11', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '240', 'groupId': 'BG000'}, {'value': '232', 'groupId': 'BG001'}, {'value': '240', 'groupId': 'BG002'}, {'value': '712', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}, {'value': '166', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Argentina', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}]}]}, {'title': 'Australia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}, {'title': 'Austria', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}, {'title': 'Belgium', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}]}, {'title': 'France', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}]}, {'title': 'Japan', 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}, {'value': '116', 'groupId': 'BG003'}]}]}, {'title': 'Lithuania', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}]}]}, {'title': 'Mexico', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}]}]}, {'title': 'Netherlands', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '76', 'groupId': 'BG003'}]}]}, {'title': 'Portugal', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}]}, {'title': 'Puerto Rico', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}]}, {'title': 'Republic of Korea', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}]}]}, {'title': 'Russian Federation', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '50', 'groupId': 'BG003'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}]}]}, {'title': 'Taiwan, Province of China', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '148', 'groupId': 'BG000'}, {'value': '145', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}, {'value': '445', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 878}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'dispFirstSubmitDate': '2016-01-18', 'completionDateStruct': {'date': '2016-01-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-23', 'studyFirstSubmitDate': '2012-05-24', 'dispFirstSubmitQcDate': '2016-01-18', 'resultsFirstSubmitDate': '2017-11-24', 'studyFirstSubmitQcDate': '2012-05-24', 'dispFirstPostDateStruct': {'date': '2016-02-10', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2018-03-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-01-19', 'studyFirstPostDateStruct': {'date': '2012-05-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-03-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response at Week 16', 'timeFrame': 'Week 16', 'description': "The ACR 20 Response is defined as greater than or equal to (\\>=) 20 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and \\>=20 percent improvement in 3 of following 5 assessments: patient's assessment of pain using Visual Analog Scale (VAS; 0-10 scale, 0 =no pain and 10 =worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 to 10, \\[0 =no pain to 10 =worst possible pain\\]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by Health Assessment Questionnaire-Disability Index (HAQ-DI, defined as a 20-question instrument assessing 8 functional areas. The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and serum C-Reactive Protein (CRP)."}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Week 24', 'timeFrame': 'Baseline and Week 24', 'description': 'The HAQ-DI is a 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping and activities of daily living). Responses in each functional area are scored from 0 to 3 (0=no difficulty and 3=inability to perform a task in that area). Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.'}, {'measure': 'Percentage of Participants Achieving American College of Rheumatology (ACR) 50 Response at Week 24', 'timeFrame': 'Week 24', 'description': "The ACR 50 Response is defined as \\>= 50 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and \\>=50 percent improvement in 3 of following 5 assessments: patient's assessment of pain using VAS ( 0-10 scale, 0 =no pain and 10 =worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 to 10, \\[0 =no pain to 10 =worst possible pain\\]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by HAQ-DI (defined as a 20-question instrument assessing 8 functional areas. The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and serum C-Reactive Protein (CRP)."}, {'measure': 'Percentage of Participants With Disease Activity Index Score 28 (CRP) Remission at Week 24', 'timeFrame': 'Week 24', 'description': "The Disease Activity Index Score 28 (DAS28) based on C-Reactive Protein (CRP) is a statistically derived index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. The values are 0=best to 10=worst. DAS28 (CRP) remission is defined as a DAS28 (CRP) value of less than (\\<) 2.6 at any study visit."