Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2026-02-25 @ 8:17 PM
Study NCT ID:
NCT00113269
Status:
COMPLETED
Last Update Posted:
2011-08-11
First Post:
2005-06-07
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety/Efficacy of Induction Agents With Tacrolimus, MMF, and Rapid Steroid Withdrawal in Renal Transplant Recipients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077552', 'term': 'Basiliximab'}, {'id': 'D000961', 'term': 'Antilymphocyte Serum'}, {'id': 'C512542', 'term': 'thymoglobulin'}, {'id': 'D016559', 'term': 'Tacrolimus'}, {'id': 'D000074323', 'term': 'Alemtuzumab'}, {'id': 'D009173', 'term': 'Mycophenolic Acid'}, {'id': 'D013256', 'term': 'Steroids'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'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': 'D007106', 'term': 'Immune Sera'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002208', 'term': 'Caproates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@us.astellas.com', 'title': 'Senior Medical Director', 'organization': 'Astellas Pharma Global Development'}, 'certainAgreement': {'otherDetails': "Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data. Sponsor must receive a site's manuscript at least 30 days prior to publication to ensure that no confidential information of Sponsor is included in the document. Sponsor may delay the publication for an additional 60 days to seek patent protection.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Company makes no warranties or representations of any kind as to the posting, expressed or implied, including warranties of merchantability and fitness for a particular purpose, and shall not be liable for any damages.'}}, 'adverseEventsModule': {'description': 'Data includes Adverse Events (AEs) that started any time between skin closure and 10 days after the last dose of tacrolimus.\n\nWithin a system organ class patients may have reported more than one type of event.', 'eventGroups': [{'id': 'EG000', 'title': 'Alemtuzumab High-Risk Patients', 'description': 'Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American', 'otherNumAtRisk': 70, 'otherNumAffected': 61, 'seriousNumAtRisk': 70, 'seriousNumAffected': 33}, {'id': 'EG001', 'title': 'Conventional High-Risk Patients', 'description': 'Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American', 'otherNumAtRisk': 69, 'otherNumAffected': 66, 'seriousNumAtRisk': 69, 'seriousNumAffected': 40}, {'id': 'EG002', 'title': 'Alemtuzumab Low- Risk Patients', 'description': 'Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody \\< 20% and first transplant and non-African American', 'otherNumAtRisk': 164, 'otherNumAffected': 151, 'seriousNumAtRisk': 164, 'seriousNumAffected': 91}, {'id': 'EG003', 'title': 'Conventional Low-Risk Patients', 'description': 'Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody \\< 20% and first transplant and non-African American', 'otherNumAtRisk': 171, 'otherNumAffected': 157, 'seriousNumAtRisk': 171, 'seriousNumAffected': 81}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 41}, {'groupId': 'EG002', 'numAtRisk': 164, 'numAffected': 90}, {'groupId': 'EG003', 'numAtRisk': 171, 'numAffected': 73}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 40}, {'groupId': 'EG002', 'numAtRisk': 164, 'numAffected': 84}, {'groupId': 'EG003', 'numAtRisk': 171, 'numAffected': 48}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 164, 'numAffected': 23}, {'groupId': 'EG003', 'numAtRisk': 171, 'numAffected': 13}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 164, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 171, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 164, 'numAffected': 53}, {'groupId': 'EG003', 'numAtRisk': 171, 'numAffected': 65}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 164, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 171, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 164, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 171, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'BK Viris infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 164, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 171, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 164, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 171, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Cytomegalovirus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 164, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 171, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Escherichia urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 164, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 171, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 164, 'numAffected': 27}, {'groupId': 'EG003', 'numAtRisk': 171, 'numAffected': 23}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 164, 'numAffected': 32}, {'groupId': 'EG003', 'numAtRisk': 171, 'numAffected': 37}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Urinary tract infection bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 164, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 171, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Complications of transplanted kidney', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 164, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 171, 'numAffected': 13}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Therapeutic agent toxicity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 164, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 171, 'numAffected': 13}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 164, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 171, 'numAffected': 14}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 164, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 171, 'numAffected': 21}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 164, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 171, 'numAffected': 11}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Hyperlipidaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 164, 'numAffected': 33}, {'groupId': 'EG003', 'numAtRisk': 171, 'numAffected': 32}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 164, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 171, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 164, 'numAffected': 25}, {'groupId': 'EG003', 'numAtRisk': 171, 'numAffected': 18}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}], 'seriousEvents': [{'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 164, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 171, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 164, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 171, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Bk virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 164, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 164, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 171, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 164, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 171, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Cytomegalovirus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 164, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 171, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Cytomegalovirus viraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 164, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 171, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 164, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 164, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 171, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Urinary tract infection bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 164, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 171, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Bacterial pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 164, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 171, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Bacterial sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 171, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 171, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 164, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 171, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Clostridial infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 171, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Cytomegalovirus colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 171, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Endocarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 171, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Escherichia sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 171, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 164, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 164, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 171, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, 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70, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 171, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Hyperparathyroidism tertiary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 164, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 171, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Myositis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 171, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Flank pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Rheumatoid arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Mental status changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 164, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 164, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 171, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Mania', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 164, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 171, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Adnexa uteri mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 164, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 171, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Endometrial hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 164, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 171, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Epididymitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 164, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 171, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 164, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 171, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Patient Incidence of Biopsy-confirmed Acute Rejection (BCAR) at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '164', 'groupId': 'OG002'}, {'value': '171', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Alemtuzumab High-Risk Patients', 'description': 'Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American'}, {'id': 'OG001', 'title': 'Conventional High-Risk Patients', 'description': 'Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American'}, {'id': 'OG002', 'title': 'Alemtuzumab Low- Risk Patients', 'description': 'Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody \\< 20% and first transplant and non-African American'}, {'id': 'OG003', 'title': 'Conventional Low-Risk Patients', 'description': 'Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody \\< 20% and first transplant and non-African American'}], 'classes': [{'categories': [{'measurements': [{'value': '6.2', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '12.0'}, {'value': '9.4', 'groupId': 'OG001', 'lowerLimit': '2.2', 'upperLimit': '16.7'}, {'value': '1.9', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '4.0'}, {'value': '17.5', 'groupId': 'OG003', 'lowerLimit': '11.7', 'upperLimit': '23.3'}]}]}], 'analyses': [{'pValue': '0.4889', 'groupIds': ['OG000', 'OG001'], 'paramType': 'differences in event rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95.305', 'paramValue': '-3.3', 'ciLowerLimit': '-12.7', 'ciUpperLimit': '6.1', 'estimateComment': "95.305% Confidence Interval is reported, as adjusted for interim analysis based on normal approximation using Greenwood's formula for standard error.", 'statisticalMethod': 'Normal approximation', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': "Analysis based on normal approximation using Greenwood's formula for standard error.", 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'differences in event rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95.305', 'paramValue': '-15.7', 'ciLowerLimit': '-21.9', 'ciUpperLimit': '-9.4', 'estimateComment': "95.305% Confidence Interval is reported, as adjusted for interim analysis based on normal approximation using Greenwood's formula for standard error.", 'statisticalMethod': 'normal approximation', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': "Analysis based on normal approximation using Greenwood's formula for standard error.", 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'A BCAR is a suspected new rejection w/in 6 mos. of skin closure, confirmed by Banff Grade ≥1A assigned by a pathologist. The Banff 97 classification system is used for interpreting histology of allograft biopsies, including Mild (1A/1B), Moderate (2A/2B) \\& Severe (3).