Ignite Creation Date:
2025-12-24 @ 5:56 PM
Ignite Modification Date:
2026-05-25 @ 3:57 AM
Study NCT ID:
NCT00402168
Status:
COMPLETED
Last Update Posted:
2017-01-05
First Post:
2006-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of BMS-224818 (Belatacept) in Patients Who Have Undergone a Kidney Transplant and Are Currently on Stable Cyclosporine or Tacrolimus Regimen With or Without Corticosteroids
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['South Korea']}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069594', 'term': 'Abatacept'}, {'id': 'D016572', 'term': 'Cyclosporine'}, {'id': 'D016559', 'term': 'Tacrolimus'}], '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'}, {'id': 'D003524', 'term': 'Cyclosporins'}, {'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Clinical.Trials@bms.com', 'title': 'Bristol-Myers Squibb 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}, 'limitationsAndCaveats': {'description': 'CNI arm discontinued Year 3, and those not switching treatment discontinued from study. No formal comparisons in calculated GFR were planned post Month 36, and these data up to the final database lock should be interpreted with caution.'}}, 'adverseEventsModule': {'timeFrame': 'Date of first dose to 56 days post final dose, up to June 2013 (approximately 80 months)', 'description': 'Study initiated: January 2007; Study Completion: June 2013', 'eventGroups': [{'id': 'EG000', 'title': 'Belatacept 5 mg/kg', 'description': 'Belatacept 5 milligrams per kilogram of body weight (mg/kg) given intravenously (IV) every 28 days. Adverse events reported for participants who were treated with only Belatacept throughout the study.', 'otherNumAtRisk': 83, 'otherNumAffected': 78, 'seriousNumAtRisk': 83, 'seriousNumAffected': 45}, {'id': 'EG001', 'title': 'Calcineurin Inhibitor (CNI)', 'description': 'Participants received a calcineurin inhibitor (CNI)-based immunosuppressive regimen, Cyclosporin A (CsA) and tacrolimus (TAC). CsA was to be adjusted to maintain a range of trough serum concentrations of 100 - 250 nanograms per milliliter (ng/mL). TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the long term (LT) treatment period participants were allowed to switch to Belatacept treatment arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the Belatacept arm. Adverse events reported for participants who were treated with only CNI for the entire study and those who were later switched from Calcineurin Inhibitor (CNI) treatment to Belatacept 5 mg/kg during the LT period prior to their first Belatacept dose.', 'otherNumAtRisk': 88, 'otherNumAffected': 74, 'seriousNumAtRisk': 88, 'seriousNumAffected': 40}, {'id': 'EG002', 'title': 'Belatacept 5 mg/kg in Participants Switched During LT Period', 'description': 'During the long term treatment period participants were allowed to switch from CNI to Belatacept. For those switching to Belatacept, the CNI dose was tapered and discontinued, after which they received Belatacept 5 mg/kg IV every 2 weeks for 2 months. Thereafter, they received Belatacept 5 mg/kg IV every 28 days. Adverse events reported for participants who were switched from Calcineurin Inhibitor (CNI) treatment to Belatacept 5 mg/kg during the LT period on or after their first Belatacept dose.', 'otherNumAtRisk': 38, 'otherNumAffected': 27, 'seriousNumAtRisk': 38, 'seriousNumAffected': 9}], 'otherEvents': [{'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Blood potassium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Dyslipidaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Leukocyturia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Iron deficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Limb injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Onychomycosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Renal impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Tinea versicolour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Polycythaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Productive cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Aphthous stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Hyperuricaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Hepatic function abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Skin lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Ear infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Hypercholesterolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 3}], 'organSystem': 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'Glomerulonephritis proliferative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Inclusion body myositis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Lung disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Obstructive uropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Palatal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Phlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Sudden death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Cholecystitis infective', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Focal segmental glomerulosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Necrotising retinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Non-small cell lung cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Postoperative wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Squamous cell carcinoma of skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Traumatic fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Urinary tract infection pseudomonal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 83, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Calculated Glomerular Filtration Rate (GFR) With Imputed Values to 6 Months Post Randomization - All Randomized Participants (Intent-to-Treat Population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Belatacept 5 mg/kg', 'description': 'Belatacept 5 mg/kg was given IV every 28 days.'}, {'id': 'OG001', 'title': 'Calcineurin Inhibitor (CNI)', 'description': 'Participants received a CNI-based immunosuppressive regimen, CsA and TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.9', 'spread': '11.97', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '9.84', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 6 months post randomization', 'description': 'Calculated GFR assessment used the modification of diet in renal disease (MDRD) formula. GFR was measured as mL/min/1.73 m\\^2. For death or graft loss participants, calculated GFR (cGFR) value 10 was used, for other participants who had a post baseline cGFR value missing, but had baseline value and at least 2 post baseline values available, which were at least 120 days apart, linear regression model was used to impute the cGFR value. Baseline = value at screening.', 'unitOfMeasure': 'mL/min/1.73 m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) population: all randomized participants with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Acute Rejection (AR) by Months 6 and 12 Post Randomization - All Randomized Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Belatacept 5 mg/kg', 'description': 'Belatacept 5 mg/kg IV every 28 days.'}, {'id': 'OG001', 'title': 'Calcineurin Inhibitor (CNI)', 'description': 'Participants received a CNI-based immunosuppressive regimen, CsA and TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.'}], 'classes': [{'title': 'Total Number by Month 6', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'By Month 6 Mild Acute (IA)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Month 6 Mild Acute (IB)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Month 6 Moderate Acute (IIA)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Month 6 Moderate Acute (IIB)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Month 6 Severe Acute (III)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Total Number by Month 12', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Month 12 Mild Acute (IA)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Month 12 Mild Acute (IB)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Month12 Moderate Acute (IIA)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Month 12 Moderate Acute (IIB)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Month 12 Severe Acute (III)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.1', 'ciLowerLimit': '2.1', 'ciUpperLimit': '14.9', 'groupDescription': 'At Month 6, difference in percentage of participants with acute rejection (number with acute rejection/number randomized) using exact method.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.1', 'ciLowerLimit': '2.1', 'ciUpperLimit': '14.9', 'groupDescription': 'At Month 12, difference in percentage of participants with acute rejection using exact method.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'At 6 and 12 months post randomization', 'description': 'AR defined: if either a or b was satisfied: a: the reason for clinical suspicion was reported to be an unexplained rise of serum creatinine ≥ 25% from baseline creatinine; or an unexplained decreased urine output; or fever and graft tenderness and the episode was a case of biopsy proven AR (AR of Banff histopathologic classification Grade IA or higher as assessed by the blinded central pathologist); b: the reason for clinical suspicion was reported to be something other than: an unexplained rise of serum creatinine ≥ 25% from baseline creatinine; or an unexplained decreased urine output; or fever and graft tenderness; the episode was a case of biopsy proven AR, and the participant was treated for this episode. Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification. AR is defined by a renal biopsy demonstrating a Banff 97 classification of Grade IA or greater, with higher scores indicating more severe rejection.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population: All randomized participants were summarized. N=number analyzed for Months 6 and 12'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Surviving With a Functioning Graft, Have Graft Loss or Death (Graft Loss, Death, Death With Functioning Graft) By Month 6 and Month 12 Post Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Belatacept 5 mg/kg', 'description': 'Belatacept 5 mg/kg IV every 28 days.'}, {'id': 'OG001', 'title': 'Calcineurin Inhibitor (CNI)', 'description': 'Participants received a CNI-based immunosuppressive regimen, CsA and TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.'