Ignite Creation Date:
2025-12-24 @ 9:54 PM
Ignite Modification Date:
2025-12-25 @ 7:32 PM
Study NCT ID:
NCT00048932
Status:
COMPLETED
Last Update Posted:
2011-11-24
First Post:
2002-11-11
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Phase III Study of BMS-188667 in Subjects With Active Rheumatoid Arthritis
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': 'D000069594', 'term': 'Abatacept'}], 'ancestors': [{'id': 'D018796', 'term': 'Immunoconjugates'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Clinical.Trials@bms.com', 'title': 'BMS Study Director', 'organization': 'Bristol-Myers Squibb'}, 'certainAgreement': {'otherDetails': "Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Open Label (OL) Abatacept', 'description': 'Participants received abatacept (weight-tiered 10 mg/kg dose) IV every 28 days during the open-label period.', 'otherNumAtRisk': 1184, 'otherNumAffected': 1010, 'seriousNumAtRisk': 1184, 'seriousNumAffected': 425}, {'id': 'EG001', 'title': 'Abatacept (ABA)', 'description': 'Participants received a fixed dose of abatacept approximating 10 mg/kg (500 mg for subjects \\< 60 kg, 750 mg for subjects 60 to 100 kg and 1 g for subjects \\> 100 kg). Abatacept was administered intravenously (IV) on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses. Participants also received background therapy(ies) for rheumatoid arthritis (RA) (non-biologic or biologic disease-modifying drugs \\[DMARDs\\], or combination) throughout the double-blind treatment period.', 'otherNumAtRisk': 959, 'otherNumAffected': 715, 'seriousNumAtRisk': 959, 'seriousNumAffected': 124}, {'id': 'EG002', 'title': 'Placebo (PLA)', 'description': 'Participants received Placebo (dextrose 5% water \\[D5W\\] for injection U.S.P or normal saline \\[NS\\]) for IV infusion administered on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses. Participants also received background therapy(ies) for rheumatoid arthritis (RA) (non-biologic or biologic disease-modifying drugs \\[DMARDs\\], or combination) throughout the double-blind treatment period.', 'otherNumAtRisk': 482, 'otherNumAffected': 346, 'seriousNumAtRisk': 482, 'seriousNumAffected': 59}], 'otherEvents': [{'term': 'CONJUNCTIVITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1184, 'numAffected': 72}, {'groupId': 'EG001', 'numAtRisk': 959, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 11}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'HYPERTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1184, 'numAffected': 162}, {'groupId': 'EG001', 'numAtRisk': 959, 'numAffected': 68}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 24}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'INSOMNIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1184, 'numAffected': 96}, {'groupId': 'EG001', 'numAtRisk': 959, 'numAffected': 43}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 14}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'DEPRESSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1184, 'numAffected': 76}, {'groupId': 'EG001', 'numAtRisk': 959, 'numAffected': 37}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 13}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1184, 'numAffected': 216}, {'groupId': 'EG001', 'numAtRisk': 959, 'numAffected': 195}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 69}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'DIZZINESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1184, 'numAffected': 135}, {'groupId': 'EG001', 'numAtRisk': 959, 'numAffected': 105}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 43}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1184, 'numAffected': 154}, {'groupId': 'EG001', 'numAtRisk': 959, 'numAffected': 121}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 56}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'VOMITING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1184, 'numAffected': 101}, {'groupId': 'EG001', 'numAtRisk': 959, 'numAffected': 58}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 27}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1184, 'numAffected': 186}, {'groupId': 'EG001', 'numAtRisk': 959, 'numAffected': 96}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 58}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'DYSPEPSIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1184, 'numAffected': 112}, {'groupId': 'EG001', 'numAtRisk': 959, 'numAffected': 72}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 24}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'ABDOMINAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1184, 'numAffected': 96}, {'groupId': 'EG001', 'numAtRisk': 959, 'numAffected': 35}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'ABDOMINAL PAIN UPPER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1184, 'numAffected': 101}, {'groupId': 'EG001', 'numAtRisk': 959, 'numAffected': 44}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'RHINITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1184, 'numAffected': 67}, {'groupId': 'EG001', 'numAtRisk': 959, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'INFLUENZA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1184, 'numAffected': 145}, {'groupId': 'EG001', 'numAtRisk': 959, 'numAffected': 60}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 30}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'SINUSITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1184, 'numAffected': 198}, {'groupId': 'EG001', 'numAtRisk': 959, 'numAffected': 66}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 35}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'BRONCHITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1184, 'numAffected': 229}, {'groupId': 'EG001', 'numAtRisk': 959, 'numAffected': 52}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 25}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'PHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1184, 'numAffected': 90}, {'groupId': 'EG001', 'numAtRisk': 959, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'GASTROENTERITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1184, 'numAffected': 87}, {'groupId': 'EG001', 'numAtRisk': 959, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'NASOPHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1184, 'numAffected': 266}, {'groupId': 'EG001', 'numAtRisk': 959, 'numAffected': 98}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 46}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'URINARY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1184, 'numAffected': 195}, {'groupId': 'EG001', 'numAtRisk': 959, 'numAffected': 78}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 23}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'UPPER RESPIRATORY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1184, 'numAffected': 362}, {'groupId': 'EG001', 'numAtRisk': 959, 'numAffected': 143}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 74}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1184, 'numAffected': 65}, {'groupId': 'EG001', 'numAtRisk': 959, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 14}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'RASH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1184, 'numAffected': 85}, {'groupId': 'EG001', 'numAtRisk': 959, 'numAffected': 45}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 19}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'MYALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1184, 'numAffected': 69}, {'groupId': 'EG001', 'numAtRisk': 959, 'numAffected': 33}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 19}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'BACK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1184, 'numAffected': 210}, {'groupId': 'EG001', 'numAtRisk': 959, 'numAffected': 68}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 28}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'MUSCLE SPASMS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1184, 'numAffected': 70}, {'groupId': 'EG001', 'numAtRisk': 959, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 13}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'COUGH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1184, 'numAffected': 195}, {'groupId': 'EG001', 'numAtRisk': 959, 'numAffected': 84}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 