Ignite Creation Date:
2025-12-24 @ 4:59 PM
Ignite Modification Date:
2026-04-04 @ 7:35 PM
Study NCT ID:
NCT00256750
Status:
COMPLETED
Last Update Posted:
2016-08-19
First Post:
2005-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression (BENEFIT)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Chile', 'Norway', 'Portugal', 'United Kingdom']}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}], 'ancestors': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016572', 'term': 'Cyclosporine'}], 'ancestors': [{'id': 'D003524', 'term': 'Cyclosporins'}, {'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, '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}}, 'adverseEventsModule': {'timeFrame': 'Randomization to Long Term Extension, up to 84 Months', 'description': 'Study start: March 2005; Study Completion: April 2015. All randomized, transplanted, and treated participants (ITT population)', 'eventGroups': [{'id': 'EG000', 'title': 'Cyclosporine', 'description': 'Cyclosporine (CsA): tablet, oral\n\n1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)', 'otherNumAtRisk': 215, 'otherNumAffected': 213, 'seriousNumAtRisk': 215, 'seriousNumAffected': 167}, {'id': 'EG001', 'title': 'Belatacept - LI', 'description': 'Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)', 'otherNumAtRisk': 226, 'otherNumAffected': 222, 'seriousNumAtRisk': 226, 'seriousNumAffected': 160}, {'id': 'EG002', 'title': 'Belatacept - MI', 'description': 'Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)', 'otherNumAtRisk': 219, 'otherNumAffected': 216, 'seriousNumAtRisk': 219, 'seriousNumAffected': 164}], 'otherEvents': [{'term': 'Delayed graft function', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 22}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 34}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 12}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 75}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 65}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 41}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 18}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 82}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 87}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 70}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hypertriglyceridaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 15}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 17}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 13}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 49}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 48}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 48}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 40}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Metabolic acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 13}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 70}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 62}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 59}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Transplant dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 5}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Vitamin D deficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 17}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 55}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 45}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 11}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 24}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 10}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Fungal skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 25}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 39}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 33}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 12}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Leukocyturia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 6}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 87}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 70}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 64}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 20}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 40}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 36}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Productive cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 10}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Renal impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 7}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Skin lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 24}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 5}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 27}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 8}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 26}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Gingival hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hypercholesterolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 31}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 34}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 38}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 42}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 18}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Incision site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 33}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 39}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 42}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Onychomycosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 15}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 16}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 14}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Skin papilloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 14}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 19}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 226, 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'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Tibia fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Toxicity to various agents', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Tuberculous pleurisy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Ureteral necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Urinary bladder haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 226, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 219, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent of Participants Surviving With a Functioning Graft by Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}, {'value': '219', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cyclosporine', 'description': 'Cyclosporine (CsA): tablet, oral\n\n1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)'}, {'id': 'OG001', 'title': 'Belatacept LI', 'description': 'Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)'}, {'id': 'OG002', 'title': 'Belatacept MI', 'description': 'Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)'}], 'classes': [{'categories': [{'measurements': [{'value': '92.8', 'groupId': 'OG000', 'lowerLimit': '89.3', 'upperLimit': '96.2'}, {'value': '96.5', 'groupId': 'OG001', 'lowerLimit': '94.1', 'upperLimit': '98.9'}, {'value': '95.4', 'groupId': 'OG002', 'lowerLimit': '92.7', 'upperLimit': '98.2'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.3', 'paramValue': '3.7', 'ciLowerLimit': '-1.1', 'ciUpperLimit': '9.0', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': "A non-inferiority margin of 10% for the co-primary endpoint of participant and graft survival was used. Determination of a margin for non-inferiority based on 'preservation of benefit' is not feasible, given the low rate of patient death and/or graft loss in the first year post-transplantation, and the absence of published, adequately sized, parallel-group trials with which to assess the effect of CsA on patient death and/or graft loss in the setting of MMF/steroids/basiliximab."}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.3', 'paramValue': '2.7', 'ciLowerLimit': '-2.5', 'ciUpperLimit': '8.1', 'estimateComment': 'If the lower bound of the CI (belatacept-CsA) was \\> -10%, then the corresponding belatacept regimen was considered non-inferior to CsA.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': "A non-inferiority margin of 10% for the co-primary endpoint of participant and graft survival was used. Determination of a margin for non-inferiority based on 'preservation of benefit' is not feasible, given the low rate of patient death and/or graft loss in the first year post-transplantation, and the absence of published, adequately sized, parallel-group trials with which to assess the effect of CsA on patient death and/or graft loss in the setting of MMF/steroids/basiliximab."}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 to Month 12', 'description': 'Graft loss was defined as either functional loss or physical loss (nephrectomy). Functional loss was defined as a sustained level of serum creatinine (SCr) ≥ 6.0 milligrams per deciliter (mg/dL) or 530 micromolar per liter (μmol/L) as determined by the central laboratory for ≥ 4 weeks or ≥ 56 consecutive days of dialysis or impairment of renal function to such a degree that the participant underwent retransplant.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized, transplanted, and treated participants; intent to treat (ITT) population'}, {'type': 'PRIMARY', 'title': 'Percent of Participants With a Composite of Measured Glomerular Filtration Rate (mGFR) Less Than 60 mL/Min/1.73 m^2 at Month 12 or With a Decrease in mGFR Greater Than or Equal to 10 mL/Min/1.73m^2 From Month 3 to Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '213', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}, {'value': '209', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cyclosporine', 'description': 'Cyclosporine (CsA): tablet, oral\n\n1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)'}, {'id': 'OG001', 'title': 'Belatacept LI', 'description': 'Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)'}, {'id': 'OG002', 'title': 'Belatacept MI', 'description': 'Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)'}], 'classes': [{'categories': [{'measurements': [{'value': '77.9', 'groupId': 'OG000', 'lowerLimit': '72.4', 'upperLimit': '83.5'}, {'value': '54.2', 'groupId': 'OG001', 'lowerLimit': '47.5', 'upperLimit': '60.9'}, {'value': '55.0', 'groupId': 'OG002', 'lowerLimit': '48.3', 'upperLimit': '61.8'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.3', 'paramValue': '-23.7', 'ciLowerLimit': '-33.3', 'ciUpperLimit': '-13.7', 'statisticalMethod': 'Chi-squared, Corrected', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'A continuity-corrected Chi-square test at significance level 0.027 was performed for the difference between the belatacept regimen and cyclosporine', 'testedNonInferiority': False}, {'pValue': '<.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.3', 'paramValue': '-22.9', 'ciLowerLimit': '-32.6', 'ciUpperLimit': '-12.9', 'statisticalMethod': 'Chi-squared, Corrected', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'A continuity-corrected Chi-square test at significance level 0.027 was performed for the difference between the belatacept regimen and cyclosporine', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Month 12; Month 3 to Month 12', 'description': 'Measured glomerular filtration rate (mGFR) is the direct measurement of renal function and was assessed by measurement of the clearance of a true glomerular filtration marker (non-radiolabeled iothalamate) using a validated procedure. A GFR of 60 mL/min/1.73 m\\^2 was used as the approximate equal of the threshold values of serum creatinine (SCr) of 1.5 mg/dL. A change in GFR of at least 10 mL/min/1.73 m\\^2 was used as the approximate change in SCr of at least 0.3 mg/dL. The change component of the composite renal endpoint was assessed from Month 3 to Month 12, since post-transplant renal function is largely stable by Month 3.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component'}, {'type': 'PRIMARY', 'title': 'Percent of Participants Experiencing Acute Rejection (AR) Post-transplant by Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}, {'value': '219', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cyclosporine', 'description': 'Cyclosporine (CsA): tablet, oral\n\n1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)'}, {'id': 'OG001', 'title': 'Belatacept LI', 'description': 'Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)'}, {'id': 'OG002', 'title': 'Belatacept MI', 'description': 'Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)'}], 'classes': [{'categories': [{'measurements': [{'value': '7.2', 'groupId': 'OG000', 'lowerLimit': '3.8', 'upperLimit': '10.7'}, {'value': '17.3', 'groupId': 'OG001', 'lowerLimit': '12.3', 'upperLimit': '22.2'}, {'value': '21.9', 'groupId': 'OG002', 'lowerLimit': '16.4', 'upperLimit': '27.4'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.3', 'paramValue': '10.0', 'ciLowerLimit': '3.3', 'ciUpperLimit': '17.1', 'estimateComment': 'For 97.3% CI of difference, normal approximation is used if N\\>=5 in both arms. Otherwise exact method is used.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'A 20% margin for non-inferiority was used and provides 99% power to ascertain that the upper bound of the 97.3% 2-sided confidence intervals for the absolute difference between each belatacept regimen and cyclosporine, assuming the true acute rejection rate by 12 months is 15% for all three regimens'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.3', 'paramValue': '14.7', 'ciLowerLimit': '7.5', 'ciUpperLimit': '22.2', 'estimateComment': 'For 97.3% CI of difference, normal approximation is used if N\\>=5 in both arms. Otherwise exact method is used.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'A 20% margin for non-inferiority was used and provides 99% power to ascertain that the upper bound of the 97.3% 2-sided confidence intervals for the absolute difference between each belatacept regimen and cyclosporine, assuming the true acute rejection rate by 12 months is 15% for all three regimens. The 20% non-inferiority margin was not met in the belatacept MI group.'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 to Month 12', 'description': 'Acute rejection was defined as a clinico-pathological event requiring clinical evidence and biopsy confirmation. Clinical evidence was defined if either a or b was satisfied: a: an unexplained rise of serum creatinine ≥ 25% from baseline creatinine; b: an unexplained decreased urine output; or fever and graft tenderness; or a serum creatinine that remains elevated within 14 days post-transplantation and clinical suspicion of acute rejection exists. Allograft biopsies were evaluated by a blinded central independent pathologist using Banff 97 working classification of kidney transplant pathology. Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification. AR was defined by a renal biopsy demonstrating a Banff 97 classification of Grade IA or greater, with higher scores indicating more severe rejection. Only the episode with the highest Banff grade for each participant was counted.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized, transplanted, and treated participants; intent to treat (ITT) population'}, {'type': 'SECONDARY', 'title': 'Mean Value of the Measured Glomerular Filtration Rate (mGFR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '215', 'groupId': 'OG001'}, {'value': '209', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cyclosporine', 'description': 'Cyclosporine (CsA): tablet, oral\n\n1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)'}, {'id': 'OG001', 'title': 'Belatacept LI', 'description': 'Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)'}, {'id': 'OG002', 'title': 'Belatacept MI', 'description': 'Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)'}], 'classes': [{'title': 'Month 3 (n=201, 215, 209)', 'categories': [{'measurements': [{'value': '51.9', 'spread': '21.09', 'groupId': 'OG000'}, {'value': '61.7', 'spread': '25.43', 'groupId': 'OG001'}, {'value': '59.9', 'spread': '28.47', 'groupId': 'OG002'}]}]}, {'title': 'Month 12 (n=199, 206, 200)', 'categories': [{'measurements': [{'value': '50.4', 'spread': '18.71', 'groupId': 'OG000'}, {'value': '63.4', 'spread': '27.66', 'groupId': 'OG001'}, {'value': '65.0', 'spread': '30.02', 'groupId': 'OG002'}]}]}, {'title': 'Month 24 (n=185, 199, 192)', 'categories': [{'measurements': [{'value': '50.5', 'spread': '20.52', 'groupId': 'OG000'}, {'value': '67.9', 'spread': '29.90', 'groupId': 'OG001'}, {'value': '65.0', 'spread': '27.21', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.3', 'paramValue': '13.0', 'ciLowerLimit': '7.3', 'ciUpperLimit': '18.7', 'pValueComment': 'To account for missing measured GFR due to graft loss or death, an ANOVA model on the ranks of measured GFR (with imputed missing values) at Months 12 with factor for randomization group was applied. Measured GFR missing were assigned the worst rank.', 'estimateComment': 'Test were conducted at a level of 0.027 (2-sided).', 'groupDescription': 'Time Frame = Day 1 to Month 12', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Tests comparing a belatacept to CsA were based on the Kruskal-Wallis test (using a chi-square approximation of the distribution of the test statistic)', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.3', 'paramValue': '14.6', 'ciLowerLimit': '8.9', 'ciUpperLimit': '20.4', 'pValueComment': 'To account for missing measured GFR due to graft loss or death, an ANOVA model on the ranks of measured GFR (with imputed missing values) at Months 12 with factor for randomization group was applied. Measured GFR missing were assigned the worst rank.', 'estimateComment': 'Test were conducted at a level of 0.027 (2-sided).', 'groupDescription': 'Time Frame = Day 1 to Month 12', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Tests comparing a belatacept to CsA were based on the Kruskal-Wallis test (using a chi-square approximation of the distribution of the test statistic)', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.3', 'paramValue': '17.4', 'ciLowerLimit': '11.5', 'ciUpperLimit': '23.4', 'pValueComment': 'To account for missing measured GFR due to graft loss or death, an ANOVA model on the ranks of measured GFR (with imputed missing values) at Months 24 with factor for randomization group was applied. Measured GFR missing were assigned the worst rank.', 'estimateComment': 'Test were conducted at a level of 0.027 (2-sided).', 'groupDescription': 'Time Frame = Day 1 to Month 24', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Tests comparing a belatacept to CsA were based on the Kruskal-Wallis test (using a chi-square approximation of the distribution of the test statistic)', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.3', 'paramValue': '14.5', 'ciLowerLimit': '8.5', 'ciUpperLimit': '20.5', 'pValueComment': 'To account for missing measured GFR due to graft loss or death, an ANOVA model on the ranks of measured GFR (with imputed missing values) at Months 24 with factor for randomization group was applied. Measured GFR missing were assigned the worst rank.', 'estimateComment': 'Test were conducted at a level of 0.027 (2-sided).', 'groupDescription': 'Time Frame = Day 1 to Month 24', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Tests comparing a belatacept to CsA were based on the Kruskal-Wallis test (using a chi-square approximation of the distribution of the test statistic)', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Months 3, 12, 24', 'description': 'Measured glomerular filtration rate (mGFR) is the direct measurement of renal function and was assessed by measurement of the clearance of a true glomerular filtration marker (non-radiolabeled iothalamate) using a validated procedure. Missing mGRF assessments were imputed to assess renal function. The overall imputation strategy involved a primary imputation method (linear extrapolation and quartile method) followed by 2 secondary imputation methods (regression method and graded quartile method) to assess the robustness of conclusions obtained from the application of the primary imputation method. All imputation methods entailed replacing a missing value with a value drawn from a plausible distribution incorporating theoretical and observed aspects of the data. GFR was measured as mL/min/1.73 m\\^2.', 'unitOfMeasure': 'mL/min/1.73m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component'}, {'type': 'SECONDARY', 'title': 'Percent of Participants With Prevalence of Chronic Allograft Nephropathy (CAN) at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}, {'value': '219', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cyclosporine', 'description': 'Cyclosporine (CsA): tablet, oral\n\n1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)'}, {'id': 'OG001', 'title': 'Belatacept LI', 'description': 'Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)'}, {'id': 'OG002', 'title': 'Belatacept MI', 'description': 'Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)'}], 'classes': [{'categories': [{'measurements': [{'value': '32.4', 'groupId': 'OG000', 'lowerLimit': '26.2', 'upperLimit': '38.6'}, {'value': '23.9', 'groupId': 'OG001', 'lowerLimit': '18.3', 'upperLimit': '29.5'}, {'value': '18.3', 'groupId': 'OG002', 'lowerLimit': '13.1', 'upperLimit': '23.4'}]}]}], 'analyses': [{'pValue': '0.0581', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.3', 'paramValue': '-8.5', 'ciLowerLimit': '-17.9', 'ciUpperLimit': '0.9', 'statisticalMethod': 'Chi-squared, Corrected', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'A continuity corrected chi-square test at a significance level of 0.027 was performed.', 'testedNonInferiority': True, 'nonInferiorityComment': 'Test of superiority using DerSimonian-Laird statistic at 0.027 level of significance.'}, {'pValue': '0.0010', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.3', 'paramValue': '-14.2', 'ciLowerLimit': '-23.2', 'ciUpperLimit': '-5.0', 'statisticalMethod': 'Chi-squared, Corrected', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'A continuity corrected chi-square test at a significance level of 0.027 was performed.', 'testedNonInferiority': True, 'nonInferiorityComment': 'Test of superiority using DerSimonian-Laird statistic at 0.027 level of significance.'}], 'paramType': 'NUMBER', 'timeFrame': 'Month 12', 'description': 'Prevalence of CAN = if participant met any of the following conditions: a: CAN observed in a biopsy either prior to 12 months (including baseline biopsy) or first post 12 months biopsy; b: participant had graft loss during the first year post transplant; c: no biopsy was available post 12 months and CAN not observed in biopsies prior to 12 months, but the measured GFR from Month 3 to Month 12 decreased at least 10 mL/min/1.73m\\^2; d: no biopsy available either prior to or post 12 months, and the measured GFR (incorporated missing data imputation) from Month 3 to Month 12 decreased at least 10 mL/min/1.73m\\^2. CAN = All allograft biopsies evaluated for presence and severity of CAN by a blinded central independent pathologist using Banff 97 working classification of kidney transplant pathology. Onset of CAN determined by the biopsy date when it was observed.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component; Any participant not meeting CAN criteria and who has no biopsy either prior to or post 12 months and no GFR assessment (either measured or calculated) available were excluded from the analyses.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Serious Adverse Events, Death, Discontinuation Due to Adverse Events by Month 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '166', 'groupId': 'OG001'}, {'value': '155', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cyclosporine', 'description': 'Cyclosporine (CsA): tablet, oral\n\n1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)'}, {'id': 'OG001', 'title': 'Belatacept LI', 'description': 'Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)'}, {'id': 'OG002', 'title': 'Belatacept MI', 'description': 'Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)'}], 'classes': [{'title': 'Deaths', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '107', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}, {'value': '117', 'groupId': 'OG002'}]}]}, {'title': 'Discontinued due to SAEs', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'Discontinued due to AEs', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Randomization to Month 84', 'description': 'Adverse event (AE) defined: any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Serious adverse event (SAE) defined: 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 randomized, transplanted, and treated participants from the original intent-to-treat (ITT) population who continued on assigned therapy into the long-term extension phase (ITT-LTE)'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events of Special Interest by Month 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '166', 'groupId': 'OG001'}, {'value': '155', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cyclosporine', 'description': 'Cyclosporine (CsA): tablet, oral\n\n1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)'}, {'id': 'OG001', 'title': 'Belatacept LI', 'description': 'Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)'}, {'id': 'OG002', 'title': 'Belatacept MI', 'description': 'Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)'}], 'classes': [{'title': 'Malignancies', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}]}, {'title': 'Cytomegalovirus (CMV) Infections', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}]}, {'title': 'BK Polyoma Virus Infections', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}]}, {'title': 'Herpes Virus Infections', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}]}, {'title': 'Fungal Infections', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}]}]}, {'title': 'Tuberculosis Infections', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Central Nervous System (CNS) Infections', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Pulmonary edema or Congestive Heart Failure', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Auto-immune Events', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Randomization to Month 84', '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 and Infestations, Thrombolic/embolic events, and Malignancy. 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. Time frame is from randomization to the event date, or to the last dose date+56, or to Month 84 (Day 2548), whichever is the earliest.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized, transplanted, and treated participants from the original intent-to-treat (ITT) population who continued on assigned therapy into the long-term extension phase (ITT-LTE)'}, {'type': 'SECONDARY', 'title': 'Mean Blood Pressure at Month 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '166', 'groupId': 'OG001'}, {'value': '155', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cyclosporine', 'description': 'Cyclosporine (CsA): tablet, oral\n\n1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)'}, {'id': 'OG001', 'title': 'Belatacept LI', 'description': 'Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)'}, {'id': 'OG002', 'title': 'Belatacept MI', 'description': 'Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)'}], 'classes': [{'title': 'Diastolic Blood Pressure (n=82, 125, 112)', 'categories': [{'measurements': [{'value': '78.6', 'spread': '11.03', 'groupId': 'OG000'}, {'value': '75.8', 'spread': '10.56', 'groupId': 'OG001'}, {'value': '75.1', 'spread': '10.15', 'groupId': 'OG002'}]}]}, {'title': 'Systolic Blood Pressure (n=82, 125, 112)', 'categories': [{'measurements': [{'value': '129.0', 'spread': '15.83', 'groupId': 'OG000'}, {'value': '126.7', 'spread': '18.17', 'groupId': 'OG001'}, {'value': '126.0', 'spread': '17.56', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 84', 'description': 'Blood pressure was measured in millimeters of mercury (mmHg). Blood pressure was measured soon after the participant arrived and sat quietly at rest for 10 minutes. 