}], 'classes': [{'title': 'Month 6 Surviving with Functioning Graft', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '98.9', 'groupId': 'OG001'}]}]}, {'title': 'Month 6 Graft Loss or Death', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.1', 'groupId': 'OG001'}]}]}, {'title': 'Month 6 Graft Loss', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Month 6 Death', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.1', 'groupId': 'OG001'}]}]}, {'title': 'Month 6 Death with Functioning Graft', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.1', 'groupId': 'OG001'}]}]}, {'title': 'Month 12 Surviving with Functioning Graft', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '98.9', 'groupId': 'OG001'}]}]}, {'title': 'Month 12 Graft Loss or Death', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.1', 'groupId': 'OG001'}]}]}, {'title': 'Month 12 Graft Loss', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Month 12 Death', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.1', 'groupId': 'OG001'}]}]}, {'title': 'Month 12 Death with Functioning Graft', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Percent Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.1', 'ciLowerLimit': '-3.3', 'ciUpperLimit': '6.1', 'groupDescription': 'Participants surviving with a functioning graft by Month 6: For 95% Confidence Interval (CI) of difference, exact method was used.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Percent Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.1', 'ciLowerLimit': '-3.3', 'ciUpperLimit': '6.1', 'groupDescription': 'Participants surviving with a functioning graft by Month 12: For 95% CI of difference, exact method was used.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'At 6 and 12 months post randomization', 'description': 'Graft loss was defined as either functional loss or physical loss. Functional loss was defined as a sustained level of serum creatinine (SCr) ≥ 6.0 mg/dL (530 μmol/L) for ≥ 4 weeks or administration of a maintenance dialysis regimen for at least 56 days or impairment of renal function to such a degree that the participant undergoes re-transplantation.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized were summarized.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Had Any Study Drug Dose Alteration by Month 12 Due to Any Reason - Randomized and Treated Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Belatacept 5 mg/kg', 'description': 'Belatacept 5 mg/kg IV every 28 days.'}, {'id': 'OG001', 'title': 'Calcineurin Inhibitor (CNI)', 'description': 'Participants received a CNI-based immunosuppressive regimen, CsA and tacrolimus TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.'}], 'classes': [{'title': 'Number with Dose Alteration (Any Reason)', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}]}, {'title': 'Decline in renal function', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Treatment of Acute Rejection', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 12', 'description': 'Reasons for study drug dose modification included categories of decline in renal function (as determined by the investigator), treatment of acute rejection, and other reasons. More than 1 reason could be given for dose alteration.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who were randomized and received at least one dose of any study drug.'}, {'type': 'PRIMARY', 'title': 'Mean Change From Baseline in Calculated Glomerular Filtration Rate (GFR) With Imputed Values to 12 Months Post Randomization - All Randomized Participants (Intent-to-Treat Population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Belatacept 5 mg/kg', 'description': 'Belatacept 5 milligrams per kilogram of body weight (mg/kg) given intravenously (IV) every 28 days.'}, {'id': 'OG001', 'title': 'Calcineurin Inhibitor (CNI)', 'description': 'Participants received a CNI-based immunosuppressive regimen, CsA and TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm by Year 3.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.0', 'spread': '11.99', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '10.34', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 12 months post randomization', 'description': 'Calculated GFR assessment used the modification of diet in renal disease (MDRD) formula. GFR was measured as mL/min/1.73 m\\^2. For death or graft loss participants, calculated GFR (cGFR) value 10 was used, for other participants who had a post baseline cGFR value missing, but had baseline value and at least 2 post baseline values available, which were at least 120 days apart, linear regression model was used to impute the cGFR value. Baseline = value at screening. Randomization/First Dose was on Day 1.', 'unitOfMeasure': 'mL/min/1.73 m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) population: all randomized participants with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Composite Endpoint of Death, Graft Loss and Acute Rejection at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Belatacept 5 mg/kg', 'description': 'Belatacept 5 mg/kg IV every 28 days.'}, {'id': 'OG001', 'title': 'Calcineurin Inhibitor (CNI)', 'description': 'Participants received a CNI-based immunosuppressive regimen, CsA and tacrolimus TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.1', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '12.7'}, {'value': '1.1', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '6.1'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.0', 'ciLowerLimit': '-0.1', 'ciUpperLimit': '13.8', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '12 Months post randomization', 'description': 'Percentage=number with composite divided by number randomized. Graft loss was functional loss or physical loss. Functional loss = sustained level of serum creatinine (SCr) ≥ 6.0 mg/dL for ≥ 4 weeks or administration of a maintenance dialysis regimen for at least 56 days or impairment of renal function to such a degree that participant undergoes re-transplantation. AR: if either a or b: (a) the reason for clinical suspicion was reported to be an unexplained rise of serum creatinine ≥ 25% from baseline; or an unexplained decreased urine output; or fever and graft tenderness and the episode was a case of biopsy-proven AR (grade IA or higher as assessed by the blinded central pathologist); (b) the reason for clinical suspicion was reported to be something other than: an unexplained rise of serum creatinine ≥ 25% from baseline; or an unexplained decreased urine output; or fever and graft tenderness; the episode was a case of biopsy-proven AR, and the participant was treated for it.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were randomized were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With New Onset Diabetes Mellitus - All Randomized Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Belatacept 5 mg/kg', 'description': 'Belatacept 5 mg/kg IV every 28 days.'}, {'id': 'OG001', 'title': 'Calcineurin Inhibitor (CNI)', 'description': 'Participants received a CNI-based immunosuppressive regimen, CsA and tacrolimus TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '9.1'}, {'value': '2.9', 'groupId': 'OG001', 'lowerLimit': '0.4', 'upperLimit': '10.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 12 post randomization', 'description': 'A participant who did not have diabetes prior to randomization is determined to have new onset diabetes mellitus if they received an antidiabetic medication for a duration of at least 30 days or at least two fasting plasma glucose (FPG) tests indicated that FPG is \\>=126 mg/dL. Percentage was the number of participants with new onset of diabetes mellitus divided by the number of participants without pre-randomization diabetes.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants without pre-randomization diabetes.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Anti-Donor Human Leukocyte Antigen (HLA) Positive Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Belatacept 5 mg/kg', 'description': 'Belatacept 5 mg/kg given IV every 28 days.'}, {'id': 'OG001', 'title': 'Calcineurin Inhibitor (CNI)', 'description': 'Participants received a CNI-based immunosuppressive regimen, CsA and tacrolimus TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.'}], 'classes': [{'title': 'Baseline (n=80,82)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Month 6 (n=82,82', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Month 12 (n=82, 83)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 6 and Month 12 Post Randomization', 'description': 'Samples were obtained at Day 1 (first dose), Week 24, and Week 52 (or end of therapy). This was a cumulative summary in that once a participant was positive, that participant remained positive for later time points. Evaluation of anti-donor HLA antibodies was performed by an external laboratory (Emory University, Atlanta, Georgia).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who had at least one test result or finding were summarized. n=number of participants analyzed at each specific time point.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline to Month 6 and to Month 12 in Serum Creatinine - All Randomized Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Belatacept 5 mg/kg', 'description': 'Belatacept 5 mg/kg IV every 28 days.'}, {'id': 'OG001', 'title': 'Calcineurin Inhibitor (CNI)', 'description': 'Participants received a CNI-based immunosuppressive regimen, CsA and tacrolimus TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.'}], 'classes': [{'title': 'Month 6 (n=81,82)', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.26', 'groupId': 'OG000'}, {'value': '-0.0', 'spread': '0.20', 'groupId': 'OG001'}]}]}, {'title': 'Month 12 (n=81,86)', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.28', 'groupId': 'OG000'}, {'value': '-0.0', 'spread': '0.21', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Month 6 and Month 12 Post Randomization', 'description': 'Baseline was value at screening or prior to first dose of study drug. Serum creatinine was measured in milligrams per deciliter (mg/dL). Baseline = value at screening.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with baseline and laboratory value at specific time point were summarized.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Serious Adverse Events (SAEs), Deaths, and Discontinuation Due to Adverse Events (AEs) From First Dose up to Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Belatacept 5 mg/kg', 'description': 'Belatacept 5 mg/kg IV every 28 days.'