\n\nKaplan Meier analysis was used to estimate % of pts. w/event. Patients w/no event at time of scheduled visit or whose 1st event was after premature discontinuation of study drug/tacrolimus were censored on the scheduled day of a) assessment, b) of premature treatment discontinuation or c) last evaluation, whichever came 1st.', 'unitOfMeasure': 'Percentage of Patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed per arm represents Full Analysis Set (FAS), which included all patients who were transplanted in the study and received at least 1 dose of tacrolimus and at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Overall Patient Incidence of BCAR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '164', 'groupId': 'OG002'}, {'value': '171', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Alemtuzumab High-Risk Patients', 'description': 'Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American'}, {'id': 'OG001', 'title': 'Conventional High-Risk Patients', 'description': 'Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American'}, {'id': 'OG002', 'title': 'Alemtuzumab Low- Risk Patients', 'description': 'Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody \\< 20% and first transplant and non-African American'}, {'id': 'OG003', 'title': 'Conventional Low-Risk Patients', 'description': 'Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody \\< 20% and first transplant and non-African American'}], 'classes': [{'categories': [{'measurements': [{'value': '15.7', 'groupId': 'OG000'}, {'value': '13.0', 'groupId': 'OG001'}, {'value': '9.8', 'groupId': 'OG002'}, {'value': '21.6', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.6533', 'groupIds': ['OG000', 'OG001'], 'paramType': 'differences in event rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.7', 'ciLowerLimit': '-9.0', 'ciUpperLimit': '14.3', 'statisticalMethod': 'normal approximation', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0024', 'groupIds': ['OG002', 'OG003'], 'paramType': 'differences in event rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-11.9', 'ciLowerLimit': '-19.5', 'ciUpperLimit': '-4.2', 'statisticalMethod': 'normal approximation', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'End of Study (36 months)', 'description': 'Overall patient incidence of BCAR is defined as a suspected new rejection at any time following skin closure confirmed by a Banff Grade ≥ 1A as assigned by a local pathologist. Incidence is reported as the percentage of patients with BCAR. The Banff 97 scale is a classification system for interpreting histology of allograft biopsies. The grades range from Mild (1A \\& 1B) to Moderate (2A \\& 2B) to Severe (3).\n\nEnd of Study was defined as the last day of evaluation and could have included bivariate assessments after 36 months.', 'unitOfMeasure': 'Percentage of Patients', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed per arm represents Full Analysis Set (FAS), which included all patients who were transplanted in the study and received at least 1 dose of tacrolimus and at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Efficacy Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '164', 'groupId': 'OG002'}, {'value': '171', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Alemtuzumab High-Risk Patients', 'description': 'Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American'}, {'id': 'OG001', 'title': 'Conventional High-Risk Patients', 'description': 'Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American'}, {'id': 'OG002', 'title': 'Alemtuzumab Low- Risk Patients', 'description': 'Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody \\< 20% and first transplant and non-African American'}, {'id': 'OG003', 'title': 'Conventional Low-Risk Patients', 'description': 'Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody \\< 20% and first transplant and non-African American'}], 'classes': [{'categories': [{'measurements': [{'value': '22.9', 'groupId': 'OG000'}, {'value': '29.0', 'groupId': 'OG001'}, {'value': '15.9', 'groupId': 'OG002'}, {'value': '24.6', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.4087', 'groupIds': ['OG000', 'OG001'], 'paramType': 'differences in event rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.1', 'ciLowerLimit': '-20.7', 'ciUpperLimit': '8.4', 'statisticalMethod': 'normal approximation', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0456', 'groupIds': ['OG002', 'OG003'], 'paramType': 'differences in event rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.7', 'ciLowerLimit': '-17.2', 'ciUpperLimit': '-0.2', 'statisticalMethod': 'normal approximation', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'End of Study (36 months)', 'description': 'Efficacy Failure is a composite measure of biopsy confirmed acute rejection, graft loss and death. Data is reported as the percentage of patients with Efficacy Failure.\n\nEnd of Study was defined as the last day of evaluation and could have included bivariate assessments after 36 months.', 'unitOfMeasure': 'Percentage of Patients', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed per arm represents Full Analysis Set (FAS), which included all patients who were transplanted in the study and received at least 1 dose of tacrolimus and at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Clinically Treated Acute Rejection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '164', 'groupId': 'OG002'}, {'value': '171', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Alemtuzumab High-Risk Patients', 'description': 'Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American'}, {'id': 'OG001', 'title': 'Conventional High-Risk Patients', 'description': 'Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American'}, {'id': 'OG002', 'title': 'Alemtuzumab Low- Risk Patients', 'description': 'Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody \\< 20% and first transplant and non-African American'}, {'id': 'OG003', 'title': 'Conventional Low-Risk Patients', 'description': 'Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody \\< 20% and first transplant and non-African American'}], 'classes': [{'categories': [{'measurements': [{'value': '22.9', 'groupId': 'OG000'}, {'value': '21.7', 'groupId': 'OG001'}, {'value': '12.8', 'groupId': 'OG002'}, {'value': '26.9', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.8742', 'groupIds': ['OG000', 'OG001'], 'paramType': 'differences in event rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.1', 'ciLowerLimit': '-12.7', 'ciUpperLimit': '15.0', 'statisticalMethod': 'normal approximation', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0010', 'groupIds': ['OG002', 'OG003'], 'paramType': 'differences in event rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-14.1', 'ciLowerLimit': '-22.5', 'ciUpperLimit': '-5.7', 'statisticalMethod': 'normal approximation', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'End of Study (36 months)', 'description': 'Clinically treated acute rejection is defined as patient incidence of any rejection (suspected or otherwise) for which treatment was provided. Data is reported as the percentage of patients with Clinically Treated Acute Rejection.