Ignite Creation Date:
2025-12-24 @ 7:59 PM
Ignite Modification Date:
2026-01-02 @ 2:57 AM
Study NCT ID:
NCT00617604
Status:
COMPLETED
Last Update Posted:
2016-02-04
First Post:
2008-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Assess the Efficacy and Safety of Alefacept in Kidney Transplant Recipients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077944', 'term': 'Alefacept'}, {'id': 'D016559', 'term': 'Tacrolimus'}, {'id': 'D009173', 'term': 'Mycophenolic Acid'}, {'id': 'D013256', 'term': 'Steroids'}], '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': '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': 'Astellas.resultsdisclosure@astellas.com', 'title': 'Senior Director Medical Science', 'organization': 'Astellas Pharma Europe B.V'}, '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 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 temporarily to seek patent protection.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '6 months', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.', 'otherNumAtRisk': 107, 'otherNumAffected': 98, 'seriousNumAtRisk': 107, 'seriousNumAffected': 62}, {'id': 'EG001', 'title': 'Alefacept', 'description': 'Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.', 'otherNumAtRisk': 105, 'otherNumAffected': 92, 'seriousNumAtRisk': 105, 'seriousNumAffected': 57}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 54}, {'groupId': 'EG001', 'numAtRisk': 105, 'numAffected': 42}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 105, 'numAffected': 14}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 105, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 105, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 105, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 105, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 105, 'numAffected': 19}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 105, 'numAffected': 25}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 105, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 105, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 105, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 105, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 105, 'numAffected': 26}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Complications of transplanted kidney', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 105, 'numAffected': 10}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 105, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 105, 'numAffected': 10}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 105, 'numAffected': 13}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hypercholesterolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 105, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 105, 'numAffected': 17}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 105, 'numAffected': 10}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hyperlipidaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 105, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hyperuricaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 105, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 105, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 105, 'numAffected': 15}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 105, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hypophosphataemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 105, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 105, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 105, 'numAffected': 16}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 105, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 105, 'numAffected': 11}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 105, 'numAffected': 4}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Renal impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 105, 'numAffected': 9}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 105, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 105, 'numAffected': 25}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Lymphocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 105, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}], 'seriousEvents': [{'term': 'Cytomegalovirus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 105, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 105, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Bk virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 105, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 105, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pyelonephritis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 105, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 105, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Cytomegalovirus viraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 105, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 105, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Epstein-barr virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 105, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 105, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Orchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 105, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Renal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 105, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Wound abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 105, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 105, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Polyomavirus-associated nephropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 105, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 105, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Arteriovenous fistula site infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 105, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Erythema infectiosum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 105, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Kidney infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 105, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Mastitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 105, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 105, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pneumonia bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 105, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Renal cyst infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 105, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 105, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 105, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 105, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Renal impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 105, 'numAffected': 4}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 105, 'numAffected': 4}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hydronephrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 105, 'numAffected': 4}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Renal artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 105, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Renal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 105, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Renal tubular necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 105, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Ureteric stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 105, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Microalbuminuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 105, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Nephropathy toxic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 105, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 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'EG001', 'numAtRisk': 105, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 105, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 105, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Acute pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 105, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pleurisy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 105, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Reversible posterior leukoencephalopathy syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 105, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Epididymitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 105, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Prostatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 105, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 105, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Mental disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 105, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Tooth extraction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 105, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Biopsy-confirmed Acute T-cell Mediated Rejection at Month 6 Assessed by Local Review', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.'}, {'id': 'OG001', 'title': 'Alefacept', 'description': 'Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000', 'lowerLimit': '2.7', 'upperLimit': '10.7'}, {'value': '10.6', 'groupId': 'OG001', 'lowerLimit': '5.6', 'upperLimit': '15.6'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '3.9', 'ciLowerLimit': '-2.5', 'ciUpperLimit': '10.3', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Biopsies were graded by the clinical site pathologist.according to the Banff 97/05 updated histological classification:\n\n* Grade IA: significant interstitial infiltration (\\>25% parenchyma affected) and foci of moderate tubulitis;\n* Grade IB: significant interstitial infiltration (\\>25% parenchyma affected) and foci of severe tubulitis;\n* Grade IIA: mild to moderate intimal arteritis;\n* Grade IIB: severe intimal arteritis comprising \\>25% of the luminal area;\n* Grade III: "transmural" arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocyte inflammation.\n\nA biopsy confirmed acute rejection was an event of suspected acute rejection confirmed by a graft biopsy result of Banff grade ≥ 1.\n\nThe Kaplan-Meier estimate of biopsy-confirmed acute T-cell mediated rejection within the first 6 months following transplantation is reported. Participants lost to follow-up or 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 (all randomized and transplanted participants who received at least 1 dose of study drug)'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Biopsy Confirmed Antibody-Mediated Acute Rejection at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.'}, {'id': 'OG001', 'title': 'Alefacept', 'description': 'Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.9', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '5.5'}, {'value': '3.8', 'groupId': 'OG001', 'lowerLimit': '0.7', 'upperLimit': '6.9'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.0', 'ciLowerLimit': '-3.1', 'ciUpperLimit': '5.0', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': "Biopsies were graded by the clinical site pathologist.according to the Banff 97/05 updated histological classification:\n\nAcute antibody-mediated rejection - documented anti-donor antibody ('suspicious for' if antibody not demonstrated):\n\n* Grade I: acute tubular necrosis-like - complement split product positive (C4d+), minimal inflammation;\n* Grade II: capillary-margination and/or thromboses, C4d+\n* Grade III: arterial - v3, C4d+.