}, {'id': 'OG001', 'title': 'Calcineurin Inhibitor (CNI)', 'description': 'Participants received a CNI-based immunosuppressive regimen, CsA and tacrolimus TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.'}], 'classes': [{'title': 'Deaths', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Treatment Related SAEs', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Discontinued due to SAEs', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Treatment Related AEs', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}, {'title': 'Discontinued due to AEs', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'First Dose (Day 1) to Month 12', 'description': 'AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug were summarized.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in SF-36 Questionnaire Physical Component Score and in Mental Component Score at Month 12 - All Randomized Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Belatacept 5 mg/kg', 'description': 'Belatacept 5 mg/kg IV every 28 days.'}, {'id': 'OG001', 'title': 'Calcineurin Inhibitor (CNI)', 'description': 'Participants received a CNI-based immunosuppressive regimen, CsA and tacrolimus TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.'}], 'classes': [{'title': 'MCS (n=64, 75)', 'categories': [{'measurements': [{'value': '0.3', 'spread': '1.032', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '0.959', 'groupId': 'OG001'}]}]}, {'title': 'PCS (n=64, 75)', 'categories': [{'measurements': [{'value': '0.5', 'spread': '0.808', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '0.752', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.4491', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.1', 'ciLowerLimit': '-1.7', 'ciUpperLimit': '3.9', 'groupDescription': 'Mental Component Scales (MCS)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.7892', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-2.5', 'ciUpperLimit': '1.9', 'groupDescription': 'Physical Component Scales (PCS)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 12', 'description': 'SF-36 was a Participant-Reported Quality of Life (QoL) Short Form (SF) questionnaire. The subscale in the mental component (MCS) part of the instrument ranged from 1 to 6 with 1=all of the time and 6= none of the time. The subscale for physical component (PCS) ranged from 1 to 3 with 1=Yes, limited a lot and 3=No, not limited at all. The subscale for the extent that physical health or emotional problems interfered with normal activities ranged from 1 to 5 with 1=not at all and 5= extremely. Baseline was at randomization or prior to first dose. Baseline = value at screening. The subscale scores were transformed using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who completed the questionnaire at baseline and at Month 12.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline to Month 12 for Eight Domain Scores of Quality of Life (QoL) Instrument SF-36 - All Randomized Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Belatacept 5 mg/kg', 'description': 'Belatacept 5 mg/kg IV every 28 days.'}, {'id': 'OG001', 'title': 'Calcineurin Inhibitor (CNI)', 'description': 'Participants received a CNI-based immunosuppressive regimen, CsA and tacrolimus TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.'}], 'classes': [{'title': 'Bodily Pain (n=74,79)', 'categories': [{'measurements': [{'value': '0.7', 'spread': '0.979', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.950', 'groupId': 'OG001'}]}]}, {'title': 'General Health (n=75,79)', 'categories': [{'measurements': [{'value': '1.6', 'spread': '0.921', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '0.900', 'groupId': 'OG001'}]}]}, {'title': 'Mental Health (n=73,79)', 'categories': [{'measurements': [{'value': '0.7', 'spread': '0.913', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '0.881', 'groupId': 'OG001'}]}]}, {'title': 'Physical Functioning (n=67,75)', 'categories': [{'measurements': [{'value': '-0.5', 'spread': '0.840', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '0.800', 'groupId': 'OG001'}]}]}, {'title': 'Role Emotional (n=75,79)', 'categories': [{'measurements': [{'value': '-1.4', 'spread': '1.043', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '1.021', 'groupId': 'OG001'}]}]}, {'title': 'Role Physical (n=75,79)', 'categories': [{'measurements': [{'value': '0.5', 'spread': '0.961', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '0.939', 'groupId': 'OG001'}]}]}, {'title': 'Social Functioning (n=75,79)', 'categories': [{'measurements': [{'value': '0.9', 'spread': '0.929', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '0.906', 'groupId': 'OG001'}]}]}, {'title': 'Vitality (n=73,79)', 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.973', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '0.940', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (screening) to Month 12', 'description': 'SF-36 was a Participant-Reported Quality of Life (QoL) Short Form (SF) questionnaire measuring health-related quality of life (HRQL) covering 8 domains of physical and mental component summaries: physical function, role limitations due to physical problems, pain, general health perception, and vitality, social function, role limitations due to emotional problems, and mental health.\n\nAll domains were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants with available questionnaires were analyzed.'}, {'type': 'SECONDARY', 'title': 'Ridit Score at Month 12 - All Randomized Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Belatacept 5 mg/kg', 'description': 'Belatacept 5 mg/kg IV every 28 days.'}, {'id': 'OG001', 'title': 'Calcineurin Inhibitor (CNI)', 'description': 'Participants received a CNI-based immunosuppressive regimen, CsA and tacrolimus TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.'}], 'classes': [{'title': 'Symptom Distress (n=46,44)', 'categories': [{'measurements': [{'value': '0.5162', 'groupId': 'OG000'}, {'value': '0.5014', 'groupId': 'OG001'}]}]}, {'title': 'Symptom Occurrence (n=46,45)', 'categories': [{'measurements': [{'value': '0.5074', 'groupId': 'OG000'}, {'value': '0.4998', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimated Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '.0076', 'ciLowerLimit': '-.010', 'ciUpperLimit': '.0252', 'groupDescription': 'Difference in Symptom Occurrence between treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimated Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '.0148', 'ciLowerLimit': '-.002', 'ciUpperLimit': '.0321', 'groupDescription': 'Difference in Symptom Distress between treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Month 12', 'description': 'The Modified Transplant Symptom Occurrence and Symptom Distress Scale (MTSOSD-59R) was used to assess the occurrence (never, occasionally, regularly, almost always, always) and distress (0=no distress to 4=terrible distress) of symptoms associated with immunosuppressive therapies. Ridit (relative to an identified distribution) analysis (Fleiss JL. Statistical methods for rates and proportions. New York: John Wiley \\& Sons, Inc. 1991) was used. Ridit scores were calculated at 12 months for overall symptom occurrence score and overall symptom distress. The Ridit score reflects the probability that a score observed for an individual randomly selected from a group would be higher (worse symptom) than a score observed for a randomly selected individual from the reference group. The reference group was constituted by the frequency distribution of the responses of all participants on all items at baseline. The ridit of the reference group is by definition, 0.5.', 'unitOfMeasure': 'Ridit score', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with MTSOSD-59R data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Meeting Marked Laboratory Abnormality Criteria From Baseline up to Month 12 - Randomized and Treated Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Belatacept 5 mg/kg', 'description': 'Belatacept 5 mg/kg IV every 28 days.'}, {'id': 'OG001', 'title': 'Calcineurin Inhibitor (CNI)', 'description': 'Participants received a CNI-based immunosuppressive regimen, CsA and tacrolimus TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.'}], 'classes': [{'title': 'Leukocytes Low', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Lymphocytes Low', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Bilirubin High', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Potassium Low', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Potassium High', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Magnesium High', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Sodium Low', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Phosphorus Inorganic Low', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Uric Acid High', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Month 12', 'description': 'Upper limits of normal (ULL). Leukocytes: \\< 2.0\\*10\\^3 cells per microliter (c/µL); Lymphocytes (absolute): \\< 0.5\\*10\\^3 c/µL; bilirubin: \\> 3.0\\*ULN milligrams per deciliter (mg/dL); Potassium: \\< 3.0 milliequivalents per liter (meq/L) or \\> 6.0 meq/L; Magnesium \\>2.6 meq/L; Sodium: \\< 130 meq/L; Phosphorus: \\< 2.0 mg/dL; Uric Acid: \\> 10 mg/dL. Baseline = value at screening.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study drug and had a laboratory value available post randomization. N= number of participants analyzed in all categories'}, {'type': 'SECONDARY', 'title': 'Long Term Period: Mean Change From Baseline to 54 Months Post Randomization in Calculated GFR on Imputed Values at Specified Timepoints - Intent to Treat (ITT) Participants Who Entered LT Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Belatacept 5 mg/kg', 'description': 'Belatacept 5 mg/kg IV every 28 days.'}, {'id': 'OG001', 'title': 'Calcineurin Inhibitor (CNI)', 'description': 'Participants received a CNI-based immunosuppressive regimen, CsA and tacrolimus TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.'