\n\nEnd of Study was defined as the last day of evaluation and could have included bivariate assessments after 36 months.', 'unitOfMeasure': 'Percentage of Patients', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed per arm represents Full Analysis Set (FAS), which included all patients who were transplanted in the study and received at least 1 dose of tacrolimus and at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Time to First BCAR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Alemtuzumab High-Risk Patients', 'description': 'Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American'}, {'id': 'OG001', 'title': 'Conventional High-Risk Patients', 'description': 'Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American'}, {'id': 'OG002', 'title': 'Alemtuzumab Low- Risk Patients', 'description': 'Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody \\< 20% and first transplant and non-African American'}, {'id': 'OG003', 'title': 'Conventional Low-Risk Patients', 'description': 'Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody \\< 20% and first transplant and non-African American'}], 'classes': [{'categories': [{'measurements': [{'value': '226', 'groupId': 'OG000', 'lowerLimit': '25', 'upperLimit': '1023'}, {'value': '49', 'groupId': 'OG001', 'lowerLimit': '10', 'upperLimit': '769'}, {'value': '469', 'groupId': 'OG002', 'lowerLimit': '53', 'upperLimit': '1065'}, {'value': '13', 'groupId': 'OG003', 'lowerLimit': '2', 'upperLimit': '848'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'End of Study (36 months)', 'description': 'Time to first BCAR is defined as the number of days from skin closure to the first episode of BCAR.\n\nEnd of Study was defined as the last day of evaluation and could have included bivariate assessments after 36 months.', 'unitOfMeasure': 'Days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed per arm represents Full Analysis Set (FAS), which included all patients who were transplanted in the study and received at least 1 dose of tacrolimus and at least 1 dose of study drug.\n\nOnly patients who experienced BCAR were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Graft Survival at 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '164', 'groupId': 'OG002'}, {'value': '171', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Alemtuzumab High-Risk Patients', 'description': 'Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American'}, {'id': 'OG001', 'title': 'Conventional High-Risk Patients', 'description': 'Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American'}, {'id': 'OG002', 'title': 'Alemtuzumab Low- Risk Patients', 'description': 'Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody \\< 20% and first transplant and non-African American'}, {'id': 'OG003', 'title': 'Conventional Low-Risk Patients', 'description': 'Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody \\< 20% and first transplant and non-African American'}], 'classes': [{'categories': [{'measurements': [{'value': '95.6', 'groupId': 'OG000'}, {'value': '92.1', 'groupId': 'OG001'}, {'value': '97.5', 'groupId': 'OG002'}, {'value': '95.1', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.4134', 'groupIds': ['OG000', 'OG001'], 'paramType': 'differences in event rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.5', 'ciLowerLimit': '-4.8', 'ciUpperLimit': '11.7', 'statisticalMethod': 'normal approximation', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': "Analysis based on normal approximation using Greenwood's formula for standard error.", 'testedNonInferiority': False}, {'pValue': '0.2459', 'groupIds': ['OG002', 'OG003'], 'paramType': 'differences in event rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.4', 'ciLowerLimit': '-1.7', 'ciUpperLimit': '6.5', 'statisticalMethod': 'normal approximation', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': "Analysis based on normal approximation using Greenwood's formula for standard error.", 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Graft survival is defined as no graft loss (re-transplant, return to dialysis for more than 30 days or death) with 12 months of skin closure.\n\nKaplan Meier analysis was used to estimate percentage of patients with event. Patients with no event by the time of the scheduled visit or whose first event was after premature discontinuation of randomized study drug or tacrolimus were censored on the scheduled day of assessment, on the day of premature treatment discontinuation or last evaluation day, whichever came first.', 'unitOfMeasure': 'Percentage of Patients', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed per arm represents Full Analysis Set (FAS), which included all patients who were transplanted in the study and received at least 1 dose of tacrolimus and at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Overall Graft Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '164', 'groupId': 'OG002'}, {'value': '171', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Alemtuzumab High-Risk Patients', 'description': 'Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American'}, {'id': 'OG001', 'title': 'Conventional High-Risk Patients', 'description': 'Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American'}, {'id': 'OG002', 'title': 'Alemtuzumab Low- Risk Patients', 'description': 'Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody \\< 20% and first transplant and non-African American'}, {'id': 'OG003', 'title': 'Conventional Low-Risk Patients', 'description': 'Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody \\< 20% and first transplant and non-African American'}], 'classes': [{'categories': [{'measurements': [{'value': '88.6', 'groupId': 'OG000'}, {'value': '82.6', 'groupId': 'OG001'}, {'value': '90.9', 'groupId': 'OG002'}, {'value': '91.2', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.3155', 'groupIds': ['OG000', 'OG001'], 'paramType': 'differences in event rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.0', 'ciLowerLimit': '-5.7', 'ciUpperLimit': '17.6', 'statisticalMethod': 'normal approximation', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.9045', 'groupIds': ['OG002', 'OG003'], 'paramType': 'differences in event rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-6.5', 'ciUpperLimit': '5.7', 'statisticalMethod': 'normal approximation', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'End of Study (36 months)', 'description': 'Overall graft survival is defined as not having graft loss (re-transplant, return to dialysis for more than 30 consecutive days, or death) at any time following skin closure. Data is reported as the percentage of patients with Overall Graft Survival.