37}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'RHINITIS ALLERGIC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1184, 'numAffected': 77}, {'groupId': 'EG001', 'numAtRisk': 959, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'OROPHARYNGEAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1184, 'numAffected': 80}, {'groupId': 'EG001', 'numAtRisk': 959, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 25}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'FATIGUE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1184, 'numAffected': 63}, {'groupId': 'EG001', 'numAtRisk': 959, 'numAffected': 65}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 25}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'PYREXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1184, 'numAffected': 65}, {'groupId': 'EG001', 'numAtRisk': 959, 'numAffected': 37}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 18}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'CHEST PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1184, 'numAffected': 73}, {'groupId': 'EG001', 'numAtRisk': 959, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'OEDEMA PERIPHERAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1184, 'numAffected': 83}, {'groupId': 'EG001', 'numAtRisk': 959, 'numAffected': 35}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 31}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}], 'seriousEvents': [{'term': 'CATARACT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 959, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'PTERYGIUM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 959, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'SCLEROMALACIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 959, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'HIV TEST POSITIVE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 959, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'HAEMATOCRIT DECREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 959, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'BLOOD GLUCOSE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 959, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'TRANSAMINASES INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 959, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'ELECTROCARDIOGRAM CHANGE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 959, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'HEPATIC ENZYME INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 959, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'ELECTROCARDIOGRAM ST-T SEGMENT ABNORMAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 959, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'ARRHYTHMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 959, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'BRADYCARDIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 959, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'TACHYCARDIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 959, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'PERICARDITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 959, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'ATRIAL FLUTTER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 959, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'CARDIAC ARREST', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1184, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 959, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'CARDIOMYOPATHY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 959, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'ANGINA PECTORIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1184, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 959, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'ANGINA UNSTABLE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1184, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 959, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'CARDIAC FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 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unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'LEIOMYOSARCOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 959, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'THYROID CANCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 959, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': "BOWEN'S DISEASE", 'stats': [{'groupId': 'EG000', 'numAtRisk': 1184, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 959, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'PROSTATE CANCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1184, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 959, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': "KAPOSI'S SARCOMA", 'stats': [{'groupId': 'EG000', 'numAtRisk': 1184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 959, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'UTERINE LEIOMYOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1184, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 959, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'ENDOMETRIAL CANCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 959, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'MALIGNANT MELANOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 959, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'LUNG ADENOCARCINOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 959, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'SEBACEOUS CARCINOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 959, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'BASAL CELL CARCINOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1184, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 959, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'PANCREATIC CARCINOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 959, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'RENAL CELL CARCINOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 959, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'BREAST CANCER IN SITU', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 959, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'LUNG CANCER METASTATIC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 959, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': "NON-HODGKIN'S LYMPHOMA", 'stats': [{'groupId': 'EG000', 'numAtRisk': 1184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 959, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'LUNG NEOPLASM MALIGNANT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1184, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 959, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'PITUITARY TUMOUR BENIGN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 959, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'SQUAMOUS CELL CARCINOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1184, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 959, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'MYELODYSPLASTIC SYNDROME', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1184, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 959, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'CERVIX CARCINOMA STAGE II', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 959, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'MALIGNANT MELANOMA IN SITU', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 959, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'NON-SMALL CELL LUNG CANCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 959, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'SQUAMOUS CELL CARCINOMA OF SKIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1184, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 959, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'SQUAMOUS CELL CARCINOMA OF THE CERVIX', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1184, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 959, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'SMALL CELL LUNG CANCER STAGE UNSPECIFIED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 959, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'LUNG SQUAMOUS CELL CARCINOMA STAGE UNSPECIFIED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 959, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'EXTRANODAL MARGINAL ZONE B-CELL LYMPHOMA (MALT TYPE)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1184, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 959, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 482, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Double Blind Period (DB); Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Related AEs, or AEs Leading to Discontinuation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '959', 'groupId': 'OG000'}, {'value': '482', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept (ABA)', 'description': 'Participants received a fixed dose of abatacept approximating 10 mg/kg (500 mg for participants \\< 60 kg, 750 mg for participants 60 to 100 kg and 1 g for participants \\> 100 kg). Abatacept was administered intravenously (IV) on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses. Participants also received background therapy(ies) for rheumatoid arthritis (RA) (non-biologic or biologic disease-modifying drugs \\[DMARDs\\], or combination) throughout the double-blind treatment period.'