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True}, 'conditionsModule': {'keywords': ['Arthritis, Rheumatoid', 'Active rheumatoid arthritis despite anti-TNF-alpha therapy', 'Sirukumab', 'Human Anti-IL-6 monoclonal antibody'], 'conditions': ['Arthritis, Rheumatoid']}, 'referencesModule': {'references': [{'pmid': '28215362', 'type': 'DERIVED', 'citation': 'Aletaha D, Bingham CO 3rd, Tanaka Y, Agarwal P, Kurrasch R, Tak PP, Popik S. Efficacy and safety of sirukumab in patients with active rheumatoid arthritis refractory to anti-TNF therapy (SIRROUND-T): a randomised, double-blind, placebo-controlled, parallel-group, multinational, phase 3 study. Lancet. 2017 Mar 25;389(10075):1206-1217. doi: 10.1016/S0140-6736(17)30401-4. Epub 2017 Feb 16.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the efficacy of sirukumab as measured by the reduction of the signs and symptoms of rheumatoid arthritis (RA) in patients with active RA who are unresponsive or intolerant to treatment with anti-TNF-alpha agents.', 'detailedDescription': 'Patients will be randomly assigned to treatment groups, and they and study personnel will not know the identity of the treatments given. Some patients will receive a placebo, which resembles a medication, but does not contain an active substance. This helps to determine if the study agent is effective. Patients will receive placebo or sirukumab by injection under the skin. The expected duration of the study is 68 weeks, which includes 52 weeks of treatment. Participants who complete participation in the study will be eligible for inclusion into the long term extension study if enrollment at a participating site is available to them. If they do not participate in the long-term study, they will continue into the safety follow-up for approximately 16 weeks. The placebo-controlled portion of the study is through Week 24, when placebo patients will cross over to one of two sirukumab dose regimens. Patient safety will be monitored throughout the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have a diagnosis of rheumatoid arthritis (RA) for at least 3 months before screening\n* Have moderately to severely active RA with at least 4 of 68 tender joints and 4 of 66 swollen joints, at screening and at baseline\n* Have had anti-tumor necrosis factor (TNF)-alpha therapy and were unresponsive by 1 of the following 2 reasons: Lack of benefit to at least 1 anti-TNF-alpha biologic therapy, as assessed by the treating physician, after at least 12 weeks of etanercept, yisaipu, adalimumab, golimumab, or certolizumab pegol therapy and/or at least a 14-week dosage regimen (ie, at least 4 doses) of infliximab; Intolerance to at least 2 anti-TNF-alpha biologic therapies, as assessed by the treating physician, to etanercept, yisaipu, adalimumab, golimumab, certolizumab pegol, or infliximab or have documented intolerance to an anti-TNF-alpha agent as described above that precludes further administration of anti-TNF-alpha agents\n* If using oral corticosteroids, must be on a stable dose equivalent to less than or equal to 10 mg/day of prednisone for at least 2 weeks prior to the first administration of study agent. If currently not using corticosteroids, must not have received oral corticosteroids for at least 2 weeks prior to the first administration of study agent\n* If using non nonsteroidal anti-inflammatory drug (NSAIDs) or other analgesics for RA, must be on a stable dose for at least 2 weeks prior to the first administration of study agent\n* If using non-biologic disease modifying antirheumatic drugs (DMARDs) such as methotrexate (MTX), sulfasalazine (SSZ), hydroxychloroquine, chloroquine, or bucillamine, must be on a stable dose for at least 4 weeks prior to the first administration of study agent and should have no serious toxic side effects attributable to the DMARD\n* C-reactive protein (CRP) 8.00 mg/L or more or erythrocyte sedimentation rate (ESR) 28 mm/hr or more at screening\n\nExclusion Criteria:\n\n* Has received infliximab, infliximab biosimilar, or golimumab intravenous (IV) within 8 weeks of the first study agent administration\n* Has received subcutaneously (SC) golimumab, adalimumab, or certolizumab pegol within 6 weeks of the first study agent administration\n* Has received etanercept or yisaipu within 4 weeks of the first study agent administration\n* Has a history of intolerance to tocilizumab that precluded further treatment with it, or inadequate response to 3 months of tocilizumab (anti-IL-6 