\n\nEnd of Study was defined as the last day of evaluation and could have included bivariate assessments after 36 months.', 'unitOfMeasure': 'Percentage of Patients', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed per arm represents Full Analysis Set (FAS), which included all patients who were transplanted in the study and received at least 1 dose of tacrolimus and at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Patient Survival at 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '164', 'groupId': 'OG002'}, {'value': '171', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Alemtuzumab High-Risk Patients', 'description': 'Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American'}, {'id': 'OG001', 'title': 'Conventional High-Risk Patients', 'description': 'Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American'}, {'id': 'OG002', 'title': 'Alemtuzumab Low- Risk Patients', 'description': 'Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody \\< 20% and first transplant and non-African American'}, {'id': 'OG003', 'title': 'Conventional Low-Risk Patients', 'description': 'Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody \\< 20% and first transplant and non-African American'}], 'classes': [{'categories': [{'measurements': [{'value': '98.6', 'groupId': 'OG000'}, {'value': '96.9', 'groupId': 'OG001'}, {'value': '98.1', 'groupId': 'OG002'}, {'value': '98.7', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.5265', 'groupIds': ['OG000', 'OG001'], 'paramType': 'differences in event rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.6', 'ciLowerLimit': '-3.4', 'ciUpperLimit': '6.7', 'statisticalMethod': 'normal approximation', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': "Analysis based on normal approximation using Greenwood's formula for standard error.", 'testedNonInferiority': False}, {'pValue': '0.6820', 'groupIds': ['OG002', 'OG003'], 'paramType': 'differences in event rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-3.4', 'ciUpperLimit': '2.2', 'statisticalMethod': 'normal approximation', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': "Analysis based on normal approximation using Greenwood's formula for standard error.", 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Patient survival is defined as not dead within 12 months after skin closure.\n\nKaplan Meier analysis was used to estimate percentage of patients with event. Patients with no event by the time of the scheduled visit or whose first event was after premature discontinuation of randomized study drug or tacrolimus were censored on the scheduled day of assessment, on the day of premature treatment discontinuation or last evaluation day, whichever came first.', 'unitOfMeasure': 'Percentage of Patients', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed per arm represents Full Analysis Set (FAS), which included all patients who were transplanted in the study and received at least 1 dose of tacrolimus and at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Overall Patient Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '164', 'groupId': 'OG002'}, {'value': '171', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Alemtuzumab High-Risk Patients', 'description': 'Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American'}, {'id': 'OG001', 'title': 'Conventional High-Risk Patients', 'description': 'Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American'}, {'id': 'OG002', 'title': 'Alemtuzumab Low- Risk Patients', 'description': 'Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody \\< 20% and first transplant and non-African American'}, {'id': 'OG003', 'title': 'Conventional Low-Risk Patients', 'description': 'Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody \\< 20% and first transplant and non-African American'}], 'classes': [{'categories': [{'measurements': [{'value': '95.7', 'groupId': 'OG000'}, {'value': '89.9', 'groupId': 'OG001'}, {'value': '93.9', 'groupId': 'OG002'}, {'value': '95.3', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.1797', 'groupIds': ['OG000', 'OG001'], 'paramType': 'differences in event rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.9', 'ciLowerLimit': '-2.7', 'ciUpperLimit': '14.4', 'statisticalMethod': 'normal approximation', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.5655', 'groupIds': ['OG002', 'OG003'], 'paramType': 'differences in event rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.4', 'ciLowerLimit': '-6.3', 'ciUpperLimit': '3.4', 'statisticalMethod': 'normal approximation', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'End of Study (36 months)', 'description': 'Overall patient survival is defined as not dead at any time following skin closure. Data is reported as the percentage of patients with Overall Patient Survival.\n\nEnd of Study was defined as the last day of evaluation and could have included bivariate assessments after 36 months.', 'unitOfMeasure': 'Percentage of Patients', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed per arm represents Full Analysis Set (FAS), which included all patients who were transplanted in the study and received at least 1 dose of tacrolimus and at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Renal Function Abnormalities Based on Creatinine Clearance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '164', 'groupId': 'OG002'}, {'value': '171', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Alemtuzumab High-Risk Patients', 'description': 'Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American'}, {'id': 'OG001', 'title': 'Conventional High-Risk Patients', 'description': 'Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American'}, {'id': 'OG002', 'title': 'Alemtuzumab Low- Risk Patients', 'description': 'Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody \\< 20% and first transplant and non-African American'}, {'id': 'OG003', 'title': 'Conventional Low-Risk Patients', 'description': 'Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody \\< 20% and first transplant and non-African American'}], 'classes': [{'title': 'Month 1 (N= 65; 65; 162; 161)', 'categories': [{'measurements': [{'value': '0.882', 'spread': '0.3585', 'groupId': 'OG000'}, {'value': '0.833', 'spread': '0.2515', 'groupId': 'OG001'}, {'value': '0.906', 'spread': '0.2720', 'groupId': 'OG002'}, {'value': '0.891', 'spread': '0.2668', 'groupId': 'OG003'}]}]}, {'title': 'Month 36 (N= 48; 47; 125; 131)', 'categories': [{'measurements': [{'value': '0.976', 'spread': '0.3772', 'groupId': 'OG000'}, {'value': '0.862', 'spread': '0.2929', 'groupId': 'OG001'}, {'value': '1.011', 'spread': '0.2736', 'groupId': 'OG002'}, {'value': '1.039', 'spread': '0.3195', 'groupId': 'OG003'}]}]}, {'title': 'Change from Month 1 (N= 48; 46; 125; 129)', 'categories': [{'measurements': [{'value': '0.031', 'spread': '0.3599', 'groupId': 'OG000'}, {'value': '0.039', 'spread': '0.2649', 'groupId': 'OG001'}, {'value': '0.080', 'spread': '0.2592', 'groupId': 'OG002'}, {'value': '0.140', 'spread': '0.2698', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.4735', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': "P-Value applies to 'Change from Month 1'", 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Analysis tests the difference between treatment groups for the mean change from month 1 with the month 1 value as covariate.', 'testedNonInferiority': False}, {'pValue': '0.1186', 'groupIds': ['OG002', 'OG003'], 'ciPctValue': '95', 'groupDescription': "P-Value applies to 'Change from Month 1'", 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Analysis tests the difference between treatment groups for the mean change from month 1 with the month 1 value as covariate.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '1 month and End of Study (36 months)', 'description': 'Increases in creatinine clearance usually indicates an improvement.