}, {'id': 'OG001', 'title': 'Placebo (PLA)', 'description': 'Participants received Placebo (dextrose 5% water \\[D5W\\] for injection U.S.P or normal saline \\[NS\\]) for IV infusion administered on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses. Participants also received background therapy(ies) for rheumatoid arthritis (RA) (non-biologic or biologic disease-modifying drugs \\[DMARDs\\], or combination) throughout the double-blind treatment period.'}], 'classes': [{'title': 'Death', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '123', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}]}, {'title': 'Related SAEs', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'SAEs Leading to Discontinuation', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'AEs', 'categories': [{'measurements': [{'value': '866', 'groupId': 'OG000'}, {'value': '417', 'groupId': 'OG001'}]}]}, {'title': 'Related AEs', 'categories': [{'measurements': [{'value': '534', 'groupId': 'OG000'}, {'value': '239', 'groupId': 'OG001'}]}]}, {'title': 'AEs Leading to Discontinuation', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 to Day 365, and including data up to 56 days post last dose of double-blind medication', 'description': 'AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. Related SAE/AE = possibly, probably, or certainly related to study drug', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All Treated Participants, all participants who received at least 1 dose of study medication'}, {'type': 'PRIMARY', 'title': 'DB; Number of Participants With AEs of Special Interest', 'denoms': [{'units': 'Participants', 'counts': [{'value': '959', 'groupId': 'OG000'}, {'value': '482', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept (ABA)', 'description': 'Participants received a fixed dose of abatacept approximating 10 mg/kg (500 mg for participants \\< 60 kg, 750 mg for participants 60 to 100 kg and 1 g for participants \\> 100 kg). Abatacept was administered intravenously (IV) on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses. Participants also received background therapy(ies) for rheumatoid arthritis (RA) (non-biologic or biologic disease-modifying drugs \\[DMARDs\\], or combination) throughout the double-blind treatment period.'}, {'id': 'OG001', 'title': 'Placebo (PLA)', 'description': 'Participants received Placebo (dextrose 5% water \\[D5W\\] for injection U.S.P or normal saline \\[NS\\]) for IV infusion administered on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses. Participants also received background therapy(ies) for rheumatoid arthritis (RA) (non-biologic or biologic disease-modifying drugs \\[DMARDs\\], or combination) throughout the double-blind treatment period.'}], 'classes': [{'title': 'Infections/Infestations', 'categories': [{'measurements': [{'value': '95', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}, {'title': 'Serious Infections/Infestations', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Neoplasms', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Pre-specified Autoimmune Disorders', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Pre-specified Acute Infusional AEs', 'categories': [{'measurements': [{'value': '96', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}]}, {'title': 'Pre-specified Peri-Infusional AEs', 'categories': [{'measurements': [{'value': '233', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 to Day 365, and including data up to 56 days post last dose of double-blind medication', 'description': 'AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including all infections, serious infections, and opportunistic infections; autoimmune disorders; neoplasms; acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion) and peri-infusional AEs (pre-specified AEs occurring within 24 hours of the start of infusion).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All Treated Participants, all participants who received at least 1 dose of study medication'}, {'type': 'PRIMARY', 'title': 'DB; Number of Participants With Hematology Laboratories Meeting Marked Abnormality Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '958', 'groupId': 'OG000'}, {'value': '481', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept (ABA)', 'description': 'Participants received a fixed dose of abatacept approximating 10 mg/kg (500 mg for participants \\< 60 kg, 750 mg for participants 60 to 100 kg and 1 g for participants \\> 100 kg). Abatacept was administered intravenously (IV) on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses. Participants also received background therapy(ies) for rheumatoid arthritis (RA) (non-biologic or biologic disease-modifying drugs \\[DMARDs\\], or combination) throughout the double-blind treatment period.'}, {'id': 'OG001', 'title': 'Placebo (PLA)', 'description': 'Participants received Placebo (dextrose 5% water \\[D5W\\] for injection U.S.P or normal saline \\[NS\\]) for IV infusion administered on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses. Participants also received background therapy(ies) for rheumatoid arthritis (RA) (non-biologic or biologic disease-modifying drugs \\[DMARDs\\], or combination) throughout the double-blind treatment period.'}], 'classes': [{'title': 'Low HGB (LLN=1.5%)', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Low hematocrit (LLN=36%)', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Low erythrocytes (LLN=3.72-4.27 x10*6 c/uL)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Low PLT (LLN=140-157*10^9 c/L)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'High PLT (ULN=415-440*10^9 c/L)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Low leukocytes (LLN= 4-9*10^3 c/uL)', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'High leukocytes (ULN = 10.5-30*10^3 c/uL)', 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}]}, {'title': 'Low neutrophils + bands (LLN= 1.5-2.9*10^3 c/uL)', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Low lymphocytes (LLN= 0.7-2.9*10^3 c/uL)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'High lymphocytes (ULN= 4.5-13.3*10^3 c/uL)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'High monocytes (ULN=1-3.9*10^3 c/uL)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'High basophils (ULN= 0.6*10^3 c/uL)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'High eosinophils (ULN= 1.5*10^3 c/uL)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 to Day 365, and including data up to 56 days post last dose of double-blind medication', 'description': 'Upper Normal Limit (ULN), Lower Normal Limit (LLN), Baseline (BL). Marked abnormality criteria are: Hemoglobin (HGB): \\>3 g/dL decrease from BL; Hematocrit: \\<0.75 \\* BL; Erythrocytes: \\<0.75 \\* BL; Platelets (PLT): \\<0.67 \\* LLN/\\>1.5 \\* ULN, or if BL \\< LLN then use \\<0.5 \\* BL and \\<100,000 mm\\^3; Leukocytes: \\<0.75 \\* LLN/ \\>1.25 \\* ULN, or if BL\\<LLN then use \\<0.8 \\* BL or \\>ULN, or if BL\\>ULN then use \\>1.2 \\* BL or \\<LLN; neutrophils+bands: \\<1.0 \\* 10\\^3 c/uL; eosinophils: \\>0.750 \\* 10\\^3 c/uL; basophils: \\> 400 mm\\^3; monocytes: \\>2000 mm\\^3; lymphocytes: \\<0.750 \\* 10\\^3 c/uL/ \\>7.50 \\* 10\\^3 c/uL.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All Treated Population. One participant in each group was not evaluated for hematology abnormalities due to data unavailability (missing data).'