\n\nA biopsy confirmed acute rejection was an event of suspected acute rejection confirmed by a graft biopsy result of Banff grade ≥ 1.\n\nThe Kaplan-Meier estimate of biopsy-confirmed antibody-mediated acute rejection within the first 6 months following transplantation is reported. Participants lost to follow-up or 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 Biopsy Confirmed Acute Rejection (T-Cell Mediated or Antibody Mediated) at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.'}, {'id': 'OG001', 'title': 'Alefacept', 'description': 'Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.3', 'groupId': 'OG000', 'lowerLimit': '4.7', 'upperLimit': '14.0'}, {'value': '12.4', 'groupId': 'OG001', 'lowerLimit': '7.1', 'upperLimit': '17.7'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '3.0', 'ciLowerLimit': '-4.0', 'ciUpperLimit': '10.1', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Biopsies were graded by the clinical site pathologist.according to the Banff 97/05 updated histological classification. A biopsy confirmed acute rejection was an event of suspected acute rejection confirmed by a graft biopsy result of Banff grade ≥ 1.\n\nThe Kaplan-Meier estimate of biopsy-confirmed acute T-cell mediated or antibody-mediated rejection within the first 6 months following transplantation is reported. Participants lost to follow-up or 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 Biopsy Confirmed Acute Mixed T-Cell Mediated and Antibody-Mediated Rejection at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.'}, {'id': 'OG001', 'title': 'Alefacept', 'description': 'Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.0'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '2.5'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.0', 'ciLowerLimit': '-0.6', 'ciUpperLimit': '2.5', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Biopsies were graded by the clinical site pathologist.according to the Banff 97/05 updated histological classification. A biopsy confirmed acute rejection was an event of suspected acute rejection confirmed by a graft biopsy result of Banff grade ≥ 1.\n\nThe Kaplan-Meier estimate of biopsy-confirmed acute mixed T-cell mediated and antibody-mediated rejections within the first 6 months following transplantation is reported. Participants lost to follow-up or 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 Acute Rejection Diagnosed by Signs and Symptoms at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.'}, {'id': 'OG001', 'title': 'Alefacept', 'description': 'Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '27.4', 'groupId': 'OG000', 'lowerLimit': '20.3', 'upperLimit': '34.6'}, {'value': '22.3', 'groupId': 'OG001', 'lowerLimit': '15.6', 'upperLimit': '29.1'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-5.1', 'ciLowerLimit': '-14.9', 'ciUpperLimit': '4.7', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Acute rejection diagnosed by signs and symptoms, including biopsy-confirmed or suspected (not confirmed by biopsy - i.e. no biopsy was performed or biopsy did not confirm an acute T-cell mediated rejection). The Kaplan-Meier estimate of acute rejection diagnosed by signs and symptoms within the first 6 months following transplantation is reported. Participants lost to follow-up or 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 Clinically Treated Acute Rejection at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.'}, {'id': 'OG001', 'title': 'Alefacept', 'description': 'Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '24.8', 'groupId': 'OG000', 'lowerLimit': '17.9', 'upperLimit': '31.7'}, {'value': '15.4', 'groupId': 'OG001', 'lowerLimit': '9.6', 'upperLimit': '21.2'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-9.4', 'ciLowerLimit': '-18.5', 'ciUpperLimit': '0.0', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Patients who received immunosuppressive medications for the treatment of suspected or biopsy-confirmed acute rejections were considered to have a clinically-treated acute rejection. The Kaplan-Meier estimate of clinically treated acute rejection within the first 6 months following transplantation is reported. Participants lost to follow-up or 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 Steroid-resistant Acute Rejection at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.'}, {'id': 'OG001', 'title': 'Alefacept', 'description': 'Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.6', 'groupId': 'OG000', 'lowerLimit': '3.4', 'upperLimit': '11.9'}, {'value': '5.7', 'groupId': 'OG001', 'lowerLimit': '2.0', 'upperLimit': '9.5'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-1.9', 'ciLowerLimit': '-7.6', 'ciUpperLimit': '3.8', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'A steroid-resistant acute rejection is defined as a rejection episode which did not resolve following treatment with corticosteroids. In the case that a rejection episode was not treated with corticosteroids first but only with antibodies, it was included in this category.\n\nThe Kaplan-Meier estimate of steroid-resistant acute rejection within the first 6 months following transplantation is reported. Participants lost to follow-up or 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 Biopsy-Confirmed Acute T-cell Mediated Rejection as Assessed by Central Review at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.'}, {'id': 'OG001', 'title': 'Alefacept', 'description': 'Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.6', 'groupId': 'OG000', 'lowerLimit': '4.8', 'upperLimit': '14.3'}, {'value': '7.7', 'groupId': 'OG001', 'lowerLimit': '3.4', 'upperLimit': '12.0'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-1.8', 'ciLowerLimit': '-8.2', 'ciUpperLimit': '4.6', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Biopsies were graded by the central reviewer according to the Banff 97/05 updated histological classification. A biopsy confirmed acute rejection was an event of suspected acute rejection confirmed by a graft biopsy result of Banff grade ≥ 1.