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Ignite Creation Date: 2025-12-24 @ 10:51 PM

Ignite Modification Date: 2026-06-08 @ 7:58 PM

Study NCT ID: NCT00543569

Status: COMPLETED

Last Update Posted: 2015-12-11

First Post: 2007-10-11

Is NOT Gene Therapy: True

Has Adverse Events: True

Brief Title: A Study to Assess the Safety and Efficacy of Alefacept in Kidney Transplant Recipients

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077944', 'term': 'Alefacept'}, {'id': 'D016559', 'term': 'Tacrolimus'}, {'id': 'D000077552', 'term': 'Basiliximab'}, {'id': 'D009173', 'term': 'Mycophenolic Acid'}, {'id': 'D000305', 'term': 'Adrenal Cortex Hormones'}], 'ancestors': [{'id': 'D018968', 'term': 'CD58 Antigens'}, {'id': 'D008562', 'term': 'Membrane Glycoproteins'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D007074', 'term': 'Immunoglobulin G'}, {'id': 'D007132', 'term': 'Immunoglobulin Isotypes'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D008565', 'term': 'Membrane Proteins'}, {'id': 'D011993', 'term': 'Recombinant Fusion Proteins'}, {'id': 'D011994', 'term': 'Recombinant Proteins'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D002208', 'term': 'Caproates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Astellas.resultsdisclosure@astellas.com', 'title': 'Global Head Global Medical Sciences--Transplant and Immunology/Inflammation', 'organization': 'Astellas Pharma Global Development, Inc. (APGD)'}, 'certainAgreement': {'otherDetails': "Standard Restriction Description: Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data or 12 months after data-lock, whichever is first. Sponsor must receive a site's manuscript at least 30 days prior to publication for review and comment. Sponsor may delay the publication for up to 60 days to seek patent protection.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '12 months', 'eventGroups': [{'id': 'EG000', 'title': 'Tacrolimus/MMF/Basiliximab', 'description': 'Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.', 'otherNumAtRisk': 79, 'otherNumAffected': 79, 'seriousNumAtRisk': 79, 'seriousNumAffected': 41}, {'id': 'EG001', 'title': 'Alefacept QW/Tacrolimus/MMF', 'description': 'Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.', 'otherNumAtRisk': 77, 'otherNumAffected': 77, 'seriousNumAtRisk': 77, 'seriousNumAffected': 48}, {'id': 'EG002', 'title': 'Alefacept QW/Tacrolimus', 'description': 'Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.', 'otherNumAtRisk': 75, 'otherNumAffected': 75, 'seriousNumAtRisk': 75, 'seriousNumAffected': 40}, {'id': 'EG003', 'title': 'Alefacept QOW/Tacrolimus/MMF', 'description': 'Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.', 'otherNumAtRisk': 78, 'otherNumAffected': 78, 'seriousNumAtRisk': 78, 'seriousNumAffected': 45}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 23}, {'groupId': 'EG003', 'numAtRisk': 78, 'numAffected': 32}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 78, 'numAffected': 10}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 78, 'numAffected': 16}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 78, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Polycythaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 78, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 78, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Angina Pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 78, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 78, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 78, 'numAffected': 9}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 78, 'numAffected': 3}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Abdominal Distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 78, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 78, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Abdominal Pain Lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 78, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Abdominal Pain Upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 78, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 31}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 31}, {'groupId': 'EG003', 'numAtRisk': 78, 'numAffected': 37}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 34}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 30}, {'groupId': 'EG003', 'numAtRisk': 78, 'numAffected': 34}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Dry Mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 78, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 78, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 78, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 78, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Gastrooesophageal Reflux Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 78, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 78, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 52}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 37}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 39}, {'groupId': 'EG003', 'numAtRisk': 78, 'numAffected': 42}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 78, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 78, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Catheter Site Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 78, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Generalised Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 78, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Impaired Healing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 78, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 78, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Oedema Peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 28}, {'groupId': 'EG003', 'numAtRisk': 78, 'numAffected': 31}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 78, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 78, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'BK Virus Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 17}, {'groupId': 'EG003', 'numAtRisk': 78, 'numAffected': 20}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Candiduria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 78, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Cytomegalovirus Viraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 78, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Escherichia Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 78, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 78, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Oral Candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 78, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 78, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 78, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Urinary Tract Infection Bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 78, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Urinary Tract Infection Enterococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 2}, {'groupId': 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'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 78, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Suicide Attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Bile Duct Stone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Cholecystitis Acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Cholestasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Benign Prostatic Hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 78, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Haemorrhagic Ovarian Cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Atrial Septal Defect', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Parathyroid Gland Enlargement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Serum Sickness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Biopsy-confirmed Acute Rejection (BCAR) at Month 6 Assessed by Local Review', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Tacrolimus/MMF/Basiliximab', 'description': 'Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.'}, {'id': 'OG001', 'title': 'Alefacept QW/Tacrolimus/MMF', 'description': 'Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.'}, {'id': 'OG002', 'title': 'Alefacept QW/Tacrolimus', 'description': 'Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.'}, {'id': 'OG003', 'title': 'Alefacept QOW/Tacrolimus/MMF', 'description': 'Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.7', 'groupId': 'OG000', 'lowerLimit': '6.5', 'upperLimit': '18.9'}, {'value': '26.3', 'groupId': 'OG001', 'lowerLimit': '18.0', 'upperLimit': '34.6'}, {'value': '18.8', 'groupId': 'OG002', 'lowerLimit': '11.4', 'upperLimit': '26.3'}, {'value': '16.7', 'groupId': 'OG003', 'lowerLimit': '9.8', 'upperLimit': '23.7'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '13.6', 'ciLowerLimit': '3.2', 'ciUpperLimit': '23.9', 'estimateComment': 'A positive difference indicates a higher failure rate in the experimental arm as compared to the comparator arm (Arm 1).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The aim of this study was to assess the non-inferiority of each experimental arm (Arms 2-4) to a comparator regimen (Arm 1) over a non-inferiority margin of 10%. If the upper bound of the 90% confidence interval was less than the margin, i.e., 10%, then the test treatment was considered to be non-inferior to the comparator regimen.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '6.1', 'ciLowerLimit': '-3.6', 'ciUpperLimit': '15.8', 'estimateComment': 'A positive difference indicates a higher failure rate in the experimental arm as compared to the comparator arm (Arm 1).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The aim of this study was to assess the non-inferiority of each experimental arm (Arms 2-4) to a comparator regimen (Arm 1) over a non-inferiority margin of 10%. If the upper bound of the 90% confidence interval was less than the margin, i.e., 10%, then the test treatment was considered to be non-inferior to the comparator regimen.'