}, {'type': 'PRIMARY', 'title': 'DB; Number of Participants With Blood Chemistry Laboratories Meeting Marked Abnormality (MA) Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '957', 'groupId': 'OG000'}, {'value': '479', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept (ABA)', 'description': 'Participants received a fixed dose of abatacept approximating 10 mg/kg (500 mg for participants \\< 60 kg, 750 mg for participants 60 to 100 kg and 1 g for participants \\> 100 kg). Abatacept was administered intravenously (IV) on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses. Participants also received background therapy(ies) for rheumatoid arthritis (RA) (non-biologic or biologic disease-modifying drugs \\[DMARDs\\], or combination) throughout the double-blind treatment period.'}, {'id': 'OG001', 'title': 'Placebo (PLA)', 'description': 'Participants received Placebo (dextrose 5% water \\[D5W\\] for injection U.S.P or normal saline \\[NS\\]) for IV infusion administered on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses. Participants also received background therapy(ies) for rheumatoid arthritis (RA) (non-biologic or biologic disease-modifying drugs \\[DMARDs\\], or combination) throughout the double-blind treatment period.'}], 'classes': [{'title': 'High AST (ULN=80 U/L)', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'High ALT (ULN=34-47 U/L)', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'High creatinine (ULN=14.6 pg/mg)', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 to Day 365, and including data up to 56 days post last dose of double-blind medication', 'description': 'ULN=upper level of normal; BL=baseline.Marked abnormality criteria: High alkaline phosphatase (ALP): \\>2\\* ULN, or if BL\\>ULN then use \\>3\\* BL; high aspartate aminotransferase (AST): \\>3\\* ULN (80 U/L), or if BL\\>ULN then use \\>4\\* BL; high alanine aminotransferase (ALT): \\>3\\* ULN (34-47 U/L), or if BL\\>ULN then use \\>4\\* BL; high G-Glutamyl transferase (GGT): \\>2\\* ULN, or if BL\\>ULN then use \\>3\\* BL; high bilirubin: \\>2\\* ULN, or if BL\\>ULN then use \\>4\\* BL; high blood urea nitrogen (BUN): \\>2\\* BL; high creatinine: \\>1.5\\* BL (ULN 14.6 pg/mg. AST ULN=80 U/L; ALT ULN=34-47 U/L;creatinine ULN=14.6 pg/mg.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All Treated Population. Two participants in the ABA group and 3 participants in the PLA group were not evaluated for blood chemistry abnormalities due to data unavailability (missing data).'}, {'type': 'SECONDARY', 'title': 'DB; Number of Participants With Positive Anti-Abatacept or Anti-Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Responses by Enzyme-Linked Immunosorbant Assay (ELISA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '880', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Treated Participants', 'description': 'Participants received abatacept (weight-tiered 10 mg/kg dose) IV every 28 days during the open-label period.'}], 'classes': [{'title': 'Anti-abatacept antibodies', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'Anti-CTLA4 antibodies', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Total antibodies', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 1, 29, 57, 85, 113,169, 281, 365', 'description': 'Serum samples from all treated adult participants with active rheumatoid arthritis (RA) were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants treated during DB who received at least 1 dose of abatacept and had antibody samples collected at baseline and at least 1 post-baseline visit. 561 participants were not evaluated for anti-abatacept anti-bodies during the DB.'}, {'type': 'PRIMARY', 'title': 'DB; Number of Participants With Clinically Significant Physical Examination or Vital Signs Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '959', 'groupId': 'OG000'}, {'value': '482', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept (ABA)', 'description': 'Participants received a fixed dose of abatacept approximating 10 mg/kg (500 mg for participants \\< 60 kg, 750 mg for participants 60 to 100 kg and 1 g for participants \\> 100 kg). Abatacept was administered intravenously (IV) on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses. Participants also received background therapy(ies) for rheumatoid arthritis (RA) (non-biologic or biologic disease-modifying drugs \\[DMARDs\\], or combination) throughout the double-blind treatment period.'}, {'id': 'OG001', 'title': 'Placebo (PLA)', 'description': 'Participants received Placebo (dextrose 5% water \\[D5W\\] for injection U.S.P or normal saline \\[NS\\]) for IV infusion administered on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses. Participants also received background therapy(ies) for rheumatoid arthritis (RA) (non-biologic or biologic disease-modifying drugs \\[DMARDs\\], or combination) throughout the double-blind treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337. Vital signs were measured at these visits before and after study medication infusion.', 'description': 'Physical examinations were performed at the discretion of the investigator and included breast examinations for female participants. Vital sign measurements were performed for participants before and after infusion of study medication at each visit and included seated systolic blood pressure, seated diastolic blood pressure, temperature, and heart rate. Abnormalities were determined to be clinically significant by the investigator.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All Treated Population.'}, {'type': 'PRIMARY', 'title': 'Open Label Period (OL); Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Related AEs, or AEs Leading to Discontinuation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1184', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'OL ABA', 'description': 'Participants received abatacept (weight-tiered 10 mg/kg dose) IV every 28 days during the open-label period.'}], 'classes': [{'title': 'Death', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '425', 'groupId': 'OG000'}]}]}, {'title': 'Related SAEs', 'categories': [{'measurements': [{'value': '124', 'groupId': 'OG000'}]}]}, {'title': 'SAEs Leading to Discontinuation', 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}]}]}, {'title': 'AEs', 'categories': [{'measurements': [{'value': '1123', 'groupId': 'OG000'}]}]}, {'title': 'Related AEs', 'categories': [{'measurements': [{'value': '737', 'groupId': 'OG000'}]}]}, {'title': 'AEs Leading to Discontinuation', 'categories': [{'measurements': [{'value': '103', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 365 to Day 1,821', 'description': 'AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. Related SAE/AE = possibly, probably, or certainly related to study drug', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All Treated Participants'}, {'type': 'PRIMARY', 'title': 'OL; Number of Participants With AEs of Special Interest', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1184', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'OL ABA', 'description': 'Participants received abatacept (weight-tiered 10 mg/kg dose) IV every 28 days during the open-label period.'}], 'classes': [{'title': 'Infections/Infestations', 'categories': [{'measurements': [{'value': '957', 'groupId': 'OG000'}]}]}, {'title': 'Total Neoplasms', 'categories': [{'measurements': [{'value': '168', 'groupId': 'OG000'}]}]}, {'title': 'Malignant Neoplasms', 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}]}]}, {'title': 'Benign and Unspecified Neoplasms', 'categories': [{'measurements': [{'value': '112', 'groupId': 'OG000'}]}]}, {'title': 'Pre-specified Autoimmune Disorders', 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}]}]}, {'title': 'Pre-specified Acute Infusional AEs', 'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}]}]}, {'title': 'Pre-specified Peri-Infusional AEs', 'categories': [{'measurements': [{'value': '219', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 365 to Day 1821', 'description': 'AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including all infections, serious infections, and opportunistic infections; autoimmune disorders; neoplasms; acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion) and peri-infusional AEs (pre-specified AEs occurring within 24 hours of the start of infusion).