}], 'classes': [{'title': 'Month 3 (n=81, 81)', 'categories': [{'measurements': [{'value': '5.1', 'spread': '10.16', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '9.92', 'groupId': 'OG001'}]}]}, {'title': 'Month 6 (n=80, 77)', 'categories': [{'measurements': [{'value': '7.1', 'spread': '11.94', 'groupId': 'OG000'}, {'value': '2.3', 'spread': '8.95', 'groupId': 'OG001'}]}]}, {'title': 'Month 12 (n=81, 81)', 'categories': [{'measurements': [{'value': '7.1', 'spread': '12.02', 'groupId': 'OG000'}, {'value': '2.8', 'spread': '9.70', 'groupId': 'OG001'}]}]}, {'title': 'Month 18 (n=81, 75)', 'categories': [{'measurements': [{'value': '8.8', 'spread': '13.88', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '12.47', 'groupId': 'OG001'}]}]}, {'title': 'Month 24 (n=81, 78)', 'categories': [{'measurements': [{'value': '8.8', 'spread': '13.77', 'groupId': 'OG000'}, {'value': '-0.0', 'spread': '14.84', 'groupId': 'OG001'}]}]}, {'title': 'Month 30 (n=80, 69)', 'categories': [{'measurements': [{'value': '9.1', 'spread': '16.10', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '14.45', 'groupId': 'OG001'}]}]}, {'title': 'Month 36 (n=57, 52)', 'categories': [{'measurements': [{'value': '7.7', 'spread': '15.91', 'groupId': 'OG000'}, {'value': '3.9', 'spread': '17.46', 'groupId': 'OG001'}]}]}, {'title': 'Month 42 (n=71, 54)', 'categories': [{'measurements': [{'value': '9.1', 'spread': '17.56', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '17.04', 'groupId': 'OG001'}]}]}, {'title': 'Month 48 (n=16, 32)', 'categories': [{'measurements': [{'value': '-1.7', 'spread': '32.15', 'groupId': 'OG000'}, {'value': '4.2', 'spread': '18.03', 'groupId': 'OG001'}]}]}, {'title': 'Month 54 (n=14, 26)', 'categories': [{'measurements': [{'value': '-0.9', 'spread': '35.69', 'groupId': 'OG000'}, {'value': '2.4', 'spread': '18.72', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 3, 6, 12, 18, 24, 30, 36, 42, 48, 54', 'description': 'ITT=participants randomized to their original treatment arm and who entered the LT period are presented. Baseline=value at screening. Calculated GFR assessment used the MDRD formula. GFR was measured as mL/min/1.73 m\\^2. For death or graft loss participants, calculated GFR (cGFR) value of 0 was imputed and carried forward after death or graft loss up to the end of the analysis period. Sponsor discontinued the CNI treatment arm in Year 3, and participants treated with CNI could elect to switch to belatacept. If a participant did not switch to belatacept, they were required to discontinue from the study. Therefore, efficacy results from Month 36 through Month 54 are difficult to interpret. No formal comparisons were planned between the belatacept and CNI treatment groups post Month 36, and the data up to the final database lock should be interpreted with caution.', 'unitOfMeasure': 'mL/min/1.73 m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants randomized to their original treatment arm who entered the LT Period (ITT - LT) and had data at baseline and at specific timepoints . Participants were grouped according to the treatment to which they were randomized (belatacept or CNI).'}, {'type': 'SECONDARY', 'title': 'Long Term Period: Number of Participants With Acute Rejection (AR) - All Randomized Participants in LT Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Belatacept 5 mg/kg', 'description': 'Belatacept 5 mg/kg IV every 28 days.'}, {'id': 'OG001', 'title': 'Calcineurin Inhibitor (CNI)', 'description': 'Participants received a CNI-based immunosuppressive regimen, CsA and tacrolimus TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.'}], 'classes': [{'title': 'Total Number', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Mild Acute IA', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Mild Acute IB', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Moderate Acute IIA', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Moderate Acute IIB', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Severe Acute III', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Post Month 12 up to Year 6 of the Study', 'description': 'AR was defined: if either a or b was satisfied: (a) the reason for clinical suspicion was reported to be an unexplained rise of serum creatinine ≥ 25% from baseline creatinine; or an unexplained decreased urine output; or fever and graft tenderness and the episode was a case of biopsy proven AR (AR of Banff histopathologic classification grade IA or higher as assessed by the blinded central pathologist); (b) the reason for clinical suspicion was reported to be something other than: an unexplained rise of serum creatinine ≥ 25% from baseline creatinine; or an unexplained decreased urine output; or fever and graft tenderness; the episode was a case of biopsy proven AR, and the participant was treated for this episode. Banff 97 working classification of kidney transplant pathology was used to categorize the severity of the AR.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants, randomized to their original treatment arm, who entered the LT Period (ITT - LT) were analyzed. Participants were grouped according to the treatment to which they were randomized (belatacept or CNI).'}, {'type': 'SECONDARY', 'title': 'Long Term Period: Number of Participants Who Survived With a Functioning Graft or Survived With Pure Graft Loss or Death With Functioning Graft - ITT Participants Who Entered the LT Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Belatacept 5 mg/kg', 'description': 'Belatacept 5 mg/kg IV every 28 days.'}, {'id': 'OG001', 'title': 'Calcineurin Inhibitor (CNI)', 'description': 'Participants received a CNI-based immunosuppressive regimen, CsA and tacrolimus TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.'}], 'classes': [{'title': 'Month 24 Surviving with Functioning Graft', 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}]}, {'title': 'Month 24 Graft Loss or Death', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Month 24 Graft Loss', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Month 24 Death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Month 36 Surviving with Functioning Graft', 'categories': [{'measurements': [{'value': '79', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}]}, {'title': 'Month 36 Graft Loss or Death', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Month 36 Graft Loss', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Month 36 Death', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Month 36 Death with Functioning Graft', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Month 48 Surviving with Functioning Graft', 'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}]}, {'title': 'Month 48 Graft Loss or Death', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Month 48 Graft Loss', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Month 48 Death', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Month 48 Death with Functioning Graft', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'up to year 6 Surviving with Functioning Graft', 'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}]}, {'title': 'up to year 6 Graft Loss or Death', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'up to year 6 Graft Loss', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'up to year 6, Death', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'up to year 6 Death with Functioning Graft', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Post Months 24, 36, 48, up to Year 6 of the Study', 'description': 'Graft loss = either pure graft loss (participant survived to the end of the study period after graft loss) or death with functioning graft. Pure graft loss = either functional loss or physical loss. Functional loss = a sustained level of serum creatinine (SCr) ≥ 6.0 mg/dL (530 μmol/L) for ≥ 4 weeks or administration of a maintenance dialysis regimen for at least 56 days or impairment of renal function to such a degree that the participant undergoes re-transplantation. The table was designed with built-in redundancy to capture all possible combinations of death and/or graft loss, but not all lines can be summed to reach the total number surviving and the total number who die and/or lose grafts. If a participant experiences pure graft loss and dies at a later date independent of the graft loss event, they are counted only once in the cumulative tabulation of death or graft loss. Only the first event experienced by the participant counted toward the cumulative total.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants, randomized to their original treatment arm, who entered the LT Period (ITT - LT) were analyzed. Participants were grouped according to the treatment to which they were randomized (belatacept or CNI).'}, {'type': 'SECONDARY', 'title': 'Long Term Period: Percentage of Participants With New Onset Diabetes Mellitus Up to Month 36- All Randomized Participants Who Entered LT Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Belatacept 5 mg/kg', 'description': 'Belatacept 5 mg/kg IV every 28 days.'}, {'id': 'OG001', 'title': 'Calcineurin Inhibitor (CNI)', 'description': 'Participants received a CNI-based immunosuppressive regimen, CsA and tacrolimus TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.9', 'groupId': 'OG000', 'lowerLimit': '1.9', 'upperLimit': '16.7'}, {'value': '4.8', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '13.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (screening) up to Month 36 post randomization', 'description': 'A participant who did not have diabetes prior to randomization is determined to have new onset diabetes mellitus if they received an antidiabetic medication for a duration of at least 30 days or at least two fasting plasma glucose (FPG) tests indicated that FPG is \\>=126 mg/dL. Percentage was the number of participants with new onset of diabetes mellitus divided by the number of participants without pre-randomization diabetes.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants without pre-randomization diabetes, who were randomized and entered LT Period.'}, {'type': 'SECONDARY', 'title': 'Long Term Period: Number of Participants With SAEs, Death, Discontinuation Due to AEs - All Randomized Participants Who Entered the Long Term Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Belatacept 5 mg/kg', 'description': 'Belatacept 5 mg/kg IV every 28 days.'}, {'id': 'OG001', 'title': 'Calcineurin Inhibitor (CNI)', 'description': 'Participants received a CNI-based immunosuppressive regimen, CsA and tacrolimus TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.'