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '4.0', 'ciLowerLimit': '-5.3', 'ciUpperLimit': '13.3', 'estimateComment': 'A positive difference indicated a higher failure rate in the experimental arm as compared to the comparator arm (Arm 1).', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The aim of this study was to assess the non-inferiority of each experimental arm (Arms 2-4) to a comparator regimen (Arm 1) over a non-inferiority margin of 10%. If the upper bound of the 90% confidence interval was less than the margin, i.e., 10%, then the test treatment was considered to be non-inferior to the comparator regimen.'}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Rejection episodes were confirmed by biopsy by the clinical site pathologist. Biopsies were graded according to the 2005 Banff criteria. All biopsies (T-cell and/or antibody mediated) of grade 1 or higher were considered a BCAR.\n\nThe Kaplan-Meier estimates at Day 182 was used for the analyses at 6 months. Lost to follow-up or patients with missing outcomes were censored at their last follow up visit.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': 'Patient Survival at Month 6 and Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Tacrolimus/MMF/Basiliximab', 'description': 'Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.'}, {'id': 'OG001', 'title': 'Alefacept QW/Tacrolimus/MMF', 'description': 'Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.'}, {'id': 'OG002', 'title': 'Alefacept QW/Tacrolimus', 'description': 'Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.'}, {'id': 'OG003', 'title': 'Alefacept QOW/Tacrolimus/MMF', 'description': 'Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.'}], 'classes': [{'title': 'Month 6', 'categories': [{'measurements': [{'value': '96.2', 'groupId': 'OG000', 'lowerLimit': '92.7', 'upperLimit': '99.7'}, {'value': '94.8', 'groupId': 'OG001', 'lowerLimit': '90.6', 'upperLimit': '99.0'}, {'value': '97.3', 'groupId': 'OG002', 'lowerLimit': '94.3', 'upperLimit': '100.0'}, {'value': '93.6', 'groupId': 'OG003', 'lowerLimit': '89.0', 'upperLimit': '98.2'}]}]}, {'title': 'Month 12', 'categories': [{'measurements': [{'value': '87.3', 'groupId': 'OG000', 'lowerLimit': '81.2', 'upperLimit': '93.5'}, {'value': '92.2', 'groupId': 'OG001', 'lowerLimit': '87.2', 'upperLimit': '97.2'}, {'value': '87.8', 'groupId': 'OG002', 'lowerLimit': '81.5', 'upperLimit': '94.1'}, {'value': '89.7', 'groupId': 'OG003', 'lowerLimit': '84.1', 'upperLimit': '95.4'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-1.4', 'ciLowerLimit': '-6.9', 'ciUpperLimit': '4.1', 'groupDescription': 'Patient survival at 6 months', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.1', 'ciLowerLimit': '-3.5', 'ciUpperLimit': '5.8', 'groupDescription': 'Patient survival at 6 months', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-2.6', 'ciLowerLimit': '-8.4', 'ciUpperLimit': '3.2', 'groupDescription': 'Patient survival at 6 months', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '4.9', 'ciLowerLimit': '-3.1', 'ciUpperLimit': '12.8', 'groupDescription': 'Patient survival at 12 months', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.5', 'ciLowerLimit': '-8.3', 'ciUpperLimit': '9.2', 'groupDescription': 'Patient survival at 12 months', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '2.4', 'ciLowerLimit': '-6.0', 'ciUpperLimit': '10.8', 'groupDescription': 'Patient survival at 12 months', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '6 months and 12 months', 'description': 'Patient survival is any participant who is known to be alive 6 months and 12 months after the skin closure date.\n\nThe Kaplan-Meier estimates at Days 182 and 365 were used for the analyses at 6 months and 12 months respectively. Lost to follow-up or participants with missing outcomes were censored at their last follow up visit.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': 'Graft Survival at Month 6 and Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Tacrolimus/MMF/Basiliximab', 'description': 'Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.'}, {'id': 'OG001', 'title': 'Alefacept QW/Tacrolimus/MMF', 'description': 'Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.'}, {'id': 'OG002', 'title': 'Alefacept QW/Tacrolimus', 'description': 'Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.'}, {'id': 'OG003', 'title': 'Alefacept QOW/Tacrolimus/MMF', 'description': 'Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.'}], 'classes': [{'title': 'Month 6', 'categories': [{'measurements': [{'value': '96.2', 'groupId': 'OG000', 'lowerLimit': '92.7', 'upperLimit': '99.7'}, {'value': '93.5', 'groupId': 'OG001', 'lowerLimit': '88.9', 'upperLimit': '98.1'}, {'value': '96.0', 'groupId': 'OG002', 'lowerLimit': '92.3', 'upperLimit': '99.7'}, {'value': '92.3', 'groupId': 'OG003', 'lowerLimit': '87.3', 'upperLimit': '97.3'}]}]}, {'title': 'Month 12', 'categories': [{'measurements': [{'value': '87.3', 'groupId': 'OG000', 'lowerLimit': '81.2', 'upperLimit': '93.5'}, {'value': '90.9', 'groupId': 'OG001', 'lowerLimit': '85.5', 'upperLimit': '96.3'}, {'value': '86.5', 'groupId': 'OG002', 'lowerLimit': '79.9', 'upperLimit': '93.0'}, {'value': '85.8', 'groupId': 'OG003', 'lowerLimit': '79.2', 'upperLimit': '92.3'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-2.7', 'ciLowerLimit': '-8.5', 'ciUpperLimit': '3.1', 'groupDescription': 'Graft survival at 6 months', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.2', 'ciLowerLimit': '-5.3', 'ciUpperLimit': '4.9', 'groupDescription': 'Graft survival at 6 months', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-3.9', 'ciLowerLimit': '-10.0', 'ciUpperLimit': '2.2', 'groupDescription': 'Graft survival at 6 months', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '3.6', 'ciLowerLimit': '-4.6', 'ciUpperLimit': '11.7', 'groupDescription': 'Graft survival at 12 months', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.9', 'ciLowerLimit': '-9.9', 'ciUpperLimit': '8.1', 'groupDescription': 'Graft survival at 12 months', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-1.6', 'ciLowerLimit': '-10.6', 'ciUpperLimit': '7.4', 'groupDescription': 'Graft survival at 12 months', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '6 months and 12 months', 'description': 'Graft survival was defined as any participant who was known to have a functioning graft (i.e., not graft loss) at 6 months and 12 months after the skin closure date. Graft loss was defined as patient death, retransplant, permanent return to dialysis (dialysis greater than 30 days) or transplant nephrectomy.\n\nThe Kaplan-Meier estimates at Days 182 and 365 were used for the analyses at 6 months and 12 months respectively. Lost to follow-up or participants with missing outcomes were censored at their last follow up visit.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With BCAR at Month 12 Assessed by Local Review', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Tacrolimus/MMF/Basiliximab', 'description': 'Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.'}, {'id': 'OG001', 'title': 'Alefacept QW/Tacrolimus/MMF', 'description': 'Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.'}, {'id': 'OG002', 'title': 'Alefacept QW/Tacrolimus', 'description': 'Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.'}, {'id': 'OG003', 'title': 'Alefacept QOW/Tacrolimus/MMF', 'description': 'Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.4', 'groupId': 'OG000', 'lowerLimit': '8.6', 'upperLimit': '22.1'}, {'value': '29.0', 'groupId': 'OG001', 'lowerLimit': '20.4', 'upperLimit': '37.6'}, {'value': '20.2', 'groupId': 'OG002', 'lowerLimit': '12.5', 'upperLimit': '27.9'}, {'value': '18.1', 'groupId': 'OG003', 'lowerLimit': '10.9', 'upperLimit': '25.3'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '13.7', 'ciLowerLimit': '2.8', 'ciUpperLimit': '24.6', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '4.8', 'ciLowerLimit': '-5.4', 'ciUpperLimit': '15.0', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '2.8', 'ciLowerLimit': '-7.1', 'ciUpperLimit': '12.6', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Rejection episodes were confirmed by biopsy by the clinical site pathologist. Biopsies were graded according to the 2005 Banff criteria. All biopsies (T-cell and/or antibody mediated) of grade 1 or higher were considered a BCAR.\n\nThe Kaplan-Meier estimates at Day 365 was used for the analyses at 12 months. Lost to follow-up or participants with missing outcomes were censored at their last follow up visit.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With BCAR at Month 6 and 12 Assessed by Central Review', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Tacrolimus/MMF/Basiliximab', 'description': 'Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.'}, {'id': 'OG001', 'title': 'Alefacept QW/Tacrolimus/MMF', 'description': 'Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.'}, {'id': 'OG002', 'title': 'Alefacept QW/Tacrolimus', 'description': 'Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.'}, {'id': 'OG003', 'title': 'Alefacept QOW/Tacrolimus/MMF', 'description': 'Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.'}], 'classes': [{'title': 'Month 6', 'categories': [{'measurements': [{'value': '7.7', 'groupId': 'OG000', 'lowerLimit': '2.7', 'upperLimit': '12.7'}, {'value': '18.3', 'groupId': 'OG001', 'lowerLimit': '11.0', 'upperLimit': '25.6'}, {'value': '12.1', 'groupId': 'OG002', 'lowerLimit': '5.9', 'upperLimit': '18.3'}, {'value': '14.2', 'groupId': 'OG003', 'lowerLimit': '7.7', 'upperLimit': '20.7'}]}]}, {'title': 'Month 12', 'categories': [{'measurements': [{'value': '7.7', 'groupId': 'OG000', 'lowerLimit': '2.7', 'upperLimit': '12.7'}, {'value': '19.7', 'groupId': 'OG001', 'lowerLimit': '12.2', 'upperLimit': '27.2'}, {'value': '12.1', 'groupId': 'OG002', 'lowerLimit': '5.9', 'upperLimit': '18.3'}, {'value': '15.5', 'groupId': 'OG003', 'lowerLimit': '8.8', 'upperLimit': '22.3'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '10.6', 'ciLowerLimit': '1.8', 'ciUpperLimit': '19.5', 'groupDescription': 'BCAR at Month 6', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '4.3', 'ciLowerLimit': '-3.6', 'ciUpperLimit': '12.3', 'groupDescription': 'BCAR at Month 6', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '6.4', 'ciLowerLimit': '-1.7', 'ciUpperLimit': '14.6', 'groupDescription': 'BCAR at Month 6', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '12.0', 'ciLowerLimit': '3.0', 'ciUpperLimit': '21.0', 'groupDescription': 'BCAR at Month 12', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '4.3', 'ciLowerLimit': '-3.6', 'ciUpperLimit': '12.3', 'groupDescription': 'BCAR at Month 12', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '7.8', 'ciLowerLimit': '-0.6', 'ciUpperLimit': '16.2', 'groupDescription': 'BCAR at Month 12', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '6 months and 12 months', 'description': 'Rejection episodes were confirmed by biopsy by a central reviewer. Biopsies were graded according to the 2005 Banff criteria. All biopsies (T-cell and/or antibody mediated) of grade 1 or higher were considered a BCAR.