\n\nChange in creatinine clearance from month 1 was calculated.\n\nChange from 1 month is calculated by month 36 - month 1.', 'unitOfMeasure': 'mL/s', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed represents Full Analysis Set: all patients who were transplanted in the study and received at least 1 dose of tacrolimus and at least 1 dose of study drug. Only patients with the test result at a given time point were included in each time point analysis, and these numbers are noted in the category titles as "N".'}, {'type': 'SECONDARY', 'title': 'Renal Function Abnormalities Based on Serum Creatinine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '164', 'groupId': 'OG002'}, {'value': '171', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Alemtuzumab High-Risk Patients', 'description': 'Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American'}, {'id': 'OG001', 'title': 'Conventional High-Risk Patients', 'description': 'Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American'}, {'id': 'OG002', 'title': 'Alemtuzumab Low- Risk Patients', 'description': 'Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody \\< 20% and first transplant and non-African American'}, {'id': 'OG003', 'title': 'Conventional Low-Risk Patients', 'description': 'Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody \\< 20% and first transplant and non-African American'}], 'classes': [{'title': 'Month 1 (N= 67; 65; 163; 162)', 'categories': [{'measurements': [{'value': '151.7', 'spread': '88.12', 'groupId': 'OG000'}, {'value': '155.9', 'spread': '97.18', 'groupId': 'OG001'}, {'value': '139.0', 'spread': '56.82', 'groupId': 'OG002'}, {'value': '138.2', 'spread': '46.03', 'groupId': 'OG003'}]}]}, {'title': 'Month 36 (N= 49; 47; 126; 131)', 'categories': [{'measurements': [{'value': '136.6', 'spread': '68.38', 'groupId': 'OG000'}, {'value': '152.0', 'spread': '84.85', 'groupId': 'OG001'}, {'value': '121.7', 'spread': '40.09', 'groupId': 'OG002'}, {'value': '117.1', 'spread': '35.50', 'groupId': 'OG003'}]}]}, {'title': 'Change from Month 1 (N= 49; 46; 126; 129)', 'categories': [{'measurements': [{'value': '1.8', 'spread': '69.41', 'groupId': 'OG000'}, {'value': '3.4', 'spread': '92.80', 'groupId': 'OG001'}, {'value': '-8.0', 'spread': '44.07', 'groupId': 'OG002'}, {'value': '-18.7', 'spread': '42.35', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.5231', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': "P-Value applies to 'Change from Month 1'", 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Analysis tests the difference between treatment groups for the mean change from month 1 with the month 1 value as covariate.', 'testedNonInferiority': False}, {'pValue': '0.1220', 'groupIds': ['OG002', 'OG003'], 'ciPctValue': '95', 'groupDescription': "P-Value applies to 'Change from Month 1'", 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Analysis tests the difference between treatment groups for the mean change from month 1 with the month 1 value as covariate.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '1 month and End of Study (36 months)', 'description': 'Decrease in serum creatinine usually indicates an improvement.\n\nChange in creatinine clearance from month 1 was calculated.\n\nChange from 1 month is calculated by month 36 - month 1.', 'unitOfMeasure': 'mcmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed represents Full Analysis Set: all patients who were transplanted in the study and received at least 1 dose of tacrolimus and at least 1 dose of study drug. Only patients with the test result at a given time point were included in each time point analysis, and these numbers are noted in the category titles as "N".'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Alemtuzumab High-Risk Patients', 'description': 'Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American'}, {'id': 'FG001', 'title': 'Conventional High-Risk Patients', 'description': 'Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American'}, {'id': 'FG002', 'title': 'Alemtuzumab Low- Risk Patients', 'description': 'Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody \\< 20% and first transplant and non-African American'}, {'id': 'FG003', 'title': 'Conventional Low-Risk Patients', 'description': 'Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody \\< 20% and first transplant and non-African American'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '76'}, {'groupId': 'FG001', 'numSubjects': '70'}, {'groupId': 'FG002', 'numSubjects': '175'}, {'groupId': 'FG003', 'numSubjects': '180'}]}, {'type': 'Received Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '70'}, {'groupId': 'FG001', 'numSubjects': '69'}, {'groupId': 'FG002', 'numSubjects': '164'}, {'groupId': 'FG003', 'numSubjects': '171'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}, {'groupId': 'FG001', 'numSubjects': '48'}, {'groupId': 'FG002', 'numSubjects': '134'}, {'groupId': 'FG003', 'numSubjects': '140'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '22'}, {'groupId': 'FG002', 'numSubjects': '41'}, {'groupId': 'FG003', 'numSubjects': '40'}]}], 'dropWithdraws': [{'type': 'Not transplanted, donor issues', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Not transplanted, recipient issues', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'Early graft loss, technical', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Death in operating room', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Did not meet eligibility - pre-treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '7'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Graft loss', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '9'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Sponsor elected to discontinue patient', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Discontinued due to rejection', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Moved', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Received pancreas transplant', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Withdrew consent, Prednisone initiated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Did not meet eligibility criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Unable to return for follow up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '164', 'groupId': 'BG002'}, {'value': '171', 'groupId': 'BG003'}, {'value': '474', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Alemtuzumab High-Risk Patients', 'description': 'Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American'}, {'id': 'BG001', 'title': 'Conventional High-Risk Patients', 'description': 'Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American'}, {'id': 'BG002', 'title': 'Alemtuzumab Low- Risk Patients', 'description': 'Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody \\< 20% and first transplant and non-African American'}, {'id': 'BG003', 'title': 'Conventional Low-Risk Patients', 