3 consecutive seated blood pressure readings were made at least 1 minute apart.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized, transplanted, and treated participants from the original intent-to-treat (ITT) population who continued on assigned therapy into the long-term extension phase (ITT-LTE).'}, {'type': 'SECONDARY', 'title': 'Number of Participants Meeting Marked Laboratory Abnormality Criteria Post-transplant by Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}, {'value': '219', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cyclosporine', 'description': 'Cyclosporine (CsA): tablet, oral\n\n1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)'}, {'id': 'OG001', 'title': 'Belatacept LI', 'description': 'Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)'}, {'id': 'OG002', 'title': 'Belatacept MI', 'description': 'Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)'}], 'classes': [{'title': 'Hemoglobin, low (n=213, 226, 219)', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}]}, {'title': 'Platelet count, low (n=213, 226, 218)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Leukocytes, low (n=213, 226, 219)', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Alkaline phosphatase, high (n=214, 226, 219)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Alanine aminotransferase, high (n=214, 226, 219)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Aspartate aminotransferase, high (n=214, 226, 219)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Bilirubin total, high (n=214, 226, 219)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Creatinine, high (n=213, 223, 219)', 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}]}, {'title': 'Calcium total, low (n=214, 226, 219)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Calcium total, high (n=214, 226, 219)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Bicarbonate, low (n=214, 226, 219)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Bicarbonate, high (n=214, 226, 219)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Potassium serum, low (n=213, 223, 219)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}]}, {'title': 'Potassium serum, high (n=213, 223, 219)', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Magnessium serum, low (n=214, 225, 219)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Magnessium serum, high (n=214, 225, 219)', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}]}, {'title': 'Sodium serum, low (n=214, 226, 219)', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}, {'title': 'Sodium serum, high (n=214, 226, 219)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Phosphorus inorganic, low (n=213, 224, 219)', 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '112', 'groupId': 'OG002'}]}]}, {'title': 'Albumin, low (n=214, 226, 219)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Uric acid, high (n=214, 226, 219)', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}, {'title': 'Protein in urine, high (n=213, 224, 217)', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Month 36', 'description': 'Upper limit of normal (ULN). Units per Liter (U/L). Cells per microliter (c/µL). Grams per deciliter (g/dL). Milligrams per deciliter (mg/dL).Cells per Liter (c/L). Milliequivalents/Liter (mEq/L).\n\nHemoglobin (low): \\<8.0 g/dL; Platelet count: \\<50\\*10\\^9 c/L; Leukocytes: \\<2\\*10\\^3 c/µL; Alkaline phosphatase (ALP): \\>5.0\\*ULN U/L; Alanine aminotransferase (ALT): \\>5.0\\*ULN U/L; Asparate aminotransferase (AST): \\>5.0\\*ULN U/L; Bilirubin Total: \\>3.0\\*ULN mg/dL; Creatinine: \\>3.0\\*ULN mg/dL; Calcium Total: low if \\<7.0 mg/dL or high if \\>12.5 mg/dL; Bicarbonate: \\<11.0 mEq/L; Potassium serum: low if \\<3.0 mEq/L or high if \\>6.0 mEq/L; Magnesium serum: low is \\<0.8 mEq/L or high if \\>2.46 mEq/L; Sodium serum: low if \\<130.0 mEq/L or high if \\>155.0 mEq/L; Phosphorus inorganic: \\<2.0 mg/dL; Albumin: \\<2 g/dL; Uric acid: \\>10 mg/dL; Protein urine: \\>=3+', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized, transplanted, and treated participants from the original intent-to-treat (ITT) population'}, {'type': 'SECONDARY', 'title': 'Percent of Participants With Development of Anti-Donor HLA Positive Antibodies by Month 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}, {'value': '219', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cyclosporine', 'description': 'Cyclosporine (CsA): tablet, oral\n\n1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)'}, {'id': 'OG001', 'title': 'Belatacept LI', 'description': 'Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)'}, {'id': 'OG002', 'title': 'Belatacept MI', 'description': 'Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)'}], 'classes': [{'categories': [{'measurements': [{'value': '11.6', 'groupId': 'OG000', 'lowerLimit': '7.34', 'upperLimit': '15.91'}, {'value': '3.1', 'groupId': 'OG001', 'lowerLimit': '0.84', 'upperLimit': '5.36'}, {'value': '1.4', 'groupId': 'OG002', 'lowerLimit': '0.28', 'upperLimit': '3.95'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.3', 'paramValue': '-8.5', 'ciLowerLimit': '-14.6', 'ciUpperLimit': '-3.3', 'estimateComment': 'For 97.3% CI of difference, normal approximation is used if N\\>=5 in both arms. Otherwise exact method is used.', 'groupDescription': 'Percent treatment difference measured as Belatacept - LI minus Cyclosporine', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.3', 'paramValue': '-10.3', 'ciLowerLimit': '-16.1', 'ciUpperLimit': '-5.1', 'estimateComment': 'For 97.3% CI of difference, normal approximation is used if N\\>=5 in both arms. Otherwise exact method is used.', 'groupDescription': 'Percent treatment difference measured as Belatacept - LI minus Cyclosporine', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Randomization to Month 84', 'description': 'Only participants who had non-missing test result for Class I or Class II anti-donor HLA antibodies were included in analysis and only participants who had at least one non-NA test result or finding were counted. This was a cumulative summary (excluding baseline) and once a participant was positive, that participant remained positive for the later time point. Acute rejection (AR) defined: a clinico-pathological event requiring clinical evidence and biopsy confirmation. Clinical evidence defined: if either a or b was satisfied: a: an unexplained rise of serum creatinine ≥ 25% from baseline creatinine; b: an unexplained decreased urine output; or fever and graft tenderness; or a serum creatinine that remains elevated within 14 days post-transplantation and clinical suspicion of acute rejection exists. AR defined as allograft biopsies of Banff 97 classification Grade IA or greater (higher scores indicate more severe rejection). Evaluated by blinded central independent pathologist.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized, transplanted, and treated participants; intent to treat (ITT) population'}, {'type': 'SECONDARY', 'title': 'Mean Change of the Measured Glomerular Filtration Rate (mGFR) From Month 3 to Month 12 and From Month 3 to Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}, {'value': '206', 'groupId': 'OG001'}, {'value': '200', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cyclosporine', 'description': 'Cyclosporine (CsA): tablet, oral\n\n1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)'}, {'id': 'OG001', 'title': 'Belatacept LI', 'description': 'Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)'}, {'id': 'OG002', 'title': 'Belatacept MI', 'description': 'Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)'}], 'classes': [{'title': 'Baseline (Month 3) to Month 12 (n=195, 206, 200)', 'categories': [{'measurements': [{'value': '-1.7', 'spread': '21.58', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '30.43', 'groupId': 'OG001'}, {'value': '4.4', 'spread': '31.10', 'groupId': 'OG002'}]}]}, {'title': 'Baseline (Month 3) to Month 24 (n=184, 199, 192)', 'categories': [{'measurements': [{'value': '-2.0', 'spread': '25.23', 'groupId': 'OG000'}, {'value': '5.3', 'spread': '33.03', 'groupId': 'OG001'}, {'value': '4.2', 'spread': '30.96', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 3 to Month 12; Month 3 to Month 24', 'description': 'Measured glomerular filtration rate (mGFR) is the direct measurement of renal function and was assessed by measurement of the clearance of a true glomerular filtration marker (non-radiolabeled iothalamate) using a validated procedure. Missing mGRF assessments were imputed to assess renal function. The overall imputation strategy involved a primary imputation method (linear extrapolation and quartile method) followed by 2 secondary imputation methods (regression method and graded quartile method) to assess the robustness of conclusions obtained from the application of the primary imputation method. All imputation methods entailed replacing a missing value with a value drawn from a plausible distribution incorporating theoretical and observed aspects of the data. GFR was measured as mL/min/1.73 m\\^2.', 'unitOfMeasure': 'mL/min/1.73m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component'}, {'type': 'SECONDARY', 'title': 'Percent of Participants With a Decrease in Measured Glomerular Filtration Rate (mGFR) Greater Than or Equal to 10mL/Min/1.73m^2 From Month 3 to Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '213', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}, {'value': '209', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cyclosporine', 'description': 'Cyclosporine (CsA): tablet, oral\n\n1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)'}, {'id': 'OG001', 'title': 'Belatacept LI', 'description': 'Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)'}, {'id': 'OG002', 'title': 'Belatacept MI', 'description': 'Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)'}], 'classes': [{'categories': [{'measurements': [{'value': '28.2', 'groupId': 'OG000', 'lowerLimit': '22.1', 'upperLimit': '34.2'}, {'value': '23.4', 'groupId': 'OG001', 'lowerLimit': '17.7', 'upperLimit': '29.0'}, {'value': '23.0', 'groupId': 'OG002', 'lowerLimit': '17.3', 'upperLimit': '28.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 3 to Month 12', 'description': 'Measured glomerular filtration rate (mGFR) is the direct measurement of renal function and was assessed by measurement of the clearance of a true glomerular filtration marker (non-radiolabeled iothalamate) using a validated procedure. A change in GFR of at least 10 mL/min/1.73 m\\^2 was used as the approximate change in serum creatinine (SCr) of at least 0.3 mg/dL. The change component of the composite renal endpoint was assessed from Month 3 to Month 12, since post-transplant renal function is largely stable by Month 3. Month 3 = baseline', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component'}, {'type': 'SECONDARY', 'title': 'Percent of Participants With a Measured Glomerular Filtration Rate (mGFR) Less Than 60 mL/Min/1.73 m^2 at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '213', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}, {'value': '209', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cyclosporine', 'description': 'Cyclosporine (CsA): tablet, oral\n\n1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)'}, {'id': 'OG001', 'title': 'Belatacept LI', 'description': 'Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)'}, {'id': 'OG002', 'title': 'Belatacept MI', 'description': 'Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)'}], 'classes': [{'categories': [{'measurements': [{'value': '67.6', 'groupId': 'OG000', 'lowerLimit': '61.3', 'upperLimit': '73.9'}, {'value': '43', 'groupId': 'OG001', 'lowerLimit': '36.4', 'upperLimit': '49.6'}, {'value': '43.5', 'groupId': 'OG002', 'lowerLimit': '36.8', 'upperLimit': '50.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 12', 'description': 'Measured glomerular filtration rate (mGFR) is the direct measurement of renal function and was assessed by measurement of the clearance of a true glomerular filtration marker (non-radiolabeled iothalamate) using a validated procedure. A GFR of 60 mL/min/1.73 m\\^2 was used as the approximate equal of the threshold values of serum creatinine (SCr) of 1.5 milligrams per deciliter (mg/dL).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component'}, {'type': 'SECONDARY', 'title': 'Mean Value of the Calculated Glomerular Filtration Rate (cGFR) With Imputation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '201', 'groupId': 'OG001'}, {'value': '201', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cyclosporine', 'description': 'Cyclosporine (CsA): tablet, oral\n\n1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)'}, {'id': 'OG001', 'title': 'Belatacept LI', 'description': 'Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)'}, {'id': 'OG002', 'title': 'Belatacept MI', 'description': 'Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)'}], 'classes': [{'title': 'Month 6 (n=189, 185, 170)', 'categories': [{'measurements': [{'value': '48.8', 'spread': '19.22', 'groupId': 'OG000'}, {'value': '62.6', 'spread': '20.41', 'groupId': 'OG001'}, {'value': '62.4', 'spread': '20.94', 'groupId': 'OG002'}]}]}, {'title': 'Month 12 (n=199, 200, 201)', 'categories': [{'measurements': [{'value': '50.1', 'spread': '21.06', 'groupId': 'OG000'}, {'value': '65.4', 'spread': '22.94', 'groupId': 'OG001'}, {'value': '65.2', 'spread': '23.51', 'groupId': 'OG002'}]}]}, {'title': 'Month 24 (n=182, 201, 191)', 'categories': [{'measurements': [{'value': '47.9', 'spread': '23.00', 'groupId': 'OG000'}, {'value': '65.4', 'spread': '25.22', 'groupId': 'OG001'}, {'value': '65.5', 'spread': '24.87', 'groupId': 'OG002'}]}]}, {'title': 'Month 36 (n=171, 190, 186)', 'categories': [{'measurements': [{'value': '44.4', 'spread': '23.58', 'groupId': 'OG000'}, {'value': '65.8', 'spread': '27.00', 'groupId': 'OG001'}, {'value': '65.2', 'spread': '26.31', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Value)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.3', 'paramValue': '15.3', 'ciLowerLimit': '10.3', 'ciUpperLimit': '20.3', 'estimateComment': 'ANOVA model: GFR = treatment', 'groupDescription': 'Month 12', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Value)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.3', 'paramValue': '15.1', 'ciLowerLimit': '10.1', 'ciUpperLimit': '20.1', 'estimateComment': 'ANOVA model: GFR = treatment', 'groupDescription': 'Month 12', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Value)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.3', 'paramValue': '17.5', 'ciLowerLimit': '12.0', 'ciUpperLimit': '23.1', 'estimateComment': 'ANOVA model: GFR = treatment', 'groupDescription': 'Month 24', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Value)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.3', 'paramValue': '17.6', 'ciLowerLimit': '12.0', 'ciUpperLimit': '23.3', 'estimateComment': 'ANOVA model: GFR = treatment', 'groupDescription': 'Month 24', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Value)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.3', 'paramValue': '21.4', 'ciLowerLimit': '15.4', 'ciUpperLimit': '27.4', 'estimateComment': 'ANOVA model: GFR = treatment', 'groupDescription': 'Month 36', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Value)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.3', 'paramValue': '20.8', 'ciLowerLimit': '14.8', 'ciUpperLimit': '26.9', 'estimateComment': 'ANOVA model: GFR = treatment', 'groupDescription': 'Month 36', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Months 6, 12, 24, 36', 'description': 'Calculated glomerular filtration rate (cGFR) was used to assess renal function (as measured by the estimated creatinine clearance) using the following modification of diet in renal disease (MDRD) formula: MDRD: GFR = 170 x \\[SCr/0.95\\]\\^(-0.999) x \\[Age\\]\\^(-0.176) x \\[0.762 if participant is female\\] x \\[1.180 if participant is black\\] x \\[BUN\\]\\^(-0.170) x \\[Alb\\]\\^(+0.318); Age in years; Alb = Albumin in g/dL; SCr = Serum creatinine in mg/dL; BUN = Blood urea nitrogen in mg/dL; cGFR = mL/min/1.73m2', 'unitOfMeasure': 'mL/min/1.73 m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component'}, {'type': 'SECONDARY', 'title': 'Mean Change in Calculated Glomerular Filtration Rate (cGFR) From Month 6 to Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}, {'value': '160', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cyclosporine', 'description': 'Cyclosporine (CsA): tablet, oral\n\n1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)'}, {'id': 'OG001', 'title': 'Belatacept LI', 'description': 'Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)'}, {'id': 'OG002', 'title': 'Belatacept MI', 'description': 'Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)'}], 'classes': [{'categories': [{'measurements': [{'value': '2.3', 'spread': '10.09', 'groupId': 'OG000'}, {'value': '4.7', 'spread': '11.52', 'groupId': 'OG001'}, {'value': '5.1', 'spread': '11.37', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 6 to Month 12', 'description': 'Calculated glomerular filtration rate (cGFR) was used to assess renal function (as measured by the estimated creatinine clearance) using the following modification of diet in renal disease (MDRD) formula: MDRD: GFR = 170 x \\[SCr/0.95\\]\\^(-0.999) x \\[Age\\]\\^(-0.176) x \\[0.762 if participant is female\\] x \\[1.180 if participant is black\\] x \\[BUN\\]\\^(-0.170) x \\[Alb\\]\\^(+0.318); Age in years; Alb = Albumin in g/dL; SCr = Serum creatinine in mg/dL; BUN = Blood urea nitrogen in mg/dL; cGFR = mL/min/1.73m\\^2', 'unitOfMeasure': 'mL/Min/1.73 m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component'}, {'type': 'SECONDARY', 'title': 'Percent of Participants With Incidence of New Onset Diabetes Mellitus by Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}, {'value': '156', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cyclosporine', 'description': 'Cyclosporine (CsA): tablet, oral\n\n1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)'}, {'id': 'OG001', 'title': 'Belatacept LI', 'description': 'Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)'}, {'id': 'OG002', 'title': 'Belatacept MI', 'description': 'Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)'}], 'classes': [{'title': 'Month 12', 'categories': [{'measurements': [{'value': '9.9', 'groupId': 'OG000', 'lowerLimit': '5.3', 'upperLimit': '14.5'}, {'value': '4.2', 'groupId': 'OG001', 'lowerLimit': '1.1', 'upperLimit': '7.2'}, {'value': '7.1', 'groupId': 'OG002', 'lowerLimit': '3.0', 'upperLimit': '11.1'}]}]}, {'title': 'Month 24', 'categories': [{'measurements': [{'value': '10.5', 'groupId': 'OG000', 'lowerLimit': '5.8', 'upperLimit': '15.2'}, {'value': '5.4', 'groupId': 'OG001', 'lowerLimit': '2.0', 'upperLimit': '8.8'}, {'value': '8.3', 'groupId': 'OG002', 'lowerLimit': '4.0', 'upperLimit': '12.7'}]}]}, {'title': 'Month 36', 'categories': [{'measurements': [{'value': '11.1', 'groupId': 'OG000', 'lowerLimit': '6.3', 'upperLimit': '16.0'}, {'value': '6.5', 'groupId': 'OG001', 'lowerLimit': '2.8', 'upperLimit': '10.3'}, {'value': '10.3', 'groupId': 'OG002', 'lowerLimit': '5.5', 'upperLimit': '15.0'}]}]}], 'analyses': [{'pValue': '0.0687', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.3', 'paramValue': '-5.7', 'ciLowerLimit': '-12.6', 'ciUpperLimit': '0.5', 'pValueComment': 'Normal approximation is used if N\\>=5 in both arms. Otherwise, exact method is used.', 'groupDescription': 'Month 12', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.4825', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.3', 'paramValue': '-2.8', 'ciLowerLimit': '-10.2', 'ciUpperLimit': '4.4', 'pValueComment': 'Normal approximation is used if N\\>=5 in both arms. Otherwise, exact method is used.', 'groupDescription': 'Month 12', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.1267', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.3', 'paramValue': '-5.1', 'ciLowerLimit': '-12.3', 'ciUpperLimit': '1.5', 'pValueComment': 'Normal approximation is used if N\\>=5 in both arms. Otherwise, exact method is used.', 'groupDescription': 'Month 24', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.6405', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.3', 'paramValue': '-2.2', 'ciLowerLimit': '-9.8', 'ciUpperLimit': '5.4', 'pValueComment': 'Normal approximation is used if N\\>=5 in both arms. Otherwise, exact method is used.', 'groupDescription': 'Month 24', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.2043', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.3', 'paramValue': '-4.6', 'ciLowerLimit': '-12.0', 'ciUpperLimit': '2.5', 'groupDescription': 'Month 36', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Normal approximation is used if N\\>=5 in both arms. Otherwise, exact method is used.', 'testedNonInferiority': False}, {'pValue': '0.9481', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.3', 'paramValue': '-0.9', 'ciLowerLimit': '-8.8', 'ciUpperLimit': '7.1', 'pValueComment': 'Normal approximation is used if N\\>=5 in both arms. Otherwise, exact method is used.', 'groupDescription': 'Month 36', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 4 post-transplantation to Month 36', 'description': 'The incidence of new onset diabetes mellitus defined as participants who developed diabetes mellitus after randomization and transplantation. Participants that did not have diabetes prior to randomization were determined to have new onset diabetes mellitus if (i) the participant received an anti-diabetic medication for a duration of at least 30 days or (ii) at least two fasting plasma glucose (FPG) tests indicate that FPG is \\>=126 mg/dL (7.0 mmol/L). New onset diabetes mellitus (NODM) = post-transplant diabetes mellitus (PTDM)', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component'}, {'type': 'SECONDARY', 'title': 'Percent of Participants Using At Least One Anti-Hypertensive Medication to Control Hypertension at Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '182', 'groupId': 'OG000'}, {'value': '199', 'groupId': 'OG001'}, {'value': '192', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cyclosporine', 'description': 'Cyclosporine (CsA): tablet, oral\n\n1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)'}, {'id': 'OG001', 'title': 'Belatacept LI', 'description': 'Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)'}, {'id': 'OG002', 'title': 'Belatacept MI', 'description': 'Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)'}], 'classes': [{'categories': [{'measurements': [{'value': '92.9', 'groupId': 'OG000', 'lowerLimit': '89.12', 'upperLimit': '96.60'}, {'value': '81.9', 'groupId': 'OG001', 'lowerLimit': '76.56', 'upperLimit': '87.36'}, {'value': '83.9', 'groupId': 'OG002', 'lowerLimit': '78.65', 'upperLimit': '89.06'}]}]}], 'analyses': [{'pValue': '0.0002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.3', 'paramValue': '0.5', 'ciLowerLimit': '0.31', 'ciUpperLimit': '0.74', 'estimateComment': 'Odds ratio is estimated by a cumulative logit model.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0092', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio, log', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.3', 'paramValue': '0.6', 'ciLowerLimit': '0.38', 'ciUpperLimit': '0.92', 'estimateComment': 'Odds ratio is estimated by a cumulative logit model.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Month 36', 'description': 'This analysis was based on all participants who had been followed up at least 1092 days after transplantation. Hypertension was defined in according to the Seventh Report of the Joint National Committee on the Prevention, Detection, Evaluation, and Treatment of High Blood Pressure for participants with chronic kidney disease. This definition was based upon SBP ≥ 130 mm Hg or DBP ≥ 80 mm Hg. In addition, all participants who had a SBP \\< 130 mm Hg and a DBP \\< 80 mm Hg who received an antihypertensive medication(s) for the indication of hypertension or with a medical history of hypertension were included in this definition. Systolic blood pressure = SBP; Diastolic blood pressure = DBP', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component'}, {'type': 'SECONDARY', 'title': 'Percent of Participants With Incidence of Hypertension Post-Transplantation at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cyclosporine', 'description': 'Cyclosporine (CsA): tablet, oral\n\n1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)'}, {'id': 'OG001', 'title': 'Belatacept LI', 'description': 'Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)'}, {'id': 'OG002', 'title': 'Belatacept MI', 'description': 'Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)'}], 'classes': [{'categories': [{'measurements': [{'value': '75.0', 'groupId': 'OG000', 'lowerLimit': '19.4', 'upperLimit': '99.4'}, {'value': '53.8', 'groupId': 'OG001', 'lowerLimit': '26.7', 'upperLimit': '80.9'}, {'value': '57.1', 'groupId': 'OG002', 'lowerLimit': '18.4', 'upperLimit': '90.1'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.3', 'paramValue': '-21.2', 'ciLowerLimit': '-67.6', 'ciUpperLimit': '43.2', 'estimateComment': 'For 97.3% CI of difference, normal approximation is used if N\\>=5 in both arms. Otherwise exact method is used.', 'groupDescription': 'Month 12', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.3', 'paramValue': '-17.9', 'ciLowerLimit': '-72.3', 'ciUpperLimit': '52.2', 'estimateComment': 'For 97.3% CI of difference, normal approximation is used if N\\>=5 in both arms. Otherwise exact method is used.', 'groupDescription': 'Month 12', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Month 12', 'description': 'The incidence of hypertension was defined as the proportion of participants who developed hypertension after randomization and transplantation. Specifically, the incidence of hypertension was assessed only after the Week 4 visit. This period allowed for adequate stabilization and resolution of transient changes. If participants received antihypertensive medication for the indication of hypertension at this (or later) time point, they were considered to have developed hypertension. Hypertension was defined according to the Seventh Report of the Joint National Committee on the Prevention, Detection, Evaluation, and Treatment of High Blood Pressure for subjects with chronic kidney disease. This definition was based upon SBP ≥ 130 mm Hg or DBP ≥ 80 mm Hg. Systolic blood pressure = SBP; Diastolic blood pressure = DBP', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component'}, {'type': 'SECONDARY', 'title': 'Percent of Participants With Prevalence of Hypertension Post-Transplantation at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}, {'value': '219', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cyclosporine', 'description': 'Cyclosporine (CsA): tablet, oral\n\n1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)'}, {'id': 'OG001', 'title': 'Belatacept LI', 'description': 'Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)'}, {'id': 'OG002', 'title': 'Belatacept MI', 'description': 'Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)'}], 'classes': [{'categories': [{'measurements': [{'value': '91.0', 'groupId': 'OG000', 'lowerLimit': '87.17', 'upperLimit': '94.73'}, {'value': '89.8', 'groupId': 'OG001', 'lowerLimit': '85.88', 'upperLimit': '93.76'}, {'value': '88.6', 'groupId': 'OG002', 'lowerLimit': '84.37', 'upperLimit': '92.80'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.3', 'paramValue': '-1.13', 'ciLowerLimit': '-7.51', 'ciUpperLimit': '5.23', 'estimateComment': 'For 97.3% CI of difference, normal approximation is used if N\\>=5 in both arms. Otherwise exact method is used.', 'groupDescription': 'Month 12', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.3', 'paramValue': '-2.37', 