\n\nThe Kaplan-Meier estimate of biopsy-confirmed acute T-cell mediated rejection within the first 6 months following transplantation is reported. Participants lost to follow-up or 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', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.'}, {'id': 'OG001', 'title': 'Alefacept', 'description': 'Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '97.1', 'groupId': 'OG000', 'lowerLimit': '94.4', 'upperLimit': '99.8'}, {'value': '99.0', 'groupId': 'OG001', 'lowerLimit': '97.3', 'upperLimit': '100.0'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.9', 'ciLowerLimit': '-1.3', 'ciUpperLimit': '5.0', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Patient survival is any participant known to be alive at Month 6. The Kaplan-Meier estimate of patient survival within the first 6 months following transplantation is reported. Participants lost to follow-up were censored at the time of last assessment.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': 'Graft Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.'}, {'id': 'OG001', 'title': 'Alefacept', 'description': 'Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '90.6', 'groupId': 'OG000', 'lowerLimit': '86.0', 'upperLimit': '95.3'}, {'value': '95.2', 'groupId': 'OG001', 'lowerLimit': '91.7', 'upperLimit': '98.6'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '4.6', 'ciLowerLimit': '-1.2', 'ciUpperLimit': '10.4', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '6 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. Graft loss is defined as re-transplantation, nephrectomy, death or as dialysis ongoing at end of study or at discontinuation of the participant unless superseded by follow-up information.\n\nThe Kaplan-Meier estimate of graft survival within the first 6 months following transplantation is reported. Participants lost to follow-up were censored at the time of last assessment.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': 'Maximum Histological Grade of All Biopsies After Local Review', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.'}, {'id': 'OG001', 'title': 'Alefacept', 'description': 'Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.'}], 'classes': [{'title': 'T-Cell Mediated Rejection - No Event', 'categories': [{'measurements': [{'value': '93.5', 'groupId': 'OG000'}, {'value': '89.5', 'groupId': 'OG001'}]}]}, {'title': 'T-Cell Mediated Rejection - Grade IA', 'categories': [{'measurements': [{'value': '2.8', 'groupId': 'OG000'}, {'value': '1.9', 'groupId': 'OG001'}]}]}, {'title': 'T-Cell Mediated Rejection - Grade IB', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.0', 'groupId': 'OG001'}]}]}, {'title': 'T-Cell Mediated Rejection - Grade IIA', 'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000'}, {'value': '4.8', 'groupId': 'OG001'}]}]}, {'title': 'T-Cell Mediated Rejection - Grade IIB', 'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000'}, {'value': '2.9', 'groupId': 'OG001'}]}]}, {'title': 'T-Cell Mediated Rejection - Grade III', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Antibody Mediated Rejection - No Event', 'categories': [{'measurements': [{'value': '97.2', 'groupId': 'OG000'}, {'value': '96.2', 'groupId': 'OG001'}]}]}, {'title': 'Antibody Mediated Rejection - Grade I', 'categories': [{'measurements': [{'value': '2.8', 'groupId': 'OG000'}, {'value': '1.9', 'groupId': 'OG001'}]}]}, {'title': 'Antibody Mediated Rejection - Grade II', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.9', 'groupId': 'OG001'}]}]}, {'title': 'Antibody Mediated Rejection - Grade III', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'The grade of acute rejection was classified according to Banff 97/05 updated version. If a patient had more than 1 rejection episode, the episode with the most severe grade was used.\n\nAcute T-cell mediated rejection:\n\n* Grade IA: significant interstitial infiltration (\\>25% parenchyma affected) and foci of moderate tubulitis;\n* Grade IB: significant interstitial infiltration (\\>25% parenchyma affected) and foci of severe tubulitis;\n* Grade IIA: mild to moderate intimal arteritis;\n* Grade IIB: severe intimal arteritis comprising \\>25% of the luminal area;\n* Grade III: "transmural" arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocyte inflammation.\n\nAcute antibody-mediated rejection:\n\n* Grade I: acute tubular necrosis-like - complement split product positive (C4d+), minimal inflammation;\n* Grade II: capillary-margination and/or thromboses, C4d+\n* Grade III: arterial - v3, C4d+.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Anti-Lymphocyte Antibody Therapy for Treatment of Rejection at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.'}, {'id': 'OG001', 'title': 'Alefacept', 'description': 'Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.7', 'groupId': 'OG000', 'lowerLimit': '1.3', 'upperLimit': '8.2'}, {'value': '6.7', 'groupId': 'OG001', 'lowerLimit': '2.7', 'upperLimit': '10.7'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '2.0', 'ciLowerLimit': '-3.3', 'ciUpperLimit': '7.2', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'The Kaplan-Meier estimate of anti-lymphocyte antibody therapy for acute rejection (clinically-treated or biopsy-confirmed) within the first 6 months following transplantation is reported. Participants lost to follow-up or 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 Month 1 in Serum Creatinine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.'