'description': 'Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody \\< 20% and first transplant and non-African American'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '<18 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}, {'title': 'Between 18 and 64 years', 'categories': [{'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '145', 'groupId': 'BG002'}, {'value': '146', 'groupId': 'BG003'}, {'value': '421', 'groupId': 'BG004'}]}]}, {'title': '>=65 years', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}, {'value': '52', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'description': 'One patient turned 18 years of age during the study.', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}, {'value': '58', 'groupId': 'BG003'}, {'value': '170', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}, {'value': '113', 'groupId': 'BG003'}, {'value': '304', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '155', 'groupId': 'BG002'}, {'value': '161', 'groupId': 'BG003'}, {'value': '354', 'groupId': 'BG004'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '100', 'groupId': 'BG004'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Previous Transplant', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '29', 'groupId': 'BG004'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '162', 'groupId': 'BG002'}, {'value': '168', 'groupId': 'BG003'}, {'value': '445', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Type of Transplant', 'classes': [{'title': 'Living related', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}, {'value': '74', 'groupId': 'BG003'}, {'value': '174', 'groupId': 'BG004'}]}]}, {'title': 'Living non-related', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}, {'value': '48', 'groupId': 'BG003'}, {'value': '111', 'groupId': 'BG004'}]}]}, {'title': 'Deceased', 'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}, {'value': '49', 'groupId': 'BG003'}, {'value': '189', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Panel Reactive Antibody (PRA) Group', 'classes': [{'title': 'Missing', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}]}, {'title': '0%', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '134', 'groupId': 'BG002'}, {'value': '130', 'groupId': 'BG003'}, {'value': '329', 'groupId': 'BG004'}]}]}, {'title': '> 0% - 20%', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '39', 'groupId': 'BG003'}, {'value': '93', 'groupId': 'BG004'}]}]}, {'title': '> 20% - 50%', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '21', 'groupId': 'BG004'}]}]}, {'title': '> 50%', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '28', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'description': 'PRA is defined as the highest level at time of transplant or 6 months prior to transplant.', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 501}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-08', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-08-09', 'studyFirstSubmitDate': '2005-06-07', 'resultsFirstSubmitDate': '2011-06-07', 'studyFirstSubmitQcDate': '2005-06-07', 'lastUpdatePostDateStruct': {'date': '2011-08-11', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-06-07', 'studyFirstPostDateStruct': {'date': '2005-06-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-07-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient Incidence of Biopsy-confirmed Acute Rejection (BCAR) at 6 Months', 'timeFrame': '6 months', 'description': 'A BCAR is a suspected new rejection w/in 6 mos. of skin closure, confirmed by Banff Grade ≥1A assigned by a pathologist. The Banff 97 classification system is used for interpreting histology of allograft biopsies, including Mild (1A/1B), Moderate (2A/2B) \\& Severe (3).\n\nKaplan Meier analysis was used to estimate % of pts. w/event. Patients w/no event at time of scheduled visit or whose 1st event was after premature discontinuation of study drug/tacrolimus were censored on the scheduled day of a) assessment, b) of premature treatment discontinuation or c) last evaluation, whichever came 1st.'}], 'secondaryOutcomes': [{'measure': 'Overall Patient Incidence of BCAR', 'timeFrame': 'End of Study (36 months)', 'description': 'Overall patient incidence of BCAR is defined as a suspected new rejection at any time following skin closure confirmed by a Banff Grade ≥ 1A as assigned by a local pathologist. Incidence is reported as the percentage of patients with BCAR. The Banff 97 scale is a classification system for interpreting histology of allograft biopsies. The grades range from Mild (1A \\& 1B) to Moderate (2A \\& 2B) to Severe (3).\n\nEnd of Study was defined as the last day of evaluation and could have included bivariate assessments after 36 months.'}, {'measure': 'Efficacy Failure', 'timeFrame': 'End of Study (36 months)', 'description': 'Efficacy Failure is a composite measure of biopsy confirmed acute rejection, graft loss and death. Data is reported as the percentage of patients with Efficacy Failure.\n\nEnd of Study was defined as the last day of evaluation and could have included bivariate assessments after 36 months.'}, {'measure': 'Clinically Treated Acute Rejection', 'timeFrame': 'End of Study (36 months)', 'description': 'Clinically treated acute rejection is defined as patient incidence of any rejection (suspected or otherwise) for which treatment was provided. Data is reported as the percentage of patients with Clinically Treated Acute Rejection.\n\nEnd of Study was defined as the last day of evaluation and could have included bivariate assessments after 36 months.'}, {'measure': 'Time to First BCAR', 'timeFrame': 'End of Study (36 months)', 'description': 'Time to first BCAR is defined as the number of days from skin closure to the first episode of BCAR.\n\nEnd of Study was defined as the last day of evaluation and could have included bivariate assessments after 36 months.'}, {'measure': 'Graft Survival at 12 Months', 'timeFrame': '12 months', 'description': 'Graft survival is defined as no graft loss (re-transplant, return to dialysis for more than 30 days or death) with 12 months of skin closure.\n\nKaplan Meier analysis was used to estimate percentage of patients with event. Patients with no event by the time of the scheduled visit or whose first event was after premature discontinuation of randomized study drug or tacrolimus were censored on the scheduled day of assessment, on the day of premature treatment discontinuation or last evaluation day, whichever came first.'}, {'measure': 'Overall Graft Survival', 'timeFrame': 'End of Study (36 months)', 'description': 'Overall graft survival is defined as not having graft loss (re-transplant, return to dialysis for more than 30 consecutive days, or death) at any time following skin closure. Data is reported as the percentage of patients with Overall Graft Survival.\n\nEnd of Study was defined as the last day of evaluation and could have included bivariate assessments after 36 months.'}, {'measure': 'Patient Survival at 12 Months', 'timeFrame': '12 months', 'description': 'Patient survival is defined as not dead within 12 months after skin closure.