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All Treated Participants, all participants who received at least 1 dose of study medication'}, {'type': 'PRIMARY', 'title': 'OL; Number of Participants With Hematology Laboratories Meeting Marked Abnormality Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1184', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'OL ABA', 'description': 'Participants received abatacept (weight-tiered 10 mg/kg dose) IV every 28 days during the open-label period.'}], 'classes': [{'title': 'Low HGB (LLN=1.5%)', 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}]}]}, {'title': 'Low hematocrit (LLN=36%)', 'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}]}]}, {'title': 'Erythrocytes (LLN=3.72-4.27 x10*6 c/uL)', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}]}]}, {'title': 'Low PLT (LLN=140-157*10^9 c/L)', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}, {'title': 'High PLT (ULN=415-440*10^9 c/L)', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Low leukocytes (LLN= 4-9*10^3 c/uL)', 'categories': [{'measurements': [{'value': '110', 'groupId': 'OG000'}]}]}, {'title': 'High leukocytes (ULN = 10.5-30*10^3 c/uL)', 'categories': [{'measurements': [{'value': '162', 'groupId': 'OG000'}]}]}, {'title': 'Low neutrophils + bands (LLN= 1.5-2.9*10^3 c/uL)', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}]}]}, {'title': 'Low lymphocytes (LLN= 0.7-2.9*10^3 c/uL)', 'categories': [{'measurements': [{'value': '220', 'groupId': 'OG000'}]}]}, {'title': 'High lymphocytes (ULN= 4.5-13.3*10^3 c/uL)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'High monocytes (ULN=1-3.9*10^3 c/uL)', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'High basophils (ULN= 0.6*10^3 c/uL)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'High eosinophils (ULN= 1.5*10^3 c/uL)', 'categories': [{'measurements': [{'value': '151', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 365 to Day 1821, and including data up to 56 days post last dose of double-blind medication', 'description': 'Upper Normal Limit (ULN), Lower Normal Limit (LLN), Baseline (BL). Marked abnormality criteria are: Hemoglobin (HGB): \\>3 g/dL decrease from BL; Hematocrit: \\<0.75 \\* BL; Erythrocytes: \\<0.75 \\* BL; Platelets (PLT): \\<0.67 \\* LLN/\\>1.5 \\* ULN, or if BL \\< LLN then use \\<0.5 \\* BL and \\<100,000 mm\\^3; Leukocytes: \\<0.75 \\* LLN/ \\>1.25 \\* ULN, or if BL\\<LLN then use \\<0.8 \\* BL or \\>ULN, or if BL\\>ULN then use \\>1.2 \\* BL or \\<LLN; neutrophils+bands: \\<1.0 \\* 10\\^3 c/uL; eosinophils: \\>0.750 \\* 10\\^3 c/uL; basophils: \\> 400 mm\\^3; monocytes: \\>2000 mm\\^3; lymphocytes: \\<0.750 \\* 10\\^3 c/uL/ \\>7.50 \\* 10\\^3 c/uL.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All Treated Population.'}, {'type': 'PRIMARY', 'title': 'OL; Number of Participants With Liver Function Laboratories Meeting Marked Abnormality Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1183', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'OL ABA', 'description': 'Participants received abatacept (weight-tiered 10 mg/kg dose) IV every 28 days during the open-label period.'}], 'classes': [{'title': 'High ALP (ULN=150 U/L)', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'High AST (ULN=80 U/L)', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}]}]}, {'title': 'High ALT (ULN=34-47 U/L)', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}]}]}, {'title': 'High GGT (ULN=43-54 U/L)', 'categories': [{'measurements': [{'value': '91', 'groupId': 'OG000'}]}]}, {'title': 'High bilirubin (ULN=0.3 mg/dL)', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'High BUN (normal=4-25 mg/dL)', 'categories': [{'measurements': [{'value': '108', 'groupId': 'OG000'}]}]}, {'title': 'High creatinine (ULN=14.6 pg/mg)', 'categories': [{'measurements': [{'value': '204', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 365 to Day 1821, and including data up to 56 days post last dose of double-blind medication', 'description': 'Marked abnormality criteria: Alkaline phosphatase (ALP): \\>2\\* ULN, or if BL\\>ULN then use \\>3\\* BL; aspartate aminotransferase (AST): \\>3\\* ULN, or if BL\\>ULN then use \\>4\\* BL; alanine aminotransferase (ALT): \\>3\\* ULN, or if BL\\>ULN then use \\>4\\* BL; G-Glutamyl transferase (GGT): \\>2\\* ULN, or if BL\\>ULN then use \\>3\\* BL; Bilirubin: \\>2\\* ULN, or if BL\\>ULN then use \\>4\\* BL; blood urea nitrogen (BUN): \\>2\\* BL; creatinine: \\>1.5\\* BL', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All Treated Population. One participant was not evaluated for liver function abnormalities.'}, {'type': 'PRIMARY', 'title': 'OL; Number of Participants With Electrolyte Laboratories Meeting Marked Abnormality Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1183', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'OL ABA', 'description': 'Participants received abatacept (weight-tiered 10 mg/kg dose) IV every 28 days during the open-label period.'}], 'classes': [{'title': 'Low Na (LLN=135 mEq/L)', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': 'High Na (ULN=148 mEq/L)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Low K (LLN=3.5 mEq/L)', 'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000'}]}]}, {'title': 'High K (ULN=5.5 mEq/L)', 'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000'}]}]}, {'title': 'Low Cl (LLN= 96 mEq/L)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'High Cl (ULN=109 mEq/L)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Low Ca (LLN=8.5 mg/dL)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'High Ca (ULN=11 mg/dL)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Low P (LLN=2.5 mg/dL)', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': 'High P (ULN 7.1 mg/dL)', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 365 to Day 1821, and including data up to 56 days post last dose of double-blind medication', 'description': 'Marked abnormality criteria: Sodium (Na): \\<0.95\\*LLN/ \\>1.05\\*ULN, or if BL\\<LLN then use \\<0.95\\* BL or \\>ULN, or if BL\\>ULN then use\\>1.05\\* BL or \\<LLN; potassium (K): \\<0.9\\* LLN/\\>1.1\\*ULN, or if BL\\<LLN then use \\<0.9\\* BL or \\>ULN, or if BL\\>ULN then use\\>1.1\\* BL or \\<LLN; (Cl): \\<0.9\\* LLN/\\>1.1\\* ULN, or if BL\\<LLN then use \\<0.9\\* BL or \\>ULN, or if BL\\>ULN then use\\>1.1\\* BL or \\<LLN; calcium (Ca): \\<0.8\\* LLN/\\>1.2\\* ULN, or if BL\\<LLN then use \\<0.75\\* BL or \\>ULN, or if BL\\>ULN then use\\>1.25\\* BL or \\<LLN; phosphorous (P): \\<0.75\\* LLN/ \\>1.25\\* ULN, or if BL\\<LLN then use 0.67\\* BL or \\>ULN, or if BL\\>ULN then use\\>1.33\\* BL or \\<LLN', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All Treated Population. One participant was not evaluated for electrolyte abnormalities.'}, {'type': 'PRIMARY', 'title': 'OL; Number of Participants With Other Chemistry and Urinalysis Laboratories Meeting Marked Abnormality Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1184', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'OL ABA', 'description': 'Participants received abatacept (weight-tiered 10 mg/kg dose) IV every 28 days during the open-label period.'