receptor) therapy. Has used tocilizumab within 8 weeks of the first study agent administration\n* Has used B-cell-depleting therapy (eg, rituximab) within 7 months of first study agent administration or have evidence during screening of abnormally low B-cell level caused by previous B-cell depletion therapy\n* Has used anakinra within 1 week of first study agent administration\n* Has used abatacept or any other biologic therapy for the treatment of RA within 8 weeks of the first study agent administration\n* Has received intra-articular (IA), intramuscular (IM), or IV corticosteroids for RA, including adrenocorticotrophic hormone during the 4 weeks prior to first study agent administration\n* Has received leflunomide within 24 months before the first study agent administration and has not undergone a drug elimination procedure, unless the M1 metabolite is measured and is undetectable\n* Has a history of cyclophosphamide or cytotoxic agent use\n* Has received cyclosporine A, azathioprine, tacrolimus, mycophenolate mofetil, oral or parenteral gold, or D-penicillamine within 4 weeks of the first study agent administration\n* Has received an investigational drug (including investigational vaccines) or used an investigational medical device within 3 months or 5 half-lives, whichever is longer, before the first study agent administration'}, 'identificationModule': {'nctId': 'NCT01606761', 'briefTitle': 'A Study of CNTO 136 (Sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Patients With Active Rheumatoid Arthritis Despite Anti-TNF-Alpha Therapy (SIRROUND-T)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Janssen Research & Development, LLC'}, 'officialTitle': 'A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study of CNTO 136 (Sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Subjects With Active Rheumatoid Arthritis Despite Anti-TNF-Alpha Therapy', 'orgStudyIdInfo': {'id': 'CR100864'}, 'secondaryIdInfos': [{'id': 'CNTO136ARA3003', 'type': 'OTHER', 'domain': 'Janssen Research & Development, LLC'}, {'id': '2010-022243-38', 'type': 'EUDRACT_NUMBER'}, {'id': 'U1111-1135-6365', 'type': 'OTHER', 'domain': 'Universal Trial Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1', 'description': 'Patients will receive placebo every 2 weeks from Week 0 through Week 22, followed by a subcutaneous (SC) sirukumab dose regimen every 2 weeks through Week 52.', 'interventionNames': ['Drug: Placebo', 'Drug: Sirukumab']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2', 'description': 'Patients will receive sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks through Week 52.', 'interventionNames': ['Drug: Sirukumab']}, {'type': 'EXPERIMENTAL', 'label': 'Group 3', 'description': 'Patients will receive sirukumab 50 mg SC at Weeks 0, 4, and every 4 weeks through Week 52. Between sirukumab injections, placebo SC administrations will be made at Weeks 2, 6, and every 4 weeks through Week 52.', 'interventionNames': ['Drug: Placebo', 'Drug: Sirukumab']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'Form=solution for injection, route=subcutaneous use; every 2 weeks from Week 0 through Week 22.', 'armGroupLabels': ['Group 1']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Form=solution for injection, route=subcutaneous use; Weeks 2, 6, and every 4 weeks through Week 52.', 'armGroupLabels': ['Group 3']}, {'name': 'Sirukumab', 'type': 'DRUG', 'description': 'Type=exact, unit=mg, number=50 or 100, form=solution for injection, route=subcutaneous use; every 2 weeks for 100 mg and every 4 weeks for 50 mg, Week 23 through Week 52.', 'armGroupLabels': ['Group 1']}, {'name': 'Sirukumab', 'type': 'DRUG', 'description': 'Type=exact, unit=mg, number=100, form=solution for injection, route=subcutaneous use; Weeks 0, 2, and every 2 weeks through Week 52.', 'armGroupLabels': ['Group 2']}, {'name': 'Sirukumab', 'type': 'DRUG', 'description': 'Type=exact, unit=mg, number=50, form=solution for injection, route=subcutaneous use; Weeks 0, 4, and every 4 weeks through Week 52.', 'armGroupLabels': ['Group 3']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'city': 'Glendale', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.53865, 'lon': -112.18599}}, {'city': 'Mesa', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.42227, 'lon': -111.82264}}, {'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'city': 'Covina', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.09001, 'lon': -117.89034}}, {'city': 'El Cajon', 'state': 'California', 'country': 'United States', 'geoPoint': 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