}], 'classes': [{'title': 'Deaths', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}, {'title': 'Treatment Related SAEs', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Discontinued Due to SAEs', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Treatment Related AEs', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}]}, {'title': 'Discontinued Due to AEs', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'First dose after randomization (Day 1) to 56 days post last dose, up to Year 6 of the Study', 'description': 'AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of study drug, were randomized to their original treatment arm, and who entered the LT Period (ITT - LT) were analyzed. Participants were grouped according to the treatment to which they were randomized (belatacept or CNI).'}, {'type': 'SECONDARY', 'title': 'Long Term Period: Number of Participants With AEs of Special Interest - All Randomized Participants Who Entered the Long Term Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Belatacept 5 mg/kg', 'description': 'Belatacept 5 mg/kg IV every 28 days.'}, {'id': 'OG001', 'title': 'Calcineurin Inhibitor (CNI)', 'description': 'Participants received a CNI-based immunosuppressive regimen, CsA and tacrolimus TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.'}], 'classes': [{'title': 'Malignancies', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Serious Infections', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}, {'title': 'Thrombolic/embolic', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Peri-infusional Events', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Acute Peri-infusional Events', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Autoimmune Disease', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Pulmonary Edema/Congestive Heart Failure', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'First dose after randomization (Day 1) to last dose, plus 56 days, up to Year 6 of the Study', 'description': 'Prospectively identified events of special interest which were a subset of all AEs, and were either SAEs or non-serious AEs, included the following categories: Serious Infections, Thrombolic/embolic events, Autoimmune Disease, Malignancy, Peri-infusional reactions (only belatacept treatment group was IV) , Acute Peri-infusional events occurring within 24 hours of injection, Pulmonary Edema and Congestive Heart Failure. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of study drug, were randomized to their original treatment arm, and who entered the LT Period (ITT - LT) were analyzed. Participants were grouped according to the treatment to which they were randomized (belatacept or CNI).'}, {'type': 'SECONDARY', 'title': 'Long Term Period: Mean Change From Baseline to Month 54 in Serum Creatinine- ITT Participants Who Entered LT Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Belatacept 5 mg/kg', 'description': 'Belatacept 5 mg/kg IV every 28 days.'}, {'id': 'OG001', 'title': 'Calcineurin Inhibitor (CNI)', 'description': 'Participants received a CNI-based immunosuppressive regimen, CsA and tacrolimus TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.'}], 'classes': [{'title': 'Month 3 (n=81,81)', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.24', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.21', 'groupId': 'OG001'}]}]}, {'title': 'Month 6 (n=81,77)', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.26', 'groupId': 'OG000'}, {'value': '-0.0', 'spread': '0.19', 'groupId': 'OG001'}]}]}, {'title': 'Month 12 (n=81,81)', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.28', 'groupId': 'OG000'}, {'value': '-0.0', 'spread': '0.21', 'groupId': 'OG001'}]}]}, {'title': 'Month 18 (n=80,75)', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.31', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.77', 'groupId': 'OG001'}]}]}, {'title': 'Month 24 (n=80,77)', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.28', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.37', 'groupId': 'OG001'}]}]}, {'title': 'Month 30 (n=78, 68)', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '0.35', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.32', 'groupId': 'OG001'}]}]}, {'title': 'Month 36 (n=55, 51)', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.29', 'groupId': 'OG000'}, {'value': '-0.0', 'spread': '0.39', 'groupId': 'OG001'}]}]}, {'title': 'Month 42 (n=68, 53)', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '0.30', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.41', 'groupId': 'OG001'}]}]}, {'title': 'Month 48 (n=12, 31)', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '0.16', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '0.30', 'groupId': 'OG001'}]}]}, {'title': 'Month 54 (n=10, 25)', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.25', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '0.29', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Months 3, 6, 12, 18, 24, 30, 36, 42, 48, 54', 'description': 'Baseline was value at screening. Serum creatinine was measured in mg/dL. Only participants who entered into Long Term Period were included in the analysis.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of study drug, were randomized to their original treatment arm, who entered the LT Period (ITT - LT), and had laboratory values were analyzed. Participants were grouped according to the treatment to which they were randomized (belatacept or CNI). n=entered LT Period with laboratory value available.'}, {'type': 'SECONDARY', 'title': 'Long Term Period: Number of Participants Meeting Marked Laboratory Abnormality Criteria - All ITT Participants Who Entered the Long Term Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Belatacept 5 mg/kg', 'description': 'Belatacept 5 mg/kg IV every 28 days.'}, {'id': 'OG001', 'title': 'Calcineurin Inhibitor (CNI)', 'description': 'Participants received a CNI-based immunosuppressive regimen, CsA and tacrolimus TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.'}], 'classes': [{'title': 'Hemoglobin Low', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Platelet Count Low', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Leukocytes Low', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Lymphocytes Low', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Neutrophils Low', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'ALT High', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Bilirubin High', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine High', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Calcium Low', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Bicarbonate Low', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Potassium Low', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Potassium High', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Magnesium High', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Sodium Low', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Phosphorus Inorganic Low', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Uric Acid High', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Screening), up to Year 6 of the Study', 'description': 'Upper limits of normal (ULN). Hemoglobin: \\< 8 g/dL; Platelet count: \\< 50\\*10\\^9 c/L; Leukocytes: \\< 2.0\\*10\\^3 c/µL; Lymphocytes (absolute): \\< 0.5\\*10\\^3 c/µL; Neutrophils: \\< 1.0\\*10\\^3 c/µL; Alanine Aminotransferase (ALT): \\> 5.0\\*ULN Units per liter (U/L); bilirubin: \\> 3.0\\*ULN mg/dL; Creatinine: \\> 3.0\\*ULN mg/dL; Calcium: \\< 7 mg/dL; Bicarbonate: \\> 12.5 mg/dL; Potassium: \\< 3.0 meq/L or \\> 6.0 meq/L; Magnesium \\>2.6 meq/L; Sodium: \\< 130 meq/L; Phosphorus: \\< 2.0 mg/dL; Uric Acid: \\> 10 mg/dL.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of study drug, were randomized to their original treatment arm, who entered the LT Period (ITT - LT), and had laboratory values were analyzed. Participants were grouped according to the treatment to which they were randomized (belatacept or CNI). n=entered LT Period with laboratory value available.'}, {'type': 'SECONDARY', 'title': 'Long Term Period: Mean Change From Baseline to Month 54 in Systolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Belatacept 5 mg/kg', 'description': 'Belatacept 5 mg/kg IV every 28 days.'}, {'id': 'OG001', 'title': 'Calcineurin Inhibitor (CNI)', 'description': 'Participants received a CNI-based immunosuppressive regimen, CsA and tacrolimus TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.'}], 'classes': [{'title': 'Month 6 (n=78,73)', 'categories': [{'measurements': [{'value': '-3.6', 'spread': '19.06', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '17.52', 'groupId': 'OG001'}]}]}, {'title': 'Month 12 (n=77,71)', 'categories': [{'measurements': [{'value': '-4.6', 'spread': '18.33', 'groupId': 'OG000'}, {'value': '-4.2', 'spread': '16.26', 'groupId': 'OG001'}]}]}, {'title': 'Month 18 (n=77,1)', 'categories': [{'measurements': [{'value': '-4.4', 'spread': '17.40', 'groupId': 'OG000'}, {'value': '9.0', 'spread': 'NA', 'comment': 'Only 1 participant was available for analysis so standard deviation was not calculated.', 'groupId': 'OG001'}]}]}, {'title': 'Month 24 (n=77,1)', 'categories': [{'measurements': [{'value': '-6.0', 'spread': '17.94', 'groupId': 'OG000'}, {'value': '4.0', 'spread': 'NA', 'comment': 'Only 1 participant was available for analysis so standard deviation was not calculated.', 'groupId': 'OG001'}]}]}, {'title': 'Month 30 (n=75, 6)', 'categories': [{'measurements': [{'value': '-3.6', 'spread': '17.94', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '20.78', 'groupId': 'OG001'}]}]}, {'title': 'Month 36 (n=75,13)', 'categories': [{'measurements': [{'value': '-6.6', 'spread': '17.49', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '13.61', 'groupId': 'OG001'}]}]}, {'title': 'Month 42 (n=74, 29)', 'categories': [{'measurements': [{'value': '-5.4', 'spread': '17.08', 'groupId': 'OG000'}, {'value': '-3.5', 'spread': '19.33', 'groupId': 'OG001'}]}]}, {'title': 'Month 48 (n=73,32)', 'categories': [{'measurements': [{'value': '-4.4', 'spread': '16.16', 'groupId': 'OG000'}, {'value': '-3.7', 'spread': '14.35', 'groupId': 'OG001'}]}]}, {'title': 'Month 54 (n=72,33)', 'categories': [{'measurements': [{'value': '-4.9', 'spread': '16.90', 'groupId': 'OG000'}, {'value': '-3.8', 'spread': '12.96', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Months 6, 12, 18, 24, 30, 36, 42, 48, 54', 'description': 'Blood pressure was measured while the participant was sitting quietly for 5 minutes and was measured in millimeters of mercury (mmHg). Baseline was value at screening. Only those participants who entered long term period were evaluated.