}], 'classes': [{'title': 'Low Glu, n=1184', 'categories': [{'measurements': [{'value': '207', 'groupId': 'OG000'}]}]}, {'title': 'High Glu, n=1184', 'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}]}]}, {'title': 'Low fasting Glu, n=647 (LLN=65 mg/dL)', 'categories': [{'measurements': [{'value': '647', 'groupId': 'OG000'}]}]}, {'title': 'High fasting Glu, n=647 (ULN=115 mg/dL)', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}]}]}, {'title': 'Low protein, n=1183 (LLN=6 g/dL)', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'High protein, n=1183 (ULN=8.5 g/dL)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Low albumin, n=1183 (LLN=3.5 g/dL)', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}]}]}, {'title': 'High uric acid, n=1183 (ULN=8.7 mg/dL)', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}, {'title': 'High urine protein, n=1184 (normal=trace)', 'categories': [{'measurements': [{'value': '125', 'groupId': 'OG000'}]}]}, {'title': 'High urine glucose, n=1184 (normal=negative)', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}]}]}, {'title': 'High urine ketones, n=33 (normal=negative)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'High urine blood, n=1184 (normal=negative)', 'categories': [{'measurements': [{'value': '310', 'groupId': 'OG000'}]}]}, {'title': 'High leukocyte esterase, n=32', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'High urine WBC, n=852', 'categories': [{'measurements': [{'value': '429', 'groupId': 'OG000'}]}]}, {'title': 'High urine RBC, n=852', 'categories': [{'measurements': [{'value': '403', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 365 to Day 1821, and including data up to 56 days post last dose of double-blind medication', 'description': 'MA criteria: serum glucose (Glu): \\<65 mg/dL/\\>220 mg/dL;fasting serum Glu: \\<0.8\\* LLN/\\>1.5\\*ULN,or if BL\\<LLN then use 0.8\\*BL or \\>ULN,or if BL\\>ULN then use \\>2.0\\*BL or \\<LLN;total protein: \\<0.9\\*LLN/\\>1.1\\*ULN,or if BL\\<LLN then use \\<0.9\\*BL or \\>UNL,or if BL\\>UNL then use \\>1.1\\*BL or \\<LLN; albumin: \\<0.9\\*LLN,or if BL\\<LLN then use \\<0.75 BL;uric acid: \\>1.5\\*ULN,or if BL\\>ULN then use \\>2\\*BL. Urinalysis (Urine protein,urine Glu,urine blood,leukocyte esterase,Red Blood Cells \\[RBCs\\], White Blood Cells \\[WBCs\\]):Use ≥2 when BL value missing or when pre-dose=0 or 0.5; use ≥3 when pre-dose=1, use ≥4 when pre-dose=2 or 3', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All Treated Population. N=Number of Participants Analyzed, n=number of participants with measurements at time point'}, {'type': 'PRIMARY', 'title': 'OL; Number of Participants With Clinically Significant Physical Examination or Vital Signs Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1184', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'OL ABA', 'description': 'Participants received abatacept (weight-tiered 10 mg/kg dose) IV every 28 days during the open-label period.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 365 to Day 1821', 'description': 'Physical examinations were performed at the discretion of the investigator and included breast examinations for female participants. Vital sign measurements were performed for participants before and after infusion of study medication at each visit and included seated systolic blood pressure, seated diastolic blood pressure, temperature, and heart rate. Abnormalities were determined to be clinically significant by the investigator.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All Treated Population.'}, {'type': 'SECONDARY', 'title': 'DB; Number of Participants With Positive Anti-Abatacept or Anti-Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Responses by ELISA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1296', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Treated Participants', 'description': 'Participants received abatacept (weight-tiered 10 mg/kg dose) IV every 28 days during the open-label period.'}], 'classes': [{'title': 'Anti-abatacept antibodies (n=1228)', 'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000'}]}]}, {'title': 'Anti-CTLA4 antibodies (n=1296)', 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}]}]}, {'title': 'Total antibodies (n=1296)', 'categories': [{'measurements': [{'value': '107', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337', 'description': 'Serum samples from all treated adult participants with active rheumatoid arthritis were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All DB participants treated on study who received at least 1 dose of abatacept and had antibody samples collected at baseline and at least 1 post-baseline visit. 68 participants were not evaluated for anti-abatacept anti-bodies on study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Abatacept (ABA)', 'description': 'Participants received a fixed dose of abatacept approximating 10 mg/kg (500 mg for participants \\< 60 kg, 750 mg for participants 60 to 100 kg and 1 g for participants \\> 100 kg). Abatacept was administered intravenously (IV) on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses. Participants also received background therapy(ies) for rheumatoid arthritis (RA) (non-biologic or biologic disease-modifying drugs \\[DMARDs\\], or combination) throughout the double-blind treatment period.'}, {'id': 'FG001', 'title': 'Placebo (PLA)', 'description': 'Participants received Placebo (dextrose 5% water \\[D5W\\] for injection U.S.P or normal saline \\[NS\\]) for IV infusion administered on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses. Participants also received background therapy(ies) for rheumatoid arthritis (RA) (non-biologic or biologic disease-modifying drugs \\[DMARDs\\], or combination) throughout the double-blind treatment period.'}, {'id': 'FG002', 'title': 'Open Label (OL) Abatacept', 'description': 'Participants received abatacept (weight-tiered 10 mg/kg dose) IV every 28 days during the open-label period.'}], 'periods': [{'title': 'Double Blind Period (DB)', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Number Treated', 'groupId': 'FG000', 'numSubjects': '959'}, {'comment': 'Number Treated', 'groupId': 'FG001', 'numSubjects': '482'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '836'}, {'groupId': 'FG001', 'numSubjects': '395'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '123'}, {'groupId': 'FG001', 'numSubjects': '87'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Administrative Reason By Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '51'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '44'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Relocation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Uncontrolled hypertension', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Missed 2 doses while undergoing work-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'No Longer Meets Study Criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Poor/Non-Compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Open Label Period (OL)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'comment': '47 participants who completed the double-blind did not enter the open-label', 'groupId': 'FG002', 'numSubjects': '1184'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '743'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '441'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '25'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '103'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '81'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '27'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '117'}]}, {'type': 'No Longer Meets Study Criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'Poor/Non-Compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '13'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'Administrative Reason By Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '20'}]}, {'type': 'Investigator Retiring', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Participant Transportation Issues', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Participant Relocated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'Investigator Dosing the Trial', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Site Closure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Trial Terminated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Difficult IV Access with Participant', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Patient Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Participant Received Wrong Medication', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Participant Desires Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Participant Missed Consecutive Doses', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'Medication Lost Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Investigator Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Site Staff Issues', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Site Not Participating in Open Label', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '9'}]}, {'type': 'Participant Surgery', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': '1795 enrolled in study and 339 were not randomized due to no longer meeting study criteria (n=214), withdraw of consent (n=83), other reasons (n=32), participant was lost to follow-up (n=5), administrative reason by sponsor (n=2), adverse event (n=2), and poor/non-compliance (n=1). Of 1456 randomized, 15 were not treated.