\n\nThe Kaplan-Meier estimates at Days 182 and 365 were used for the analyses at 6 months and 12 months respectively. Lost to follow-up or participants with missing outcomes were censored at their last follow up visit.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With T-cell Mediated BCAR at Month 6 and 12 Assessed by Local Review', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Tacrolimus/MMF/Basiliximab', 'description': 'Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.'}, {'id': 'OG001', 'title': 'Alefacept QW/Tacrolimus/MMF', 'description': 'Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.'}, {'id': 'OG002', 'title': 'Alefacept QW/Tacrolimus', 'description': 'Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.'}, {'id': 'OG003', 'title': 'Alefacept QOW/Tacrolimus/MMF', 'description': 'Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.'}], 'classes': [{'title': 'Month 6', 'categories': [{'measurements': [{'value': '12.7', 'groupId': 'OG000', 'lowerLimit': '6.5', 'upperLimit': '18.9'}, {'value': '25.0', 'groupId': 'OG001', 'lowerLimit': '16.8', 'upperLimit': '33.1'}, {'value': '18.8', 'groupId': 'OG002', 'lowerLimit': '11.4', 'upperLimit': '26.3'}, {'value': '16.7', 'groupId': 'OG003', 'lowerLimit': '9.8', 'upperLimit': '23.7'}]}]}, {'title': 'Month 12', 'categories': [{'measurements': [{'value': '14.0', 'groupId': 'OG000', 'lowerLimit': '7.6', 'upperLimit': '20.5'}, {'value': '27.7', 'groupId': 'OG001', 'lowerLimit': '19.2', 'upperLimit': '36.1'}, {'value': '18.8', 'groupId': 'OG002', 'lowerLimit': '11.4', 'upperLimit': '26.3'}, {'value': '18.1', 'groupId': 'OG003', 'lowerLimit': '10.9', 'upperLimit': '25.3'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '12.2', 'ciLowerLimit': '2.0', 'ciUpperLimit': '22.5', 'groupDescription': 'T-cell Mediated BCAR at Month 6', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '6.1', 'ciLowerLimit': '-3.6', 'ciUpperLimit': '15.8', 'groupDescription': 'T-cell Mediated BCAR at Month 6', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '4.0', 'ciLowerLimit': '-5.3', 'ciUpperLimit': '13.3', 'groupDescription': 'T-cell Mediated BCAR at Month 6', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '13.6', 'ciLowerLimit': '3.0', 'ciUpperLimit': '24.3', 'groupDescription': 'T-cell Mediated BCAR at Month 12', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '4.8', 'ciLowerLimit': '-5.1', 'ciUpperLimit': '14.6', 'groupDescription': 'T-cell Mediated BCAR at Month 12', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '4.1', 'ciLowerLimit': '-5.6', 'ciUpperLimit': '13.8', 'groupDescription': 'T-cell Mediated BCAR at Month 12', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '6 months and 12 months', 'description': 'Rejection episodes were confirmed by biopsy by the clinical site pathologist. Biopsies were graded according to the 2005 Banff criteria. All biopsies of grade 1 or higher were considered a BCAR.\n\nThe Kaplan-Meier estimates at Days 182 and 365 were used for the analyses at 6 months and 12 months respectively. Lost to follow-up or participants with missing outcomes were censored at their last follow up visit.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With T-cell Mediated BCAR at Month 6 and 12 Assessed by Central Review', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Tacrolimus/MMF/Basiliximab', 'description': 'Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.'}, {'id': 'OG001', 'title': 'Alefacept QW/Tacrolimus/MMF', 'description': 'Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.'}, {'id': 'OG002', 'title': 'Alefacept QW/Tacrolimus', 'description': 'Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.'}, {'id': 'OG003', 'title': 'Alefacept QOW/Tacrolimus/MMF', 'description': 'Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.'}], 'classes': [{'title': 'Month 6', 'categories': [{'measurements': [{'value': '7.7', 'groupId': 'OG000', 'lowerLimit': '2.7', 'upperLimit': '12.7'}, {'value': '17.0', 'groupId': 'OG001', 'lowerLimit': '9.9', 'upperLimit': '24.1'}, {'value': '12.1', 'groupId': 'OG002', 'lowerLimit': '5.9', 'upperLimit': '18.3'}, {'value': '14.2', 'groupId': 'OG003', 'lowerLimit': '7.7', 'upperLimit': '20.7'}]}]}, {'title': 'Month 12', 'categories': [{'measurements': [{'value': '7.7', 'groupId': 'OG000', 'lowerLimit': '2.7', 'upperLimit': '12.7'}, {'value': '18.4', 'groupId': 'OG001', 'lowerLimit': '11.1', 'upperLimit': '25.7'}, {'value': '12.1', 'groupId': 'OG002', 'lowerLimit': '5.9', 'upperLimit': '18.3'}, {'value': '15.5', 'groupId': 'OG003', 'lowerLimit': '8.8', 'upperLimit': '22.3'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '9.3', 'ciLowerLimit': '0.7', 'ciUpperLimit': '18.0', 'groupDescription': 'T-cell Mediated BCAR at Month 6', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '4.3', 'ciLowerLimit': '-3.6', 'ciUpperLimit': '12.3', 'groupDescription': 'T-cell Mediated BCAR at Month 6', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '6.4', 'ciLowerLimit': '-1.7', 'ciUpperLimit': '14.6', 'groupDescription': 'T-cell Mediated BCAR at Month 6', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '10.7', 'ciLowerLimit': '1.8', 'ciUpperLimit': '19.5', 'groupDescription': 'T-cell Mediated BCAR at Month 12', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '4.3', 'ciLowerLimit': '-3.6', 'ciUpperLimit': '12.3', 'groupDescription': 'T-cell Mediated BCAR at Month 12', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '7.8', 'ciLowerLimit': '-0.6', 'ciUpperLimit': '16.2', 'groupDescription': 'T-cell Mediated BCAR at Month 12', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '6 months and 12 months', 'description': 'Rejection episodes were confirmed by biopsy by the central reviewer. Biopsies were graded according to the 2005 Banff criteria. All biopsies of grade 1 or higher were considered a BCAR.\n\nThe Kaplan-Meier estimates at Days 182 and 365 were used for the analyses at 6 months and 12 months respectively. Lost to follow-up or participants with missing outcomes were censored at their last follow up visit.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': 'Change From Week 4 in Glomerular Filtration Rate Estimated by the MDRD Method at Month 6 and Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}, {'value': '72', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Tacrolimus/MMF/Basiliximab', 'description': 'Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.'}, {'id': 'OG001', 'title': 'Alefacept QW/Tacrolimus/MMF', 'description': 'Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.'}, {'id': 'OG002', 'title': 'Alefacept QW/Tacrolimus', 'description': 'Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.'}, {'id': 'OG003', 'title': 'Alefacept QOW/Tacrolimus/MMF', 'description': 'Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '54.7', 'spread': '17.16', 'groupId': 'OG000'}, {'value': '59.3', 'spread': '24.01', 'groupId': 'OG001'}, {'value': '51.6', 'spread': '19.32', 'groupId': 'OG002'}, {'value': '58.0', 'spread': '16.97', 'groupId': 'OG003'}]}]}, {'title': 'Change at Month 6 (N=65, 66, 67, 66)', 'categories': [{'measurements': [{'value': '5.7', 'spread': '16.44', 'groupId': 'OG000'}, {'value': '3.2', 'spread': '13.86', 'groupId': 'OG001'}, {'value': '8.3', 'spread': '12.96', 'groupId': 'OG002'}, {'value': '2.5', 'spread': '12.82', 'groupId': 'OG003'}]}]}, {'title': 'Change at Month 12 (n=66, 64, 64, 66)', 'categories': [{'measurements': [{'value': '8.9', 'spread': '18.88', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '16.55', 'groupId': 'OG001'}, {'value': '9.1', 'spread': '13.59', 'groupId': 'OG002'}, {'value': '2.7', 'spread': '16.60', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 4, Month 6 and Month 12', 'description': 'The glomerular filtration rate (GFR) was calculated using the Modification of Diet in Renal Disease (MDRD) method.', 'unitOfMeasure': 'mL/min per 1.73 m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set with available data at Week 4. "N" indicates the number of participants with available data at each time point.'}, {'type': 'SECONDARY', 'title': 'Change From Week 4 in GFR by Iothalamate Clearance at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Tacrolimus/MMF/Basiliximab', 'description': 'Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.'}, {'id': 'OG001', 'title': 'Alefacept QW/Tacrolimus/MMF', 'description': 'Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.'}, {'id': 'OG002', 'title': 'Alefacept QW/Tacrolimus', 'description': 'Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.'}, {'id': 'OG003', 'title': 'Alefacept QOW/Tacrolimus/MMF', 'description': 'Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '48.00', 'spread': '26.327', 'groupId': 'OG000'}, {'value': '56.51', 'spread': '33.612', 'groupId': 'OG001'}, {'value': '44.36', 'spread': '19.045', 'groupId': 'OG002'}, {'value': '52.09', 'spread': '25.696', 'groupId': 'OG003'}]}]}, {'title': 'Change at Month 6 (N=48, 45, 45, 47)', 'categories': [{'measurements': [{'value': '5.81', 'spread': '24.298', 'groupId': 'OG000'}, {'value': '3.47', 'spread': '34.708', 'groupId': 'OG001'}, {'value': '3.56', 'spread': '21.104', 'groupId': 'OG002'}, {'value': '6.60', 'spread': '35.090', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 4 and Month 6', 'description': 'The glomerular filtration rate was measured directly using iothalamate clearance.', 'unitOfMeasure': 'mL/min per 1.73 m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set with available data at Week 4. "N" indicates participants with available data at Week 4 and Month 6.'