'ciLowerLimit': '-9.01', 'ciUpperLimit': '4.15', 'estimateComment': 'For 97.3% CI of difference, normal approximation is used if N\\>=5 in both arms. Otherwise exact method is used.', 'groupDescription': 'Month 12', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Month 12', 'description': 'The prevalence of hypertension was defined as the proportion of participants at any given time who meet the definition of hypertension. Hypertension defined according to the Seventh Report of the Joint National Committee on the Prevention, Detection, Evaluation, and Treatment of High Blood Pressure for participants with chronic kidney disease. This definition is based upon SBP ≥ 130 mm Hg or DBP ≥ 80 mm Hg. Systolic blood pressure = SBP; Diastolic blood pressure = DBP', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component'}, {'type': 'SECONDARY', 'title': 'Mean Systolic Blood Pressure and Diastolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}, {'value': '193', 'groupId': 'OG001'}, {'value': '191', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cyclosporine', 'description': 'Cyclosporine (CsA): tablet, oral\n\n1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)'}, {'id': 'OG001', 'title': 'Belatacept LI', 'description': 'Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)'}, {'id': 'OG002', 'title': 'Belatacept MI', 'description': 'Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)'}], 'classes': [{'title': 'Systolic; Month 12 (n=188, 193, 191)', 'categories': [{'measurements': [{'value': '138.7', 'spread': '19.98', 'groupId': 'OG000'}, {'value': '131.4', 'spread': '16.54', 'groupId': 'OG001'}, {'value': '132.7', 'spread': '16.21', 'groupId': 'OG002'}]}]}, {'title': 'Diastolic; Month 12 (n=188, 193, 191)', 'categories': [{'measurements': [{'value': '81.9', 'spread': '11.10', 'groupId': 'OG000'}, {'value': '78.7', 'spread': '10.91', 'groupId': 'OG001'}, {'value': '79.3', 'spread': '11.54', 'groupId': 'OG002'}]}]}, {'title': 'Systolic; Month 24 (n=160, 185, 174)', 'categories': [{'measurements': [{'value': '135.4', 'spread': '19.71', 'groupId': 'OG000'}, {'value': '130.5', 'spread': '17.35', 'groupId': 'OG001'}, {'value': '129.8', 'spread': '16.84', 'groupId': 'OG002'}]}]}, {'title': 'Diastolic; Month 24 (n=160, 185, 174)', 'categories': [{'measurements': [{'value': '80.3', 'spread': '10.20', 'groupId': 'OG000'}, {'value': '78.3', 'spread': '10.51', 'groupId': 'OG001'}, {'value': '77.8', 'spread': '10.31', 'groupId': 'OG002'}]}]}, {'title': 'Systolic; Month 36 (n=145, 180, 166)', 'categories': [{'measurements': [{'value': '133.5', 'spread': '17.93', 'groupId': 'OG000'}, {'value': '127.7', 'spread': '16.48', 'groupId': 'OG001'}, {'value': '126.0', 'spread': '16.14', 'groupId': 'OG002'}]}]}, {'title': 'Diastolic; Month 36 (n=145, 180, 166)', 'categories': [{'measurements': [{'value': '79.5', 'spread': '9.16', 'groupId': 'OG000'}, {'value': '76.6', 'spread': '9.75', 'groupId': 'OG001'}, {'value': '76.1', 'spread': '11.20', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Value)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.3', 'paramValue': '-7.3', 'ciLowerLimit': '-11.4', 'ciUpperLimit': '-3.3', 'groupDescription': 'Systolic, Month 12', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Value)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.3', 'paramValue': '-6.0', 'ciLowerLimit': '-10.1', 'ciUpperLimit': '-2.0', 'groupDescription': 'Systolic, Month 12', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Value)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.3', 'paramValue': '-3.2', 'ciLowerLimit': '-5.8', 'ciUpperLimit': '-0.7', 'groupDescription': 'Diastolic, Month 12', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Value)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.3', 'paramValue': '-2.6', 'ciLowerLimit': '-5.1', 'ciUpperLimit': '0.0', 'groupDescription': 'Diastolic, Month 12', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Value)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.3', 'paramValue': '-4.9', 'ciLowerLimit': '-9.2', 'ciUpperLimit': '-0.6', 'groupDescription': 'Systolic, Month 24', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Value)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.3', 'paramValue': '-5.5', 'ciLowerLimit': '-9.9', 'ciUpperLimit': '-1.1', 'groupDescription': 'Systolic, Month 24', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Value)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.3', 'paramValue': '-1.9', 'ciLowerLimit': '-4.4', 'ciUpperLimit': '0.5', 'groupDescription': 'Diastolic, Month 24', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Value)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.3', 'paramValue': '-2.4', 'ciLowerLimit': '-5.0', 'ciUpperLimit': '0.1', 'groupDescription': 'Diastolic, Month 24', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Value)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.3', 'paramValue': '-5.8', 'ciLowerLimit': '-10.0', 'ciUpperLimit': '-1.6', 'groupDescription': 'Systolic, Month 36', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Value)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.3', 'paramValue': '-7.5', 'ciLowerLimit': '-11.7', 'ciUpperLimit': '-3.3', 'groupDescription': 'Systolic, Month 36', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Value)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.3', 'paramValue': '-2.9', 'ciLowerLimit': '-5.4', 'ciUpperLimit': '-0.4', 'groupDescription': 'Diastolic, Month 36', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Value)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.3', 'paramValue': '-3.4', 'ciLowerLimit': '-6.0', 'ciUpperLimit': '-0.9', 'groupDescription': 'Diastolic, Month 36', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Months 12, 24, 36', 'description': 'Blood pressure was measured in millimeters of mercury (mmHg). Blood pressure was measured soon after the participant arrived and sat quietly at rest for 10 minutes. 3 consecutive seated blood pressure readings were made at least 1 minute apart.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component'}, {'type': 'SECONDARY', 'title': 'Percent of Participants at Baseline With Controlled Hypertension Post Transplantation by Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '182', 'groupId': 'OG000'}, {'value': '182', 'groupId': 'OG001'}, {'value': '183', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cyclosporine', 'description': 'Cyclosporine (CsA): tablet, oral\n\n1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)'}, {'id': 'OG001', 'title': 'Belatacept LI', 'description': 'Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)'}, {'id': 'OG002', 'title': 'Belatacept MI', 'description': 'Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)'}], 'classes': [{'categories': [{'measurements': [{'value': '21.4', 'groupId': 'OG000', 'lowerLimit': '15.5', 'upperLimit': '27.4'}, {'value': '28.6', 'groupId': 'OG001', 'lowerLimit': '22.0', 'upperLimit': '35.1'}, {'value': '24.6', 'groupId': 'OG002', 'lowerLimit': '18.4', 'upperLimit': '30.8'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.3', 'paramValue': '7.1', 'ciLowerLimit': '-2.9', 'ciUpperLimit': '17.1', 'estimateComment': 'A continuity-corrected Chi-square test at significance level 0.027 was performed for the difference between the belatacept regimen and cyclosporine', 'groupDescription': 'At Month 12', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.3', 'paramValue': '3.2', 'ciLowerLimit': '-6.6', 'ciUpperLimit': '12.9', 'estimateComment': 'A continuity-corrected Chi-square test at significance level 0.027 was performed for the difference between the belatacept regimen and cyclosporine', 'groupDescription': 'At Month 12', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 to Month 12', 'description': 'Controlled hypertension was defined as a SBP \\< 130 mm Hg and a DBP \\< 80 mm Hg while receiving an antihypertensive medication for the indication of hypertension or receiving an antihypertensive medication for another indication with a medical history of hypertension. Participants with a SBP \\< 130 mm Hg and a DBP \\< 80 mm Hg who were prescribed an antihypertensive medication(s) for an indication(s) other than hypertension (eg, beta blockers for migraine prophylaxis) with no medical history of hypertension were not considered to have either hypertension or controlled hypertension. Systolic blood pressure = SBP; Diastolic blood pressure = DBP', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized, transplanted, and treated participants; intent to treat (ITT) population with baseline hypertension'}, {'type': 'SECONDARY', 'title': 'Percent of Participants With Prevalence of Controlled Hypertension at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '193', 'groupId': 'OG001'}, {'value': '190', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cyclosporine', 'description': 'Cyclosporine (CsA): tablet, oral\n\n1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)'}, {'id': 'OG001', 'title': 'Belatacept LI', 'description': 'Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)'}, {'id': 'OG002', 'title': 'Belatacept MI', 'description': 'Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)'}], 'classes': [{'categories': [{'measurements': [{'value': '21.0', 'groupId': 'OG000', 'lowerLimit': '15.12', 'upperLimit': '26.82'}, {'value': '28.0', 'groupId': 'OG001', 'lowerLimit': '21.65', 'upperLimit': '34.31'}, {'value': '24.7', 'groupId': 'OG002', 'lowerLimit': '18.60', 'upperLimit': '30.87'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.3', 'paramValue': '7.01', 'ciLowerLimit': '-2.79', 'ciUpperLimit': '16.71', 'estimateComment': 'A continuity-corrected Chi-square test at significance level 0.027 was performed for the difference between the belatacept regimen and cyclosporine', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.3', 'paramValue': '3.77', 'ciLowerLimit': '-5.86', 'ciUpperLimit': '13.35', 'estimateComment': 'A continuity-corrected Chi-square test at significance level 0.027 was performed for the difference between the belatacept regimen and cyclosporine', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Month 12', 'description': 'The prevalence of controlled hypertension was defined as the proportion of participants at any given time who met the definition of controlled hypertension. Controlled hypertension was defined as a SBP \\< 130 mm Hg and a DBP \\< 80 mm Hg while receiving an antihypertensive medication for the indication of hypertension or receiving an antihypertensive medication for another indication with a medical history of hypertension. Participants with a SBP \\< 130 mm Hg and a DBP \\< 80 mm Hg who were prescribed an antihypertensive medication(s) for an indication(s) other than hypertension (eg, beta blockers for migraine prophylaxis) with no medical history of hypertension were not considered to have either hypertension or controlled hypertension. Systolic blood pressure = SBP; Diastolic blood pressure = DBP', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component'}, {'type': 'SECONDARY', 'title': 'Percent of Non-dyslipidemic Participants With Incidence of Dyslipidemia Post-Transplantation by Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cyclosporine', 'description': 'Cyclosporine (CsA): tablet, oral\n\n1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)'}, {'id': 'OG001', 'title': 'Belatacept LI', 'description': 'Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)'}, {'id': 'OG002', 'title': 'Belatacept MI', 'description': 'Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)'}], 'classes': [{'categories': [{'measurements': [{'value': '80.0', 'groupId': 'OG000', 'lowerLimit': '70.9', 'upperLimit': '89.1'}, {'value': '63.8', 'groupId': 'OG001', 'lowerLimit': '54.1', 'upperLimit': '73.5'}, {'value': '70.9', 'groupId': 'OG002', 'lowerLimit': '60.9', 'upperLimit': '80.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Randomization to Month 12', 'description': 'Incidence of dyslipidemia was defined as the proportion of participants who developed dyslipidemia after randomization and transplantation. Dyslipidemia was defined in accordance with recent guidelines from the National Kidney Foundation Kidney Disease Outcomes Quality Initiative (NKF-K/DOQI). Dyslipidemia = hypertriglyceridemia (TGs \\>= 500 milligrams/deciliter (mg/dL) \\[5.65 mmol/L\\]), hypercholesterolemia (LDL \\>= 100 mg/dL \\[2.59 mmol/L\\]), or elevated non-HDL (non-HDL \\>= 130 mg/dL \\[3.36 mmol/L\\]) in the presence of high TGs (TGs \\>= 200 mg/dL \\[2.26 mmol/L\\]). The TG = triglyceride; LDL = low density lipoprotein; HDL = high density lipoprotein; millimole/Liter (mmol/L). For 95% CI within each group, normal approximation is used if N \\>=5. Otherwise exact method is used.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component'}, {'type': 'SECONDARY', 'title': 'Percent of Participants With Prevalence of Dyslipidemia at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}, {'value': '219', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cyclosporine', 'description': 'Cyclosporine (CsA): tablet, oral\n\n1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)'}, {'id': 'OG001', 'title': 'Belatacept LI', 'description': 'Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)'}, {'id': 'OG002', 'title': 'Belatacept MI', 'description': 'Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)'}], 'classes': [{'categories': [{'measurements': [{'value': '52.9', 'groupId': 'OG000', 'lowerLimit': '46.4', 'upperLimit': '59.5'}, {'value': '44.7', 'groupId': 'OG001', 'lowerLimit': '38.2', 'upperLimit': '51.2'}, {'value': '46.1', 'groupId': 'OG002', 'lowerLimit': '39.5', 'upperLimit': '52.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 12', 'description': 'The prevalence of dyslipidemia was defined as the proportion of participants at any given time who met the definition of dyslipidemia. Dyslipidemia defined in accordance with recent guidelines from the National Kidney Foundation Kidney Disease Outcomes Quality Initiative (NKF-K/DOQI). Dyslipidemia defined as hypertriglyceridemia (TGs \\>= 500 milligrams/deciliter (mg/dL) \\[5.65 mmol/L\\]), hypercholesterolemia (LDL \\>= 100 mg/dL \\[2.59 mmol/L\\]), or elevated non-HDL (non-HDL \\>= 130 mg/dL \\[3.36 mmol/L\\]) in the presence of high TGs (TGs \\>= 200 mg/dL \\[2.26 mmol/L\\]). TG = triglyceride; LDL = low density lipoprotein; HDL = high density lipoprotein; millimole/Liter (mmol/L). For 95% CI within each group, normal approximation is used if N \\>=5. Otherwise exact method is used.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component'}, {'type': 'SECONDARY', 'title': 'Percent of Participants With Controlled Dyslipidemia at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}, {'value': '219', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cyclosporine', 'description': 'Cyclosporine (CsA): tablet, oral\n\n1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)'}, {'id': 'OG001', 'title': 'Belatacept LI', 'description': 'Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)'}, {'id': 'OG002', 'title': 'Belatacept MI', 'description': 'Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)'}], 'classes': [{'categories': [{'measurements': [{'value': '18.1', 'groupId': 'OG000', 'lowerLimit': '13.0', 'upperLimit': '23.2'}, {'value': '15.5', 'groupId': 'OG001', 'lowerLimit': '10.8', 'upperLimit': '20.2'}, {'value': '15.5', 'groupId': 'OG002', 'lowerLimit': '10.7', 'upperLimit': '20.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 12', 'description': 'Prevalence of controlled dyslipidemia = the proportion of participants at any given time who met the stated definition of dyslipidemia. Dyslipidemia defined in accordance with recent guidelines from the National Kidney Foundation Kidney Disease Outcomes Quality Initiative (NKF-K/DOQI). Dyslipidemia defined as hypertriglyceridemia (TGs \\>= 500 milligrams/deciliter (mg/dL) \\[5.65 mmol/L\\]), hypercholesterolemia (LDL \\>= 100 mg/dL \\[2.59 mmol/L\\]), or elevated non-HDL (non-HDL \\>= 130 mg/dL \\[3.36 mmol/L\\]) in the presence of high TGs (TGs \\>= 200 mg/dL \\[2.26 mmol/L\\]). Controlled dyslipidemia defined as participants who received successful pharmacologic treatment for 1 of the above stated dyslipidemias, and their lipid values fell below the thresholds described. TG = triglyceride; LDL = low density lipoprotein; HDL = high density lipoprotein; millimole/Liter (mmol/L). For 95% CI within each group, normal approximation is used if N \\>=5. Otherwise exact method is used.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized and transplanted participants, intent-to-treat (ITT) population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Antihyperlipidemic Medication by Intensity Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}, {'value': '92', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cyclosporine', 'description': 'Cyclosporine (CsA): tablet, oral\n\n1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)'}, {'id': 'OG001', 'title': 'Belatacept LI', 'description': 'Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)'}, {'id': 'OG002', 'title': 'Belatacept MI', 'description': 'Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)'}], 'classes': [{'title': 'Intensity Level I', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}]}, {'title': 'Intensity Level II', 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}]}]}, {'title': 'Intensity Level III', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}]}, {'title': 'Intensity Level IV', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}, {'title': 'Intensity Level V', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Intensity Level VI', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 36', 'description': 'An intensity level was associated with the dose level of the statin based anti-hyperlipidemic agent. Any other agent (i.e., non-statin therapy) used as an antihyperlipidemic were considered Level I treatment intensity. Multiple daily dose levels during a period were averaged to compute the daily dose during that period. Level I = 20 mg fluvastatin (flu), 10 mg lovastatin (lova), 10 mg pravastatin (prav), 5-10 mg simvastatin (sim); Level II = 10 mg atorvastatin (atorv), 40 mg flu, 20 mg lova, 20 mg prav, 5 mg rosuvastatin (rosu), 20 mg sim, 10/10 vytorin; Level III = 20 mg atorv, 80 mg flu, 40 mg lova, 40 mg prav, 10 mg rosu, 40 mg sim, 10/20 vytorin; Level IV = 40 mg atorv, 80 mg lova, 80 mg prav, 20 mg rosu, 80 mg sim, 10/40 vytorin; Level V = 80 mg atorv, 40 mg rosu, 10/80 vytorin. Concomitant use of a statin and an agent of another class elevated the intensity level of the statin therapy by 1 level; therefore, an intensity level of greater than V was possible.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized and transplanted participants that received at least one hyperlipidemic medication; Completer analysis is based on all participants who have been followed up at least 1092 days after transplantation.'}, {'type': 'SECONDARY', 'title': 'Percent of Participants Using At Least One Anti-Hyperlipidemic Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '182', 'groupId': 'OG000'}, {'value': '199', 'groupId': 'OG001'}, {'value': '192', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cyclosporine', 'description': 'Cyclosporine (CsA): tablet, oral\n\n1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)'}, {'id': 'OG001', 'title': 'Belatacept LI', 'description': 'Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)'}, {'id': 'OG002', 'title': 'Belatacept MI', 'description': 'Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)'}], 'classes': [{'categories': [{'measurements': [{'value': '56.6', 'groupId': 'OG000', 'lowerLimit': '49.4', 'upperLimit': '63.8'}, {'value': '46.2', 'groupId': 'OG001', 'lowerLimit': '39.3', 'upperLimit': '53.2'}, {'value': '47.9', 'groupId': 'OG002', 'lowerLimit': '40.9', 'upperLimit': '55.0'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.3', 'paramValue': '-10.4', 'ciLowerLimit': '-21.4', 'ciUpperLimit': '1.0', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.3', 'paramValue': '-8.7', 'ciLowerLimit': '-19.9', 'ciUpperLimit': '2.7', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Month 36', 'description': 'This analysis is based on all participants who were followed up at least 1092 days after transplantation.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized and transplanted participants, intent-to-treat (ITT) population; Completer analysis is based on all participants who have been followed up at least 1092 days after transplantation.'}, {'type': 'SECONDARY', 'title': 'Mean Value of Lipid Parameters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '195', 'groupId': 'OG001'}, {'value': '192', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cyclosporine', 'description': 'Cyclosporine (CsA): tablet, oral\n\n1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)'}, {'id': 'OG001', 'title': 'Belatacept LI', 'description': 'Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)'}, {'id': 'OG002', 'title': 'Belatacept MI', 'description': 'Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)'}], 'classes': [{'title': 'non-HDL Cholesterol; Month 12 (n=189, 195, 192)', 'categories': [{'measurements': [{'value': '144.1', 'spread': '47.31', 'groupId': 'OG000'}, {'value': '131.5', 'spread': '38.18', 'groupId': 'OG001'}, {'value': '131.7', 'spread': '36.76', 'groupId': 'OG002'}]}]}, {'title': 'Total Cholesterol; Month 12 (n=189, 195, 192)', 'categories': [{'measurements': [{'value': '191.5', 'spread': '49.29', 'groupId': 'OG000'}, {'value': '182.4', 'spread': '39.78', 'groupId': 'OG001'}, {'value': '181.3', 'spread': '39.92', 'groupId': 'OG002'}]}]}, {'title': 'HDL Cholesterol; Month 12 (n=189, 195, 192)', 'categories': [{'measurements': [{'value': '47.4', 'spread': '13.33', 'groupId': 'OG000'}, {'value': '50.8', 'spread': '15.98', 'groupId': 'OG001'}, {'value': '49.7', 'spread': '15.69', 'groupId': 'OG002'}]}]}, {'title': 'LDL Cholesterol; Month 12 (n=187, 186, 183)', 'categories': [{'measurements': [{'value': '107.3', 'spread': '39.60', 'groupId': 'OG000'}, {'value': '102.1', 'spread': '33.40', 'groupId': 'OG001'}, {'value': '100.8', 'spread': '29.48', 'groupId': 'OG002'}]}]}, {'title': 'Triglyceride; Month 12 (n=187, 186, 183)', 'categories': [{'measurements': [{'value': '184.6', 'spread': '106.42', 'groupId': 'OG000'}, {'value': '149.4', 'spread': '87.25', 'groupId': 'OG001'}, {'value': '155.0', 'spread': '85.08', 'groupId': 'OG002'}]}]}, {'title': 'non-HDL Cholesterol; Month 24 (n=166, 190, 181)', 'categories': [{'measurements': [{'value': '145.1', 'spread': '39.52', 'groupId': 'OG000'}, {'value': '126.7', 'spread': '38.48', 'groupId': 'OG001'}, {'value': '127.0', 'spread': '36.76', 'groupId': 'OG002'}]}]}, {'title': 'Total Cholesterol; Month 24 (n=166, 190, 181)', 'categories': [{'measurements': [{'value': '193.5', 'spread': '40.23', 'groupId': 'OG000'}, {'value': '175.3', 'spread': '42.38', 'groupId': 'OG001'}, {'value': '175.4', 'spread': '40.03', 'groupId': 'OG002'}]}]}, {'title': 'HDL ; Month 24 (n=166, 190, 181)', 'categories': [{'measurements': [{'value': '48.4', 'spread': '13.74', 'groupId': 'OG000'}, {'value': '48.6', 'spread': '15.28', 'groupId': 'OG001'}, {'value': '48.5', 'spread': '14.92', 'groupId': 'OG002'}]}]}, {'title': 'LDL Cholesterol; Month 24 (n=164, 186, 168)', 'categories': [{'measurements': [{'value': '109.1', 'spread': '35.92', 'groupId': 'OG000'}, {'value': '98.6', 'spread': '33.71', 'groupId': 'OG001'}, {'value': '96.5', 'spread': '30.52', 'groupId': 'OG002'}]}]}, {'title': 'Triglyceride; Month 24 (n=164, 186, 168)', 'categories': [{'measurements': [{'value': '179.5', 'spread': '97.51', 'groupId': 'OG000'}, {'value': '143.4', 'spread': '88.97', 'groupId': 'OG001'}, {'value': '151.2', 'spread': '95.88', 'groupId': 'OG002'}]}]}, {'title': 'non-HDL Cholesterol; Month 36 (n=154, 184, 176)', 'categories': [{'measurements': [{'value': '142.2', 'spread': '43.19', 'groupId': 'OG000'}, {'value': '122.4', 'spread': '40.12', 'groupId': 'OG001'}, {'value': '122.1', 'spread': '38.78', 'groupId': 'OG002'}]}]}, {'title': 'Total Cholesterol; Month 36 (n=154, 184, 176)', 'categories': [{'measurements': [{'value': '190.7', 'spread': '45.28', 'groupId': 'OG000'}, {'value': '171.3', 'spread': '45.78', 'groupId': 'OG001'}, {'value': '170.7', 'spread': '43.26', 'groupId': 'OG002'}]}]}, {'title': 'HDL Cholesterol; Month 36 (n=154, 184, 176)', 'categories': [{'measurements': [{'value': '48.5', 'spread': '14.27', 'groupId': 'OG000'}, {'value': '48.9', 'spread': '15.37', 'groupId': 'OG001'}, {'value': '48.6', 'spread': '16.86', 'groupId': 'OG002'}]}]}, {'title': 'LDL Cholesterol; Month 36 (n=142, 170, 161)', 'categories': [{'measurements': [{'value': '107.6', 'spread': '37.66', 'groupId': 'OG000'}, {'value': '96.7', 'spread': '36.53', 'groupId': 'OG001'}, {'value': '92.5', 'spread': '33.78', 'groupId': 'OG002'}]}]}, {'title': 'Triglyceride; Month 36 (n=142, 170, 161)', 'categories': [{'measurements': [{'value': '179.1', 'spread': '97.07', 'groupId': 'OG000'}, {'value': '132.7', 'spread': '68.69', 'groupId': 'OG001'}, {'value': '144.0', 'spread': '81.48', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Months 12, 24, 36', 'description': 'Lipid parameters included total cholesterol, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol, non-HDL cholesterol, and triglycerides (TGs).', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized and transplanted participants, intent-to-treat (ITT) population'}, {'type': 'SECONDARY', 'title': 'Percent of Participants With Prevalence of Acute Rejection (AR) by Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}, {'value': '219', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cyclosporine', 'description': 'Cyclosporine (CsA): tablet, oral\n\n1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)'}, {'id': 'OG001', 'title': 'Belatacept LI', 'description': 'Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)'}, {'id': 'OG002', 'title': 'Belatacept MI', 'description': 'Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)'}], 'classes': [{'title': 'Month 6 (n=221, 226, 219)', 'categories': [{'measurements': [{'value': '5.4', 'groupId': 'OG000', 'lowerLimit': '2.4', 'upperLimit': '8.4'}, {'value': '16.8', 'groupId': 'OG001', 'lowerLimit': '11.9', 'upperLimit': '21.7'}, {'value': '21.9', 'groupId': 'OG002', 'lowerLimit': '16.4', 'upperLimit': '27.4'}]}]}, {'title': 'Month 24 (n=221, 226, 219)', 'categories': [{'measurements': [{'value': '9.0', 'groupId': 'OG000', 'lowerLimit': '5.3', 'upperLimit': '12.8'}, {'value': '17.3', 'groupId': 'OG001', 'lowerLimit': '12.3', 'upperLimit': '22.2'}, {'value': '24.2', 'groupId': 'OG002', 'lowerLimit': '18.5', 'upperLimit': '29.9'}]}]}, {'title': 'Month 36 (n=221, 226, 219)', 'categories': [{'measurements': [{'value': '9.5', 'groupId': 'OG000', 'lowerLimit': '5.6', 'upperLimit': '13.4'}, {'value': '17.3', 'groupId': 'OG001', 'lowerLimit': '12.3', 'upperLimit': '22.2'}, {'value': '24.2', 'groupId': 'OG002', 'lowerLimit': '18.5', 'upperLimit': '29.9'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.3', 'paramValue': '11.4', 'ciLowerLimit': '5.0', 'ciUpperLimit': '18.2', 'estimateComment': 'For 97.3% CI of difference, normal approximation is used if N\\>=5 in both arms. Otherwise exact method is used.', 'groupDescription': 'Month 6', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'A 20% margin for non-inferiority was used and provides 99% power to ascertain that the upper bound of the 97.3% 2-sided confidence intervals for the absolute difference between each belatacept regimen and cyclosporine, assuming the true acute rejection rate by 12 months is 15% for all three regimens'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.3', 'paramValue': '16.5', 'ciLowerLimit': '9.6', 'ciUpperLimit': '23.8', 'estimateComment': 'For 97.3% CI of difference, normal approximation is used if N\\>=5 in both arms. Otherwise exact method is used.', 'groupDescription': 'Month 6', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'A 20% margin for non-inferiority was used and provides 99% power to ascertain that the upper bound of the 97.3% 2-sided confidence intervals for the absolute difference between each belatacept regimen and cyclosporine, assuming the true acute rejection rate by 12 months is 15% for all three regimens'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.3', 'paramValue': '8.2', 'ciLowerLimit': '1.2', 'ciUpperLimit': '15.4', 'estimateComment': 'For 97.3% CI of difference, normal approximation is used if N\\>=5 in both arms. Otherwise exact method is used', 'groupDescription': 'Month 24', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'A 20% margin for non-inferiority was used and provides 99% power to ascertain that the upper bound of the 97.3% 2-sided confidence intervals for the absolute difference between each belatacept regimen and cyclosporine, assuming the true acute rejection rate by 12 months is 15% for all three regimens.