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '959', 'groupId': 'BG000'}, {'value': '482', 'groupId': 'BG001'}, {'value': '1441', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Abatacept (ABA)', 'description': 'Participants received a fixed dose of abatacept approximating 10 mg/kg (500 mg for participants \\< 60 kg, 750 mg for participants 60 to 100 kg and 1 g for participants \\> 100 kg). Abatacept was administered intravenously (IV) on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses. Participants also received background therapy(ies) for rheumatoid arthritis (RA) (non-biologic or biologic disease-modifying drugs \\[DMARDs\\], or combination) throughout the double-blind treatment period.'}, {'id': 'BG001', 'title': 'Placebo (PLA)', 'description': 'Participants received Placebo (dextrose 5% water \\[D5W\\] for injection U.S.P or normal saline \\[NS\\]) for IV infusion administered on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses. Participants also received background therapy(ies) for rheumatoid arthritis (RA) (non-biologic or biologic disease-modifying drugs \\[DMARDs\\], or combination) throughout the double-blind treatment period.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52.4', 'spread': '11.7', 'groupId': 'BG000'}, {'value': '52.1', 'spread': '12.0', 'groupId': 'BG001'}, {'value': '52.3', 'spread': '11.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '789', 'groupId': 'BG000'}, {'value': '398', 'groupId': 'BG001'}, {'value': '1187', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '170', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '254', 'groupId': 'BG002'}]}]}], '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': 1795}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-11', 'completionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-11-15', 'studyFirstSubmitDate': '2002-11-11', 'resultsFirstSubmitDate': '2011-04-01', 'studyFirstSubmitQcDate': '2002-11-12', 'lastUpdatePostDateStruct': {'date': '2011-11-24', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-04-01', 'studyFirstPostDateStruct': {'date': '2002-11-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-05-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Double Blind Period (DB); Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Related AEs, or AEs Leading to Discontinuation', 'timeFrame': 'Day 1 to Day 365, and including data up to 56 days post last dose of double-blind medication', 'description': 'AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. Related SAE/AE = possibly, probably, or certainly related to study drug'}, {'measure': 'DB; Number of Participants With AEs of Special Interest', 'timeFrame': 'Day 1 to Day 365, and including data up to 56 days post last dose of double-blind medication', 'description': 'AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including all infections, serious infections, and opportunistic infections; autoimmune disorders; neoplasms; acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion) and peri-infusional AEs (pre-specified AEs occurring within 24 hours of the start of infusion).'}, {'measure': 'DB; Number of Participants With Hematology Laboratories Meeting Marked Abnormality Criteria', 'timeFrame': 'Day 1 to Day 365, and including data up to 56 days post last dose of double-blind medication', 'description': 'Upper Normal Limit (ULN), Lower Normal Limit (LLN), Baseline (BL). Marked abnormality criteria are: Hemoglobin (HGB): \\>3 g/dL decrease from BL; Hematocrit: \\<0.75 \\* BL; Erythrocytes: \\<0.75 \\* BL; Platelets (PLT): \\<0.67 \\* LLN/\\>1.5 \\* ULN, or if BL \\< LLN then use \\<0.5 \\* BL and \\<100,000 mm\\^3; Leukocytes: \\<0.75 \\* LLN/ \\>1.25 \\* ULN, or if BL\\<LLN then use \\<0.8 \\* BL or \\>ULN, or if BL\\>ULN then use \\>1.2 \\* BL or \\<LLN; neutrophils+bands: \\<1.0 \\* 10\\^3 c/uL; eosinophils: \\>0.750 \\* 10\\^3 c/uL; basophils: \\> 400 mm\\^3; monocytes: \\>2000 mm\\^3; lymphocytes: \\<0.750 \\* 10\\^3 c/uL/ \\>7.50 \\* 10\\^3 c/uL.'}, {'measure': 'DB; Number of Participants With Blood Chemistry Laboratories Meeting Marked Abnormality (MA) Criteria', 'timeFrame': 'Day 1 to Day 365, and including data up to 56 days post last dose of double-blind medication', 'description': 'ULN=upper level of normal; BL=baseline.Marked abnormality criteria: High alkaline phosphatase (ALP): \\>2\\* ULN, or if BL\\>ULN then use \\>3\\* BL; high aspartate aminotransferase (AST): \\>3\\* ULN (80 U/L), or if BL\\>ULN then use \\>4\\* BL; high alanine aminotransferase (ALT): \\>3\\* ULN (34-47 U/L), or if BL\\>ULN then use \\>4\\* BL; high G-Glutamyl transferase (GGT): \\>2\\* ULN, or if BL\\>ULN then use \\>3\\* BL; high bilirubin: \\>2\\* ULN, or if BL\\>ULN then use \\>4\\* BL; high blood urea nitrogen (BUN): \\>2\\* BL; high creatinine: \\>1.5\\* BL (ULN 14.6 pg/mg. AST ULN=80 U/L; ALT ULN=34-47 U/L;creatinine ULN=14.6 pg/mg.'}, {'measure': 'DB; Number of Participants With Clinically Significant Physical Examination or Vital Signs Abnormalities', 'timeFrame': 'Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337. Vital signs were measured at these visits before and after study medication infusion.', 'description': 'Physical examinations were performed at the discretion of the investigator and included breast examinations for female participants. Vital sign measurements were performed for participants before and after infusion of study medication at each visit and included seated systolic blood pressure, seated diastolic blood pressure, temperature, and heart rate. Abnormalities were determined to be clinically significant by the investigator.'}, {'measure': 'Open Label Period (OL); Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Related AEs, or AEs Leading to Discontinuation', 'timeFrame': 'Day 365 to Day 1,821', 'description': 'AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. Related SAE/AE = possibly, probably, or certainly related to study drug'}, {'measure': 'OL; Number of Participants With AEs of Special Interest', 'timeFrame': 'Day 365 to Day 1821', 'description': 'AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including all infections, serious infections, and opportunistic infections; autoimmune disorders; neoplasms; acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion) and peri-infusional AEs (pre-specified AEs occurring within 24 hours of the start of infusion).'}, {'measure': 'OL; Number of Participants With Hematology Laboratories Meeting Marked Abnormality Criteria', 'timeFrame': 'Day 365 to Day 1821, and including data up to 56 days post last dose of double-blind medication', 'description': 'Upper Normal Limit (ULN), Lower Normal Limit (LLN), Baseline (BL). Marked abnormality criteria are: Hemoglobin (HGB): \\>3 g/dL decrease from BL; Hematocrit: \\<0.75 \\* BL; Erythrocytes: \\<0.75 \\* BL; Platelets (PLT): \\<0.67 \\* LLN/\\>1.5 \\* ULN, or if BL \\< LLN then use \\<0.5 \\* BL and \\<100,000 mm\\^3; Leukocytes: \\<0.75 \\* LLN/ \\>1.25 \\* ULN, or if BL\\<LLN then use \\<0.8 \\* BL or \\>ULN, or if BL\\>ULN then use \\>1.2 \\* BL or \\<LLN; neutrophils+bands: \\<1.0 \\* 10\\^3 c/uL; eosinophils: \\>0.750 \\* 10\\^3 c/uL; basophils: \\> 400 mm\\^3; monocytes: \\>2000 mm\\^3; lymphocytes: \\<0.750 \\* 10\\^3 c/uL/ \\>7.50 \\* 10\\^3 c/uL.'