}, {'type': 'SECONDARY', 'title': 'Change From Week 4 in Serum Creatinine at Month 6 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}, {'value': '74', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Tacrolimus/MMF/Basiliximab', 'description': 'Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.'}, {'id': 'OG001', 'title': 'Alefacept QW/Tacrolimus/MMF', 'description': 'Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.'}, {'id': 'OG002', 'title': 'Alefacept QW/Tacrolimus', 'description': 'Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.'}, {'id': 'OG003', 'title': 'Alefacept QOW/Tacrolimus/MMF', 'description': 'Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '1.5', 'spread': '0.68', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '1.25', 'groupId': 'OG001'}, {'value': '1.6', 'spread': '0.84', 'groupId': 'OG002'}, {'value': '1.5', 'spread': '0.73', 'groupId': 'OG003'}]}]}, {'title': 'Change at Month 6 (N=69, 69, 68, 70)', 'categories': [{'measurements': [{'value': '-0.0', 'spread': '0.64', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '1.08', 'groupId': 'OG001'}, {'value': '-0.3', 'spread': '0.64', 'groupId': 'OG002'}, {'value': '-0.0', 'spread': '0.32', 'groupId': 'OG003'}]}]}, {'title': 'Change at Month 12 (N=67, 67, 65, 68)', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.45', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '1.24', 'groupId': 'OG001'}, {'value': '-0.2', 'spread': '0.76', 'groupId': 'OG002'}, {'value': '0.1', 'spread': '0.64', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 4 and Month 6 and 12', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set with available data at Week 4. "N" indicates participants with available data at each time point.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Efficacy Failure at 6 and 12 Months Assessed by Local Review', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Tacrolimus/MMF/Basiliximab', 'description': 'Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.'}, {'id': 'OG001', 'title': 'Alefacept QW/Tacrolimus/MMF', 'description': 'Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.'}, {'id': 'OG002', 'title': 'Alefacept QW/Tacrolimus', 'description': 'Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.'}, {'id': 'OG003', 'title': 'Alefacept QOW/Tacrolimus/MMF', 'description': 'Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.'}], 'classes': [{'title': 'Month 6', 'categories': [{'measurements': [{'value': '15.2', 'groupId': 'OG000', 'lowerLimit': '8.5', 'upperLimit': '21.8'}, {'value': '29.9', 'groupId': 'OG001', 'lowerLimit': '21.3', 'upperLimit': '38.4'}, {'value': '22.7', 'groupId': 'OG002', 'lowerLimit': '14.7', 'upperLimit': '30.6'}, {'value': '23.1', 'groupId': 'OG003', 'lowerLimit': '15.2', 'upperLimit': '30.9'}]}]}, {'title': 'Month 12', 'categories': [{'measurements': [{'value': '25.3', 'groupId': 'OG000', 'lowerLimit': '17.3', 'upperLimit': '33.4'}, {'value': '33.8', 'groupId': 'OG001', 'lowerLimit': '24.9', 'upperLimit': '42.6'}, {'value': '29.3', 'groupId': 'OG002', 'lowerLimit': '20.7', 'upperLimit': '38.0'}, {'value': '29.5', 'groupId': 'OG003', 'lowerLimit': '21.0', 'upperLimit': '38.0'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '14.7', 'ciLowerLimit': '3.8', 'ciUpperLimit': '25.5', 'groupDescription': 'Efficacy Failure at Month 6', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '7.5', 'ciLowerLimit': '-2.9', 'ciUpperLimit': '17.8', 'groupDescription': 'Efficacy Failure at Month 6', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '7.9', 'ciLowerLimit': '-2.4', 'ciUpperLimit': '18.2', 'groupDescription': 'Efficacy Failure at Month 6', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '8.4', 'ciLowerLimit': '-3.5', 'ciUpperLimit': '20.4', 'groupDescription': 'Efficacy Failure at Month12', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '4.0', 'ciLowerLimit': '-7.8', 'ciUpperLimit': '15.8', 'groupDescription': 'Efficacy Failure at Month 12', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '4.2', 'ciLowerLimit': '-7.5', 'ciUpperLimit': '15.9', 'groupDescription': 'Efficacy Failure at Month12', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '6 months and 12 months', 'description': 'Efficacy failure is defined as death, graft failure (permanent return to dialysis \\[\\>30 days\\] or retransplant), BCAR according to local review, or lost to follow-up.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Efficacy Failure at 6 and 12 Months Assessed by Central Review', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Tacrolimus/MMF/Basiliximab', 'description': 'Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.'}, {'id': 'OG001', 'title': 'Alefacept QW/Tacrolimus/MMF', 'description': 'Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.'}, {'id': 'OG002', 'title': 'Alefacept QW/Tacrolimus', 'description': 'Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.'}, {'id': 'OG003', 'title': 'Alefacept QOW/Tacrolimus/MMF', 'description': 'Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.'}], 'classes': [{'title': 'Month 6', 'categories': [{'measurements': [{'value': '11.4', 'groupId': 'OG000', 'lowerLimit': '5.5', 'upperLimit': '17.3'}, {'value': '22.1', 'groupId': 'OG001', 'lowerLimit': '14.3', 'upperLimit': '29.9'}, {'value': '16.0', 'groupId': 'OG002', 'lowerLimit': '9.0', 'upperLimit': '23.0'}, {'value': '20.5', 'groupId': 'OG003', 'lowerLimit': '13.0', 'upperLimit': '28.0'}]}]}, {'title': 'Month 12', 'categories': [{'measurements': [{'value': '19.0', 'groupId': 'OG000', 'lowerLimit': '11.7', 'upperLimit': '26.2'}, {'value': '26.0', 'groupId': 'OG001', 'lowerLimit': '17.8', 'upperLimit': '34.2'}, {'value': '21.3', 'groupId': 'OG002', 'lowerLimit': '13.6', 'upperLimit': '29.1'}, {'value': '25.6', 'groupId': 'OG003', 'lowerLimit': '17.5', 'upperLimit': '33.8'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '10.7', 'ciLowerLimit': '0.9', 'ciUpperLimit': '20.4', 'groupDescription': 'Efficacy Failure at Month 6', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '4.6', 'ciLowerLimit': '-4.5', 'ciUpperLimit': '13.7', 'groupDescription': 'Efficacy Failure at Month 6', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '9.1', 'ciLowerLimit': '-0.4', 'ciUpperLimit': '18.7', 'groupDescription': 'Efficacy Failure at Month 6', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '7.0', 'ciLowerLimit': '-4.0', 'ciUpperLimit': '18.0', 'groupDescription': 'Efficacy Failure at Month 12', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '2.3', 'ciLowerLimit': '-8.3', 'ciUpperLimit': '13.0', 'groupDescription': 'Efficacy Failure at Month 12', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '6.7', 'ciLowerLimit': '-4.2', 'ciUpperLimit': '17.6', 'groupDescription': 'Efficacy Failure at Month 12', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '6 months and 12 months', 'description': 'Efficacy failure is defined as death, graft failure (permanent return to dialysis \\[\\>30 days\\] or retransplant), BCAR according to central review, or lost to follow-up.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': 'Time to First BCAR Assessed by Local Review', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Tacrolimus/MMF/Basiliximab', 'description': 'Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.'}, {'id': 'OG001', 'title': 'Alefacept QW/Tacrolimus/MMF', 'description': 'Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.'}, {'id': 'OG002', 'title': 'Alefacept QW/Tacrolimus', 'description': 'Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.'}, {'id': 'OG003', 'title': 'Alefacept QOW/Tacrolimus/MMF', 'description': 'Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '194'}, {'value': '12', 'groupId': 'OG001', 'lowerLimit': '6', 'upperLimit': '301'}, {'value': '19', 'groupId': 'OG002', 'lowerLimit': '7', 'upperLimit': '195'}, {'value': '12.5', 'groupId': 'OG003', 'lowerLimit': '5', 'upperLimit': '186'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '12 months', 'description': 'The time to first BCAR (local review) was calculated as the first biopsy date in which the local reviewer confirmed an acute rejection minus the date of skin closure +1. Only participants with a BCAR are included in the analysis.', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set with a BCAR assessed by local review'}, {'type': 'SECONDARY', 'title': 'Time to First BCAR Assessed by Central Review', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Tacrolimus/MMF/Basiliximab', 'description': 'Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.'}, {'id': 'OG001', 'title': 'Alefacept QW/Tacrolimus/MMF', 'description': 'Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.'}, {'id': 'OG002', 'title': 'Alefacept QW/Tacrolimus', 'description': 'Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.'}, {'id': 'OG003', 'title': 'Alefacept QOW/Tacrolimus/MMF', 'description': 'Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000', 'lowerLimit': '6', 'upperLimit': '142'}, {'value': '10', 'groupId': 'OG001', 'lowerLimit': '7', 'upperLimit': '187'}, {'value': '12', 'groupId': 'OG002', 'lowerLimit': '7', 'upperLimit': '52'}, {'value': '11.5', 'groupId': 'OG003', 'lowerLimit': '5', 'upperLimit': '295'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '12 months', 'description': 'The time to first BCAR (central review) was calculated as the first biopsy date in which the central reviewer confirmed an acute rejection minus the date of skin closure +1. Only participants with a BCAR are included in the analysis.', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set with a BCAR as assessed by the central reviewer'}, {'type': 'SECONDARY', 'title': 'Time to First T-cell Mediated BCAR Assessed by Local Review', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Tacrolimus/MMF/Basiliximab', 'description': 'Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.'}, {'id': 'OG001', 'title': 'Alefacept QW/Tacrolimus/MMF', 'description': 'Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.'}, {'id': 'OG002', 'title': 'Alefacept QW/Tacrolimus', 'description': 'Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.'