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of study drug, were randomized to their original treatment arm, who entered the LT Period (ITT - LT), and had laboratory values were analyzed. Participants were grouped according to the treatment to which they were randomized (belatacept or CNI). n=entered LT Period with laboratory value available.'}, {'type': 'SECONDARY', 'title': 'Long Term Period: Mean Change From Baseline to Month 54 in Diastolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Belatacept 5 mg/kg', 'description': 'Belatacept 5 mg/kg IV every 28 days.'}, {'id': 'OG001', 'title': 'Calcineurin Inhibitor (CNI)', 'description': 'Participants received a CNI-based immunosuppressive regimen, CsA and tacrolimus TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.'}], 'classes': [{'title': 'Month 6 (n=78,73)', 'categories': [{'measurements': [{'value': '-2.0', 'spread': '10.78', 'groupId': 'OG000'}, {'value': '-2.2', 'spread': '10.50', 'groupId': 'OG001'}]}]}, {'title': 'Month 12 (n=77,71)', 'categories': [{'measurements': [{'value': '-2.5', 'spread': '11.54', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '11.04', 'groupId': 'OG001'}]}]}, {'title': 'Month 18 (n=77,1)', 'categories': [{'measurements': [{'value': '-1.7', 'spread': '11.79', 'groupId': 'OG000'}, {'value': '10.0', 'spread': 'NA', 'comment': 'Only 1 participant was available for analysis so standard deviation was not calculated.', 'groupId': 'OG001'}]}]}, {'title': 'Month 24 (n=77,1)', 'categories': [{'measurements': [{'value': '-3.9', 'spread': '10.19', 'groupId': 'OG000'}, {'value': '13.0', 'spread': 'NA', 'comment': 'Only 1 participant was available for analysis so standard deviation was not calculated.', 'groupId': 'OG001'}]}]}, {'title': 'Month 30 (n=75,6)', 'categories': [{'measurements': [{'value': '-1.8', 'spread': '10.97', 'groupId': 'OG000'}, {'value': '5.7', 'spread': '9.14', 'groupId': 'OG001'}]}]}, {'title': 'Month 36 (n=75,13)', 'categories': [{'measurements': [{'value': '-1.9', 'spread': '10.86', 'groupId': 'OG000'}, {'value': '-1.6', 'spread': '7.69', 'groupId': 'OG001'}]}]}, {'title': 'Month 42 (n=74,29)', 'categories': [{'measurements': [{'value': '-1.7', 'spread': '11.70', 'groupId': 'OG000'}, {'value': '-3.8', 'spread': '10.99', 'groupId': 'OG001'}]}]}, {'title': 'Month 48 (n=73, 32)', 'categories': [{'measurements': [{'value': '-3.2', 'spread': '10.53', 'groupId': 'OG000'}, {'value': '-3.6', 'spread': '11.92', 'groupId': 'OG001'}]}]}, {'title': 'Month 54 (n=72, 33)', 'categories': [{'measurements': [{'value': '-1.1', 'spread': '10.86', 'groupId': 'OG000'}, {'value': '-3.6', 'spread': '11.72', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Months 6, 12, 18, 24, 30, 36, 42, 48, 54', 'description': 'Blood pressure was measured while the participant was sitting quietly for 5 minutes and was measured in mmHg. Baseline was value at screening. Only those participants who entered long term period were evaluated.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of study drug, were randomized to their original treatment arm, who entered the LT Period (ITT - LT), and had laboratory values were analyzed. Participants were grouped according to the treatment to which they were randomized (belatacept or CNI). n=entered LT Period with laboratory value available.'}, {'type': 'SECONDARY', 'title': 'Participants Who Switched From CNI to Belatacept in Long Term Period : Mean Change in Calculated GFR Based on Imputed Values From Day of Switch to Week 96 Post Switch', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Belatacept 5 mg/kg in Participants Switched During LT Period', 'description': 'During the long term treatment period participants who had been randomized to CNI were allowed to switch to belatacept. For those switching to belatacept, the CNI dose was tapered and discontinued, after which they received belatacept 5 mg/kg IV every 2 weeks for 2 months. Thereafter, they received belatacept 5 mg/kg IV every 28 days.'}], 'classes': [{'title': 'Week 4 Post Switch (n=30)', 'categories': [{'measurements': [{'value': '1.3', 'spread': '5.85', 'groupId': 'OG000'}]}]}, {'title': 'Week 12 Post Switch (n=33)', 'categories': [{'measurements': [{'value': '3.3', 'spread': '9.88', 'groupId': 'OG000'}]}]}, {'title': 'Week 24 Post Switch (n= 29)', 'categories': [{'measurements': [{'value': '2.1', 'spread': '10.66', 'groupId': 'OG000'}]}]}, {'title': 'Week 48 Post Switch (n= 12)', 'categories': [{'measurements': [{'value': '0.3', 'spread': '7.75', 'groupId': 'OG000'}]}]}, {'title': 'Week 96 Post Switch (n= 8)', 'categories': [{'measurements': [{'value': '0.1', 'spread': '10.33', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day of Switch (first belatacept dose) to Week 96 Post Switch', 'description': 'Calculated GFR assessment used the MDRD formula. GFR was measured as mL/min/1.73 m\\^2. For death or graft loss participants, calculated GFR (cGFR) value 10 was used, for other participants who had a post baseline cGFR value missing, but had baseline value and at least 2 post baseline values available, which were at least 120 days apart, linear regression model was used to impute the cGFR value. Day of Switch = the first belatacept infusion day.', 'unitOfMeasure': 'mL/min/1.73 m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized and treated participants who switched from CNI to belatacept during the long-term period were summarized. n=number of participants with data available at specific time point'}, {'type': 'SECONDARY', 'title': 'Participants Who Switched to Belatacept in Long Term Period: Number of Participants With AEs and SAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Belatacept 5 mg/kg in Participants Switched During LT Period', 'description': 'During the long term treatment period participants were allowed to switch from CNI to belatacept. For those switching to belatacept, the CNI dose was tapered and discontinued, after which they received belatacept 5 mg/kg IV every 2 weeks for 2 months. Thereafter, they received belatacept 5 mg/kg IV every 28 days.'}], 'classes': [{'title': 'AEs', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day of Switch (first dose of belatacept ) to last dose plus 56 days, up to Year 6 of the Study', 'description': 'AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Day of Switch = the first belatacept infusion day.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized and treated participants who switched from CNI to belatacept during the long-term period were summarized.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Belatacept 5 mg/kg', 'description': 'Belatacept 5 milligrams per kilogram of body weight (mg/kg) given intravenously (IV) every 28 days.'}, {'id': 'FG001', 'title': 'Calcineurin Inhibitor (CNI)', 'description': 'Participants received a calcineurin inhibitor (CNI)-based immunosuppressive regimen, Cyclosporin A (CsA) and tacrolimus (TAC). CsA was to be adjusted to maintain a range of trough serum concentrations of 100 - 250 nanograms per milliliter (ng/mL). TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the long term (LT) treatment period participants were allowed to switch to belatacept treatment arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.'}], 'periods': [{'title': 'Randomized', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '84'}, {'groupId': 'FG001', 'numSubjects': '89'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '83'}, {'groupId': 'FG001', 'numSubjects': '88'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Treatment (up to 12 Months)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '83'}, {'groupId': 'FG001', 'numSubjects': '88'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '81'}, {'groupId': 'FG001', 'numSubjects': '86'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'non-specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Long Term (LT)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '81'}, {'comment': '5 completed 12 months, did not enter long term: 1 AE, 1 lack of efficacy, 3 other(non-specified).', 'groupId': 'FG001', 'numSubjects': '81'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '70'}, {'groupId': 'FG001', 'numSubjects': '64'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '17'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'non-specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}, {'title': 'Switched From CNI to Belatacept in LT', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Participants switched from CNI to Belatacept during LT period.', 'groupId': 'FG000', 'numSubjects': '38'}, {'comment': 'Out of 81 starting LT period in CNI group, 38 switched from CNI to Belatacept during the LT period.', 'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': '173 participants were enrolled, 2 participants discontinued the study following randomization, without receiving any study drug.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '173', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Belatacept 5 mg/kg', 'description': 'Belatacept 5 mg/kg IV every 28 days.'}, {'id': 'BG001', 'title': 'Calcineurin Inhibitor (CNI)', 'description': 'Participants received a CNI-based immunosuppressive regimen, CsA and TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45.3', 'spread': '13.5', 'groupId': 'BG000'}, {'value': '44.3', 'spread': '13.0', 'groupId': 'BG001'}, {'value': '44.8', 'spread': '13.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '18 - 45 years', 'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}]}]}, {'title': '46 - 65 years', 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}]}, {'title': 'Greater than (>) 65 years', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '126', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Participants randomized to a treatment arm.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 173}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'dispFirstSubmitDate': '2010-04-29', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-07', 'studyFirstSubmitDate': '2006-11-20', 'dispFirstSubmitQcDate': '2010-04-29', 'resultsFirstSubmitDate': '2015-11-10', 'studyFirstSubmitQcDate': '2006-11-21', 'dispFirstPostDateStruct': {'date': '2010-05-03', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2017-01-05', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-11-07', 'studyFirstPostDateStruct': {'date': '2006-11-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-01-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Change From Baseline in Calculated Glomerular Filtration Rate (GFR) With Imputed Values to 12 Months Post Randomization - All Randomized Participants (Intent-to-Treat Population)', 'timeFrame': 'Baseline to 12 months post randomization', 'description': 'Calculated GFR assessment used the modification of diet in renal disease (MDRD) formula. GFR was measured as mL/min/1.73 m\\^2. For death or graft loss participants, calculated GFR (cGFR) value 10 was used, for other participants who had a post baseline cGFR value missing, but had baseline value and at least 2 post baseline values available, which were at least 120 days apart, linear regression model was used to impute the cGFR value. Baseline = value at screening. Randomization/First Dose was on Day 1.'