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.3', 'paramValue': '15.2', 'ciLowerLimit': '7.5', 'ciUpperLimit': '23.0', 'estimateComment': 'For 97.3% CI of difference, normal approximation is used if N\\>=5 in both arms. Otherwise exact method is used.', 'groupDescription': 'Month 24', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'A 20% margin for non-inferiority was used and provides 99% power to ascertain that the upper bound of the 97.3% 2-sided confidence intervals for the absolute difference between each belatacept regimen and cyclosporine, assuming the true acute rejection rate by 12 months is 15% for all three regimens.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.3', 'paramValue': '7.8', 'ciLowerLimit': '0.6', 'ciUpperLimit': '15.0', 'estimateComment': 'For 97.3% CI of difference, normal approximation is used if N\\>=5 in both arms. Otherwise exact method is used.', 'groupDescription': 'Month 36', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'A 20% margin for non-inferiority was used and provides 99% power to ascertain that the upper bound of the 97.3% 2-sided confidence intervals for the absolute difference between each belatacept regimen and cyclosporine, assuming the true acute rejection rate by 12 months is 15% for all three regimens.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.3', 'paramValue': '14.7', 'ciLowerLimit': '7.0', 'ciUpperLimit': '22.6', 'estimateComment': 'For 97.3% CI of difference, normal approximation is used if N\\>=5 in both arms. Otherwise exact method is used.', 'groupDescription': 'Month 36', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'A 20% margin for non-inferiority was used and provides 99% power to ascertain that the upper bound of the 97.3% 2-sided confidence intervals for the absolute difference between each belatacept regimen and cyclosporine, assuming the true acute rejection rate by 12 months is 15% for all three regimens.'}], 'paramType': 'NUMBER', 'timeFrame': 'Randomization to Month 36', 'description': 'Prevalence of AR = participants with the stated definition of AR at any given time. AR defined as a clinico-pathological event requiring clinical evidence and renal biopsy confirmation demonstrating a Banff 97 classification of Grade IA or greater, with higher scores indicating more severe rejection. Only the episode with the highest Banff grade for each participant was counted. Clinical evidence = if either a or b was satisfied: a: an unexplained rise of serum creatinine ≥ 25% from baseline creatinine; b: an unexplained decreased urine output; or fever and graft tenderness; or a serum creatinine that remains elevated within 14 days post-transplantation and clinical suspicion of acute rejection exists. Allograft biopsies were evaluated by a blinded central independent pathologist using Banff 97 working classification of kidney transplant pathology. Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized and transplanted participants, intent to treat (ITT) population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Acute Rejection (AR) Post-transplant in Terms of Severity Using Banff Grades by Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}, {'value': '219', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cyclosporine', 'description': 'Cyclosporine (CsA): tablet, oral\n\n1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)'}, {'id': 'OG001', 'title': 'Belatacept LI', 'description': 'Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)'}, {'id': 'OG002', 'title': 'Belatacept MI', 'description': 'Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)'}], 'classes': [{'title': 'Mild Acute (IA); Month 6', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'Mild Acute (IB); Month 6', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Moderate Acute (IIA); Month 6', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}]}, {'title': 'Moderate Acute (IIB); Month 6', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}]}, {'title': 'Severe Acute (III); Month 6', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Mild Acute (IA); Month 12', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'Mild Acute (IB); Month 12', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Moderate Acute (IIA); Month 12', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}]}, {'title': 'Moderate Acute (IIB); Month 12', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}]}, {'title': 'Severe Acute (III); Month 12', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Mild Acute (IA); Month 24', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'Mild Acute (IB); Month 24', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Moderate Acute (IIA); Month 24', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}]}, {'title': 'Moderate Acute (IIB); Month 24', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}]}, {'title': 'Severe Acute (III); Month 24', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Mild Acute (IA); Month 36', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'Mild Acute (IB); Month 36', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Moderate Acute (IIA); Month 36', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}]}, {'title': 'Moderate Acute (IIB); Month 36', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}]}, {'title': 'Severe Acute (III); Month 36', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Randomization to Month 36', 'description': 'Acute rejection was defined as a clinico-pathological event requiring clinical evidence and renal biopsy confirmation demonstrating a Banff 97 classification of Grade IA or greater, with higher scores indicating more severe rejection. Clinical evidence defined: if either a or b was satisfied: a) an unexplained rise of serum creatinine ≥ 25% from baseline creatinine; b) an unexplained decreased urine output; or fever and graft tenderness; or a serum creatinine that remains elevated within 14 days post-transplantation and clinical suspicion of acute rejection exists. Allograft biopsies were evaluated by a blinded central independent pathologist using Banff 97 working classification of kidney transplant pathology. Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification. Only the episode with the highest Banff grade for each participant was counted.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized and transplanted participants, intent to treat (ITT) population'}, {'type': 'SECONDARY', 'title': 'Percent of Participants Using Polyclonal Antilymphocyte Preparations for Impaired Renal Function and Anticipated Delayed Graft Function by Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}, {'value': '219', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cyclosporine', 'description': 'Cyclosporine (CsA): tablet, oral\n\n1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)'}, {'id': 'OG001', 'title': 'Belatacept LI', 'description': 'Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)'}, {'id': 'OG002', 'title': 'Belatacept MI', 'description': 'Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)'}], 'classes': [{'categories': [{'measurements': [{'value': '3.6', 'groupId': 'OG000', 'lowerLimit': '1.2', 'upperLimit': '6.1'}, {'value': '0.4', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '2.4'}, {'value': '0.5', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '2.5'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.2', 'ciLowerLimit': '-6.6', 'ciUpperLimit': '-0.6', 'estimateComment': 'For 95% CI of difference, normal approximation is used if N\\>=5 in both arms. Otherwise exact method is used.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.2', 'ciLowerLimit': '-6.6', 'ciUpperLimit': '-0.6', 'estimateComment': 'For 95% CI of difference, normal approximation is used if N\\>=5 in both arms. Otherwise exact method is used.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Randomization to Month 12', 'description': 'A participant was considered to have delayed graft function (DGF), if treated with dialysis within the first week (Day 1 - 8) after transplantation. The use of polyclonal antilymphocyte preparations (LDT) was permitted only for participants randomized to cyclosporine (CsA) who experienced impaired renal allograft function and anticipated DGF following transplantation and were not permitted in belatacept-treated participants, except for the treatment of acute rejection. Participants treated with LDT began CsA at the discretion of the investigator by Day 7. LDT could also have been used in participants who met \\>= 1 of the following criteria, observed in the presence of a transplant artery and vein and no evidence of hydronephrosis by sonogram: Urine output \\< 250 mL/12 hours, no significant improvement (\\< 1 milligram per deciliter (mg/dL)) in serum creatinine from baseline value over the first 24 - 72 hours post-transplant, or dialysis treatment.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized and transplanted participants, intent to treat (ITT) population'}, {'type': 'SECONDARY', 'title': 'Percent of Participants Using Lymphocyte Depleting Therapy (LDT) for the Initial Treatment of Acute Rejection (AR) by Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}, {'value': '219', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cyclosporine', 'description': 'Cyclosporine (CsA): tablet, oral\n\n1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)'}, {'id': 'OG001', 'title': 'Belatacept LI', 'description': 'Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)'}, {'id': 'OG002', 'title': 'Belatacept MI', 'description': 'Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)'}], 'classes': [{'title': 'Month 6', 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000'}, {'value': '4.4', 'groupId': 'OG001'}, {'value': '5.9', 'groupId': 'OG002'}]}]}, {'title': 'Month 12', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '4.4', 'groupId': 'OG001'}, {'value': '5.9', 'groupId': 'OG002'}]}]}, {'title': 'Month 24', 'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000'}, {'value': '4.4', 'groupId': 'OG001'}, {'value': '5.9', 'groupId': 'OG002'}]}]}, {'title': 'Month 36', 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000'}, {'value': '4.4', 'groupId': 'OG001'}, {'value': '5.9', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Randomization to Month 36', 'description': 'The use of LDT (thymoglobulin or antithymocyte gamma globulin \\[ATGAM\\]) was permitted only for participants randomized to cyclosporine (CsA) who experienced impaired renal allograft function and anticipated delayed graft function following transplantation. Acute rejection (AR) defined as a clinico-pathological event requiring clinical evidence (an unexplained rise of serum creatinine ≥ 25% from baseline creatinine or an unexplained decreased urine output; or fever and graft tenderness; or a serum creatinine that remained elevated within 14 days post-transplantation and clinical suspicion of acute rejection existed) and biopsy confirmation. AR defined by a renal biopsy demonstrating a Banff 97 classification of Grade IA or greater, with higher scores indicating more severe rejection. Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification. Only the episode with the highest Banff grade for each participant was counted.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized and transplanted participants, intent to treat (ITT) population'}, {'type': 'SECONDARY', 'title': 'Percent of Participants With Corticosteroid Resistant Acute Rejection (AR) by Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}, {'value': '219', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cyclosporine', 'description': 'Cyclosporine (CsA): tablet, oral\n\n1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)'}, {'id': 'OG001', 'title': 'Belatacept LI', 'description': 'Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)'}, {'id': 'OG002', 'title': 'Belatacept MI', 'description': 'Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)'}], 'classes': [{'title': 'Month 6', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '4.0', 'groupId': 'OG001'}, {'value': '5.9', 'groupId': 'OG002'}]}]}, {'title': 'Month 12', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '5.3', 'groupId': 'OG001'}, {'value': '6.4', 'groupId': 'OG002'}]}]}, {'title': 'Month 24', 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000'}, {'value': '5.3', 'groupId': 'OG001'}, {'value': '6.4', 'groupId': 'OG002'}]}]}, {'title': 'Month 36', 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000'}, {'value': '5.3', 'groupId': 'OG001'}, {'value': '6.8', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Randomization to Month 36', 'description': 'Steroid-resistant acute rejection (AR) defined as the use of lymphocyte-depletion therapy following treatment with corticosteroids. AR defined as a clinico-pathological event requiring clinical evidence and renal biopsy confirmation demonstrating a Banff 97 classification of Grade IA or greater, with higher scores indicating more severe rejection. Clinical evidence defined: either a or b was satisfied: a) an unexplained rise of serum creatinine ≥ 25% from baseline creatinine; b) an unexplained decreased urine output; or fever and graft tenderness; or a serum creatinine that remained elevated within 14 days post-transplantation and clinical suspicion of acute rejection existed. Allograft biopsies were evaluated by a blinded central independent pathologist using Banff 97 international standardized histopathological working classification of kidney transplant pathology. Only the episode with the highest Banff grade for each participant was counted.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized and transplanted participants, intent to treat (ITT) population'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Recovered Completely From an Episode of Acute Rejection (AR) by Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cyclosporine', 'description': 'Cyclosporine (CsA): tablet, oral\n\n1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)'}, {'id': 'OG001', 'title': 'Belatacept LI', 'description': 'Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)'}, {'id': 'OG002', 'title': 'Belatacept MI', 'description': 'Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)'}], 'classes': [{'title': 'Algorithm 1', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}]}]}, {'title': 'Algorithm 2', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Randomization to Month 12', 'description': 'Acute rejection (AR) = a clinico-pathological event requiring clinical evidence and renal biopsy confirmation demonstrating a Banff 97 classification of Grade IA or greater. Clinical evidence = if either a or b was satisfied: a: an unexplained rise of serum creatinine ≥ 25% from baseline creatinine; b: an unexplained decreased urine output; or fever and graft tenderness; or a serum creatinine that remains elevated within 14 days post-transplantation and clinical suspicion of acute rejection exists. Complete recovery following AR defined as serum creatinine \\[SCr\\] levels returned to baseline. Recovery calculated using 2 algorithms: Algorithm 1 = last laboratory measurement prior to onset of AR (baseline and first laboratory measurement after 84 days since onset of AR = resolution); Algorithm 2 = lowest laboratory measurement on or after transplantation and prior to onset day of AR (baseline and lowest laboratory measurement after onset on first AR up to Month 12 = resolution)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized, transplanted, and treated participants; intent to treat (ITT) population with at least one episode of AR up to Month 12'}, {'type': 'SECONDARY', 'title': 'Percent of Participants With Subclinical Rejection at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}, {'value': '164', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cyclosporine', 'description': 'Cyclosporine (CsA): tablet, oral\n\n1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)'}, {'id': 'OG001', 'title': 'Belatacept LI', 'description': 'Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)'}, {'id': 'OG002', 'title': 'Belatacept MI', 'description': 'Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)'}], 'classes': [{'categories': [{'measurements': [{'value': '5.2', 'groupId': 'OG000', 'lowerLimit': '1.7', 'upperLimit': '8.6'}, {'value': '4.7', 'groupId': 'OG001', 'lowerLimit': '1.5', 'upperLimit': '7.9'}, {'value': '4.3', 'groupId': 'OG002', 'lowerLimit': '1.2', 'upperLimit': '7.4'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.3', 'paramValue': '-0.5', 'ciLowerLimit': '-6.5', 'ciUpperLimit': '5.3', 'groupDescription': 'Month 12', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.3', 'paramValue': '-0.9', 'ciLowerLimit': '-6.9', 'ciUpperLimit': '4.8', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Month 12', 'description': 'Subclinical rejection defined as histological findings by the central pathologist consistent with acute rejection, but lacking its clinical correlate. Acute rejection defined as a clinico-pathological event requiring clinical evidence and renal biopsy confirmation demonstrating a Banff 97 classification of Grade IA or greater, with higher scores indicating more severe rejection. Only the episode with the highest Banff grade for each participant was counted. Clinical evidence defined if either a or b was satisfied: a) an unexplained rise of serum creatinine ≥ 25% from baseline creatinine; b) an unexplained decreased urine output; or fever and graft tenderness; or a serum creatinine that remained elevated within 14 days post-transplantation and clinical suspicion of acute rejection existed. Allograft biopsies were evaluated by a blinded central independent pathologist using Banff 97 working classification of kidney transplant pathology.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component'}, {'type': 'SECONDARY', 'title': 'Number of Participants Treated for Acute Rejection (AR) Regardless of Histological Findings by Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}, {'value': '219', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cyclosporine', 'description': 'Cyclosporine (CsA): tablet, oral\n\n1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)'}, {'id': 'OG001', 'title': 'Belatacept LI', 'description': 'Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)'}, {'id': 'OG002', 'title': 'Belatacept MI', 'description': 'Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)'}], 'classes': [{'title': 'Month 6', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}]}]}, {'title': 'Month 12', 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}]}]}, {'title': 'Month 24', 'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '81', 'groupId': 'OG002'}]}]}, {'title': 'Month 36', 'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Randomization to Month 36', 'description': 'Allograft rejection includes any episode of rejection including: clinically suspected rejection, treated rejection, any central biopsy-proven acute rejection (BPAR), and acute rejection (AR: a subset of BPAR) defined as central biopsy-proven rejection that was either clinically suspected by protocol-defined reasons or by other reasons and was treated. Acute rejection (AR) defined as a clinico-pathological event requiring clinical evidence ( either an unexplained rise of serum creatinine ≥ 25% from baseline creatinine or an unexplained decreased urine output; or fever and graft tenderness; or a serum creatinine that remained elevated within 14 days post-transplantation and clinical suspicion of AR) and renal biopsy confirmation biopsy demonstrating a Banff 97 working classification of kidney transplant pathology classification of Grade IA or greater, with higher scores indicating more severe rejection. Only the highest Banff grade for each participant was counted.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized and transplanted participants, intent to treat (ITT) population'}, {'type': 'SECONDARY', 'title': 'Mean Value of Physical and Mental Components Using SF-36 Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}, {'value': '218', 'groupId': 'OG001'}, {'value': '201', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cyclosporine', 'description': 'Cyclosporine (CsA): tablet, oral\n\n1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)'}, {'id': 'OG001', 'title': 'Belatacept LI', 'description': 'Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)'}, {'id': 'OG002', 'title': 'Belatacept MI', 'description': 'Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)'}], 'classes': [{'title': 'Mental Component Score; Month 6 (n=191, 205, 189)', 'categories': [{'measurements': [{'value': '49.4', 'spread': '11.08', 'groupId': 'OG000'}, {'value': '49.9', 'spread': '10.55', 'groupId': 'OG001'}, {'value': '51.1', 'spread': '10.53', 'groupId': 'OG002'}]}]}, {'title': 'Physical Component Score; Month 6 (n=191,205,189)', 'categories': [{'measurements': [{'value': '47.3', 'spread': '8.91', 'groupId': 'OG000'}, {'value': '48.9', 'spread': '8.59', 'groupId': 'OG001'}, {'value': '49.2', 'spread': '7.58', 'groupId': 'OG002'}]}]}, {'title': 'Mental Component Score; Month 12 (n=198,210,194)', 'categories': [{'measurements': [{'value': '49.5', 'spread': '10.78', 'groupId': 'OG000'}, {'value': '50.3', 'spread': '10.08', 'groupId': 'OG001'}, {'value': '49.9', 'spread': '10.54', 'groupId': 'OG002'}]}]}, {'title': 'Physical Component Score; Month 12 (n=198,210,194)', 'categories': [{'measurements': [{'value': '47.5', 'spread': '9.34', 'groupId': 'OG000'}, {'value': '49.6', 'spread': '8.18', 'groupId': 'OG001'}, {'value': '50.3', 'spread': '8.21', 'groupId': 'OG002'}]}]}, {'title': 'Mental Component Score; Month 24 (n=200,214,198)', 'categories': [{'measurements': [{'value': '48.3', 'spread': '11.14', 'groupId': 'OG000'}, {'value': '49.6', 'spread': '10.77', 'groupId': 'OG001'}, {'value': '48.8', 'spread': '11.03', 'groupId': 'OG002'}]}]}, {'title': 'Physical Component Score; Month 24 (n=200,214,198)', 'categories': [{'measurements': [{'value': '47.3', 'spread': '9.50', 'groupId': 'OG000'}, {'value': '49.0', 'spread': '8.77', 'groupId': 'OG001'}, {'value': '49.9', 'spread': '8.03', 'groupId': 'OG002'}]}]}, {'title': 'Mental Component Score; Month 36 (n=203,218,201)', 'categories': [{'measurements': [{'value': '46.9', 'spread': '11.60', 'groupId': 'OG000'}, {'value': '48.7', 'spread': '11.26', 'groupId': 'OG001'}, {'value': '48.3', 'spread': '11.50', 'groupId': 'OG002'}]}]}, {'title': 'Physical Component Score; Month 36 (n=203,218,201)', 'categories': [{'measurements': [{'value': '47.1', 'spread': '9.47', 'groupId': 'OG000'}, {'value': '49.2', 'spread': '9.15', 'groupId': 'OG001'}, {'value': '48.7', 'spread': '8.90', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.6573', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Value)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.5', 'ciLowerLimit': '-1.6', 'ciUpperLimit': '2.6', 'pValueComment': 'Baseline observations were not used for imputations at subsequent time points.', 'estimateComment': 'Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.', 'groupDescription': 'Mental Component Score; Month 6', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.', 'testedNonInferiority': False}, {'pValue': '0.1198', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Value)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.7', 'ciLowerLimit': '-0.4', 'ciUpperLimit': '3.9', 'pValueComment': 'Baseline observations were not used for imputations at subsequent time points.', 'estimateComment': 'Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.', 'groupDescription': 'Mental Component Score; Month 6', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.', 'testedNonInferiority': False}, {'pValue': '0.0672', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Value)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.5', 'ciLowerLimit': '-0.1', 'ciUpperLimit': '3.2', 'pValueComment': 'Baseline observations were not used for imputations at subsequent time points.', 'estimateComment': 'Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.', 'groupDescription': 'Physical Component Score; Month 6', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.', 'testedNonInferiority': False}, {'pValue': '0.0257', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Value)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.9', 'ciLowerLimit': '0.2', 'ciUpperLimit': '3.6', 'pValueComment': 'Baseline observations were not used for imputations at subsequent time points.', 'estimateComment': 'Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.', 'groupDescription': 'Physical Component Score; Month 6', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.', 'testedNonInferiority': False}, {'pValue': '0.4146', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Value)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.8', 'ciLowerLimit': '-1.2', 'ciUpperLimit': '2.9', 'pValueComment': 'Baseline observations were not used for imputations at subsequent time points.', 'estimateComment': 'Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.', 'groupDescription': 'Mental Component Score; Month 12', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.', 'testedNonInferiority': False}, {'pValue': '0.7327', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Value)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '-1.7', 'ciUpperLimit': '2.4', 'pValueComment': 'Baseline observations were not used for imputations at subsequent time points.', 'estimateComment': 'Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.', 'groupDescription': 'Mental Component Score; Month 12', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.', 'testedNonInferiority': False}, {'pValue': '0.0144', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Value)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.1', 'ciLowerLimit': '0.4', 'ciUpperLimit': '3.8', 'pValueComment': 'Baseline observations were not used for imputations at subsequent time points.', 'estimateComment': 'Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.', 'groupDescription': 'Physical Component Score; Month 12', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.', 'testedNonInferiority': False}, {'pValue': '0.0015', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Value)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.8', 'ciLowerLimit': '1.1', 'ciUpperLimit': '4.5', 'pValueComment': 'Baseline observations were not used for imputations at subsequent time points.', 'estimateComment': 'Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.', 'groupDescription': 'Physical Component Score; Month 12', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.', 'testedNonInferiority': False}, {'pValue': '0.2340', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Value)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.3', 'ciLowerLimit': '-0.8', 'ciUpperLimit': '3.4', 'pValueComment': 'Baseline observations were not used for imputations at subsequent time points.', 'estimateComment': 'Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.', 'groupDescription': 'Mental Component Score; Month 24', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.', 'testedNonInferiority': False}, {'pValue': '0.6635', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Value)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.5', 'ciLowerLimit': '-1.7', 'ciUpperLimit': '2.6', 'pValueComment': 'Baseline observations were not used for imputations at subsequent time points.', 'estimateComment': 'Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.', 'groupDescription': 'Mental Component Score; Month 24', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.', 'testedNonInferiority': False}, {'pValue': '0.0417', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Value)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.8', 'ciLowerLimit': '0.1', 'ciUpperLimit': '3.5', 'pValueComment': 'Baseline observations were not used for imputations at subsequent time points.', 'estimateComment': 'Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.', 'groupDescription': 'Physical Component Score; Month 24', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.', 'testedNonInferiority': False}, {'pValue': '0.0026', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Value)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.7', 'ciLowerLimit': '0.9', 'ciUpperLimit': '4.4', 'pValueComment': 'Baseline observations were not used for imputations at subsequent time points.', 'estimateComment': 'Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.', 'groupDescription': 'Physical Component Score; Month 24', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.', 'testedNonInferiority': False}, {'pValue': '0.0953', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Value)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.9', 'ciLowerLimit': '-0.3', 'ciUpperLimit': '4.1', 'pValueComment': 'Baseline observations were not used for imputations at subsequent time points.', 'estimateComment': 'Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.', 'groupDescription': 'Mental Component Score; Month 36', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.', 'testedNonInferiority': False}, {'pValue': '0.1961', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Value)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.5', 'ciLowerLimit': '-0.8', 'ciUpperLimit': '3.7', 'pValueComment': 'Baseline observations were not used for imputations at subsequent time points.', 'estimateComment': 'Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.', 'groupDescription': 'Mental Component Score; Month 36', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.', 'testedNonInferiority': False}, {'pValue': '0.0191', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Value)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.1', 'ciLowerLimit': '0.3', 'ciUpperLimit': '3.9', 'pValueComment': 'Baseline observations were not used for imputations at subsequent time points.', 'estimateComment': 'Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.', 'groupDescription': 'Physical Component Score; Month 36', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.', 'testedNonInferiority': False}, {'pValue': '0.0684', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Value)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.7', 'ciLowerLimit': '-0.1', 'ciUpperLimit': '3.5', 'pValueComment': 'Baseline observations were not used for imputations at subsequent time points.', 'estimateComment': 'Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.', 'groupDescription': 'Physical Component Score; Month 36', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANOVA model: Component Score = treatment. Missing values were imputed using last observation carried forward (LOCF) method.