}, {'id': 'OG003', 'title': 'Alefacept QOW/Tacrolimus/MMF', 'description': 'Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '194'}, {'value': '12', 'groupId': 'OG001', 'lowerLimit': '6', 'upperLimit': '301'}, {'value': '18', 'groupId': 'OG002', 'lowerLimit': '7', 'upperLimit': '178'}, {'value': '12.5', 'groupId': 'OG003', 'lowerLimit': '5', 'upperLimit': '186'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '12 months', 'description': 'The time to first T-cell mediated BCAR (local review) was calculated as the first biopsy date in which the local reviewer confirmed an acute rejection minus the date of skin closure +1.', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set with a T-cell mediated BCAR as assessed by local review'}, {'type': 'SECONDARY', 'title': 'Time to First T-cell Mediated BCAR Assessed by Central Review', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Tacrolimus/MMF/Basiliximab', 'description': 'Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.'}, {'id': 'OG001', 'title': 'Alefacept QW/Tacrolimus/MMF', 'description': 'Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.'}, {'id': 'OG002', 'title': 'Alefacept QW/Tacrolimus', 'description': 'Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.'}, {'id': 'OG003', 'title': 'Alefacept QOW/Tacrolimus/MMF', 'description': 'Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000', 'lowerLimit': '6', 'upperLimit': '142'}, {'value': '10', 'groupId': 'OG001', 'lowerLimit': '7', 'upperLimit': '187'}, {'value': '12', 'groupId': 'OG002', 'lowerLimit': '7', 'upperLimit': '52'}, {'value': '11.5', 'groupId': 'OG003', 'lowerLimit': '5', 'upperLimit': '295'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '12 months', 'description': 'The time to first T-cell mediated BCAR (central review) was calculated as the first biopsy date in which the central reviewer confirmed an acute rejection minus the date of skin closure +1. Only participants with a T-cell mediated BCAR are included in the analysis.', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set with a T-cell mediated BCAR as assessed by the central reviewer'}, {'type': 'SECONDARY', 'title': 'Maximum Grade of T-cell Mediated Rejection Assessed by Local Review', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Tacrolimus/MMF/Basiliximab', 'description': 'Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.'}, {'id': 'OG001', 'title': 'Alefacept QW/Tacrolimus/MMF', 'description': 'Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.'}, {'id': 'OG002', 'title': 'Alefacept QW/Tacrolimus', 'description': 'Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.'}, {'id': 'OG003', 'title': 'Alefacept QOW/Tacrolimus/MMF', 'description': 'Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.'}], 'classes': [{'title': 'Month 6 - Grade IA', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Month 6 - Grade IB', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'Month 6 - Grade IIA', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Month 6 - Grade IIB', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'Month 6 - Grade III', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Month 12 - Grade IA', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Month 12 - Grade IB', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'Month 12 - Grade IIA', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Month 12 - Grade IIB', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'Month 12 - Grade III', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months and 12 months', 'description': 'The grade of acute T-cell mediated rejection was classified as IA, IB, IIA, IIB and III according to Banff 2005 criteria. If a patient had more than 1 T-cell mediated rejection, the episode with the most severe grade was used in the analysis.\n\nGrade IA: Cases with significant interstitial infiltration (\\> 25% of parenchyma affected) and foci of moderate tubulitis; Grade IB: Cases with significant interstitial infiltration (\\> 25% of parenchyma affected) and foci of severe tubulitis; Grade IIA: Cases with mild to moderate intimal arteritis; Grade IIB: Cases with severe intimal arteritis comprising \\>25% of the luminal area; Grade III: Cases with "transmural" arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic inflammation.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': 'Maximum Grade of T-cell Mediated Rejection as Assessed by Central Review', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Tacrolimus/MMF/Basiliximab', 'description': 'Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.'}, {'id': 'OG001', 'title': 'Alefacept QW/Tacrolimus/MMF', 'description': 'Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.'}, {'id': 'OG002', 'title': 'Alefacept QW/Tacrolimus', 'description': 'Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.'}, {'id': 'OG003', 'title': 'Alefacept QOW/Tacrolimus/MMF', 'description': 'Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.'}], 'classes': [{'title': 'Month 6 - Grade IA', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Month 6 - Grade IB', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Month 6 - Grade IIA', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}, {'title': 'Month 6 - Grade IIB', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'Month 6 - Grade III', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Month 12 - Grade IA', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Month 12 - Grade IB', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Month 12 - Grade IIA', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}, {'title': 'Month 12 - Grade IIB', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'Month 12 - Grade III', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months and 12 months', 'description': 'The grade of acute T-cell mediated rejection was classified as IA, IB, IIA, IIB and III according to Banff 2005 criteria. If a patient had more than 1 T-cell mediated rejection, the episode with the most severe grade was used in the analysis.\n\nGrade IA: Cases with significant interstitial infiltration (\\> 25% of parenchyma affected) and foci of moderate tubulitis; Grade IB: Cases with significant interstitial infiltration (\\> 25% of parenchyma affected) and foci of severe tubulitis; Grade IIA: Cases with mild to moderate intimal arteritis; Grade IIB: Cases with severe intimal arteritis comprising \\>25% of the luminal area; Grade III: Cases with "transmural" arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic inflammation.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Clinically Treated Acute Rejection at Month 6 and Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Tacrolimus/MMF/Basiliximab', 'description': 'Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.'}, {'id': 'OG001', 'title': 'Alefacept QW/Tacrolimus/MMF', 'description': 'Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.'}, {'id': 'OG002', 'title': 'Alefacept QW/Tacrolimus', 'description': 'Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.'}, {'id': 'OG003', 'title': 'Alefacept QOW/Tacrolimus/MMF', 'description': 'Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.'}], 'classes': [{'title': 'Month 6', 'categories': [{'measurements': [{'value': '19.0', 'groupId': 'OG000', 'lowerLimit': '11.7', 'upperLimit': '26.2'}, {'value': '33.8', 'groupId': 'OG001', 'lowerLimit': '24.9', 'upperLimit': '42.6'}, {'value': '29.3', 'groupId': 'OG002', 'lowerLimit': '20.7', 'upperLimit': '38.0'}, {'value': '23.1', 'groupId': 'OG003', 'lowerLimit': '15.2', 'upperLimit': '30.9'}]}]}, {'title': 'Month 12', 'categories': [{'measurements': [{'value': '20.3', 'groupId': 'OG000', 'lowerLimit': '12.8', 'upperLimit': '27.7'}, {'value': '35.1', 'groupId': 'OG001', 'lowerLimit': '26.1', 'upperLimit': '44.0'}, {'value': '30.7', 'groupId': 'OG002', 'lowerLimit': '21.9', 'upperLimit': '39.4'}, {'value': '23.1', 'groupId': 'OG003', 'lowerLimit': '15.2', 'upperLimit': '30.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months and 12 months', 'description': 'Patients who received immunosuppressive medications for the treatment of suspected or BCAR were considered to have a clinically-treated acute rejection.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Anti-lymphocyte-treated Rejection at Months 6 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Tacrolimus/MMF/Basiliximab', 'description': 'Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.'}, {'id': 'OG001', 'title': 'Alefacept QW/Tacrolimus/MMF', 'description': 'Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.'}, {'id': 'OG002', 'title': 'Alefacept QW/Tacrolimus', 'description': 'Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.'}, {'id': 'OG003', 'title': 'Alefacept QOW/Tacrolimus/MMF', 'description': 'Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.'}], 'classes': [{'title': 'Month 6', 'categories': [{'measurements': [{'value': '6.3', 'groupId': 'OG000', 'lowerLimit': '1.8', 'upperLimit': '10.8'}, {'value': '20.8', 'groupId': 'OG001', 'lowerLimit': '13.2', 'upperLimit': '28.4'}, {'value': '12.0', 'groupId': 'OG002', 'lowerLimit': '5.8', 'upperLimit': '18.2'}, {'value': '7.7', 'groupId': 'OG003', 'lowerLimit': '2.7', 'upperLimit': '12.7'}]}]}, {'title': 'Month 12', 'categories': [{'measurements': [{'value': '6.3', 'groupId': 'OG000', 'lowerLimit': '1.8', 'upperLimit': '10.8'}, {'value': '20.8', 'groupId': 'OG001', 'lowerLimit': '13.2', 'upperLimit': '28.4'}, {'value': '12.0', 'groupId': 'OG002', 'lowerLimit': '5.8', 'upperLimit': '18.2'}, {'value': '7.7', 'groupId': 'OG003', 'lowerLimit': '2.7', 'upperLimit': '12.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months and 12 months', 'description': 'Participants with histologically proved Banff Grade II or III rejection could receive anti-rejection therapy with anti-lymphocyte antibodies per institutional protocol.\n\nThe use of anti-lymphocyte antibody therapy at any time during a suspected or proven rejection episode for the treatment of acute rejection was considered an event.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Multiple Rejection Episodes at Months 6 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Tacrolimus/MMF/Basiliximab', 'description': 'Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.'