}], 'secondaryOutcomes': [{'measure': 'Mean Change From Baseline in Calculated Glomerular Filtration Rate (GFR) With Imputed Values to 6 Months Post Randomization - All Randomized Participants (Intent-to-Treat Population)', 'timeFrame': 'Baseline to 6 months post randomization', 'description': 'Calculated GFR assessment used the modification of diet in renal disease (MDRD) formula. GFR was measured as mL/min/1.73 m\\^2. For death or graft loss participants, calculated GFR (cGFR) value 10 was used, for other participants who had a post baseline cGFR value missing, but had baseline value and at least 2 post baseline values available, which were at least 120 days apart, linear regression model was used to impute the cGFR value. Baseline = value at screening.'}, {'measure': 'Number of Participants With Acute Rejection (AR) by Months 6 and 12 Post Randomization - All Randomized Participants', 'timeFrame': 'At 6 and 12 months post randomization', 'description': 'AR defined: if either a or b was satisfied: a: the reason for clinical suspicion was reported to be an unexplained rise of serum creatinine ≥ 25% from baseline creatinine; or an unexplained decreased urine output; or fever and graft tenderness and the episode was a case of biopsy proven AR (AR of Banff histopathologic classification Grade IA or higher as assessed by the blinded central pathologist); b: the reason for clinical suspicion was reported to be something other than: an unexplained rise of serum creatinine ≥ 25% from baseline creatinine; or an unexplained decreased urine output; or fever and graft tenderness; the episode was a case of biopsy proven AR, and the participant was treated for this episode. Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification. AR is defined by a renal biopsy demonstrating a Banff 97 classification of Grade IA or greater, with higher scores indicating more severe rejection.'}, {'measure': 'Percentage of Participants Surviving With a Functioning Graft, Have Graft Loss or Death (Graft Loss, Death, Death With Functioning Graft) By Month 6 and Month 12 Post Randomization', 'timeFrame': 'At 6 and 12 months post randomization', 'description': 'Graft loss was defined as either functional loss or physical loss. Functional loss was defined as a sustained level of serum creatinine (SCr) ≥ 6.0 mg/dL (530 μmol/L) for ≥ 4 weeks or administration of a maintenance dialysis regimen for at least 56 days or impairment of renal function to such a degree that the participant undergoes re-transplantation.'}, {'measure': 'Number of Participants Who Had Any Study Drug Dose Alteration by Month 12 Due to Any Reason - Randomized and Treated Participants', 'timeFrame': 'Month 12', 'description': 'Reasons for study drug dose modification included categories of decline in renal function (as determined by the investigator), treatment of acute rejection, and other reasons. More than 1 reason could be given for dose alteration.'}, {'measure': 'Percentage of Participants With a Composite Endpoint of Death, Graft Loss and Acute Rejection at Month 12', 'timeFrame': '12 Months post randomization', 'description': 'Percentage=number with composite divided by number randomized. Graft loss was functional loss or physical loss. Functional loss = sustained level of serum creatinine (SCr) ≥ 6.0 mg/dL for ≥ 4 weeks or administration of a maintenance dialysis regimen for at least 56 days or impairment of renal function to such a degree that participant undergoes re-transplantation. AR: if either a or b: (a) the reason for clinical suspicion was reported to be an unexplained rise of serum creatinine ≥ 25% from baseline; or an unexplained decreased urine output; or fever and graft tenderness and the episode was a case of biopsy-proven AR (grade IA or higher as assessed by the blinded central pathologist); (b) the reason for clinical suspicion was reported to be something other than: an unexplained rise of serum creatinine ≥ 25% from baseline; or an unexplained decreased urine output; or fever and graft tenderness; the episode was a case of biopsy-proven AR, and the participant was treated for it.'}, {'measure': 'Percentage of Participants With New Onset Diabetes Mellitus - All Randomized Participants', 'timeFrame': 'Month 12 post randomization', 'description': 'A participant who did not have diabetes prior to randomization is determined to have new onset diabetes mellitus if they received an antidiabetic medication for a duration of at least 30 days or at least two fasting plasma glucose (FPG) tests indicated that FPG is \\>=126 mg/dL. Percentage was the number of participants with new onset of diabetes mellitus divided by the number of participants without pre-randomization diabetes.'}, {'measure': 'Number of Participants With Anti-Donor Human Leukocyte Antigen (HLA) Positive Antibodies', 'timeFrame': 'Month 6 and Month 12 Post Randomization', 'description': 'Samples were obtained at Day 1 (first dose), Week 24, and Week 52 (or end of therapy). This was a cumulative summary in that once a participant was positive, that participant remained positive for later time points. Evaluation of anti-donor HLA antibodies was performed by an external laboratory (Emory University, Atlanta, Georgia).'}, {'measure': 'Mean Change From Baseline to Month 6 and to Month 12 in Serum Creatinine - All Randomized Participants', 'timeFrame': 'Baseline to Month 6 and Month 12 Post Randomization', 'description': 'Baseline was value at screening or prior to first dose of study drug. Serum creatinine was measured in milligrams per deciliter (mg/dL). Baseline = value at screening.'}, {'measure': 'Number of Participants With Serious Adverse Events (SAEs), Deaths, and Discontinuation Due to Adverse Events (AEs) From First Dose up to Month 12', 'timeFrame': 'First Dose (Day 1) to Month 12', 'description': 'AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug.'}, {'measure': 'Mean Change From Baseline in SF-36 Questionnaire Physical Component Score and in Mental Component Score at Month 12 - All Randomized Participants', 'timeFrame': 'Baseline, Month 12', 'description': 'SF-36 was a Participant-Reported Quality of Life (QoL) Short Form (SF) questionnaire. The subscale in the mental component (MCS) part of the instrument ranged from 1 to 6 with 1=all of the time and 6= none of the time. The subscale for physical component (PCS) ranged from 1 to 3 with 1=Yes, limited a lot and 3=No, not limited at all. The subscale for the extent that physical health or emotional problems interfered with normal activities ranged from 1 to 5 with 1=not at all and 5= extremely. Baseline was at randomization or prior to first dose. Baseline = value at screening. The subscale scores were transformed using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life.'}, {'measure': 'Mean Change From Baseline to Month 12 for Eight Domain Scores of Quality of Life (QoL) Instrument SF-36 - All Randomized Participants', 'timeFrame': 'Baseline (screening) to Month 12', 'description': 'SF-36 was a Participant-Reported Quality of Life (QoL) Short Form (SF) questionnaire measuring health-related quality of life (HRQL) covering 8 domains of physical and mental component summaries: physical function, role limitations due to physical problems, pain, general health perception, and vitality, social function, role limitations due to emotional problems, and mental health.\n\nAll domains were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life.'}, {'measure': 'Ridit Score at Month 12 - All Randomized Participants', 'timeFrame': 'Month 12', 'description': 'The Modified Transplant Symptom Occurrence and Symptom Distress Scale (MTSOSD-59R) was used to assess the occurrence (never, occasionally, regularly, almost always, always) and distress (0=no distress to 4=terrible distress) of symptoms associated with immunosuppressive therapies. Ridit (relative to an identified distribution) analysis (Fleiss JL. Statistical methods for rates and proportions. New York: John Wiley \\& Sons, Inc. 1991) was used. Ridit scores were calculated at 12 months for overall symptom occurrence score and overall symptom distress. The Ridit score reflects the probability that a score observed for an individual randomly selected from a group would be higher (worse symptom) than a score observed for a randomly selected individual from the reference group. The reference group was constituted by the frequency distribution of the responses of all participants on all items at baseline. The ridit of the reference group is by definition, 0.5.'}, {'measure': 'Number of Participants Meeting Marked Laboratory Abnormality Criteria From Baseline up to Month 12 - Randomized and Treated Participants', 'timeFrame': 'Baseline up to Month 12', 'description': 'Upper limits of normal (ULL). Leukocytes: \\< 2.0\\*10\\^3 cells per microliter (c/µL); Lymphocytes (absolute): \\< 0.5\\*10\\^3 c/µL; bilirubin: \\> 3.0\\*ULN milligrams per deciliter (mg/dL); Potassium: \\< 3.0 milliequivalents per liter (meq/L) or \\> 6.0 meq/L; Magnesium \\>2.6 meq/L; Sodium: \\< 130 meq/L; Phosphorus: \\< 2.0 mg/dL; Uric Acid: \\> 10 mg/dL. Baseline = value at screening.'}, {'measure': 'Long Term Period: Mean Change From Baseline to 54 Months Post Randomization in Calculated GFR on Imputed Values at Specified Timepoints - Intent to Treat (ITT) Participants Who Entered LT Period', 'timeFrame': 'Baseline, Month 3, 6, 12, 18, 24, 30, 36, 42, 48, 54', 'description': 'ITT=participants randomized to their original treatment arm and who entered the LT period are presented. Baseline=value at screening. Calculated GFR assessment used the MDRD formula. GFR was measured as mL/min/1.73 m\\^2. For death or graft loss participants, calculated GFR (cGFR) value of 0 was imputed and carried forward after death or graft loss up to the end of the analysis period. Sponsor discontinued the CNI treatment arm in Year 3, and participants treated with CNI could elect to switch to belatacept. If a participant did not switch to belatacept, they were required to discontinue from the study. Therefore, efficacy results from Month 36 through Month 54 are difficult to interpret. No formal comparisons were planned between the belatacept and CNI treatment groups post Month 36, and the data up to the final database lock should be interpreted with caution.'