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Months 6, 12, 24, 36', 'description': 'SF-36 was a Participant-Reported Quality of Life (QoL) Short Form (SF) questionnaire measuring health-related quality of life (HRQL) covering 2 scale measures: physical component summary (PCS) and mental component summary (MCS). PCS represented by 4 domains: physical function, role limitations due to physical problems, pain, and general health perception. MCS represented by 4 domains: vitality, social function, role limitations due to emotional problems, and mental health. Their scores were computed based on weighted combinations of the 8 domain scores, which were transformed to a range from 0 to 100; 0= worst HRQL, 100=best HRQL. Higher scores reflect better health-related functional status. Scoring is standardized using the norm-based scoring method where data is scored in relation to the U.S. general population having a mean of 50 and a standard deviation of 10. Scores below 50 are below the U.S. general population norm and above 50 are above the U.S. general population norm.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized and transplanted participants, intent to treat (ITT) population'}, {'type': 'SECONDARY', 'title': 'Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '205', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}, {'value': '206', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cyclosporine', 'description': 'Cyclosporine (CsA): tablet, oral\n\n1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)'}, {'id': 'OG001', 'title': 'Belatacept LI', 'description': 'Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)'}, {'id': 'OG002', 'title': 'Belatacept MI', 'description': 'Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)'}], 'classes': [{'title': 'Bodily Pain, Month 6 (n=193, 207, 193)', 'categories': [{'measurements': [{'value': '50.6', 'spread': '10.96', 'groupId': 'OG000'}, {'value': '52.5', 'spread': '10.10', 'groupId': 'OG001'}, {'value': '52.7', 'spread': '10.04', 'groupId': 'OG002'}]}]}, {'title': 'General Health, Month 6 (n=193, 207, 194)', 'categories': [{'measurements': [{'value': '47.9', 'spread': '10.08', 'groupId': 'OG000'}, {'value': '48.2', 'spread': '9.67', 'groupId': 'OG001'}, {'value': '49.0', 'spread': '8.66', 'groupId': 'OG002'}]}]}, {'title': 'Mental Health, Month 6 (n=192, 206, 194)', 'categories': [{'measurements': [{'value': '50.1', 'spread': '11.08', 'groupId': 'OG000'}, {'value': '50.3', 'spread': '10.33', 'groupId': 'OG001'}, {'value': '51.3', 'spread': '10.78', 'groupId': 'OG002'}]}]}, {'title': 'Physical Functioning, Month 6 (n=193, 207, 194)', 'categories': [{'measurements': [{'value': '47.4', 'spread': '9.13', 'groupId': 'OG000'}, {'value': '48.3', 'spread': '9.01', 'groupId': 'OG001'}, {'value': '48.0', 'spread': '8.81', 'groupId': 'OG002'}]}]}, {'title': 'Role Emotional, Month 6 (n=192, 206, 191)', 'categories': [{'measurements': [{'value': '44.6', 'spread': '12.31', 'groupId': 'OG000'}, {'value': '46.0', 'spread': '11.19', 'groupId': 'OG001'}, {'value': '46.8', 'spread': '10.55', 'groupId': 'OG002'}]}]}, {'title': 'Role-Physical, Month 6 (n=192, 207, 192)', 'categories': [{'measurements': [{'value': '43.2', 'spread': '11.08', 'groupId': 'OG000'}, {'value': '45.2', 'spread': '10.34', 'groupId': 'OG001'}, {'value': '46.7', 'spread': '9.06', 'groupId': 'OG002'}]}]}, {'title': 'Social Functioning, Month 6 (n=193, 207, 194)', 'categories': [{'measurements': [{'value': '47.5', 'spread': '10.68', 'groupId': 'OG000'}, {'value': '47.8', 'spread': '10.41', 'groupId': 'OG001'}, {'value': '47.9', 'spread': '10.65', 'groupId': 'OG002'}]}]}, {'title': 'Vitality, Month 6 (n=192, 206, 194)', 'categories': [{'measurements': [{'value': '54.0', 'spread': '10.27', 'groupId': 'OG000'}, {'value': '55.5', 'spread': '9.75', 'groupId': 'OG001'}, {'value': '56.2', 'spread': '9.29', 'groupId': 'OG002'}]}]}, {'title': 'Bodily Pain, Month 12 (n=200, 213, 199)', 'categories': [{'measurements': [{'value': '50.8', 'spread': '10.79', 'groupId': 'OG000'}, {'value': '52.7', 'spread': '9.67', 'groupId': 'OG001'}, {'value': '53.7', 'spread': '9.60', 'groupId': 'OG002'}]}]}, {'title': 'General Health, Month 12 (n=200, 214, 199)', 'categories': [{'measurements': [{'value': '46.9', 'spread': '9.98', 'groupId': 'OG000'}, {'value': '48.8', 'spread': '9.57', 'groupId': 'OG001'}, {'value': '49.2', 'spread': '8.85', 'groupId': 'OG002'}]}]}, {'title': 'Mental Health, Month 12 (n=200, 213, 199)', 'categories': [{'measurements': [{'value': '49.8', 'spread': '10.99', 'groupId': 'OG000'}, {'value': '50.7', 'spread': '10.64', 'groupId': 'OG001'}, {'value': '50.3', 'spread': '10.29', 'groupId': 'OG002'}]}]}, {'title': 'Physical Functioning, Month 12 (n=200, 214, 198)', 'categories': [{'measurements': [{'value': '47.2', 'spread': '9.77', 'groupId': 'OG000'}, {'value': '49.0', 'spread': '8.88', 'groupId': 'OG001'}, {'value': '48.1', 'spread': '9.84', 'groupId': 'OG002'}]}]}, {'title': 'Role Emotional, Month 12 (n=198, 213, 196)', 'categories': [{'measurements': [{'value': '45.8', 'spread': '11.36', 'groupId': 'OG000'}, {'value': '46.8', 'spread': '10.82', 'groupId': 'OG001'}, {'value': '45.9', 'spread': '11.27', 'groupId': 'OG002'}]}]}, {'title': 'Role-Physical, Month 12 (n=199, 213, 196)', 'categories': [{'measurements': [{'value': '45.0', 'spread': '10.78', 'groupId': 'OG000'}, {'value': '47.1', 'spread': '10.00', 'groupId': 'OG001'}, {'value': '47.5', 'spread': '9.90', 'groupId': 'OG002'}]}]}, {'title': 'Social Functioning, Month 12 (n=200, 213, 199)', 'categories': [{'measurements': [{'value': '47.6', 'spread': '10.26', 'groupId': 'OG000'}, {'value': '48.4', 'spread': '9.61', 'groupId': 'OG001'}, {'value': '49.1', 'spread': '9.80', 'groupId': 'OG002'}]}]}, {'title': 'Vitality, Month 12 (n=200, 213, 199)', 'categories': [{'measurements': [{'value': '53.3', 'spread': '10.01', 'groupId': 'OG000'}, {'value': '55.7', 'spread': '9.81', 'groupId': 'OG001'}, {'value': '56.0', 'spread': '9.34', 'groupId': 'OG002'}]}]}, {'title': 'Bodily Pain, Month 24 (n=203, 219, 205)', 'categories': [{'measurements': [{'value': '51.0', 'spread': '10.82', 'groupId': 'OG000'}, {'value': '51.4', 'spread': '10.51', 'groupId': 'OG001'}, {'value': '52.5', 'spread': '10.47', 'groupId': 'OG002'}]}]}, {'title': 'General Health, Month 24 (n=203, 219, 205)', 'categories': [{'measurements': [{'value': '46.2', 'spread': '10.07', 'groupId': 'OG000'}, {'value': '48.4', 'spread': '9.61', 'groupId': 'OG001'}, {'value': '48.7', 'spread': '9.45', 'groupId': 'OG002'}]}]}, {'title': 'Mental Health, Month 24 (n=201, 215, 199)', 'categories': [{'measurements': [{'value': '48.5', 'spread': '11.13', 'groupId': 'OG000'}, {'value': '49.7', 'spread': '10.89', 'groupId': 'OG001'}, {'value': '49.3', 'spread': '10.85', 'groupId': 'OG002'}]}]}, {'title': 'Physical Functioning, Month 24 (n=203, 219, 205)', 'categories': [{'measurements': [{'value': '46.5', 'spread': '10.69', 'groupId': 'OG000'}, {'value': '48.7', 'spread': '9.76', 'groupId': 'OG001'}, {'value': '48.0', 'spread': '10.24', 'groupId': 'OG002'}]}]}, {'title': 'Role Emotional, Month 24 (n=202, 218, 205)', 'categories': [{'measurements': [{'value': '44.8', 'spread': '12.54', 'groupId': 'OG000'}, {'value': '46.4', 'spread': '10.89', 'groupId': 'OG001'}, {'value': '46.0', 'spread': '10.88', 'groupId': 'OG002'}]}]}, {'title': 'Role-Physical, Month 24 (n=203, 219, 204)', 'categories': [{'measurements': [{'value': '44.1', 'spread': '11.61', 'groupId': 'OG000'}, {'value': '46.6', 'spread': '10.39', 'groupId': 'OG001'}, {'value': '48.0', 'spread': '9.33', 'groupId': 'OG002'}]}]}, {'title': 'Social Functioning, Month 24 (n=203, 219, 205)', 'categories': [{'measurements': [{'value': '47.3', 'spread': '10.64', 'groupId': 'OG000'}, {'value': '48.6', 'spread': '10.28', 'groupId': 'OG001'}, {'value': '47.7', 'spread': '10.23', 'groupId': 'OG002'}]}]}, {'title': 'Vitality, Month 24 (n=201, 215, 200)', 'categories': [{'measurements': [{'value': '52.5', 'spread': '10.58', 'groupId': 'OG000'}, {'value': '54.5', 'spread': '10.30', 'groupId': 'OG001'}, {'value': '54.2', 'spread': '10.30', 'groupId': 'OG002'}]}]}, {'title': 'Bodily Pain, Month 36 (n=204, 219, 205)', 'categories': [{'measurements': [{'value': '50.0', 'spread': '11.40', 'groupId': 'OG000'}, {'value': '52.3', 'spread': '10.40', 'groupId': 'OG001'}, {'value': '51.0', 'spread': '11.05', 'groupId': 'OG002'}]}]}, {'title': 'General Health, Month 36 (n=205, 219, 206)', 'categories': [{'measurements': [{'value': '45.5', 'spread': '10.12', 'groupId': 'OG000'}, {'value': '47.7', 'spread': '10.45', 'groupId': 'OG001'}, {'value': '47.5', 'spread': '9.93', 'groupId': 'OG002'}]}]}, {'title': 'Mental Health, Month 36 (n=203, 219, 204)', 'categories': [{'measurements': [{'value': '47.4', 'spread': '11.64', 'groupId': 'OG000'}, {'value': '48.9', 'spread': '11.52', 'groupId': 'OG001'}, {'value': '48.7', 'spread': '11.43', 'groupId': 'OG002'}]}]}, {'title': 'Physical Functioning, Month 36 (n=204, 218, 206)', 'categories': [{'measurements': [{'value': '46.8', 'spread': '9.92', 'groupId': 'OG000'}, {'value': '48.1', 'spread': '10.22', 'groupId': 'OG001'}, {'value': '47.8', 'spread': '10.12', 'groupId': 'OG002'}]}]}, {'title': 'Role Emotional, Month 36 (n=204, 219, 205)', 'categories': [{'measurements': [{'value': '43.5', 'spread': '12.18', 'groupId': 'OG000'}, {'value': '46.0', 'spread': '11.85', 'groupId': 'OG001'}, {'value': '45.3', 'spread': '11.67', 'groupId': 'OG002'}]}]}, {'title': 'Role-Physical, Month 36 (n=204, 219, 205)', 'categories': [{'measurements': [{'value': '43.6', 'spread': '10.73', 'groupId': 'OG000'}, {'value': '46.3', 'spread': '11.03', 'groupId': 'OG001'}, {'value': '46.2', 'spread': '10.03', 'groupId': 'OG002'}]}]}, {'title': 'Social Functioning, Month 36 (n=204, 219, 206)', 'categories': [{'measurements': [{'value': '46.6', 'spread': '10.68', 'groupId': 'OG000'}, {'value': '48.1', 'spread': '10.28', 'groupId': 'OG001'}, {'value': '47.1', 'spread': '10.66', 'groupId': 'OG002'}]}]}, {'title': 'Vitality, Month 36 (n=203, 219, 204)', 'categories': [{'measurements': [{'value': '51.4', 'spread': '10.48', 'groupId': 'OG000'}, {'value': '53.6', 'spread': '11.38', 'groupId': 'OG001'}, {'value': '53.4', 'spread': '10.46', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0714', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Value)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.9', 'ciLowerLimit': '-0.2', 'ciUpperLimit': '3.9', 'estimateComment': 'Missing data were imputed by LOCF', 'groupDescription': 'Bodily Pain, Month 6', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Domain Score = treatment', 'testedNonInferiority': False}, {'pValue': '0.0536', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Value)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.0', 'ciLowerLimit': '-0.0', 'ciUpperLimit': '4.1', 'estimateComment': 'Missing data were imputed by LOCF', 'groupDescription': 'Bodily Pain, Month 6', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Domain score = treatment', 'testedNonInferiority': False}, {'pValue': '0.7543', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Value)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-1.6', 'ciUpperLimit': '2.2', 'estimateComment': 'Missing data were imputed by LOCF', 'groupDescription': 'General Health, Month 6', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Missing data = treatment', 'testedNonInferiority': False}, {'pValue': '0.2499', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Value)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.1', 'ciLowerLimit': '-0.8', 'ciUpperLimit': '3.0', 'estimateComment': 'Missing data were imputed by LOCF', 'groupDescription': 'General Health, Month 6', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Missing data = treatment', 'testedNonInferiority': False}, {'pValue': '0.8332', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Value)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2', 'ciLowerLimit': '-1.9', 'ciUpperLimit': '2.3', 'estimateComment': 'Missing data were imputed by LOCF', 'groupDescription': 'Mental Health, Month 6', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Missing data = treatment', 'testedNonInferiority': False}, {'pValue': '0.2523', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Value)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.3', 'ciLowerLimit': '-0.9', 'ciUpperLimit': '3.4', 'estimateComment': 'Missing data were imputed by LOCF', 'groupDescription': 'Mental Health, Month 6', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Missing data = treatment', 'testedNonInferiority': False}, {'pValue': '0.3018', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Value)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.9', 'ciLowerLimit': '-0.8', 'ciUpperLimit': '2.7', 'estimateComment': 'Missing data were imputed by LOCF', 'groupDescription': 'Physical Functioning, Month 6', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Missing data = treatment', 'testedNonInferiority': False}, {'pValue': '0.5437', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Value)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.6', 'ciLowerLimit': '-1.2', 'ciUpperLimit': '2.3', 'estimateComment': 'Missing data were imputed by LOCF', 'groupDescription': 'Physical Functioning, Month 6', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Missing data = treatment', 'testedNonInferiority': False}, {'pValue': '0.2370', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Value)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.3', 'ciLowerLimit': '-0.9', 'ciUpperLimit': '3.6', 'estimateComment': 'Missing data were imputed by LOCF', 'groupDescription': 'Role Emotional, Month 6', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Missing data = treatment', 'testedNonInferiority': False}, {'pValue': '0.0588', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Value)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.2', 'ciLowerLimit': '-0.1', 'ciUpperLimit': '4.5', 'estimateComment': 'Missing data were imputed by LOCF', 'groupDescription': 'Role Emotional, Month 6', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Missing data = treatment', 'testedNonInferiority': False}, {'pValue': '0.0502', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Value)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.0', 'ciLowerLimit': '-0.0', 'ciUpperLimit': '4.0', 'estimateComment': 'Missing data were imputed by LOCF', 'groupDescription': 'Role Physical, Month 6', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Missing data = treatment', 'testedNonInferiority': False}, {'pValue': '0.0007', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Value)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.6', 'ciLowerLimit': '1.5', 'ciUpperLimit': '5.6', 'estimateComment': 'Missing data were imputed by LOCF', 'groupDescription': 'Role-Physical, Month 6', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Missing data = treatment', 'testedNonInferiority': False}, {'pValue': '0.7637', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Value)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-1.8', 'ciUpperLimit': '2.4', 'estimateComment': 'Missing data were imputed by LOCF', 'groupDescription': 'Social Functioning, Month 6', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Missing data = treatment', 'testedNonInferiority': False}, {'pValue': '0.7006', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Value)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '-1.7', 'ciUpperLimit': '2.5', 'estimateComment': 'Missing data were imputed by LOCF', 'groupDescription': 'Social Functioning, Month 6', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Missing data = treatment', 'testedNonInferiority': False}, {'pValue': '0.1222', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Value)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.5', 'ciLowerLimit': '-0.4', 'ciUpperLimit': '3.4', 'estimateComment': 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'ciPctValue': '95', 'paramValue': '2.5', 'ciLowerLimit': '0.2', 'ciUpperLimit': '4.8', 'estimateComment': 'Missing data were imputed by LOCF', 'groupDescription': 'Role Emotional, Month 36', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Missing data = treatment', 'testedNonInferiority': False}, {'pValue': '0.1141', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Value)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.9', 'ciLowerLimit': '-0.4', 'ciUpperLimit': '4.2', 'estimateComment': 'Missing data were imputed by LOCF', 'groupDescription': 'Role Emotional, Month 36', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Missing data = treatment', 'testedNonInferiority': False}, {'pValue': '0.0087', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Value)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.7', 'ciLowerLimit': '0.7', 'ciUpperLimit': '4.7', 'estimateComment': 'Missing data were imputed by LOCF', 'groupDescription': 'Role-Physical, Month 36', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Missing data = treatment', 'testedNonInferiority': False}, {'pValue': '0.0128', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Value)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.6', 'ciLowerLimit': '0.6', 'ciUpperLimit': '4.7', 'estimateComment': 'Missing data were imputed by LOCF', 'groupDescription': 'Role-Physical, Month 36', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Missing data = treatment', 'testedNonInferiority': False}, {'pValue': '0.1369', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Value)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.5', 'ciLowerLimit': '-0.5', 'ciUpperLimit': '3.5', 'estimateComment': 'Missing data were imputed by LOCF', 'groupDescription': 'Social Functioning, Month 36', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Missing data = treatment', 'testedNonInferiority': False}, {'pValue': '0.6331', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Value)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.5', 'ciLowerLimit': '-1.5', 'ciUpperLimit': '2.5', 'estimateComment': 'Missing data were imputed by LOCF', 'groupDescription': 'Social Functioning, Month 36', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Missing data = treatment', 'testedNonInferiority': False}, {'pValue': '0.0361', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Value)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.2', 'ciLowerLimit': '0.1', 'ciUpperLimit': '4.3', 'estimateComment': 'Missing data were imputed by LOCF', 'groupDescription': 'Vitality, Month 36', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Missing data = treatment', 'testedNonInferiority': False}, {'pValue': '0.0525', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Value)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.1', 'ciLowerLimit': '-0.0', 'ciUpperLimit': '4.2', 'estimateComment': 'Missing data were imputed by LOCF', 'groupDescription': 'Vitality, Month 36', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Missing data = treatment', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Months 6, 12, 24, 36', 'description': 'SF-36 was a Participant-Reported Quality of Life (QoL) Short Form (SF) questionnaire measuring health-related quality of life (HRQL) covering 2 scale measures: physical component summary (PCS) and mental component summary (MCS). PCS represented by 4 domains: physical function, role limitations due to physical problems, pain, and general health perception. MCS represented by 4 domains: vitality, social function, role limitations due to emotional problems, and mental health. Their scores were computed based on weighted combinations of the 8 domain scores, which were transformed to a range from 0 to 100; 0= worst HRQL, 100=best HRQL. Higher scores reflect better health-related functional status. Scoring is standardized using the norm-based scoring method where data is scored in relation to the U.S. general population having a mean of 50 and a standard deviation of 10. Scores below 50 are below the U.S. general population norm and above 50 are above the U.S. general population norm.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized and transplanted participants, intent to treat (ITT) population'}, {'type': 'SECONDARY', 'title': 'Mean Relative to an Identified Distribution (Ridit) Value of Symptom Occurrence and Symptom Distress Using Modified Transplant Symptom Occurrence and Symptom Distress Scale (MTSOSDS-59R)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}, {'value': '187', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cyclosporine', 'description': 'Cyclosporine (CsA): tablet, oral\n\n1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)'}, {'id': 'OG001', 'title': 'Belatacept LI', 'description': 'Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)'}, {'id': 'OG002', 'title': 'Belatacept MI', 'description': 'Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)'}], 'classes': [{'title': 'Symptom Distress, Month 6 (n=157, 164, 155)', 'categories': [{'measurements': [{'value': '0.4643', 'spread': '0.00452', 'groupId': 'OG000'}, {'value': '0.4407', 'spread': '0.00404', 'groupId': 'OG001'}, {'value': '0.4451', 'spread': '0.00422', 'groupId': 'OG002'}]}]}, {'title': 'Symptom Occurrence, Month 6 (n=166, 176, 165)', 'categories': [{'measurements': [{'value': '0.4721', 'spread': '0.00463', 'groupId': 'OG000'}, {'value': '0.4495', 'spread': '0.00425', 'groupId': 'OG001'}, {'value': '0.4459', 'spread': '0.00432', 'groupId': 'OG002'}]}]}, {'title': 'Symptom Distress, Month 12 (n=169, 185, 169)', 'categories': [{'measurements': [{'value': '0.4751', 'spread': '0.00453', 'groupId': 'OG000'}, {'value': '0.4510', 'spread': '0.00397', 'groupId': 'OG001'}, {'value': '0.4546', 'spread': '0.00421', 'groupId': 'OG002'}]}]}, {'title': 'Symptom Occurrence, Month 12 (n=173, 188, 173)', 'categories': [{'measurements': [{'value': '0.4776', 'spread': '0.00458', 'groupId': 'OG000'}, {'value': '0.4519', 'spread': '0.00411', 'groupId': 'OG001'}, {'value': '0.4525', 'spread': '0.00430', 'groupId': 'OG002'}]}]}, {'title': 'Symptom Distress, Month 24 (n=182, 195, 179)', 'categories': [{'measurements': [{'value': '0.4798', 'spread': '0.00443', 'groupId': 'OG000'}, {'value': '0.4584', 'spread': '0.00397', 'groupId': 'OG001'}, {'value': '0.4646', 'spread': '0.00424', 'groupId': 'OG002'}]}]}, {'title': 'Symptom Occurrence, Month 24 (n=184, 197, 184)', 'categories': [{'measurements': [{'value': '0.4804', 'spread': '0.00446', 'groupId': 'OG000'}, {'value': '0.4574', 'spread': '0.00406', 'groupId': 'OG001'}, {'value': '0.4593', 'spread': '0.00423', 'groupId': 'OG002'}]}]}, {'title': 'Symptom Distress, Month 36 (n=184, 196, 183)', 'categories': [{'measurements': [{'value': '0.5000', 'spread': '0.00456', 'groupId': 'OG000'}, {'value': '0.4746', 'spread': '0.00408', 'groupId': 'OG001'}, {'value': '0.4892', 'spread': '0.00442', 'groupId': 'OG002'}]}]}, {'title': 'Symptom Occurrence, Month 36 (n=186, 197, 187)', 'categories': [{'measurements': [{'value': '0.5000', 'spread': '0.00459', 'groupId': 'OG000'}, {'value': '0.4732', 'spread': '0.00421', 'groupId': 'OG001'}, {'value': '0.4846', 'spread': '0.00441', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Value)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.024', 'ciLowerLimit': '-0.032', 'ciUpperLimit': '-0.015', 'pValueComment': 'Missing data were imputed by LOCF. The ridit of the reference group is by definition 0.5.', 'groupDescription': 'Symptom Distress, Month 6. For calculation of symptom distress, those symptoms that never occurred will be converted to missing values, in order to avoid anticipatory symptom distress.', 'statisticalMethod': 'z-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The obtained ridits between treatment groups will be compared using z-test at 0.05 significance level for each year.', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Value)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.019', 'ciLowerLimit': '-0.028', 'ciUpperLimit': '-0.011', 'pValueComment': 'Missing data were imputed by LOCF. The ridit of the reference group is by definition 0.5.', 'groupDescription': 'Symptom Distress, Month 6. For calculation of symptom distress, those symptoms that never occurred will be converted to missing values, in order to avoid anticipatory symptom distress.', 'statisticalMethod': 'z-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The obtained ridits between treatment groups will be compared using z-test at 0.05 significance