}, {'id': 'OG001', 'title': 'Alefacept QW/Tacrolimus/MMF', 'description': 'Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.'}, {'id': 'OG002', 'title': 'Alefacept QW/Tacrolimus', 'description': 'Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.'}, {'id': 'OG003', 'title': 'Alefacept QOW/Tacrolimus/MMF', 'description': 'Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.'}], 'classes': [{'title': 'Month 6', 'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '3.3'}, {'value': '3.9', 'groupId': 'OG001', 'lowerLimit': '0.3', 'upperLimit': '7.5'}, {'value': '4.0', 'groupId': 'OG002', 'lowerLimit': '0.3', 'upperLimit': '7.7'}, {'value': '2.6', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '5.5'}]}]}, {'title': 'Month 12', 'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '3.3'}, {'value': '7.8', 'groupId': 'OG001', 'lowerLimit': '2.8', 'upperLimit': '12.8'}, {'value': '4.0', 'groupId': 'OG002', 'lowerLimit': '0.3', 'upperLimit': '7.7'}, {'value': '3.8', 'groupId': 'OG003', 'lowerLimit': '0.3', 'upperLimit': '7.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months and 12 months', 'description': 'All participants were evaluated for the incidence of multiple rejection episodes (clinically treated and/or BCAR as assessed by the local reviewer) through 6 months and 12 months.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Treatment Failure at Month 6 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Tacrolimus/MMF/Basiliximab', 'description': 'Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.'}, {'id': 'OG001', 'title': 'Alefacept QW/Tacrolimus/MMF', 'description': 'Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.'}, {'id': 'OG002', 'title': 'Alefacept QW/Tacrolimus', 'description': 'Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.'}, {'id': 'OG003', 'title': 'Alefacept QOW/Tacrolimus/MMF', 'description': 'Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.'}], 'classes': [{'title': 'Month 6', 'categories': [{'measurements': [{'value': '26.6', 'groupId': 'OG000', 'lowerLimit': '18.4', 'upperLimit': '34.8'}, {'value': '37.7', 'groupId': 'OG001', 'lowerLimit': '28.6', 'upperLimit': '46.7'}, {'value': '38.4', 'groupId': 'OG002', 'lowerLimit': '29.0', 'upperLimit': '47.7'}, {'value': '29.5', 'groupId': 'OG003', 'lowerLimit': '21.0', 'upperLimit': '38.0'}]}]}, {'title': 'Month 12', 'categories': [{'measurements': [{'value': '35.5', 'groupId': 'OG000', 'lowerLimit': '26.6', 'upperLimit': '44.4'}, {'value': '45.5', 'groupId': 'OG001', 'lowerLimit': '36.1', 'upperLimit': '54.8'}, {'value': '45.2', 'groupId': 'OG002', 'lowerLimit': '35.7', 'upperLimit': '54.8'}, {'value': '34.7', 'groupId': 'OG003', 'lowerLimit': '25.8', 'upperLimit': '43.6'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '11.1', 'ciLowerLimit': '-1.1', 'ciUpperLimit': '23.3', 'groupDescription': 'Treatment Failure at Month 6', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '11.8', 'ciLowerLimit': '-0.7', 'ciUpperLimit': '24.2', 'groupDescription': 'Treatment Failure at Month 6', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '2.9', 'ciLowerLimit': '-8.9', 'ciUpperLimit': '14.7', 'groupDescription': 'Treatment Failure at Month 6', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '10.0', 'ciLowerLimit': '-2.9', 'ciUpperLimit': '22.8', 'groupDescription': 'Treatment Failure at Month 12', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '9.7', 'ciLowerLimit': '-3.3', 'ciUpperLimit': '22.8', 'groupDescription': 'Treatment Failure at Month 12', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.8', 'ciLowerLimit': '-13.3', 'ciUpperLimit': '11.7', 'groupDescription': 'Treatment Failure at Month 12', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '6 months and 12 months', 'description': 'Treatment failure was defined as death, graft loss, BCAR (local review), lost to follow-up or early discontinuation of treatment regimen. The Kaplan-Meier estimates at Days 182 and 365 were used for the analyses at 6 months and 12 months respectively. Lost to follow-up or participants with missing outcomes were censored at their last follow up visit.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': 'Gastrointestinal Quality of Life Index Score Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Tacrolimus/MMF/Basiliximab', 'description': 'Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.'}, {'id': 'OG001', 'title': 'Alefacept QW/Tacrolimus/MMF', 'description': 'Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.'}, {'id': 'OG002', 'title': 'Alefacept QW/Tacrolimus', 'description': 'Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.'}, {'id': 'OG003', 'title': 'Alefacept QOW/Tacrolimus/MMF', 'description': 'Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.'}], 'classes': [{'title': 'Month 1 (N=63, 60, 59, 58)', 'categories': [{'measurements': [{'value': '2.85', 'spread': '0.602', 'groupId': 'OG000'}, {'value': '2.97', 'spread': '0.541', 'groupId': 'OG001'}, {'value': '3.00', 'spread': '0.513', 'groupId': 'OG002'}, {'value': '2.98', 'spread': '0.493', 'groupId': 'OG003'}]}]}, {'title': 'Month 3 (N=53, 52, 53, 54)', 'categories': [{'measurements': [{'value': '2.96', 'spread': '0.595', 'groupId': 'OG000'}, {'value': '3.29', 'spread': '0.441', 'groupId': 'OG001'}, {'value': '3.11', 'spread': '0.516', 'groupId': 'OG002'}, {'value': '3.16', 'spread': '0.442', 'groupId': 'OG003'}]}]}, {'title': 'Month 6 (N=58, 61, 57, 59)', 'categories': [{'measurements': [{'value': '3.05', 'spread': '0.589', 'groupId': 'OG000'}, {'value': '3.26', 'spread': '0.450', 'groupId': 'OG001'}, {'value': '3.24', 'spread': '0.491', 'groupId': 'OG002'}, {'value': '3.17', 'spread': '0.456', 'groupId': 'OG003'}]}]}, {'title': 'Month 12 (N=62, 60, 52, 58)', 'categories': [{'measurements': [{'value': '3.13', 'spread': '0.524', 'groupId': 'OG000'}, {'value': '3.18', 'spread': '0.554', 'groupId': 'OG001'}, {'value': '3.26', 'spread': '0.605', 'groupId': 'OG002'}, {'value': '3.19', 'spread': '0.531', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Months 1, 3, 6, and 12', 'description': 'The impact of gastrointestinal (GI) symptoms on health-related quality of life was assessed using the Gastrointestinal Quality of Life Index (GIQLI) symptom severity score. The GIQLI is a 36-item self-administered questionnaire that assesses the impact of gastrointestinal symptoms during the past 2 weeks on a scale from 0 (all of the time) to 4 (never). Possible overall scores ranged from 0 to 4, with higher scores indicating a better quality of life according to the different symptomatic criteria.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set with available data at each time point (indicated by "N")'}, {'type': 'SECONDARY', 'title': 'Gastrointestinal Symptom Rating Scale Scores Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Tacrolimus/MMF/Basiliximab', 'description': 'Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.'}, {'id': 'OG001', 'title': 'Alefacept QW/Tacrolimus/MMF', 'description': 'Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.'}, {'id': 'OG002', 'title': 'Alefacept QW/Tacrolimus', 'description': 'Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.'}, {'id': 'OG003', 'title': 'Alefacept QOW/Tacrolimus/MMF', 'description': 'Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.'}], 'classes': [{'title': 'Month 1 (N=70, 61, 61, 64)', 'categories': [{'measurements': [{'value': '1.72', 'spread': '0.665', 'groupId': 'OG000'}, {'value': '1.43', 'spread': '0.490', 'groupId': 'OG001'}, {'value': '1.59', 'spread': '0.674', 'groupId': 'OG002'}, {'value': '1.48', 'spread': '0.491', 'groupId': 'OG003'}]}]}, {'title': 'Month 3 (N=58, 55, 53, 56)', 'categories': [{'measurements': [{'value': '1.52', 'spread': '0.480', 'groupId': 'OG000'}, {'value': '1.42', 'spread': '0.672', 'groupId': 'OG001'}, {'value': '1.47', 'spread': '0.568', 'groupId': 'OG002'}, {'value': '1.34', 'spread': '0.370', 'groupId': 'OG003'}]}]}, {'title': 'Month 6 (N=63, 67, 62, 63)', 'categories': [{'measurements': [{'value': '1.63', 'spread': '0.602', 'groupId': 'OG000'}, {'value': '1.41', 'spread': '0.695', 'groupId': 'OG001'}, {'value': '1.49', 'spread': '0.471', 'groupId': 'OG002'}, {'value': '1.42', 'spread': '0.496', 'groupId': 'OG003'}]}]}, {'title': 'Month 12 (N=63, 65, 53, 65)', 'categories': [{'measurements': [{'value': '1.63', 'spread': '0.635', 'groupId': 'OG000'}, {'value': '1.42', 'spread': '0.564', 'groupId': 'OG001'}, {'value': '1.52', 'spread': '0.609', 'groupId': 'OG002'}, {'value': '1.57', 'spread': '0.642', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Months 1, 3, 6, and 12', 'description': 'The impact of gastrointestinal (GI) symptoms on health-related quality of life was assessed using the Gastrointestinal Symptom Rating Scale Scores (GSRS). The GSRS a 15-item self-administered questionnaire that assesses the impact of gastrointestinal symptoms during the past week on a scale from 1 (no discomfort at all) to 7 (very severe discomfort). Possible overall scores range from 1 to 7, with lower scores indicating a better quality of life with respect to gastrointestinal symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set with available data at each time point (indicated by "N")'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tacrolimus/MMF/Basiliximab', 'description': 'Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.'}, {'id': 'FG001', 'title': 'Alefacept QW/Tacrolimus/MMF', 'description': 'Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.'}, {'id': 'FG002', 'title': 'Alefacept QW/Tacrolimus', 'description': 'Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.'}, {'id': 'FG003', 'title': 'Alefacept QOW/Tacrolimus/MMF', 'description': 'Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '82'}, {'groupId': 'FG001', 'numSubjects': '80'}, {'groupId': 'FG002', 'numSubjects': '80'}, {'groupId': 'FG003', 'numSubjects': '81'}]}, {'type': 'Received Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '79'}, {'groupId': 'FG001', 'numSubjects': '77'}, {'groupId': 'FG002', 'numSubjects': '75'}, {'groupId': 'FG003', 'numSubjects': '78'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '70'}, {'groupId': 'FG001', 'numSubjects': '72'}, {'groupId': 'FG002', 'numSubjects': '60'}, {'groupId': 'FG003', 'numSubjects': '72'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '20'}, {'groupId': 'FG003', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Miscellaneous Reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'Randomized but never received study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'This study enrolled de novo kidney transplant recipients who were at least 18 years of age.