\n\nKaplan Meier analysis was used to estimate percentage of patients with event. Patients with no event by the time of the scheduled visit or whose first event was after premature discontinuation of randomized study drug or tacrolimus were censored on the scheduled day of assessment, on the day of premature treatment discontinuation or last evaluation day, whichever came first.'}, {'measure': 'Overall Patient Survival', 'timeFrame': 'End of Study (36 months)', 'description': 'Overall patient survival is defined as not dead at any time following skin closure. Data is reported as the percentage of patients with Overall Patient Survival.\n\nEnd of Study was defined as the last day of evaluation and could have included bivariate assessments after 36 months.'}, {'measure': 'Renal Function Abnormalities Based on Creatinine Clearance', 'timeFrame': '1 month and End of Study (36 months)', 'description': 'Increases in creatinine clearance usually indicates an improvement.\n\nChange in creatinine clearance from month 1 was calculated.\n\nChange from 1 month is calculated by month 36 - month 1.'}, {'measure': 'Renal Function Abnormalities Based on Serum Creatinine', 'timeFrame': '1 month and End of Study (36 months)', 'description': 'Decrease in serum creatinine usually indicates an improvement.\n\nChange in creatinine clearance from month 1 was calculated.\n\nChange from 1 month is calculated by month 36 - month 1.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Treatment Effectiveness', 'Treatment Efficacy', 'Anti-rejection therapy', 'Immunosuppression', 'Therapy, antirejection', 'Renal Transplantation', 'Transplantation, Kidney', 'Transplantation, Renal', 'Grafting, Kidney'], 'conditions': ['Kidney Transplantation']}, 'referencesModule': {'references': [{'pmid': '21591943', 'type': 'BACKGROUND', 'citation': 'Hanaway MJ, Woodle ES, Mulgaonkar S, Peddi VR, Kaufman DB, First MR, Croy R, Holman J; INTAC Study Group. Alemtuzumab induction in renal transplantation. N Engl J Med. 2011 May 19;364(20):1909-19. doi: 10.1056/NEJMoa1009546.'}], 'seeAlsoLinks': [{'url': 'http://www.astellas.us/docs/prograf.pdf', 'label': 'Link to Prescribing Information'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the safety and efficacy of different induction agents (alemtuzumab, basiliximab or rabbit anti-thymocyte globulin) in renal transplant recipients treated with tacrolimus, mycophenolate mofetil (MMF) and a rapid steroid withdrawal.', 'detailedDescription': 'A 2 arm (1 Active, 1 Active Control) study is to compare the safety and efficacy of different induction agents (alemtuzumab, basiliximab or rabbit anti-thymocyte globulin) in renal transplant recipients treated with tacrolimus, MMF and a rapid steroid withdrawal.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Recipient of a primary or re-transplanted deceased donor kidney or a primary or re-transplanted non-human leukocyte antigen (HLA) living donor kidney (ie., HLA identical or 0 antigen mismatch deceased donor kidneys are allowed).\n\nExclusion Criteria:\n\n* Patient has previously received an organ transplant other than a kidney\n* Patient receiving chronic steroid therapy at time of transplant'}, 'identificationModule': {'nctId': 'NCT00113269', 'acronym': 'INTAC', 'briefTitle': 'Safety/Efficacy of Induction Agents With Tacrolimus, MMF, and Rapid Steroid Withdrawal in Renal Transplant Recipients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': 'Phase 4, Randomized, Open-label, Comparative, Multicenter Study to Assess the Safety and Efficacy of Induction Agents, Alemtuzumab, Basiliximab or Rabbit Anti-thymocyte Globulin in Combination With Tacrolimus, MMF, and a Rapid Steroid Withdrawal in Renal Transplant Recipients', 'orgStudyIdInfo': {'id': '20-04-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Alemtuzumab High-Risk Patients', 'description': 'Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American', 'interventionNames': ['Drug: tacrolimus', 'Drug: alemtuzumab', 'Drug: mycophenolate mofetil', 'Drug: steroids']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional High-Risk Patients', 'description': 'Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American', 'interventionNames': ['Drug: rabbit anti-thymocyte globulin', 'Drug: tacrolimus', 'Drug: mycophenolate mofetil', 'Drug: steroids']}, {'type': 'EXPERIMENTAL', 'label': 'Alemtuzumab Low- Risk Patients', 'description': 'Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody \\< 20% and first transplant and non-African American', 'interventionNames': ['Drug: tacrolimus', 'Drug: alemtuzumab', 'Drug: mycophenolate mofetil', 'Drug: steroids']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional Low-Risk Patients', 'description': 'Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody \\< 20% and first transplant and non-African American', 'interventionNames': ['Drug: basiliximab', 'Drug: tacrolimus', 'Drug: mycophenolate mofetil', 'Drug: steroids']}], 'interventions': [{'name': 'basiliximab', 'type': 'DRUG', 'otherNames': ['simulect'], 'description': 'IV', 'armGroupLabels': ['Conventional Low-Risk Patients']}, {'name': 'rabbit anti-thymocyte globulin', 'type': 'DRUG', 'otherNames': ['Thymoglobulin'], 'description': 'IV', 'armGroupLabels': ['Conventional High-Risk Patients']}, {'name': 'tacrolimus', 'type': 'DRUG', 'otherNames': ['Prograf, FK506'], 'description': 'oral', 'armGroupLabels': ['Alemtuzumab High-Risk Patients', 'Alemtuzumab Low- Risk Patients', 'Conventional High-Risk Patients', 'Conventional Low-Risk Patients']}, {'name': 'alemtuzumab', 'type': 'DRUG', 'otherNames': ['campath'], 'description': 'Intravenous (IV)', 'armGroupLabels': ['Alemtuzumab High-Risk Patients', 'Alemtuzumab Low- Risk Patients']}, {'name': 'mycophenolate mofetil', 'type': 'DRUG', 'otherNames': ['MMF', 'CellCept'], 'description': 'oral', 'armGroupLabels': ['Alemtuzumab High-Risk Patients', 'Alemtuzumab Low- Risk Patients', 'Conventional High-Risk Patients', 'Conventional Low-Risk Patients']}, {'name': 'steroids', 'type': 'DRUG', 'description': 'IV and/or oral', 'armGroupLabels': ['Alemtuzumab High-Risk Patients', 'Alemtuzumab Low- Risk Patients', 'Conventional High-Risk Patients', 'Conventional Low-Risk Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '90057', 'city': 'Los Angeles', 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'geoPoint': {'lat': 40.96342, 'lon': -76.61273}}, {'zip': '17105', 'city': 'Harrisburg', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 40.2737, 'lon': -76.88442}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '84132', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'overallOfficials': [{'name': 'Central Contact', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Astellas Pharma Global Development'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Astellas Pharma Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Clinical Trial Registries', 'oldOrganization': 'Astellas Pharma Global Development'}}}}