level for each year.', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Value)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.023', 'ciLowerLimit': '-0.031', 'ciUpperLimit': '-0.014', 'pValueComment': 'Missing data were imputed by LOCF. The ridit of the reference group is by definition 0.5.', 'groupDescription': 'Symptom Occurrence, Month 6.', 'statisticalMethod': 'z-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The obtained ridits between treatment groups will be compared using z-test at 0.05 significance level for each year.', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Value)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.026', 'ciLowerLimit': '-0.035', 'ciUpperLimit': '-0.017', 'pValueComment': 'Missing data were imputed by LOCF. The ridit of the reference group is by definition 0.5.', 'groupDescription': 'Symptom Occurrence, Month 6.', 'statisticalMethod': 'z-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The obtained ridits between treatment groups will be compared using z-test at 0.05 significance level for each year.', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Value)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.024', 'ciLowerLimit': '-0.032', 'ciUpperLimit': '-0.016', 'pValueComment': 'Missing data were imputed by LOCF. The ridit of the reference group is by definition 0.5.', 'groupDescription': 'Symptom Distress, Month 12. For calculation of symptom distress, those symptoms that never occurred will be converted to missing values, in order to avoid anticipatory symptom distress.', 'statisticalMethod': 'z-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The obtained ridits between treatment groups will be compared using z-test at 0.05 significance level for each year.', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Value)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.020', 'ciLowerLimit': '-0.029', 'ciUpperLimit': '-0.012', 'pValueComment': 'Missing data were imputed by LOCF. The ridit of the reference group is by definition 0.5.', 'groupDescription': 'Symptom Distress, Month 12. For calculation of symptom distress, those symptoms that never occurred will be converted to missing values, in order to avoid anticipatory symptom distress.', 'statisticalMethod': 'z-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The obtained ridits between treatment groups will be compared using z-test at 0.05 significance level for each year.', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Value)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.026', 'ciLowerLimit': '-0.034', 'ciUpperLimit': '-0.017', 'pValueComment': 'Missing data were imputed by LOCF. The ridit of the reference group is by definition 0.5.', 'groupDescription': 'Symptom Occurrence, Month 12.', 'statisticalMethod': 'z-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The obtained ridits between treatment groups will be compared using z-test at 0.05 significance level for each year.', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Value)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.025', 'ciLowerLimit': '-0.034', 'ciUpperLimit': '-0.016', 'pValueComment': 'Missing data were imputed by LOCF. The ridit of the reference group is by definition 0.5.', 'groupDescription': 'Symptom Occurrence, Month 12.', 'statisticalMethod': 'z-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The obtained ridits between treatment groups will be compared using z-test at 0.05 significance level for each year.', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Value)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.021', 'ciLowerLimit': '-0.030', 'ciUpperLimit': '-0.013', 'pValueComment': 'Missing data were imputed by LOCF. The ridit of the reference group is by definition 0.5.', 'groupDescription': 'Symptom Distress, Month 24. For calculation of symptom distress, those symptoms that never occurred will be converted to missing values, in order to avoid anticipatory symptom distress.', 'statisticalMethod': 'z-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The obtained ridits between treatment groups will be compared using z-test at 0.05 significance level for each year.', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Value)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.015', 'ciLowerLimit': '-0.024', 'ciUpperLimit': '-0.007', 'pValueComment': 'Missing data were imputed by LOCF. The ridit of the reference group is by definition 0.5.', 'groupDescription': 'Symptom Distress, Month 24. For calculation of symptom distress, those symptoms that never occurred will be converted to missing values, in order to avoid anticipatory symptom distress.', 'statisticalMethod': 'z-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The obtained ridits between treatment groups will be compared using z-test at 0.05 significance level for each year.', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Value)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.023', 'ciLowerLimit': '-0.031', 'ciUpperLimit': '-0.015', 'pValueComment': 'Missing data were imputed by LOCF. The ridit of the reference group is by definition 0.5.', 'groupDescription': 'Symptom Occurrence, Month 24', 'statisticalMethod': 'z-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The obtained ridits between treatment groups will be compared using z-test at 0.05 significance level for each year.', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Value)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.021', 'ciLowerLimit': '-0.030', 'ciUpperLimit': '-0.013', 'pValueComment': 'Missing data were imputed by LOCF. The ridit of the reference group is by definition 0.5.', 'groupDescription': 'Symptom Occurrence, Month 24', 'statisticalMethod': 'z-test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The obtained ridits between treatment groups will be compared using z-test at 0.05 significance level for each year.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Months 6, 12, 24, 36', '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 baseline and at 6, 12, 24, and 36 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', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized and transplanted participants, intent to treat (ITT) population.'}, {'type': 'SECONDARY', 'title': 'Mean Changes in the Value of Physical and Mental Components Using SF-36 From Baseline Up To Months 6, 12, 24, and 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '193', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cyclosporine', 'description': 'Cyclosporine (CsA): tablet, oral\n\n1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)'}, {'id': 'OG001', 'title': 'Belatacept LI', 'description': 'Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)'}, {'id': 'OG002', 'title': 'Belatacept MI', 'description': 'Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)'}], 'classes': [{'title': 'Mental Component Score; Month 6 (n=187, 197, 184)', 'categories': [{'measurements': [{'value': '5.4', 'spread': '0.714', 'groupId': 'OG000'}, {'value': '6.2', 'spread': '0.695', 'groupId': 'OG001'}, {'value': '7.3', 'spread': '0.720', 'groupId': 'OG002'}]}]}, {'title': 'Physical Component Score; Month 6 (n=187, 197, 184', 'categories': [{'measurements': [{'value': '5.0', 'spread': '0.580', 'groupId': 'OG000'}, {'value': '6.2', 'spread': '0.566', 'groupId': 'OG001'}, {'value': '6.7', 'spread': '0.585', 'groupId': 'OG002'}]}]}, {'title': 'Mental Component Score; Month 12 (n=192, 200, 189)', 'categories': [{'measurements': [{'value': '5.4', 'spread': '0.687', 'groupId': 'OG000'}, {'value': '6.8', 'spread': '0.673', 'groupId': 'OG001'}, {'value': '6.2', 'spread': '0.693', 'groupId': 'OG002'}]}]}, {'title': 'Physical Component Score; Month 12 (n=192,200,189)', 'categories': [{'measurements': [{'value': '5.5', 'spread': '0.589', 'groupId': 'OG000'}, {'value': '7.1', 'spread': '0.577', 'groupId': 'OG001'}, {'value': '7.8', 'spread': '0.594', 'groupId': 'OG002'}]}]}, {'title': 'Mental Component Score; Month 24 (n=191,202,193)', 'categories': [{'measurements': [{'value': '4.4', 'spread': '0.732', 'groupId': 'OG000'}, {'value': '5.7', 'spread': '0.712', 'groupId': 'OG001'}, {'value': '5.1', 'spread': '0.728', 'groupId': 'OG002'}]}]}, {'title': 'Physical Component Score; Month 24 (n=191,202,193)', 'categories': [{'measurements': [{'value': '5.1', 'spread': '0.601', 'groupId': 'OG000'}, {'value': '6.5', 'spread': '0.584', 'groupId': 'OG001'}, {'value': '7.3', 'spread': '0.597', 'groupId': 'OG002'}]}]}, {'title': 'Mental Component Score; Month 36 (n=190,203,191)', 'categories': [{'measurements': [{'value': '2.6', 'spread': '0.756', 'groupId': 'OG000'}, {'value': '5.1', 'spread': '0.732', 'groupId': 'OG001'}, {'value': '4.5', 'spread': '0.754', 'groupId': 'OG002'}]}]}, {'title': 'Physical Component Score; Month 36 (n=190,203,191)', 'categories': [{'measurements': [{'value': '4.9', 'spread': '0.633', 'groupId': 'OG000'}, {'value': '6.5', 'spread': '0.612', 'groupId': 'OG001'}, {'value': '6.1', 'spread': '0.631', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.4498', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Value)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.8', 'ciLowerLimit': '-1.2', 'ciUpperLimit': '2.7', 'estimateComment': 'Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.', 'groupDescription': 'Mental Component Score; Month 6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.', 'testedNonInferiority': False}, {'pValue': '0.0584', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Value)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.9', 'ciLowerLimit': '-0.1', 'ciUpperLimit': '3.9', 'estimateComment': 'Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.', 'groupDescription': 'Mental Component Score; Month 6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.', 'testedNonInferiority': False}, {'pValue': '0.1595', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Value)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.1', 'ciLowerLimit': '-0.5', 'ciUpperLimit': '2.7', 'estimateComment': 'Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.', 'groupDescription': 'Physical Component Score; Month 6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.', 'testedNonInferiority': False}, {'pValue': '0.0457', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Value)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.7', 'ciLowerLimit': '0.0', 'ciUpperLimit': '3.3', 'estimateComment': 'Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.', 'groupDescription': 'Physical Component Score; Month 6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.', 'testedNonInferiority': False}, {'pValue': '0.1729', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Value)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.3', 'ciLowerLimit': '-0.6', 'ciUpperLimit': '3.2', 'estimateComment': 'Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.', 'groupDescription': 'Mental Component Score; Month 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.', 'testedNonInferiority': False}, {'pValue': '0.4209', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Value)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.8', 'ciLowerLimit': '-1.1', 'ciUpperLimit': '2.7', 'estimateComment': 'Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.', 'groupDescription': 'Mental Component Score; Month 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.', 'testedNonInferiority': False}, {'pValue': '0.0526', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Value)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.6', 'ciLowerLimit': '-0.0', 'ciUpperLimit': '3.2', 'estimateComment': 'Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.', 'groupDescription': 'Physical Component Score; Month 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.', 'testedNonInferiority': False}, {'pValue': '0.0077', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Value)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.2', 'ciLowerLimit': '0.6', 'ciUpperLimit': '3.9', 'estimateComment': 'Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.', 'groupDescription': 'Physical Component Score; Month 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.', 'testedNonInferiority': False}, {'pValue': '0.1849', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Value)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.4', 'ciLowerLimit': '-0.6', 'ciUpperLimit': '3.4', 'estimateComment': 'Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.', 'groupDescription': 'Mental Component Score; Month 24', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.', 'testedNonInferiority': False}, {'pValue': '0.4633', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Value)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.8', 'ciLowerLimit': '-1.3', 'ciUpperLimit': '2.8', 'estimateComment': 'Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.', 'groupDescription': 'Mental Component Score; Month 24', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.', 'testedNonInferiority': False}, {'pValue': '0.0971', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Value)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.4', 'ciLowerLimit': '-0.3', 'ciUpperLimit': '3.0', 'estimateComment': 'Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.', 'groupDescription': 'Physical Component Score; Month 24', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.', 'testedNonInferiority': False}, {'pValue': '0.0102', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Value)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.2', 'ciLowerLimit': '0.5', 'ciUpperLimit': '3.8', 'estimateComment': 'Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.', 'groupDescription': 'Physical Component Score; Month 24', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.', 'testedNonInferiority': False}, {'pValue': '0.0186', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Value)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.5', 'ciLowerLimit': '0.4', 'ciUpperLimit': '4.5', 'estimateComment': 'Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.', 'groupDescription': 'Mental Component Score; Month 36', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.', 'testedNonInferiority': False}, {'pValue': '0.0775', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Value)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.9', 'ciLowerLimit': '-0.2', 'ciUpperLimit': '4.0', 'estimateComment': 'Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.', 'groupDescription': 'Mental Component Score; Month 36', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.', 'testedNonInferiority': False}, {'pValue': '0.0768', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Value)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.6', 'ciLowerLimit': '-0.2', 'ciUpperLimit': '3.3', 'estimateComment': 'Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.', 'groupDescription': 'Physical Component Score; Month 36', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.', 'testedNonInferiority': False}, {'pValue': '0.1876', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Value)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.2', 'ciLowerLimit': '-0.6', 'ciUpperLimit': '2.9', 'estimateComment': 'Statistical tests comparing each belatacept regimen to the CsA regimen were conducted at a significance level of 0.05. Subjects with only baseline observations were excluded from these summaries.', 'groupDescription': 'Physical Component Score; Month 36', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted mean based on an ANCOVA model with treatment as factor, and baseline value as covariate.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Months 6, 12, 24,and 36', 'description': 'SF-36 was a Participant-Reported Quality of Life (QoL) Short Form (SF) questionnaire measuring health-related quality of life (HRQL) covering 2 scale measures: physical component summary (PCS) and mental component summary (MCS). PCS represented by 4 domains: physical function, role limitations due to physical problems, pain, and general health perception. MCS represented by 4 domains: vitality, social function, role limitations due to emotional problems, and mental health. Their scores were computed based on weighted combinations of the 8 domain scores, which were transformed to a range from 0 to 100; 0= worst HRQL, 100=best HRQL. Higher scores reflect better health-related functional status. Scoring is standardized using the norm-based scoring method where data is scored in relation to the U.S. general population having a mean of 50 and a standard deviation of 10. Scores below 50 are below the U.S. general population norm and above 50 are above the U.S. general population norm.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized and transplanted participants, intent to treat (ITT) population'}, {'type': 'SECONDARY', 'title': 'Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '207', 'groupId': 'OG001'}, {'value': '197', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cyclosporine', 'description': 'Cyclosporine (CsA): tablet, oral\n\n1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)'}, {'id': 'OG001', 'title': 'Belatacept LI', 'description': 'Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)'}, {'id': 'OG002', 'title': 'Belatacept MI', 'description': 'Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)'}], 'classes': [{'title': 'Bodily Pain, Month 6 (n=189,201,189)', 'categories': [{'measurements': [{'value': '2.9', 'spread': '0.712', 'groupId': 'OG000'}, {'value': '4.5', 'spread': '0.691', 'groupId': 'OG001'}, {'value': '4.6', 'spread': '0.712', 'groupId': 'OG002'}]}]}, {'title': 'General Health, Month 6 (n=189,201,190)', 'categories': [{'measurements': [{'value': '6.7', 'spread': '0.631', 'groupId': 'OG000'}, {'value': '7.1', 'spread': '0.612', 'groupId': 'OG001'}, {'value': '7.3', 'spread': '0.630', 'groupId': 'OG002'}]}]}, {'title': 'Mental Health, Month 6 (n=188,198,190)', 'categories': [{'measurements': [{'value': '4.7', 'spread': '0.716', 'groupId': 'OG000'}, {'value': '5.2', 'spread': '0.698', 'groupId': 'OG001'}, {'value': '6.1', 'spread': '0.712', 'groupId': 'OG002'}]}]}, {'title': 'Physical Functioning, Month 6 (n=189,201,190)', 'categories': [{'measurements': [{'value': '4.7', 'spread': '0.610', 'groupId': 'OG000'}, {'value': '5.3', 'spread': '0.592', 'groupId': 'OG001'}, {'value': '5.6', 'spread': '0.610', 'groupId': 'OG002'}]}]}, {'title': 'Role Emotional, Month 6 (n=188,200,186)', 'categories': [{'measurements': [{'value': '4.7', 'spread': '0.767', 'groupId': 'OG000'}, {'value': '5.8', 'spread': '0.744', 'groupId': 'OG001'}, {'value': '6.9', 'spread': '0.772', 'groupId': 'OG002'}]}]}, {'title': 'Role-Physical, Month 6 (n=188,201,187)', 'categories': [{'measurements': [{'value': '6.4', 'spread': '0.718', 'groupId': 'OG000'}, {'value': '8.4', 'spread': '0.694', 'groupId': 'OG001'}, {'value': '9.6', 'spread': '0.720', 'groupId': 'OG002'}]}]}, {'title': 'Social Functioning, Month 6 (n=189,201,190)', 'categories': [{'measurements': [{'value': '6.0', 'spread': '0.724', 'groupId': 'OG000'}, {'value': '6.8', 'spread': '0.702', 'groupId': 'OG001'}, {'value': '6.9', 'spread': '0.722', 'groupId': 'OG002'}]}]}, {'title': 'Vitality, Month 6 (n=188,198,190)', 'categories': [{'measurements': [{'value': '7.5', 'spread': '0.668', 'groupId': 'OG000'}, {'value': '9.0', 'spread': '0.651', 'groupId': 'OG001'}, {'value': '9.9', 'spread': '0.665', 'groupId': 'OG002'}]}]}, {'title': 'Bodily Pain, Month 12 (n=194,205,195)', 'categories': [{'measurements': [{'value': '3.1', 'spread': '0.665', 'groupId': 'OG000'}, {'value': '4.8', 'spread': '0.647', 'groupId': 'OG001'}, {'value': '5.5', 'spread': '0.664', 'groupId': 'OG002'}]}]}, {'title': 'General Health, Month 12 (n=194,206,195)', 'categories': [{'measurements': [{'value': '6.0', 'spread': '0.638', 'groupId': 'OG000'}, {'value': '7.7', 'spread': '0.619', 'groupId': 'OG001'}, {'value': '7.6', 'spread': '0.636', 'groupId': 'OG002'}]}]}, {'title': 'Mental Health, Month 12 (n=194,203,195)', 'categories': [{'measurements': [{'value': '4.4', 'spread': '0.685', 'groupId': 'OG000'}, {'value': '6.0', 'spread': '0.670', 'groupId': 'OG001'}, {'value': '5.0', 'spread': '0.684', 'groupId': 'OG002'}]}]}, {'title': 'Physical Functioning, Month 12 (n=194,206,194)', 'categories': [{'measurements': [{'value': '4.7', 'spread': '0.640', 'groupId': 'OG000'}, {'value': '6.2', 'spread': '0.621', 'groupId': 'OG001'}, {'value': '5.8', 'spread': '0.641', 'groupId': 'OG002'}]}]}, {'title': 'Role Emotional, Month 12 (n=192,205,191)', 'categories': [{'measurements': [{'value': '5.7', 'spread': '0.765', 'groupId': 'OG000'}, {'value': '6.6', 'spread': '0.741', 'groupId': 'OG001'}, {'value': '5.9', 'spread': '0.768', 'groupId': 'OG002'}]}]}, {'title': 'Role-Physical, Month 12 (n=193,205,191)', 'categories': [{'measurements': [{'value': '8.3', 'spread': '0.716', 'groupId': 'OG000'}, {'value': '10.3', 'spread': '0.695', 'groupId': 'OG001'}, {'value': '10.4', 'spread': '0.720', 'groupId': 'OG002'}]}]}, {'title': 'Social Functioning, Month 12 (n=194,205,195)', 'categories': [{'measurements': [{'value': '6.4', 'spread': '0.669', 'groupId': 'OG000'}, {'value': '7.7', 'spread': '0.650', 'groupId': 'OG001'}, {'value': '8.0', 'spread': '0.667', 'groupId': 'OG002'}]}]}, {'title': 'Vitality, Month 12 (n=194,203,195)', 'categories': [{'measurements': [{'value': '7.0', 'spread': '0.651', 'groupId': 'OG000'}, {'value': '9.2', 'spread': '0.636', 'groupId': 'OG001'}, {'value': '9.7', 'spread': '0.649', 'groupId': 'OG002'}]}]}, {'title': 'Bodily Pain, Month 24 (n=192,207,197)', 'categories': [{'measurements': [{'value': '3.2', 'spread': '0.722', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '0.696', 'groupId': 'OG001'}, {'value': '4.1', 'spread': '0.713', 'groupId': 'OG002'}]}]}, {'title': 'General Health, Month 24 (n=193,207,197)', 'categories': [{'measurements': [{'value': '5.1', 'spread': '0.641', 'groupId': 'OG000'}, {'value': '7.2', 'spread': '0.619', 'groupId': 'OG001'}, {'value': '6.8', 'spread': '0.635', 'groupId': 'OG002'}]}]}, {'title': 'Mental Health, Month 24 (n=193,203,195)', 'categories': [{'measurements': [{'value': '3.2', 'spread': '0.710', 'groupId': 'OG000'}, {'value': '4.6', 'spread': '0.692', 'groupId': 'OG001'}, {'value': '4.0', 'spread': '0.706', 'groupId': 'OG002'}]}]}, {'title': 'Physical Functioning, Month 24 (n=193,207,197)', 'categories': [{'measurements': [{'value': '4.1', 'spread': '0.685', 'groupId': 'OG000'}, {'value': '5.7', 'spread': '0.662', 'groupId': 'OG001'}, {'value': '5.5', 'spread': '0.679', 'groupId': 'OG002'}]}]}, {'title': 'Role Emotional, Month 24 (n=192,206,196)', 'categories': [{'measurements': [{'value': '4.7', 'spread': '0.793', 'groupId': 'OG000'}, {'value': '6.0', 'spread': '0.766', 'groupId': 'OG001'}, {'value': '5.9', 'spread': '0.785', 'groupId': 'OG002'}]}]}, {'title': 'Role-Physical, Month 24 (n=193,207,195)', 'categories': [{'measurements': [{'value': '7.4', 'spread': '0.740', 'groupId': 'OG000'}, {'value': '9.4', 'spread': '0.715', 'groupId': 'OG001'}, {'value': '10.7', 'spread': '0.737', 'groupId': 'OG002'}]}]}, {'title': 'Social Functioning, Month 24 (n=193, 207,197)', 'categories': [{'measurements': [{'value': '5.9', 'spread': '0.722', 'groupId': 'OG000'}, {'value': '7.4', 'spread': '0.697', 'groupId': 'OG001'}, {'value': '6.3', 'spread': '0.715', 'groupId': 'OG002'}]}]}, {'title': 'Vitality, Month 24 (n=193,203,196)', 'categories': [{'measurements': [{'value': '6.2', 'spread': '0.700', 'groupId': 'OG000'}, {'value': '7.9', 'spread': '0.682', 'groupId': 'OG001'}, {'value': '8.0', 'spread': '0.695', 'groupId': 'OG002'}]}]}, {'title': 'Bodily Pain, Month 36 (n=191,207,196)', 'categories': [{'measurements': [{'value': '2.3', 'spread': '0.739', 'groupId': 'OG000'}, {'value': '4.2', 'spread': '0.710', 'groupId': 'OG001'}, {'value': '3.0', 'spread': '0.730', 'groupId': 'OG002'}]}]}, {'title': 'General Health, Month 36 (n=193,207,197)', 'categories': [{'measurements': [{'value': '4.1', 'spread': '0.681', 'groupId': 'OG000'}, {'value': '6.6', 'spread': '0.657', 'groupId': 'OG001'}, {'value': '5.8', 'spread': '0.674', 'groupId': 'OG002'}]}]}, {'title': 'Mental Health, Month 36 (n=191,204,195)', 'categories': [{'measurements': [{'value': '1.8', 'spread': '0.754', 'groupId': 'OG000'}, {'value': '4.1', 'spread': '0.729', 'groupId': 'OG001'}, {'value': '3.4', 'spread': '0.746', 'groupId': 'OG002'}]}]}, {'title': 'Physical Functioning, Month 36 (n=192,206,197)', 'categories': [{'measurements': [{'value': '4.4', 'spread': '0.692', 'groupId': 'OG000'}, {'value': '5.3', 'spread': '0.668', 'groupId': 'OG001'}, {'value': '5.1', 'spread': '0.684', 'groupId': 'OG002'}]}]}, {'title': 'Role Emotional, Month 36 (n=192,207,195)', 'categories': [{'measurements': [{'value': '3.3', 'spread': '0.830', 'groupId': 'OG000'}, {'value': '5.6', 'spread': '0.800', 'groupId': 'OG001'}, {'value': '5.0', 'spread': '0.824', 'groupId': 'OG002'}]}]}, {'title': 'Role-Physical, Month 36 (n=192,207,195)', 'categories': [{'measurements': [{'value': '6.8', 'spread': '0.754', 'groupId': 'OG000'}, {'value': '9.2', 'spread': '0.727', 'groupId': 'OG001'}, {'value': '8.9', 'spread': '0.749', 'groupId': 'OG002'}]}]}, {'title': 'Social Functioning, Month 36 (n=192,207,197)', 'categories': [{'measurements': [{'value': '5.1', 'spread': '0.736', 'groupId': 'OG000'}, {'value': '7.0', 'spread': '0.708', 'groupId': 'OG001'}, {'value': '5.6', 'spread': '0.726', 'groupId': 'OG002'}]}]}, {'title': 'Vitality, Month 36 (n=191,204,195)', 'categories': [{'measurements': [{'value': '4.9', 'spread': '0.721', 'groupId': 'OG000'}, {'value': '7.3', 'spread': '0.698', 'groupId': 'OG001'}, {'value': '7.3', 'spread': '0.714', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Months 6, 12, 24, and 36', 'description': 'SF-36 was a Participant-Reported Quality of Life (QoL) Short Form (SF) questionnaire measuring health-related quality of life (HRQL) covering 2 scale measures: physical component summary (PCS) and mental component summary (MCS). PCS represented by 4 domains: physical function, role limitations due to physical problems, pain, and general health perception. MCS represented by 4 domains: vitality, social function, role limitations due to emotional problems, and mental health. Their scores were computed based on weighted combinations of the 8 domain scores, which were transformed to a range from 0 to 100; 0= worst HRQL, 100=best HRQL. Higher scores reflect better health-related functional status. Scoring is standardized using the norm-based scoring method where data is scored in relation to the U.S. general population having a mean of 50 and a standard deviation of 10. Scores below 50 are below the U.S. general population norm and above 50 are above the U.S. general population norm.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized and transplanted participants, intent to treat (ITT) population'}, {'type': 'SECONDARY', 'title': 'Percent of Participants Surviving With a Functioning Graft', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}, {'value': '219', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cyclosporine', 'description': 'Cyclosporine (CsA): tablet, oral\n\n1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)'}, {'id': 'OG001', 'title': 'Belatacept LI', 'description': 'Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)'}, {'id': 'OG002', 'title': 'Belatacept MI', 'description': 'Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)'}], 'classes': [{'title': 'Month 24', 'categories': [{'measurements': [{'value': '90.5', 'groupId': 'OG000', 'lowerLimit': '86.6', 'upperLimit': '94.4'}, {'value': '94.7', 'groupId': 'OG001', 'lowerLimit': '91.8', 'upperLimit': '97.6'}, {'value': '94.1', 'groupId': 'OG002', 'lowerLimit': '90.9', 'upperLimit': '97.2'}]}]}, {'title': 'Month 36', 'categories': [{'measurements': [{'value': '88.7', 'groupId': 'OG000', 'lowerLimit': '84.5', 'upperLimit': '92.9'}, {'value': '92.0', 'groupId': 'OG001', 'lowerLimit': '88.5', 'upperLimit': '95.6'}, {'value': '92.2', 'groupId': 'OG002', 'lowerLimit': '88.7', 'upperLimit': '95.8'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.3', 'paramValue': '4.2', 'ciLowerLimit': '-1.3', 'ciUpperLimit': '10.1', 'groupDescription': 'Month 24', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': "A non-inferiority margin of 10% for the co-primary endpoint of participant and graft survival was used. Determination of a margin for non-inferiority based on 'preservation of benefit' is not feasible, given the low rate of patient death and/or graft loss in the first year post-transplantation, and the absence of published, adequately sized, parallel-group trials with which to assess the effect of CsA on patient death and/or graft loss in the setting of MMF/steroids/basiliximab."