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}, {'value': '78', 'groupId': 'BG003'}, {'value': '309', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Tacrolimus/MMF/Basiliximab', 'description': 'Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.'}, {'id': 'BG001', 'title': 'Alefacept QW/Tacrolimus/MMF', 'description': 'Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.'}, {'id': 'BG002', 'title': 'Alefacept QW/Tacrolimus', 'description': 'Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.'}, {'id': 'BG003', 'title': 'Alefacept QOW/Tacrolimus/MMF', 'description': 'Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '48.44', 'spread': '15.077', 'groupId': 'BG000'}, {'value': '49.26', 'spread': '13.532', 'groupId': 'BG001'}, {'value': '47.80', 'spread': '12.469', 'groupId': 'BG002'}, {'value': '49.68', 'spread': '13.749', 'groupId': 'BG003'}, {'value': '48.80', 'spread': '13.707', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '99', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}, {'value': '54', 'groupId': 'BG003'}, {'value': '210', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Full Analysis Set (FAS): All randomized participants who received at least 1 dose of study drug.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 323}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-06', 'studyFirstSubmitDate': '2007-10-11', 'resultsFirstSubmitDate': '2015-11-06', 'studyFirstSubmitQcDate': '2007-10-12', 'lastUpdatePostDateStruct': {'date': '2015-12-11', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-11-06', 'studyFirstPostDateStruct': {'date': '2007-10-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-12-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Biopsy-confirmed Acute Rejection (BCAR) at Month 6 Assessed by Local Review', 'timeFrame': '6 months', 'description': 'Rejection episodes were confirmed by biopsy by the clinical site pathologist. Biopsies were graded according to the 2005 Banff criteria. All biopsies (T-cell and/or antibody mediated) of grade 1 or higher were considered a BCAR.\n\nThe Kaplan-Meier estimates at Day 182 was used for the analyses at 6 months. Lost to follow-up or patients with missing outcomes were censored at their last follow up visit.'}], 'secondaryOutcomes': [{'measure': 'Patient Survival at Month 6 and Month 12', 'timeFrame': '6 months and 12 months', 'description': 'Patient survival is any participant who is known to be alive 6 months and 12 months after the skin closure date.\n\nThe Kaplan-Meier estimates at Days 182 and 365 were used for the analyses at 6 months and 12 months respectively. Lost to follow-up or participants with missing outcomes were censored at their last follow up visit.'}, {'measure': 'Graft Survival at Month 6 and Month 12', 'timeFrame': '6 months and 12 months', 'description': 'Graft survival was defined as any participant who was known to have a functioning graft (i.e., not graft loss) at 6 months and 12 months after the skin closure date. Graft loss was defined as patient death, retransplant, permanent return to dialysis (dialysis greater than 30 days) or transplant nephrectomy.\n\nThe Kaplan-Meier estimates at Days 182 and 365 were used for the analyses at 6 months and 12 months respectively. Lost to follow-up or participants with missing outcomes were censored at their last follow up visit.'}, {'measure': 'Percentage of Participants With BCAR at Month 12 Assessed by Local Review', 'timeFrame': '12 months', 'description': 'Rejection episodes were confirmed by biopsy by the clinical site pathologist. Biopsies were graded according to the 2005 Banff criteria. All biopsies (T-cell and/or antibody mediated) of grade 1 or higher were considered a BCAR.\n\nThe Kaplan-Meier estimates at Day 365 was used for the analyses at 12 months. Lost to follow-up or participants with missing outcomes were censored at their last follow up visit.'}, {'measure': 'Percentage of Participants With BCAR at Month 6 and 12 Assessed by Central Review', 'timeFrame': '6 months and 12 months', 'description': 'Rejection episodes were confirmed by biopsy by a central reviewer. Biopsies were graded according to the 2005 Banff criteria. All biopsies (T-cell and/or antibody mediated) of grade 1 or higher were considered a BCAR.\n\nThe Kaplan-Meier estimates at Days 182 and 365 were used for the analyses at 6 months and 12 months respectively. Lost to follow-up or participants with missing outcomes were censored at their last follow up visit.'}, {'measure': 'Percentage of Participants With T-cell Mediated BCAR at Month 6 and 12 Assessed by Local Review', 'timeFrame': '6 months and 12 months', 'description': 'Rejection episodes were confirmed by biopsy by the clinical site pathologist. Biopsies were graded according to the 2005 Banff criteria. All biopsies of grade 1 or higher were considered a BCAR.\n\nThe Kaplan-Meier estimates at Days 182 and 365 were used for the analyses at 6 months and 12 months respectively. Lost to follow-up or participants with missing outcomes were censored at their last follow up visit.'}, {'measure': 'Percentage of Participants With T-cell Mediated BCAR at Month 6 and 12 Assessed by Central Review', 'timeFrame': '6 months and 12 months', 'description': 'Rejection episodes were confirmed by biopsy by the central reviewer. Biopsies were graded according to the 2005 Banff criteria. All biopsies of grade 1 or higher were considered a BCAR.\n\nThe Kaplan-Meier estimates at Days 182 and 365 were used for the analyses at 6 months and 12 months respectively. Lost to follow-up or participants with missing outcomes were censored at their last follow up visit.'}, {'measure': 'Change From Week 4 in Glomerular Filtration Rate Estimated by the MDRD Method at Month 6 and Month 12', 'timeFrame': 'Week 4, Month 6 and Month 12', 'description': 'The glomerular filtration rate (GFR) was calculated using the Modification of Diet in Renal Disease (MDRD) method.'}, {'measure': 'Change From Week 4 in GFR by Iothalamate Clearance at Month 6', 'timeFrame': 'Week 4 and Month 6', 'description': 'The glomerular filtration rate was measured directly using iothalamate clearance.'}, {'measure': 'Change From Week 4 in Serum Creatinine at Month 6 and 12', 'timeFrame': 'Week 4 and Month 6 and 12'}, {'measure': 'Percentage of Participants With Efficacy Failure at 6 and 12 Months Assessed by Local Review', 'timeFrame': '6 months and 12 months', 'description': 'Efficacy failure is defined as death, graft failure (permanent return to dialysis \\[\\>30 days\\] or retransplant), BCAR according to local review, or lost to follow-up.'}, {'measure': 'Percentage of Participants With Efficacy Failure at 6 and 12 Months Assessed by Central Review', 'timeFrame': '6 months and 12 months', 'description': 'Efficacy failure is defined as death, graft failure (permanent return to dialysis \\[\\>30 days\\] or retransplant), BCAR according to central review, or lost to follow-up.'}, {'measure': 'Time to First BCAR Assessed by Local Review', 'timeFrame': '12 months', 'description': 'The time to first BCAR (local review) was calculated as the first biopsy date in which the local reviewer confirmed an acute rejection minus the date of skin closure +1. Only participants with a BCAR are included in the analysis.'}, {'measure': 'Time to First BCAR Assessed by Central Review', 'timeFrame': '12 months', 'description': 'The time to first BCAR (central review) was calculated as the first biopsy date in which the central reviewer confirmed an acute rejection minus the date of skin closure +1. Only participants with a BCAR are included in the analysis.'}, {'measure': 'Time to First T-cell Mediated BCAR Assessed by Local Review', 'timeFrame': '12 months', 'description': 'The time to first T-cell mediated BCAR (local review) was calculated as the first biopsy date in which the local reviewer confirmed an acute rejection minus the date of skin closure +1.'}, {'measure': 'Time to First T-cell Mediated BCAR Assessed by Central Review', 'timeFrame': '12 months', 'description': 'The time to first T-cell mediated BCAR (central review) was calculated as the first biopsy date in which the central reviewer confirmed an acute rejection minus the date of skin closure +1. Only participants with a T-cell mediated BCAR are included in the analysis.'}, {'measure': 'Maximum Grade of T-cell Mediated Rejection Assessed by Local Review', 'timeFrame': '6 months and 12 months', 'description': 'The grade of acute T-cell mediated rejection was classified as IA, IB, IIA, IIB and III according to Banff 2005 criteria. If a patient had more than 1 T-cell mediated rejection, the episode with the most severe grade was used in the analysis.\n\nGrade IA: Cases with significant interstitial infiltration (\\> 25% of parenchyma affected) and foci of moderate tubulitis; Grade IB: Cases with significant interstitial infiltration (\\> 25% of parenchyma affected) and foci of severe tubulitis; Grade IIA: Cases with mild to moderate intimal arteritis; Grade IIB: Cases with severe intimal arteritis comprising \\>25% of the luminal area; Grade III: Cases with "transmural" arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic inflammation.'}, {'measure': 'Maximum Grade of T-cell Mediated Rejection as Assessed by Central Review', 'timeFrame': '6 months and 12 months', 'description': 'The grade of acute T-cell mediated rejection was classified as IA, IB, IIA, IIB and III according to Banff 2005 criteria. If a patient had more than 1 T-cell mediated rejection, the episode with the most severe grade was used in the analysis.