}, {'measure': 'OL; Number of Participants With Liver Function Laboratories Meeting Marked Abnormality Criteria', 'timeFrame': 'Day 365 to Day 1821, and including data up to 56 days post last dose of double-blind medication', 'description': 'Marked abnormality criteria: Alkaline phosphatase (ALP): \\>2\\* ULN, or if BL\\>ULN then use \\>3\\* BL; aspartate aminotransferase (AST): \\>3\\* ULN, or if BL\\>ULN then use \\>4\\* BL; alanine aminotransferase (ALT): \\>3\\* ULN, or if BL\\>ULN then use \\>4\\* BL; G-Glutamyl transferase (GGT): \\>2\\* ULN, or if BL\\>ULN then use \\>3\\* BL; Bilirubin: \\>2\\* ULN, or if BL\\>ULN then use \\>4\\* BL; blood urea nitrogen (BUN): \\>2\\* BL; creatinine: \\>1.5\\* BL'}, {'measure': 'OL; Number of Participants With Electrolyte Laboratories Meeting Marked Abnormality Criteria', 'timeFrame': 'Day 365 to Day 1821, and including data up to 56 days post last dose of double-blind medication', 'description': 'Marked abnormality criteria: Sodium (Na): \\<0.95\\*LLN/ \\>1.05\\*ULN, or if BL\\<LLN then use \\<0.95\\* BL or \\>ULN, or if BL\\>ULN then use\\>1.05\\* BL or \\<LLN; potassium (K): \\<0.9\\* LLN/\\>1.1\\*ULN, or if BL\\<LLN then use \\<0.9\\* BL or \\>ULN, or if BL\\>ULN then use\\>1.1\\* BL or \\<LLN; (Cl): \\<0.9\\* LLN/\\>1.1\\* ULN, or if BL\\<LLN then use \\<0.9\\* BL or \\>ULN, or if BL\\>ULN then use\\>1.1\\* BL or \\<LLN; calcium (Ca): \\<0.8\\* LLN/\\>1.2\\* ULN, or if BL\\<LLN then use \\<0.75\\* BL or \\>ULN, or if BL\\>ULN then use\\>1.25\\* BL or \\<LLN; phosphorous (P): \\<0.75\\* LLN/ \\>1.25\\* ULN, or if BL\\<LLN then use 0.67\\* BL or \\>ULN, or if BL\\>ULN then use\\>1.33\\* BL or \\<LLN'}, {'measure': 'OL; Number of Participants With Other Chemistry and Urinalysis Laboratories Meeting Marked Abnormality Criteria', 'timeFrame': 'Day 365 to Day 1821, and including data up to 56 days post last dose of double-blind medication', 'description': 'MA criteria: serum glucose (Glu): \\<65 mg/dL/\\>220 mg/dL;fasting serum Glu: \\<0.8\\* LLN/\\>1.5\\*ULN,or if BL\\<LLN then use 0.8\\*BL or \\>ULN,or if BL\\>ULN then use \\>2.0\\*BL or \\<LLN;total protein: \\<0.9\\*LLN/\\>1.1\\*ULN,or if BL\\<LLN then use \\<0.9\\*BL or \\>UNL,or if BL\\>UNL then use \\>1.1\\*BL or \\<LLN; albumin: \\<0.9\\*LLN,or if BL\\<LLN then use \\<0.75 BL;uric acid: \\>1.5\\*ULN,or if BL\\>ULN then use \\>2\\*BL. Urinalysis (Urine protein,urine Glu,urine blood,leukocyte esterase,Red Blood Cells \\[RBCs\\], White Blood Cells \\[WBCs\\]):Use ≥2 when BL value missing or when pre-dose=0 or 0.5; use ≥3 when pre-dose=1, use ≥4 when pre-dose=2 or 3'}, {'measure': 'OL; Number of Participants With Clinically Significant Physical Examination or Vital Signs Abnormalities', 'timeFrame': 'Days 365 to Day 1821', 'description': 'Physical examinations were performed at the discretion of the investigator and included breast examinations for female participants. Vital sign measurements were performed for participants before and after infusion of study medication at each visit and included seated systolic blood pressure, seated diastolic blood pressure, temperature, and heart rate. Abnormalities were determined to be clinically significant by the investigator.'}], 'secondaryOutcomes': [{'measure': 'DB; Number of Participants With Positive Anti-Abatacept or Anti-Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Responses by Enzyme-Linked Immunosorbant Assay (ELISA)', 'timeFrame': 'Days 1, 29, 57, 85, 113,169, 281, 365', 'description': 'Serum samples from all treated adult participants with active rheumatoid arthritis (RA) were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody.'}, {'measure': 'DB; Number of Participants With Positive Anti-Abatacept or Anti-Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Responses by ELISA', 'timeFrame': 'Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337', 'description': 'Serum samples from all treated adult participants with active rheumatoid arthritis were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody.'}]}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'referencesModule': {'references': [{'pmid': '29329602', 'type': 'DERIVED', 'citation': 'Alten R, Burkhardt H, Feist E, Kruger K, Rech J, Rubbert-Roth A, Voll RE, Elbez Y, Rauch C. Abatacept used in combination with non-methotrexate disease-modifying antirheumatic drugs: a descriptive analysis of data from interventional trials and the real-world setting. Arthritis Res Ther. 2018 Jan 2;20(1):1. doi: 10.1186/s13075-017-1488-5.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this clinical research study is to learn if abatacept is safe when co-administered with other approved rheumatoid arthritis medications.', 'detailedDescription': "This was a multinational, multicenter, randomized, double-blind, 2-arm, parallel-dosing designed study. The treatment period was 12 months. Eligible participants were randomized to 1 of 2 treatment groups: abatacept fixed dose approximating 10 mg/kg (based on participant's body weight; 500 mg for participants weighing \\< 60kg; 750 mg for participants weighing 60 to 100 kg; and 1 gram for participants weighing \\> 100 kg, monthly) or placebo intravenous (IV) infusion. All participants continued their background therapy(ies) for rheumatoid arthritis (RA) (non-biologic or biologic disease-modifying drugs \\[DMARDs\\], or combination) throughout the double-blind treatment period. Double-blind study medication (abatacept or placebo) was administered on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses.\n\nAll participants who completed the 12-month double-blind study period (Day 1 through Day 365), were eligible to continue into the open-label period. All eligible participants (active or placebo) were re-allocated to receive abatacept at a weight-tiered dose that approximated 10 mg/kg, based on their Day 365 body weight. Participants continued to receive infusions every 28 days."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Meet criteria of American Rheumatism Association for the diagnosis of rheumatoid arthritis and the American College of Rheumatology functional classes I, II III or IV\n* Participants must be taking 1 or more DMARDs and/or biologic approved for rheumatoid arthritis (RA) for at least 3 months and be on a stable dose for 28 days prior to Day 1.\n\nExclusion:\n\n* Other auto-immune disease as a main diagnosis (e.g. Systemic Lupus Erythematosus \\[SLE\\], Scleroderma)\n* Active tuberculosis (TB) requiring treatment within last 3 years'}, 'identificationModule': {'nctId': 'NCT00048932', 'briefTitle': 'A Phase III Study of BMS-188667 in Subjects With Active Rheumatoid Arthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'orgStudyIdInfo': {'id': 'IM101-031'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Double-blind abatacept', 'description': 'Participants received a fixed dose of abatacept approximating 10 mg/kg (500 mg for participants \\< 60 kg, 750 mg for participants 60 to 100 kg and 1 g for participants \\> 100 kg). Abatacept was administered intravenously (IV) on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses. Participants also received background therapy(ies) for rheumatoid arthritis (RA) (non-biologic or biologic disease-modifying drugs \\[DMARDs\\], or combination) throughout the double-blind treatment period', 'interventionNames': ['Drug: Double-blind Abatacept']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Double-blind Placebo', 'description': 'Participants received Placebo (dextrose 5% water \\[D5W\\] for injection U.S.P or normal saline \\[NS\\]) for IV infusion administered on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses. Participants also received background therapy(ies) for rheumatoid arthritis (RA) (non-biologic or biologic disease-modifying drugs \\[DMARDs\\], or combination) throughout the double-blind treatment period.', 'interventionNames': ['Drug: Double-blind Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Open-label Abatacept', 'description': 'Participants received abatacept (weight-tiered 10 mg/kg dose) IV every 28 days during the open-label period.', 'interventionNames': ['Drug: Open-label Abatacept']}], 'interventions': [{'name': 'Double-blind Abatacept', 'type': 'DRUG', 'otherNames': ['Orencia', 'BMS-188667'], 'description': 'Concentrate and diluted in a solution, IV, 500 mg (body weight \\< 60 Kg); 750 mg (body weight 60-100 Kg); 1000 mg (body weight \\> 100 Kg), Once daily, Day 1, 15, and 29.', 'armGroupLabels': ['Double-blind abatacept']}, {'name': 'Double-blind Placebo', 'type': 'DRUG', 'description': 'Concentrate and diluted in a solution, IV, 0 mg, Once daily, Day 1, 15, and 29.', 'armGroupLabels': ['Double-blind Placebo']}, {'name': 'Open-label Abatacept', 'type': 'DRUG', 'otherNames': ['Orencia', 'BMS-188667'], 'description': 'Concentrate and diluted in a solution, IV, 500 mg (body weight \\< 60 Kg); 750 mg (body weight 60-100 Kg); 1000 mg (body weight \\> 100 Kg), Once daily, Every 28 days.', 'armGroupLabels': ['Open-label Abatacept']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Decatur', 'state': 'Alabama', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 34.60593, 'lon': -86.98334}}, {'city': 'Paradise', 'state': 'Arizona', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 31.93481, 'lon': -109.21895}}, {'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 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'facility': 'Local Institution', 'geoPoint': {'lat': 43.1789, 'lon': -88.11731}}, {'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}