}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.3', 'paramValue': '3.6', 'ciLowerLimit': '-2.2', 'ciUpperLimit': '9.6', 'groupDescription': 'Month 24', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': "A non-inferiority margin of 10% for the co-primary endpoint of participant and graft survival was used. Determination of a margin for non-inferiority based on 'preservation of benefit' is not feasible, given the low rate of patient death and/or graft loss in the first year post-transplantation, and the absence of published, adequately sized, parallel-group trials with which to assess the effect of CsA on patient death and/or graft loss in the setting of MMF/steroids/basiliximab."}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.3', 'paramValue': '3.3', 'ciLowerLimit': '-2.9', 'ciUpperLimit': '9.8', 'groupDescription': 'Month 36', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': "A non-inferiority margin of 10% for the co-primary endpoint of participant and graft survival was used. Determination of a margin for non-inferiority based on 'preservation of benefit' is not feasible, given the low rate of patient death and/or graft loss in the first year post-transplantation, and the absence of published, adequately sized, parallel-group trials with which to assess the effect of CsA on patient death and/or graft loss in the setting of MMF/steroids/basiliximab."}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.3', 'paramValue': '3.5', 'ciLowerLimit': '-2.8', 'ciUpperLimit': '10.0', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': "A non-inferiority margin of 10% for the co-primary endpoint of participant and graft survival was used. Determination of a margin for non-inferiority based on 'preservation of benefit' is not feasible, given the low rate of patient death and/or graft loss in the first year post-transplantation, and the absence of published, adequately sized, parallel-group trials with which to assess the effect of CsA on patient death and/or graft loss in the setting of MMF/steroids/basiliximab."}], 'paramType': 'NUMBER', 'timeFrame': 'Months 24, 36', 'description': 'Graft loss was defined as either functional loss or physical loss (nephrectomy). Functional loss was defined as a sustained level of serum creatinine (SCr) ≥ 6.0 milligrams per deciliter (mg/dL) or 530 micromoles per liter (μmol/L) as determined by the central laboratory for ≥ 4 weeks or ≥ 56 consecutive days of dialysis or impairment of renal function to such a degree that the participant underwent retransplant.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized and transplanted participants, intent to treat (ITT) population. For 95% CI within each group, normal approximation is used in N\\>=5. Otherwise exact method is used.'}, {'type': 'SECONDARY', 'title': 'Percent of Participants With Composite Endpoint or Death, Graft Loss or Acute Rejection by Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}, {'value': '219', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cyclosporine', 'description': 'Cyclosporine (CsA): tablet, oral\n\n1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)'}, {'id': 'OG001', 'title': 'Belatacept LI', 'description': 'Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)'}, {'id': 'OG002', 'title': 'Belatacept MI', 'description': 'Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)'}], 'classes': [{'title': 'Month 12', 'categories': [{'measurements': [{'value': '13.6', 'groupId': 'OG000', 'lowerLimit': '9.1', 'upperLimit': '18.1'}, {'value': '19.5', 'groupId': 'OG001', 'lowerLimit': '14.3', 'upperLimit': '24.6'}, {'value': '25.1', 'groupId': 'OG002', 'lowerLimit': '19.4', 'upperLimit': '30.9'}]}]}, {'title': 'Month 24', 'categories': [{'measurements': [{'value': '18.1', 'groupId': 'OG000', 'lowerLimit': '13.0', 'upperLimit': '23.2'}, {'value': '19.9', 'groupId': 'OG001', 'lowerLimit': '14.7', 'upperLimit': '25.1'}, {'value': '27.9', 'groupId': 'OG002', 'lowerLimit': '21.9', 'upperLimit': '33.8'}]}]}, {'title': 'Month 36', 'categories': [{'measurements': [{'value': '19.9', 'groupId': 'OG000', 'lowerLimit': '14.6', 'upperLimit': '25.2'}, {'value': '20.8', 'groupId': 'OG001', 'lowerLimit': '15.5', 'upperLimit': '26.1'}, {'value': '28.3', 'groupId': 'OG002', 'lowerLimit': '22.3', 'upperLimit': '34.3'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.9', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '12.8', 'groupDescription': 'Month 12', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.5', 'ciLowerLimit': '4.2', 'ciUpperLimit': '18.9', 'groupDescription': 'Month 12', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.8', 'ciLowerLimit': '-5.5', 'ciUpperLimit': '9.1', 'groupDescription': 'Month 24', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.8', 'ciLowerLimit': '1.9', 'ciUpperLimit': '17.6', 'groupDescription': 'Month 24', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.9', 'ciLowerLimit': '-6.6', 'ciUpperLimit': '8.4', 'groupDescription': 'Month 36', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.4', 'ciLowerLimit': '0.4', 'ciUpperLimit': '16.4', 'groupDescription': 'Month 36', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Randomization to Month 36', 'description': 'Graft loss was defined as either functional loss or physical loss (nephrectomy). Functional loss was defined as a sustained level of serum creatinine (SCr) ≥ 6.0 milligrams per deciliter (mg/dL) or 530 micromoles per liter (μmol/L) as determined by the central laboratory for ≥ 4 weeks or ≥ 56 consecutive days of dialysis or impairment of renal function to such a degree that the participant underwent retransplant. Acute rejection was defined as central biopsy proven rejection that was either (1) clinically suspected by protocol defined reasons or (2) clinically suspected by other reasons and treated. Death and graft loss were not imputed.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized and transplanted participants, intent to treat (ITT) population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cyclosporine', 'description': 'Cyclosporine (CsA): tablet, oral\n\n1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)'}, {'id': 'FG001', 'title': 'Belatacept LI', 'description': 'Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)'}, {'id': 'FG002', 'title': 'Belatacept MI', 'description': 'Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)'}], 'periods': [{'title': 'Transplanted Pre-Treatment', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '221'}, {'groupId': 'FG001', 'numSubjects': '226'}, {'groupId': 'FG002', 'numSubjects': '219'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '215'}, {'groupId': 'FG001', 'numSubjects': '226'}, {'groupId': 'FG002', 'numSubjects': '219'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Post-Transplant Treated (12 Months)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '215'}, {'groupId': 'FG001', 'numSubjects': '226'}, {'groupId': 'FG002', 'numSubjects': '219'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '174'}, {'groupId': 'FG001', 'numSubjects': '183'}, {'groupId': 'FG002', 'numSubjects': '173'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '43'}, {'groupId': 'FG002', 'numSubjects': '46'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '22'}, {'groupId': 'FG002', 'numSubjects': '27'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Post-Transplant Treated (24 Months)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '174'}, {'groupId': 'FG001', 'numSubjects': '183'}, {'groupId': 'FG002', 'numSubjects': '173'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '153'}, {'groupId': 'FG001', 'numSubjects': '176'}, {'groupId': 'FG002', 'numSubjects': '164'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}, {'title': 'Post-Transplant Treated (36 Months)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '153'}, {'groupId': 'FG001', 'numSubjects': '176'}, {'groupId': 'FG002', 'numSubjects': '164'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '143'}, {'groupId': 'FG001', 'numSubjects': '170'}, {'groupId': 'FG002', 'numSubjects': '158'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Subject no longer meets study criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}, {'title': 'Long Term Extension (LTE; 84 Months)', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Participants on drug through month 36 eligible to enroll in LTE; 2 ineligible, 5 withdrew or refused', 'groupId': 'FG000', 'numSubjects': '136'}, {'comment': 'Participants on drug through month 36 were eligible to enroll in LTE; 4 withdrew or refused.', 'groupId': 'FG001', 'numSubjects': '166'}, {'comment': 'Participants on drug through month 36 were eligible to enroll in LTE; 3 withdrew or refused.', 'groupId': 'FG002', 'numSubjects': '155'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '89'}, {'groupId': 'FG001', 'numSubjects': '136'}, {'groupId': 'FG002', 'numSubjects': '127'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '30'}, {'groupId': 'FG002', 'numSubjects': '28'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '14'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Poor/Non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Administrative Reason By Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '5'}]}]}], 'preAssignmentDetails': '738 participants enrolled, 686 randomized. Reasons for non-randomization include 5 participants withdrew consent, 1 lost to follow-up, 34 no longer met study criteria, and 12 for other non-listed reasons. 666 participants randomized, but not transplanted. 20 not transplanted; 10, 4, 6 in the CsA, Belatacept LI, Belatacept MI, respectively.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'BG000'}, {'value': '226', 'groupId': 'BG001'}, {'value': '219', 'groupId': 'BG002'}, {'value': '666', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Cyclosporine', 'description': 'Cyclosporine (CsA): tablet, oral\n\n1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)'}, {'id': 'BG001', 'title': 'Belatacept LI', 'description': 'Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)'}, {'id': 'BG002', 'title': 'Belatacept MI', 'description': 'Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '43.5', 'spread': '14.3', 'groupId': 'BG000'}, {'value': '42.6', 'spread': '13.4', 'groupId': 'BG001'}, {'value': '43.6', 'spread': '14.6', 'groupId': 'BG002'}, {'value': '43.2', 'spread': '14.1', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': 'Between 18 and 45 years:', 'categories': [{'measurements': [{'value': '110', 'groupId': 'BG000'}, {'value': '124', 'groupId': 'BG001'}, {'value': '111', 'groupId': 'BG002'}, {'value': '345', 'groupId': 'BG003'}]}]}, {'title': 'Between 46 and 65 years:', 'categories': [{'measurements': [{'value': '101', 'groupId': 'BG000'}, {'value': '93', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}, {'value': '287', 'groupId': 'BG003'}]}]}, {'title': '> 65 years:', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}, {'value': '204', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '165', 'groupId': 'BG000'}, {'value': '146', 'groupId': 'BG001'}, {'value': '151', 'groupId': 'BG002'}, {'value': '462', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Previous Number of Transplant', 'classes': [{'title': '0', 'categories': [{'measurements': [{'value': '208', 'groupId': 'BG000'}, {'value': '218', 'groupId': 'BG001'}, {'value': '210', 'groupId': 'BG002'}, {'value': '636', 'groupId': 'BG003'}]}]}, {'title': '1', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}]}]}, {'title': '2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Baseline characteristics of transplant recipients: All randomized and transplanted participants, intent to treat (ITT) population'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 738}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'dispFirstSubmitDate': '2010-04-29', 'completionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-12', 'studyFirstSubmitDate': '2005-11-15', 'dispFirstSubmitQcDate': '2010-04-29', 'resultsFirstSubmitDate': '2016-05-24', 'studyFirstSubmitQcDate': '2005-11-18', 'dispFirstPostDateStruct': {'date': '2010-05-03', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2016-08-19', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-07-12', 'studyFirstPostDateStruct': {'date': '2005-11-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-08-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent of Participants Surviving With a Functioning Graft by Month 12', 'timeFrame': 'Day 1 to Month 12', 'description': 'Graft loss was defined as either functional loss or physical loss (nephrectomy). Functional loss was defined as a sustained level of serum creatinine (SCr) ≥ 6.0 milligrams per deciliter (mg/dL) or 530 micromolar per liter (μmol/L) as determined by the central laboratory for ≥ 4 weeks or ≥ 56 consecutive days of dialysis or impairment of renal function to such a degree that the participant underwent retransplant.'}, {'measure': 'Percent of Participants With a Composite of Measured Glomerular Filtration Rate (mGFR) Less Than 60 mL/Min/1.73 m^2 at Month 12 or With a Decrease in mGFR Greater Than or Equal to 10 mL/Min/1.73m^2 From Month 3 to Month 12', 'timeFrame': 'Month 12; Month 3 to Month 12', 'description': 'Measured glomerular filtration rate (mGFR) is the direct measurement of renal function and was assessed by measurement of the clearance of a true glomerular filtration marker (non-radiolabeled iothalamate) using a validated procedure. A GFR of 60 mL/min/1.73 m\\^2 was used as the approximate equal of the threshold values of serum creatinine (SCr) of 1.5 mg/dL. A change in GFR of at least 10 mL/min/1.73 m\\^2 was used as the approximate change in SCr of at least 0.3 mg/dL. The change component of the composite renal endpoint was assessed from Month 3 to Month 12, since post-transplant renal function is largely stable by Month 3.'}, {'measure': 'Percent of Participants Experiencing Acute Rejection (AR) Post-transplant by Month 12', 'timeFrame': 'Day 1 to Month 12', 'description': 'Acute rejection was defined as a clinico-pathological event requiring clinical evidence and biopsy confirmation. Clinical evidence was defined if either a or b was satisfied: a: an unexplained rise of serum creatinine ≥ 25% from baseline creatinine; b: an unexplained decreased urine output; or fever and graft tenderness; or a serum creatinine that remains elevated within 14 days post-transplantation and clinical suspicion of acute rejection exists. Allograft biopsies were evaluated by a blinded central independent pathologist using Banff 97 working classification of kidney transplant pathology. Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification. AR was defined by a renal biopsy demonstrating a Banff 97 classification of Grade IA or greater, with higher scores indicating more severe rejection. Only the episode with the highest Banff grade for each participant was counted.'}], 'secondaryOutcomes': [{'measure': 'Mean Value of the Measured Glomerular Filtration Rate (mGFR)', 'timeFrame': 'Months 3, 12, 24', 'description': 'Measured glomerular filtration rate (mGFR) is the direct measurement of renal function and was assessed by measurement of the clearance of a true glomerular filtration marker (non-radiolabeled iothalamate) using a validated procedure. Missing mGRF assessments were imputed to assess renal function. The overall imputation strategy involved a primary imputation method (linear extrapolation and quartile method) followed by 2 secondary imputation methods (regression method and graded quartile method) to assess the robustness of conclusions obtained from the application of the primary imputation method. All imputation methods entailed replacing a missing value with a value drawn from a plausible distribution incorporating theoretical and observed aspects of the data. GFR was measured as mL/min/1.73 m\\^2.'}, {'measure': 'Percent of Participants With Prevalence of Chronic Allograft Nephropathy (CAN) at Month 12', 'timeFrame': 'Month 12', 'description': 'Prevalence of CAN = if participant met any of the following conditions: a: CAN observed in a biopsy either prior to 12 months (including baseline biopsy) or first post 12 months biopsy; b: participant had graft loss during the first year post transplant; c: no biopsy was available post 12 months and CAN not observed in biopsies prior to 12 months, but the measured GFR from Month 3 to Month 12 decreased at least 10 mL/min/1.73m\\^2; d: no biopsy available either prior to or post 12 months, and the measured GFR (incorporated missing data imputation) from Month 3 to Month 12 decreased at least 10 mL/min/1.73m\\^2. CAN = All allograft biopsies evaluated for presence and severity of CAN by a blinded central independent pathologist using Banff 97 working classification of kidney transplant pathology. Onset of CAN determined by the biopsy date when it was observed.'}, {'measure': 'Number of Participants With Serious Adverse Events, Death, Discontinuation Due to Adverse Events by Month 84', 'timeFrame': 'Randomization to Month 84', 'description': 'Adverse event (AE) defined: any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Serious adverse event (SAE) defined: 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': 'Number of Participants With Adverse Events of Special Interest by Month 84', 'timeFrame': 'Randomization to Month 84', '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 and Infestations, Thrombolic/embolic events, and Malignancy. 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. Time frame is from randomization to the event date, or to the last dose date+56, or to Month 84 (Day 2548), whichever is the earliest.'}, {'measure': 'Mean Blood Pressure at Month 84', 'timeFrame': 'Month 84', 'description': 'Blood pressure was measured in millimeters of mercury (mmHg). Blood pressure was measured soon after the participant arrived and sat quietly at rest for 10 minutes. 3 consecutive seated blood pressure readings were made at least 1 minute apart.'}, {'measure': 'Number of Participants Meeting Marked Laboratory Abnormality Criteria Post-transplant by Month 36', 'timeFrame': 'Baseline to Month 36', 'description': 'Upper limit of normal (ULN). Units per Liter (U/L). Cells per microliter (c/µL). Grams per deciliter (g/dL). Milligrams per deciliter (mg/dL).Cells per Liter (c/L). Milliequivalents/Liter (mEq/L).\n\nHemoglobin (low): \\<8.0 g/dL; Platelet count: \\<50\\*10\\^9 c/L; Leukocytes: \\<2\\*10\\^3 c/µL; Alkaline phosphatase (ALP): \\>5.0\\*ULN U/L; Alanine aminotransferase (ALT): \\>5.0\\*ULN U/L; Asparate aminotransferase (AST): \\>5.0\\*ULN U/L; Bilirubin Total: \\>3.0\\*ULN mg/dL; Creatinine: \\>3.0\\*ULN mg/dL; Calcium Total: low if \\<7.0 mg/dL or high if \\>12.5 mg/dL; Bicarbonate: \\<11.0 mEq/L; Potassium serum: low if \\<3.0 mEq/L or high if \\>6.0 mEq/L; Magnesium serum: low is \\<0.8 mEq/L or high if \\>2.46 mEq/L; Sodium serum: low if \\<130.0 mEq/L or high if \\>155.0 mEq/L; Phosphorus inorganic: \\<2.0 mg/dL; Albumin: \\<2 g/dL; Uric acid: \\>10 mg/dL; Protein urine: \\>=3+'}, {'measure': 'Percent of Participants With Development of Anti-Donor HLA Positive Antibodies by Month 84', 'timeFrame': 'Randomization to Month 84', 'description': 'Only participants who had non-missing test result for Class I or Class II anti-donor HLA antibodies were included in analysis and only participants who had at least one non-NA test result or finding were counted. This was a cumulative summary (excluding baseline) and once a participant was positive, that participant remained positive for the later time point. Acute rejection (AR) defined: a clinico-pathological event requiring clinical evidence and biopsy confirmation. Clinical evidence defined: if either a or b was satisfied: a: an unexplained rise of serum creatinine ≥ 25% from baseline creatinine; b: an unexplained decreased urine output; or fever and graft tenderness; or a serum creatinine that remains elevated within 14 days post-transplantation and clinical suspicion of acute rejection exists. AR defined as allograft biopsies of Banff 97 classification Grade IA or greater (higher scores indicate more severe rejection). Evaluated by blinded central independent pathologist.'}, {'measure': 'Mean Change of the Measured Glomerular Filtration Rate (mGFR) From Month 3 to Month 12 and From Month 3 to Month 24', 'timeFrame': 'Month 3 to Month 12; Month 3 to Month 24', 'description': 'Measured glomerular filtration rate (mGFR) is the direct measurement of renal function and was assessed by measurement of the clearance of a true glomerular filtration marker (non-radiolabeled iothalamate) using a validated procedure. Missing mGRF assessments were imputed to assess renal function. The overall imputation strategy involved a primary imputation method (linear extrapolation and quartile method) followed by 2 secondary imputation methods (regression method and graded quartile method) to assess the robustness of conclusions obtained from the application of the primary imputation method. All imputation methods entailed replacing a missing value with a value drawn from a plausible distribution incorporating theoretical and observed aspects of the data. GFR was measured as mL/min/1.73 m\\^2.'}, {'measure': 'Percent of Participants With a Decrease in Measured Glomerular Filtration Rate (mGFR) Greater Than or Equal to 10mL/Min/1.73m^2 From Month 3 to Month 12', 'timeFrame': 'Month 3 to Month 12', 'description': 'Measured glomerular filtration rate (mGFR) is the direct measurement of renal function and was assessed by measurement of the clearance of a true glomerular filtration marker (non-radiolabeled iothalamate) using a validated procedure. A change in GFR of at least 10 mL/min/1.73 m\\^2 was used as the approximate change in serum creatinine (SCr) of at least 0.3 mg/dL. The change component of the composite renal endpoint was assessed from Month 3 to Month 12, since post-transplant renal function is largely stable by Month 3. Month 3 = baseline'}, {'measure': 'Percent of Participants With a Measured Glomerular Filtration Rate (mGFR) Less Than 60 mL/Min/1.73 m^2 at Month 12', 'timeFrame': 'Month 12', 'description': 'Measured glomerular filtration rate (mGFR) is the direct measurement of renal function and was assessed by measurement of the clearance of a true glomerular filtration marker (non-radiolabeled iothalamate) using a validated procedure. A GFR of 60 mL/min/1.73 m\\^2 was used as the approximate equal of the threshold values of serum creatinine (SCr) of 1.5 milligrams per deciliter (mg/dL).'}, {'measure': 'Mean Value of the Calculated Glomerular Filtration Rate (cGFR) With Imputation', 'timeFrame': 'Months 6, 12, 24, 36', 'description': 'Calculated glomerular filtration rate (cGFR) was used to assess renal function (as measured by the estimated creatinine clearance) using the following modification of diet in renal disease (MDRD) formula: MDRD: GFR = 170 x \\[SCr/0.95\\]\\^(-0.999) x \\[Age\\]\\^(-0.176) x \\[0.762 if participant is female\\] x \\[1.180 if participant is black\\] x \\[BUN\\]\\^(-0.170) x \\[Alb\\]\\^(+0.318); Age in years; Alb = Albumin in g/dL; SCr = Serum creatinine in mg/dL; BUN = Blood urea nitrogen in mg/dL; cGFR = mL/min/1.73m2'}, {'measure': 'Mean Change in Calculated Glomerular Filtration Rate (cGFR) From Month 6 to Month 12', 'timeFrame': 'Month 6 to Month 12', 'description': 'Calculated glomerular filtration rate (cGFR) was used to assess renal function (as measured by the estimated creatinine clearance) using the following modification of diet in renal disease (MDRD) formula: MDRD: GFR = 170 x \\[SCr/0.95\\]\\^(-0.999) x \\[Age\\]\\^(-0.176) x \\[0.762 if participant is female\\] x \\[1.180 if participant is black\\] x \\[BUN\\]\\^(-0.170) x \\[Alb\\]\\^(+0.318); Age in years; Alb = Albumin in g/dL; SCr = Serum creatinine in mg/dL; BUN = Blood urea nitrogen in mg/dL; cGFR = mL/min/1.73m\\^2'}, {'measure': 'Percent of Participants With Incidence of New Onset Diabetes Mellitus by Month 36', 'timeFrame': 'Week 4 post-transplantation to Month 36', 'description': 'The incidence of new onset diabetes mellitus defined as participants who developed diabetes mellitus after randomization and transplantation. Participants that did not have diabetes prior to randomization were determined to have new onset diabetes mellitus if (i) the participant received an anti-diabetic medication for a duration of at least 30 days or (ii) at least two fasting plasma glucose (FPG) tests indicate that FPG is \\>=126 mg/dL (7.0 mmol/L). New onset diabetes mellitus (NODM) = post-transplant diabetes mellitus (PTDM)'}, {'measure': 'Percent of Participants Using At Least One Anti-Hypertensive Medication to Control Hypertension at Month 36', 'timeFrame': 'Month 36', 'description': 'This analysis was based on all participants who had been followed up at least 1092 days after transplantation. Hypertension was defined in according to the Seventh Report of the Joint National Committee on the Prevention, Detection, Evaluation, and Treatment of High Blood Pressure for participants with chronic kidney disease. This definition was based upon SBP ≥ 130 mm Hg or DBP ≥ 80 mm Hg. In addition, all participants who had a SBP \\< 130 mm Hg and a DBP \\< 80 mm Hg who received an antihypertensive medication(s) for the indication of hypertension or with a medical history of hypertension were included in this definition. Systolic blood pressure = SBP; Diastolic blood pressure = DBP'}, {'measure': 'Percent of Participants With Incidence of Hypertension Post-Transplantation at Month 12', 'timeFrame': 'Month 12', 'description': 'The incidence of hypertension was defined as the proportion of participants who developed hypertension after randomization and transplantation. Specifically, the incidence of hypertension was assessed only after the Week 4 visit. This period allowed for adequate stabilization and resolution of transient changes. If participants received antihypertensive medication for the indication of hypertension at this (or later) time point, they were considered to have developed hypertension. Hypertension was defined according to the Seventh Report of the Joint National Committee on the Prevention, Detection, Evaluation, and Treatment of High Blood Pressure for subjects with chronic kidney disease. This definition was based upon SBP ≥ 130 mm Hg or DBP ≥ 80 mm Hg. Systolic blood pressure = SBP; Diastolic blood pressure = DBP'}, {'measure': 'Percent of Participants With Prevalence of Hypertension Post-Transplantation at Month 12', 'timeFrame': 'Month 12', 'description': 'The prevalence of hypertension was defined as the proportion of participants at any given time who meet the definition of hypertension. Hypertension defined according to the Seventh Report of the Joint National Committee on the Prevention, Detection, Evaluation, and Treatment of High Blood Pressure for participants with chronic kidney disease. This definition is based upon SBP ≥ 130 mm Hg or DBP ≥ 80 mm Hg. Systolic blood pressure = SBP; Diastolic blood pressure = DBP'}, {'measure': 'Mean Systolic Blood Pressure and Diastolic Blood Pressure', 'timeFrame': 'Months 12, 24, 36', 'description': 'Blood pressure was measured in millimeters of mercury (mmHg). Blood pressure was measured soon after the participant arrived and sat quietly at rest for 10 minutes. 3 consecutive seated blood pressure readings were made at least 1 minute apart.'