\n\nGrade IA: Cases with significant interstitial infiltration (\\> 25% of parenchyma affected) and foci of moderate tubulitis; Grade IB: Cases with significant interstitial infiltration (\\> 25% of parenchyma affected) and foci of severe tubulitis; Grade IIA: Cases with mild to moderate intimal arteritis; Grade IIB: Cases with severe intimal arteritis comprising \\>25% of the luminal area; Grade III: Cases with "transmural" arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic inflammation.'}, {'measure': 'Percentage of Participants With Clinically Treated Acute Rejection at Month 6 and Month 12', 'timeFrame': '6 months and 12 months', 'description': 'Patients who received immunosuppressive medications for the treatment of suspected or BCAR were considered to have a clinically-treated acute rejection.'}, {'measure': 'Percentage of Participants With Anti-lymphocyte-treated Rejection at Months 6 and 12', 'timeFrame': '6 months and 12 months', 'description': 'Participants with histologically proved Banff Grade II or III rejection could receive anti-rejection therapy with anti-lymphocyte antibodies per institutional protocol.\n\nThe use of anti-lymphocyte antibody therapy at any time during a suspected or proven rejection episode for the treatment of acute rejection was considered an event.'}, {'measure': 'Percentage of Participants With Multiple Rejection Episodes at Months 6 and 12', 'timeFrame': '6 months and 12 months', 'description': 'All participants were evaluated for the incidence of multiple rejection episodes (clinically treated and/or BCAR as assessed by the local reviewer) through 6 months and 12 months.'}, {'measure': 'Percentage of Participants With Treatment Failure at Month 6 and 12', 'timeFrame': '6 months and 12 months', 'description': 'Treatment failure was defined as death, graft loss, BCAR (local review), lost to follow-up or early discontinuation of treatment regimen. The Kaplan-Meier estimates at Days 182 and 365 were used for the analyses at 6 months and 12 months respectively. Lost to follow-up or participants with missing outcomes were censored at their last follow up visit.'}, {'measure': 'Gastrointestinal Quality of Life Index Score Over Time', 'timeFrame': 'Months 1, 3, 6, and 12', 'description': 'The impact of gastrointestinal (GI) symptoms on health-related quality of life was assessed using the Gastrointestinal Quality of Life Index (GIQLI) symptom severity score. The GIQLI is a 36-item self-administered questionnaire that assesses the impact of gastrointestinal symptoms during the past 2 weeks on a scale from 0 (all of the time) to 4 (never). Possible overall scores ranged from 0 to 4, with higher scores indicating a better quality of life according to the different symptomatic criteria.'}, {'measure': 'Gastrointestinal Symptom Rating Scale Scores Over Time', 'timeFrame': 'Months 1, 3, 6, and 12', 'description': 'The impact of gastrointestinal (GI) symptoms on health-related quality of life was assessed using the Gastrointestinal Symptom Rating Scale Scores (GSRS). The GSRS a 15-item self-administered questionnaire that assesses the impact of gastrointestinal symptoms during the past week on a scale from 1 (no discomfort at all) to 7 (very severe discomfort). Possible overall scores range from 1 to 7, with lower scores indicating a better quality of life with respect to gastrointestinal symptoms.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['kidney transplant', 'alefacept'], 'conditions': ['Kidney Transplantation']}, 'descriptionModule': {'briefSummary': 'A study to assess the safety and efficacy of Alefacept in de novo kidney transplant patients.', 'detailedDescription': 'This is a 4 arm (all active) study to determine the safety and efficacy of Alefacept in de novo kidney transplant recipients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject is anticipated to receive first oral dose of tacrolimus within 48 hours of transplant procedure\n* Subject is a recipient of a de novo kidney transplant\n* Subject is a recipient of a kidney from a non-human leukocyte antigen (HLA) identical related living donor, a non-related living donor, or a deceased donor\n\nExclusion Criteria:\n\n* Subject has a screening (pre-operative)estimated cluster of differentiation (CD) 4+ T-cell count of \\< 250 cells/µL\n* Subject will receive a kidney with an anticipated cold ischemia time (CIT) of \\> 30 hours\n* Recipient has a positive T or B-cell cross match by investigational site's standard method of determination\n* Subject will receive a kidney from a 50-65 year old deceased donor with one of the following:\n\n * History of hypertension and a terminal serum creatinine \\> 1.5 mg/dL\n * Cerebrovascular accident as cause of death and a terminal serum creatinine \\> 1.5 mg/dL\n * History of hypertension and cerebrovascular accident as cause of death and a terminal serum creatinine \\> 1.5 mg/dL"}, 'identificationModule': {'nctId': 'NCT00543569', 'briefTitle': 'A Study to Assess the Safety and Efficacy of Alefacept in Kidney Transplant Recipients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': 'A Phase 2, Randomized, Open-Label, Parallel Group, Multi-Center Study to Assess the Safety and Efficacy of Alefacept in de Novo Kidney Transplant Recipients', 'orgStudyIdInfo': {'id': '0485-CL-U201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Tacrolimus/MMF/Basiliximab', 'description': 'Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.', 'interventionNames': ['Drug: tacrolimus', 'Drug: basiliximab', 'Drug: mycophenolate mofetil', 'Drug: Corticosteroids']}, {'type': 'EXPERIMENTAL', 'label': 'Alefacept QW/Tacrolimus/MMF', 'description': 'Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.', 'interventionNames': ['Drug: Alefacept', 'Drug: tacrolimus', 'Drug: mycophenolate mofetil', 'Drug: Corticosteroids']}, {'type': 'EXPERIMENTAL', 'label': 'Alefacept QW/Tacrolimus', 'description': 'Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.', 'interventionNames': ['Drug: Alefacept', 'Drug: tacrolimus', 'Drug: Corticosteroids']}, {'type': 'EXPERIMENTAL', 'label': 'Alefacept QOW/Tacrolimus/MMF', 'description': 'Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.', 'interventionNames': ['Drug: Alefacept', 'Drug: tacrolimus', 'Drug: mycophenolate mofetil', 'Drug: Corticosteroids']}], 'interventions': [{'name': 'Alefacept', 'type': 'DRUG', 'otherNames': ['Amevive, ASP0485'], 'description': 'Administered as a 7.5 mg intravenous bolus on day 0 (intraoperatively, prior to kidney revascularization) and Day 3; subsequently administered subcutaneously either weekly or every 2 weeks.', 'armGroupLabels': ['Alefacept QOW/Tacrolimus/MMF', 'Alefacept QW/Tacrolimus', 'Alefacept QW/Tacrolimus/MMF']}, {'name': 'tacrolimus', 'type': 'DRUG', 'otherNames': ['Prograf, FK506'], 'description': 'The initial dose of tacrolimus was administered orally within 48 hours post-transplant. Subsequent doses were to be adjusted to achieve target whole blood trough concentrations.', 'armGroupLabels': ['Alefacept QOW/Tacrolimus/MMF', 'Alefacept QW/Tacrolimus', 'Alefacept QW/Tacrolimus/MMF', 'Tacrolimus/MMF/Basiliximab']}, {'name': 'basiliximab', 'type': 'DRUG', 'otherNames': ['Simulect'], 'description': 'Administered as a 20 mg bolus injection within 2 hours prior to transplantation and a 20 mg bolus injection on Day 3.', 'armGroupLabels': ['Tacrolimus/MMF/Basiliximab']}, {'name': 'mycophenolate mofetil', 'type': 'DRUG', 'otherNames': ['CellCept, MMF'], 'description': 'Administered at 750 mg twice per day orally or intravenously for patients enrolled under Amendment 6 or earlier and at 1000 mg twice per day orally or intravenously for patients enrolled under Amendment 7. The dose of MMF could be adjusted based on clinical symptoms.', 'armGroupLabels': ['Alefacept QOW/Tacrolimus/MMF', 'Alefacept QW/Tacrolimus/MMF', 'Tacrolimus/MMF/Basiliximab']}, {'name': 'Corticosteroids', 'type': 'DRUG', 'description': 'Corticosteroids were administered as a 500 to 1000 mg intravenous bolus on Day 0 and a 125 to 250 mg methylprednisone (or equivalent oral/intravenous corticosteroid dose) on Day 1. Oral prednisone was to be tapered per protocol.', 'armGroupLabels': ['Alefacept QOW/Tacrolimus/MMF', 'Alefacept QW/Tacrolimus', 'Alefacept QW/Tacrolimus/MMF', 'Tacrolimus/MMF/Basiliximab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92354', 'city': 'Loma Linda', 'state': 'California', 'country': 'United States', 'facility': 'Loma Linda University Medical Center', 'geoPoint': {'lat': 34.04835, 'lon': -117.26115}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of Southern California - University Hospital', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90057', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'St. Vincent/National Institute of Transplantation', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'UC Davis Medical Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'UCSD', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'California Institute of Renal Research/Sharp Memorial Hospital', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California - San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Health Science Center', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida, Shands Hospital, Gainesville', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Mayo Clinic - Jacksonville', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '30921', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Medical College of Georgia, Augusta', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush - Presbyterian - St. Lukes Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Illinois at Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '40536', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Kentucky', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'University of Maryland Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02111', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Tufts Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '07039', 'city': 'Livingston', 'state': 'New Jersey', 'country': 'United States', 'facility': 'St. Barnabas Medical Center', 'geoPoint': {'lat': 40.79593, 'lon': -74.31487}}, {'zip': '14203', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Buffalo General Hospital', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mt. 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