}, {'measure': 'Long Term Period: Number of Participants With Acute Rejection (AR) - All Randomized Participants in LT Period', 'timeFrame': 'Post Month 12 up to Year 6 of the Study', 'description': 'AR was defined: if either a or b was satisfied: (a) the reason for clinical suspicion was reported to be an unexplained rise of serum creatinine ≥ 25% from baseline creatinine; or an unexplained decreased urine output; or fever and graft tenderness and the episode was a case of biopsy proven AR (AR of Banff histopathologic classification grade IA or higher as assessed by the blinded central pathologist); (b) the reason for clinical suspicion was reported to be something other than: an unexplained rise of serum creatinine ≥ 25% from baseline creatinine; or an unexplained decreased urine output; or fever and graft tenderness; the episode was a case of biopsy proven AR, and the participant was treated for this episode. Banff 97 working classification of kidney transplant pathology was used to categorize the severity of the AR.'}, {'measure': 'Long Term Period: Number of Participants Who Survived With a Functioning Graft or Survived With Pure Graft Loss or Death With Functioning Graft - ITT Participants Who Entered the LT Period', 'timeFrame': 'Post Months 24, 36, 48, up to Year 6 of the Study', 'description': 'Graft loss = either pure graft loss (participant survived to the end of the study period after graft loss) or death with functioning graft. Pure graft loss = either functional loss or physical loss. Functional loss = a sustained level of serum creatinine (SCr) ≥ 6.0 mg/dL (530 μmol/L) for ≥ 4 weeks or administration of a maintenance dialysis regimen for at least 56 days or impairment of renal function to such a degree that the participant undergoes re-transplantation. The table was designed with built-in redundancy to capture all possible combinations of death and/or graft loss, but not all lines can be summed to reach the total number surviving and the total number who die and/or lose grafts. If a participant experiences pure graft loss and dies at a later date independent of the graft loss event, they are counted only once in the cumulative tabulation of death or graft loss. Only the first event experienced by the participant counted toward the cumulative total.'}, {'measure': 'Long Term Period: Percentage of Participants With New Onset Diabetes Mellitus Up to Month 36- All Randomized Participants Who Entered LT Period', 'timeFrame': 'Baseline (screening) up to Month 36 post randomization', 'description': 'A participant who did not have diabetes prior to randomization is determined to have new onset diabetes mellitus if they received an antidiabetic medication for a duration of at least 30 days or at least two fasting plasma glucose (FPG) tests indicated that FPG is \\>=126 mg/dL. Percentage was the number of participants with new onset of diabetes mellitus divided by the number of participants without pre-randomization diabetes.'}, {'measure': 'Long Term Period: Number of Participants With SAEs, Death, Discontinuation Due to AEs - All Randomized Participants Who Entered the Long Term Period', 'timeFrame': 'First dose after randomization (Day 1) to 56 days post last dose, up to Year 6 of the Study', 'description': 'AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug.'}, {'measure': 'Long Term Period: Number of Participants With AEs of Special Interest - All Randomized Participants Who Entered the Long Term Period', 'timeFrame': 'First dose after randomization (Day 1) to last dose, plus 56 days, up to Year 6 of the Study', 'description': 'Prospectively identified events of special interest which were a subset of all AEs, and were either SAEs or non-serious AEs, included the following categories: Serious Infections, Thrombolic/embolic events, Autoimmune Disease, Malignancy, Peri-infusional reactions (only belatacept treatment group was IV) , Acute Peri-infusional events occurring within 24 hours of injection, Pulmonary Edema and Congestive Heart Failure. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.'}, {'measure': 'Long Term Period: Mean Change From Baseline to Month 54 in Serum Creatinine- ITT Participants Who Entered LT Period', 'timeFrame': 'Baseline, Months 3, 6, 12, 18, 24, 30, 36, 42, 48, 54', 'description': 'Baseline was value at screening. Serum creatinine was measured in mg/dL. Only participants who entered into Long Term Period were included in the analysis.'}, {'measure': 'Long Term Period: Number of Participants Meeting Marked Laboratory Abnormality Criteria - All ITT Participants Who Entered the Long Term Period', 'timeFrame': 'Baseline (Screening), up to Year 6 of the Study', 'description': 'Upper limits of normal (ULN). Hemoglobin: \\< 8 g/dL; Platelet count: \\< 50\\*10\\^9 c/L; Leukocytes: \\< 2.0\\*10\\^3 c/µL; Lymphocytes (absolute): \\< 0.5\\*10\\^3 c/µL; Neutrophils: \\< 1.0\\*10\\^3 c/µL; Alanine Aminotransferase (ALT): \\> 5.0\\*ULN Units per liter (U/L); bilirubin: \\> 3.0\\*ULN mg/dL; Creatinine: \\> 3.0\\*ULN mg/dL; Calcium: \\< 7 mg/dL; Bicarbonate: \\> 12.5 mg/dL; Potassium: \\< 3.0 meq/L or \\> 6.0 meq/L; Magnesium \\>2.6 meq/L; Sodium: \\< 130 meq/L; Phosphorus: \\< 2.0 mg/dL; Uric Acid: \\> 10 mg/dL.'}, {'measure': 'Long Term Period: Mean Change From Baseline to Month 54 in Systolic Blood Pressure', 'timeFrame': 'Baseline, Months 6, 12, 18, 24, 30, 36, 42, 48, 54', 'description': 'Blood pressure was measured while the participant was sitting quietly for 5 minutes and was measured in millimeters of mercury (mmHg). Baseline was value at screening. Only those participants who entered long term period were evaluated.'}, {'measure': 'Long Term Period: Mean Change From Baseline to Month 54 in Diastolic Blood Pressure', 'timeFrame': 'Baseline, Months 6, 12, 18, 24, 30, 36, 42, 48, 54', 'description': 'Blood pressure was measured while the participant was sitting quietly for 5 minutes and was measured in mmHg. Baseline was value at screening. Only those participants who entered long term period were evaluated.'}, {'measure': 'Participants Who Switched From CNI to Belatacept in Long Term Period : Mean Change in Calculated GFR Based on Imputed Values From Day of Switch to Week 96 Post Switch', 'timeFrame': 'Day of Switch (first belatacept dose) to Week 96 Post Switch', 'description': 'Calculated GFR assessment used the MDRD formula. GFR was measured as mL/min/1.73 m\\^2. For death or graft loss participants, calculated GFR (cGFR) value 10 was used, for other participants who had a post baseline cGFR value missing, but had baseline value and at least 2 post baseline values available, which were at least 120 days apart, linear regression model was used to impute the cGFR value. Day of Switch = the first belatacept infusion day.'}, {'measure': 'Participants Who Switched to Belatacept in Long Term Period: Number of Participants With AEs and SAEs', 'timeFrame': 'Day of Switch (first dose of belatacept ) to last dose plus 56 days, up to Year 6 of the Study', 'description': 'AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Day of Switch = the first belatacept infusion day.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Renal Transplant']}, 'referencesModule': {'references': [{'pmid': '21051752', 'type': 'DERIVED', 'citation': 'Rostaing L, Massari P, Garcia VD, Mancilla-Urrea E, Nainan G, del Carmen Rial M, Steinberg S, Vincenti F, Shi R, Di Russo G, Thomas D, Grinyo J. Switching from calcineurin inhibitor-based regimens to a belatacept-based regimen in renal transplant recipients: a randomized phase II study. Clin J Am Soc Nephrol. 2011 Feb;6(2):430-9. doi: 10.2215/CJN.05840710. Epub 2010 Nov 4.'}], 'seeAlsoLinks': [{'url': 'http://www.bms.com/studyconnect/Pages/home.aspx', 'label': 'BMS clinical trial educational resource'}, {'url': 'http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx', 'label': 'Investigator Inquiry form'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to learn if conversion to belatacept from cyclosporine or tacrolimus will preserve kidney function in people who have had a kidney transplant. The safety and tolerability of this treatment will also be studied'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Men and women age 18 and older\n* 6-36 months after kidney transplant receiving cyclosporine or tacrolimus\n* calculated GFR ≥35 and ≤75mL/min/1.73 m²\n* subjects must have completed 1 year in the IM103-010ST and remained on study treatment (Long Term Extension)\n\nKey Exclusion Criteria:\n\n* Significant infection\n* acute rejection within 3 months\n* prior graft loss due to rejection\n* pregnancy\n* positive crossmatch'}, 'identificationModule': {'nctId': 'NCT00402168', 'briefTitle': 'A Study of BMS-224818 (Belatacept) in Patients Who Have Undergone a Kidney Transplant and Are Currently on Stable Cyclosporine or Tacrolimus Regimen With or Without Corticosteroids', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'Belatacept Conversion Trial in Renal Transplantation', 'orgStudyIdInfo': {'id': 'IM103-010'}, 'secondaryIdInfos': [{'id': 'LEA29Y'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A: Belatacept', 'interventionNames': ['Drug: Belatacept']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B: calcineurin inhibitor (CNI)-based immunosuppressive regimen', 'interventionNames': ['Drug: Cyclosporine A', 'Drug: Tacrolimus']}], 'interventions': [{'name': 'Belatacept', 'type': 'DRUG', 'otherNames': ['BMS-224818'], 'description': 'IV, IV Infusion, 5 mg/kg once every 28 days for one year', 'armGroupLabels': ['A: Belatacept']}, {'name': 'Cyclosporine A', 'type': 'DRUG', 'description': 'Tablets, Oral, Trough of 100-250 ng/mL, 2\\* daily for one year', 'armGroupLabels': ['B: calcineurin inhibitor (CNI)-based immunosuppressive regimen']}, {'name': 'Tacrolimus', 'type': 'DRUG', 'description': 'Tablets, Oral, Trough of 5-10 ng/mL, 2\\* daily for one year', 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'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '46017', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Local Institution', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}