}, {'measure': 'Percent of Participants at Baseline With Controlled Hypertension Post Transplantation by Month 12', 'timeFrame': 'Day 1 to Month 12', 'description': 'Controlled hypertension was defined as a SBP \\< 130 mm Hg and a DBP \\< 80 mm Hg while receiving an antihypertensive medication for the indication of hypertension or receiving an antihypertensive medication for another indication with a medical history of hypertension. Participants with a SBP \\< 130 mm Hg and a DBP \\< 80 mm Hg who were prescribed an antihypertensive medication(s) for an indication(s) other than hypertension (eg, beta blockers for migraine prophylaxis) with no medical history of hypertension were not considered to have either hypertension or controlled hypertension. Systolic blood pressure = SBP; Diastolic blood pressure = DBP'}, {'measure': 'Percent of Participants With Prevalence of Controlled Hypertension at Month 12', 'timeFrame': 'Month 12', 'description': 'The prevalence of controlled hypertension was defined as the proportion of participants at any given time who met the definition of controlled hypertension. Controlled hypertension was defined as a SBP \\< 130 mm Hg and a DBP \\< 80 mm Hg while receiving an antihypertensive medication for the indication of hypertension or receiving an antihypertensive medication for another indication with a medical history of hypertension. Participants with a SBP \\< 130 mm Hg and a DBP \\< 80 mm Hg who were prescribed an antihypertensive medication(s) for an indication(s) other than hypertension (eg, beta blockers for migraine prophylaxis) with no medical history of hypertension were not considered to have either hypertension or controlled hypertension. Systolic blood pressure = SBP; Diastolic blood pressure = DBP'}, {'measure': 'Percent of Non-dyslipidemic Participants With Incidence of Dyslipidemia Post-Transplantation by Month 12', 'timeFrame': 'Randomization to Month 12', 'description': 'Incidence of dyslipidemia was defined as the proportion of participants who developed dyslipidemia after randomization and transplantation. Dyslipidemia was defined in accordance with recent guidelines from the National Kidney Foundation Kidney Disease Outcomes Quality Initiative (NKF-K/DOQI). Dyslipidemia = hypertriglyceridemia (TGs \\>= 500 milligrams/deciliter (mg/dL) \\[5.65 mmol/L\\]), hypercholesterolemia (LDL \\>= 100 mg/dL \\[2.59 mmol/L\\]), or elevated non-HDL (non-HDL \\>= 130 mg/dL \\[3.36 mmol/L\\]) in the presence of high TGs (TGs \\>= 200 mg/dL \\[2.26 mmol/L\\]). The TG = triglyceride; LDL = low density lipoprotein; HDL = high density lipoprotein; millimole/Liter (mmol/L). For 95% CI within each group, normal approximation is used if N \\>=5. Otherwise exact method is used.'}, {'measure': 'Percent of Participants With Prevalence of Dyslipidemia at Month 12', 'timeFrame': 'Month 12', 'description': 'The prevalence of dyslipidemia was defined as the proportion of participants at any given time who met the definition of dyslipidemia. Dyslipidemia defined in accordance with recent guidelines from the National Kidney Foundation Kidney Disease Outcomes Quality Initiative (NKF-K/DOQI). Dyslipidemia defined as hypertriglyceridemia (TGs \\>= 500 milligrams/deciliter (mg/dL) \\[5.65 mmol/L\\]), hypercholesterolemia (LDL \\>= 100 mg/dL \\[2.59 mmol/L\\]), or elevated non-HDL (non-HDL \\>= 130 mg/dL \\[3.36 mmol/L\\]) in the presence of high TGs (TGs \\>= 200 mg/dL \\[2.26 mmol/L\\]). TG = triglyceride; LDL = low density lipoprotein; HDL = high density lipoprotein; millimole/Liter (mmol/L). For 95% CI within each group, normal approximation is used if N \\>=5. Otherwise exact method is used.'}, {'measure': 'Percent of Participants With Controlled Dyslipidemia at Month 12', 'timeFrame': 'Month 12', 'description': 'Prevalence of controlled dyslipidemia = the proportion of participants at any given time who met the stated definition of dyslipidemia. Dyslipidemia defined in accordance with recent guidelines from the National Kidney Foundation Kidney Disease Outcomes Quality Initiative (NKF-K/DOQI). Dyslipidemia defined as hypertriglyceridemia (TGs \\>= 500 milligrams/deciliter (mg/dL) \\[5.65 mmol/L\\]), hypercholesterolemia (LDL \\>= 100 mg/dL \\[2.59 mmol/L\\]), or elevated non-HDL (non-HDL \\>= 130 mg/dL \\[3.36 mmol/L\\]) in the presence of high TGs (TGs \\>= 200 mg/dL \\[2.26 mmol/L\\]). Controlled dyslipidemia defined as participants who received successful pharmacologic treatment for 1 of the above stated dyslipidemias, and their lipid values fell below the thresholds described. TG = triglyceride; LDL = low density lipoprotein; HDL = high density lipoprotein; millimole/Liter (mmol/L). For 95% CI within each group, normal approximation is used if N \\>=5. Otherwise exact method is used.'}, {'measure': 'Number of Participants With Antihyperlipidemic Medication by Intensity Level', 'timeFrame': 'Month 36', 'description': 'An intensity level was associated with the dose level of the statin based anti-hyperlipidemic agent. Any other agent (i.e., non-statin therapy) used as an antihyperlipidemic were considered Level I treatment intensity. Multiple daily dose levels during a period were averaged to compute the daily dose during that period. Level I = 20 mg fluvastatin (flu), 10 mg lovastatin (lova), 10 mg pravastatin (prav), 5-10 mg simvastatin (sim); Level II = 10 mg atorvastatin (atorv), 40 mg flu, 20 mg lova, 20 mg prav, 5 mg rosuvastatin (rosu), 20 mg sim, 10/10 vytorin; Level III = 20 mg atorv, 80 mg flu, 40 mg lova, 40 mg prav, 10 mg rosu, 40 mg sim, 10/20 vytorin; Level IV = 40 mg atorv, 80 mg lova, 80 mg prav, 20 mg rosu, 80 mg sim, 10/40 vytorin; Level V = 80 mg atorv, 40 mg rosu, 10/80 vytorin. Concomitant use of a statin and an agent of another class elevated the intensity level of the statin therapy by 1 level; therefore, an intensity level of greater than V was possible.'}, {'measure': 'Percent of Participants Using At Least One Anti-Hyperlipidemic Medication', 'timeFrame': 'Month 36', 'description': 'This analysis is based on all participants who were followed up at least 1092 days after transplantation.'}, {'measure': 'Mean Value of Lipid Parameters', 'timeFrame': 'Months 12, 24, 36', 'description': 'Lipid parameters included total cholesterol, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol, non-HDL cholesterol, and triglycerides (TGs).'}, {'measure': 'Percent of Participants With Prevalence of Acute Rejection (AR) by Month 36', 'timeFrame': 'Randomization to Month 36', 'description': 'Prevalence of AR = participants with the stated definition of AR at any given time. AR defined as a clinico-pathological event requiring clinical evidence and renal biopsy confirmation demonstrating a Banff 97 classification of Grade IA or greater, with higher scores indicating more severe rejection. Only the episode with the highest Banff grade for each participant was counted. Clinical evidence = if either a or b was satisfied: a: an unexplained rise of serum creatinine ≥ 25% from baseline creatinine; b: an unexplained decreased urine output; or fever and graft tenderness; or a serum creatinine that remains elevated within 14 days post-transplantation and clinical suspicion of acute rejection exists. Allograft biopsies were evaluated by a blinded central independent pathologist using Banff 97 working classification of kidney transplant pathology. Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification.'}, {'measure': 'Number of Participants With Acute Rejection (AR) Post-transplant in Terms of Severity Using Banff Grades by Month 36', 'timeFrame': 'Randomization to Month 36', 'description': 'Acute rejection was defined as a clinico-pathological event requiring clinical evidence and renal biopsy confirmation demonstrating a Banff 97 classification of Grade IA or greater, with higher scores indicating more severe rejection. Clinical evidence defined: if either a or b was satisfied: a) an unexplained rise of serum creatinine ≥ 25% from baseline creatinine; b) an unexplained decreased urine output; or fever and graft tenderness; or a serum creatinine that remains elevated within 14 days post-transplantation and clinical suspicion of acute rejection exists. Allograft biopsies were evaluated by a blinded central independent pathologist using Banff 97 working classification of kidney transplant pathology. Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification. Only the episode with the highest Banff grade for each participant was counted.'}, {'measure': 'Percent of Participants Using Polyclonal Antilymphocyte Preparations for Impaired Renal Function and Anticipated Delayed Graft Function by Month 12', 'timeFrame': 'Randomization to Month 12', 'description': 'A participant was considered to have delayed graft function (DGF), if treated with dialysis within the first week (Day 1 - 8) after transplantation. The use of polyclonal antilymphocyte preparations (LDT) was permitted only for participants randomized to cyclosporine (CsA) who experienced impaired renal allograft function and anticipated DGF following transplantation and were not permitted in belatacept-treated participants, except for the treatment of acute rejection. Participants treated with LDT began CsA at the discretion of the investigator by Day 7. LDT could also have been used in participants who met \\>= 1 of the following criteria, observed in the presence of a transplant artery and vein and no evidence of hydronephrosis by sonogram: Urine output \\< 250 mL/12 hours, no significant improvement (\\< 1 milligram per deciliter (mg/dL)) in serum creatinine from baseline value over the first 24 - 72 hours post-transplant, or dialysis treatment.'}, {'measure': 'Percent of Participants Using Lymphocyte Depleting Therapy (LDT) for the Initial Treatment of Acute Rejection (AR) by Month 36', 'timeFrame': 'Randomization to Month 36', 'description': 'The use of LDT (thymoglobulin or antithymocyte gamma globulin \\[ATGAM\\]) was permitted only for participants randomized to cyclosporine (CsA) who experienced impaired renal allograft function and anticipated delayed graft function following transplantation. Acute rejection (AR) defined as a clinico-pathological event requiring clinical evidence (an unexplained rise of serum creatinine ≥ 25% from baseline creatinine or an unexplained decreased urine output; or fever and graft tenderness; or a serum creatinine that remained elevated within 14 days post-transplantation and clinical suspicion of acute rejection existed) and biopsy confirmation. AR defined by a renal biopsy demonstrating a Banff 97 classification of Grade IA or greater, with higher scores indicating more severe rejection. Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification. Only the episode with the highest Banff grade for each participant was counted.'}, {'measure': 'Percent of Participants With Corticosteroid Resistant Acute Rejection (AR) by Month 36', 'timeFrame': 'Randomization to Month 36', 'description': 'Steroid-resistant acute rejection (AR) defined as the use of lymphocyte-depletion therapy following treatment with corticosteroids. AR defined as a clinico-pathological event requiring clinical evidence and renal biopsy confirmation demonstrating a Banff 97 classification of Grade IA or greater, with higher scores indicating more severe rejection. Clinical evidence defined: either a or b was satisfied: a) an unexplained rise of serum creatinine ≥ 25% from baseline creatinine; b) an unexplained decreased urine output; or fever and graft tenderness; or a serum creatinine that remained elevated within 14 days post-transplantation and clinical suspicion of acute rejection existed. Allograft biopsies were evaluated by a blinded central independent pathologist using Banff 97 international standardized histopathological working classification of kidney transplant pathology. Only the episode with the highest Banff grade for each participant was counted.'}, {'measure': 'Number of Participants Who Recovered Completely From an Episode of Acute Rejection (AR) by Month 12', 'timeFrame': 'Randomization to Month 12', 'description': 'Acute rejection (AR) = a clinico-pathological event requiring clinical evidence and renal biopsy confirmation demonstrating a Banff 97 classification of Grade IA or greater. Clinical evidence = if either a or b was satisfied: a: an unexplained rise of serum creatinine ≥ 25% from baseline creatinine; b: an unexplained decreased urine output; or fever and graft tenderness; or a serum creatinine that remains elevated within 14 days post-transplantation and clinical suspicion of acute rejection exists. Complete recovery following AR defined as serum creatinine \\[SCr\\] levels returned to baseline. Recovery calculated using 2 algorithms: Algorithm 1 = last laboratory measurement prior to onset of AR (baseline and first laboratory measurement after 84 days since onset of AR = resolution); Algorithm 2 = lowest laboratory measurement on or after transplantation and prior to onset day of AR (baseline and lowest laboratory measurement after onset on first AR up to Month 12 = resolution)'}, {'measure': 'Percent of Participants With Subclinical Rejection at Month 12', 'timeFrame': 'Month 12', 'description': 'Subclinical rejection defined as histological findings by the central pathologist consistent with acute rejection, but lacking its clinical correlate. Acute rejection defined as a clinico-pathological event requiring clinical evidence and renal biopsy confirmation demonstrating a Banff 97 classification of Grade IA or greater, with higher scores indicating more severe rejection. Only the episode with the highest Banff grade for each participant was counted. Clinical evidence defined if either a or b was satisfied: a) an unexplained rise of serum creatinine ≥ 25% from baseline creatinine; b) an unexplained decreased urine output; or fever and graft tenderness; or a serum creatinine that remained elevated within 14 days post-transplantation and clinical suspicion of acute rejection existed. Allograft biopsies were evaluated by a blinded central independent pathologist using Banff 97 working classification of kidney transplant pathology.'}, {'measure': 'Number of Participants Treated for Acute Rejection (AR) Regardless of Histological Findings by Month 36', 'timeFrame': 'Randomization to Month 36', 'description': 'Allograft rejection includes any episode of rejection including: clinically suspected rejection, treated rejection, any central biopsy-proven acute rejection (BPAR), and acute rejection (AR: a subset of BPAR) defined as central biopsy-proven rejection that was either clinically suspected by protocol-defined reasons or by other reasons and was treated. Acute rejection (AR) defined as a clinico-pathological event requiring clinical evidence ( either an unexplained rise of serum creatinine ≥ 25% from baseline creatinine or an unexplained decreased urine output; or fever and graft tenderness; or a serum creatinine that remained elevated within 14 days post-transplantation and clinical suspicion of AR) and renal biopsy confirmation biopsy demonstrating a Banff 97 working classification of kidney transplant pathology classification of Grade IA or greater, with higher scores indicating more severe rejection. Only the highest Banff grade for each participant was counted.'}, {'measure': 'Mean Value of Physical and Mental Components Using SF-36 Questionnaire', 'timeFrame': 'Months 6, 12, 24, 36', 'description': 'SF-36 was a Participant-Reported Quality of Life (QoL) Short Form (SF) questionnaire measuring health-related quality of life (HRQL) covering 2 scale measures: physical component summary (PCS) and mental component summary (MCS). PCS represented by 4 domains: physical function, role limitations due to physical problems, pain, and general health perception. MCS represented by 4 domains: vitality, social function, role limitations due to emotional problems, and mental health. Their scores were computed based on weighted combinations of the 8 domain scores, which were transformed to a range from 0 to 100; 0= worst HRQL, 100=best HRQL. Higher scores reflect better health-related functional status. Scoring is standardized using the norm-based scoring method where data is scored in relation to the U.S. general population having a mean of 50 and a standard deviation of 10. Scores below 50 are below the U.S. general population norm and above 50 are above the U.S. general population norm.'}, {'measure': 'Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire', 'timeFrame': 'Months 6, 12, 24, 36', 'description': 'SF-36 was a Participant-Reported Quality of Life (QoL) Short Form (SF) questionnaire measuring health-related quality of life (HRQL) covering 2 scale measures: physical component summary (PCS) and mental component summary (MCS). PCS represented by 4 domains: physical function, role limitations due to physical problems, pain, and general health perception. MCS represented by 4 domains: vitality, social function, role limitations due to emotional problems, and mental health. Their scores were computed based on weighted combinations of the 8 domain scores, which were transformed to a range from 0 to 100; 0= worst HRQL, 100=best HRQL. Higher scores reflect better health-related functional status. Scoring is standardized using the norm-based scoring method where data is scored in relation to the U.S. general population having a mean of 50 and a standard deviation of 10. Scores below 50 are below the U.S. general population norm and above 50 are above the U.S. general population norm.'}, {'measure': 'Mean Relative to an Identified Distribution (Ridit) Value of Symptom Occurrence and Symptom Distress Using Modified Transplant Symptom Occurrence and Symptom Distress Scale (MTSOSDS-59R)', 'timeFrame': 'Months 6, 12, 24, 36', '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 baseline and at 6, 12, 24, and 36 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': 'Mean Changes in the Value of Physical and Mental Components Using SF-36 From Baseline Up To Months 6, 12, 24, and 36', 'timeFrame': 'Baseline to Months 6, 12, 24,and 36', 'description': 'SF-36 was a Participant-Reported Quality of Life (QoL) Short Form (SF) questionnaire measuring health-related quality of life (HRQL) covering 2 scale measures: physical component summary (PCS) and mental component summary (MCS). PCS represented by 4 domains: physical function, role limitations due to physical problems, pain, and general health perception. MCS represented by 4 domains: vitality, social function, role limitations due to emotional problems, and mental health. Their scores were computed based on weighted combinations of the 8 domain scores, which were transformed to a range from 0 to 100; 0= worst HRQL, 100=best HRQL. Higher scores reflect better health-related functional status. Scoring is standardized using the norm-based scoring method where data is scored in relation to the U.S. general population having a mean of 50 and a standard deviation of 10. Scores below 50 are below the U.S. general population norm and above 50 are above the U.S. general population norm.'}, {'measure': 'Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36', 'timeFrame': 'Baseline to Months 6, 12, 24, and 36', 'description': 'SF-36 was a Participant-Reported Quality of Life (QoL) Short Form (SF) questionnaire measuring health-related quality of life (HRQL) covering 2 scale measures: physical component summary (PCS) and mental component summary (MCS). PCS represented by 4 domains: physical function, role limitations due to physical problems, pain, and general health perception. MCS represented by 4 domains: vitality, social function, role limitations due to emotional problems, and mental health. Their scores were computed based on weighted combinations of the 8 domain scores, which were transformed to a range from 0 to 100; 0= worst HRQL, 100=best HRQL. Higher scores reflect better health-related functional status. Scoring is standardized using the norm-based scoring method where data is scored in relation to the U.S. general population having a mean of 50 and a standard deviation of 10. Scores below 50 are below the U.S. general population norm and above 50 are above the U.S. general population norm.'}, {'measure': 'Percent of Participants Surviving With a Functioning Graft', 'timeFrame': 'Months 24, 36', 'description': 'Graft loss was defined as either functional loss or physical loss (nephrectomy). Functional loss was defined as a sustained level of serum creatinine (SCr) ≥ 6.0 milligrams per deciliter (mg/dL) or 530 micromoles per liter (μmol/L) as determined by the central laboratory for ≥ 4 weeks or ≥ 56 consecutive days of dialysis or impairment of renal function to such a degree that the participant underwent retransplant.'}, {'measure': 'Percent of Participants With Composite Endpoint or Death, Graft Loss or Acute Rejection by Month 36', 'timeFrame': 'Randomization to Month 36', 'description': 'Graft loss was defined as either functional loss or physical loss (nephrectomy). Functional loss was defined as a sustained level of serum creatinine (SCr) ≥ 6.0 milligrams per deciliter (mg/dL) or 530 micromoles per liter (μmol/L) as determined by the central laboratory for ≥ 4 weeks or ≥ 56 consecutive days of dialysis or impairment of renal function to such a degree that the participant underwent retransplant. Acute rejection was defined as central biopsy proven rejection that was either (1) clinically suspected by protocol defined reasons or (2) clinically suspected by other reasons and treated. Death and graft loss were not imputed.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Kidney Transplantation', 'Chronic Kidney Failure']}, 'referencesModule': {'references': [{'pmid': '26816011', 'type': 'DERIVED', 'citation': 'Vincenti F, Rostaing L, Grinyo J, Rice K, Steinberg S, Gaite L, Moal MC, Mondragon-Ramirez GA, Kothari J, Polinsky MS, Meier-Kriesche HU, Munier S, Larsen CP. Belatacept and Long-Term Outcomes in Kidney Transplantation. N Engl J Med. 2016 Jan 28;374(4):333-43. doi: 10.1056/NEJMoa1506027.'}, {'pmid': '24831918', 'type': 'DERIVED', 'citation': 'Dobbels F, Wong S, Min Y, Sam J, Kalsekar A. Beneficial effect of belatacept on health-related quality of life and perceived side effects: results from the BENEFIT and BENEFIT-EXT trials. Transplantation. 2014 Nov 15;98(9):960-8. doi: 10.1097/TP.0000000000000159.'}, {'pmid': '21992533', 'type': 'DERIVED', 'citation': 'Vincenti F, Larsen CP, Alberu J, Bresnahan B, Garcia VD, Kothari J, Lang P, Urrea EM, Massari P, Mondragon-Ramirez G, Reyes-Acevedo R, Rice K, Rostaing L, Steinberg S, Xing J, Agarwal M, Harler MB, Charpentier B. Three-year outcomes from BENEFIT, a randomized, active-controlled, parallel-group study in adult kidney transplant recipients. Am J Transplant. 2012 Jan;12(1):210-7. doi: 10.1111/j.1600-6143.2011.03785.x. Epub 2011 Oct 12.'}], '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 Belatacept can provide protection from organ rejection following kidney transplantation while avoiding some of the toxic effects of standard immunosuppressive medications such as kidney damage. Effects on kidney function and patient survival as well as drug safety will also be studied.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The subject is a recipient of a living donor or deceased donor kidney transplant.\n* Male or Female, 18 or older\n\nExclusion Criteria:\n\n* First time recipient, PRA \\>- 50% or for retransplantation PRA \\>- 30%.\n* If retransplantation, previous graft loss cannot be due to acute rejection.\n* Positive cross match.\n* Subject receiving extended criteria donor (ECD) organ\n* For Long-term extension study-Subjects who have completed three years of study treatment (through Week 156)'}, 'identificationModule': {'nctId': 'NCT00256750', 'acronym': 'BENEFIT', 'briefTitle': 'Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression (BENEFIT)', 'nctIdAliases': ['NCT00432497'], 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression Trial (BENEFIT)', 'orgStudyIdInfo': {'id': 'IM103-008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Cyclosporine (CsA)', 'interventionNames': ['Drug: Cyclosporine (CsA)']}, {'type': 'EXPERIMENTAL', 'label': 'Belatacept LI (less intensive)', 'interventionNames': ['Drug: Belatacept LI (less intensive)']}, {'type': 'EXPERIMENTAL', 'label': 'Belatacept MI (more intensive)', 'interventionNames': ['Drug: Belatacept MI (more intensive)']}], 'interventions': [{'name': 'Cyclosporine (CsA)', 'type': 'DRUG', 'description': 'tablet, oral, 1st month target: 150-300 ng/mL, after 1st month target: 100-250 ng/mL, daily, 36 months (ST), 100-250 ng/mL, daily, 24 months (LT)', 'armGroupLabels': ['Cyclosporine (CsA)']}, {'name': 'Belatacept LI (less intensive)', 'type': 'DRUG', 'description': 'solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)', 'armGroupLabels': ['Belatacept LI (less intensive)']}, {'name': 'Belatacept MI (more intensive)', 'type': 'DRUG', 'description': 'solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)', 'armGroupLabels': ['Belatacept MI (more intensive)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University Of Alabama At Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '92354', 'city': 'Loma Linda', 'state': 'California', 'country': 'United States', 'facility': 'Loma Linda University Medical Center-Transplantation Institu', 'geoPoint': {'lat': 34.04835, 'lon': -117.26115}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'California Institute Of Renal Research', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University Of California San Francisco Medical Center', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University Of Colorado Health Sciences Center', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '06520', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale University School Of Medicine-Yale New Haven Hospital', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '30309', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Piedmont Hospital', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University Hospital', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30912', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Medical College Of Georgia', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University Of Chicago Hospitals', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '52242', 'city': 'Iowa City', 'state': 'Indiana', 'country': 'United States', 'facility': 'University Of Iowa Hospitals And Clinics'}, {'zip': '40536', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University Of Kentucky', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, 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Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '19102', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Div Of Multi-Organ Trans, Hepato-Biliary-Pancreatic Surgery', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Musc', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '27232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '75246', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor University Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '05401', 'city': 'Burlington', 'state': 'Vermont', 'country': 'United States', 'facility': 'Fletcher Allen Health Care', 'geoPoint': {'lat': 44.47588, 'lon': -73.21207}}, {'zip': '22031', 'city': 'Fairfax', 'state': 'Virginia', 'country': 'United States', 'facility': 'Inova Transplant Center', 'geoPoint': {'lat': 38.84622, 'lon': -77.30637}}, {'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Swedish Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '99204', 'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'facility': 'Sacred Heart Medical Ctr Providence Medical Research Ctr', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}, {'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University Of Wisconsin', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Froedtert Memorial Lutheran Hospital', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'zip': 'C1155APP', 'city': 'Buenos Aires', 'state': 'Buenos Aires', 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