}, {'id': 'OG001', 'title': 'Alefacept', 'description': 'Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.'}], 'classes': [{'title': 'Change From Month 1 to Month 3 (n=94, 88)', 'categories': [{'measurements': [{'value': '-5.0125', 'spread': '37.97017', 'groupId': 'OG000'}, {'value': '-5.0830', 'spread': '66.25416', 'groupId': 'OG001'}]}]}, {'title': 'Change From Month 1 to Month 6 (n=86, 81)', 'categories': [{'measurements': [{'value': '-6.1777', 'spread': '41.57056', 'groupId': 'OG000'}, {'value': '-11.7212', 'spread': '76.19852', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 1, 3, and 6', 'unitOfMeasure': 'µmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set participants with available data at Month 1 (99 and 94 participants in each treatment group respectively) and at Month 3 and Month 6 (indicated by "n").'}, {'type': 'SECONDARY', 'title': 'Change From Month 1 in Glomerular Filtration Rate (GFR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.'}, {'id': 'OG001', 'title': 'Alefacept', 'description': 'Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.'}], 'classes': [{'title': 'Change From Month 1 to Month 3 (n=93, 87)', 'categories': [{'measurements': [{'value': '3.1548', 'spread': '13.59730', 'groupId': 'OG000'}, {'value': '0.2889', 'spread': '12.54716', 'groupId': 'OG001'}]}]}, {'title': 'Change From Month 1 to Month 6 (n=83, 78)', 'categories': [{'measurements': [{'value': '2.4275', 'spread': '15.79533', 'groupId': 'OG000'}, {'value': '2.5444', 'spread': '13.06726', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 1, 3, and 6', 'description': 'The GFR was calculated using the Modification of Diet in Renal Disease (MDRD) formula.', 'unitOfMeasure': 'mL/min/1.73 m²', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set participants with available data at Month 1 (98, 93 participants respectively) and at Month 3 and Month 6 (indicated by "n").'}, {'type': 'SECONDARY', 'title': 'Change From Month 1 in Creatinine Clearance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.'}, {'id': 'OG001', 'title': 'Alefacept', 'description': 'Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.'}], 'classes': [{'title': 'Change From Month 1 to Month 3 (n=81, 79)', 'categories': [{'measurements': [{'value': '3.0336', 'spread': '13.97651', 'groupId': 'OG000'}, {'value': '-0.5849', 'spread': '12.95160', 'groupId': 'OG001'}]}]}, {'title': 'Change From Month 1 to Month 6 (n=77, 73)', 'categories': [{'measurements': [{'value': '4.5388', 'spread': '17.56456', 'groupId': 'OG000'}, {'value': '3.0227', 'spread': '13.25005', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 1, 3, and 6', 'description': 'The creatinine clearance was calculated according to the Cockcroft-Gault formula.', 'unitOfMeasure': 'mL/minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set participants with available data at Month 1 (90, 84) and at Month 3 and Month 6 (indicated by "n").'}, {'type': 'SECONDARY', 'title': 'GFR Measured by Iothalamate Clearance at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.'}, {'id': 'OG001', 'title': 'Alefacept', 'description': 'Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '59.6029', 'spread': '31.36836', 'groupId': 'OG000'}, {'value': '55.1613', 'spread': '26.46383', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 6', 'description': 'GFR measured using the iothalamate clearance method and determined by a central laboratory.', 'unitOfMeasure': 'mL/minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set participants with available data'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Efficacy Failure at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.'}, {'id': 'OG001', 'title': 'Alefacept', 'description': 'Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.0', 'groupId': 'OG000', 'lowerLimit': '9.3', 'upperLimit': '20.6'}, {'value': '21.0', 'groupId': 'OG001', 'lowerLimit': '14.4', 'upperLimit': '27.5'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '6.0', 'ciLowerLimit': '-2.7', 'ciUpperLimit': '14.6', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Efficacy failure is defined as death, graft loss, biopsy-confirmed acute T-cell mediated rejection assessed by local reading or lost to follow-up.\n\nThe Kaplan-Meier estimate of efficacy failure within the first 6 months following transplantation is reported.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Delayed Graft Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.'}, {'id': 'OG001', 'title': 'Alefacept', 'description': 'Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.1', 'groupId': 'OG000'}, {'value': '7.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-4.5', 'ciLowerLimit': '-11.2', 'ciUpperLimit': '2.2', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '1 week', 'description': 'Delayed graft function was defined as the requirement for dialysis within the first week post-transplant.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Treatment Failure at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.'}, {'id': 'OG001', 'title': 'Alefacept', 'description': 'Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '20.6', 'groupId': 'OG000', 'lowerLimit': '14.1', 'upperLimit': '27.0'}, {'value': '25.7', 'groupId': 'OG001', 'lowerLimit': '18.7', 'upperLimit': '32.7'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '5.2', 'ciLowerLimit': '-4.4', 'ciUpperLimit': '14.7', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Treatment failure is defined as efficacy failure (death, graft loss, biopsy-confirmed acute T-cell mediated rejection assessed by local reading, lost to follow-up) or early discontinuation of alefacept/placebo at any time (during the 12-week administration period) for any reason. The Kaplan-Meier estimate of treatment failure within the first 6 months following transplantation is reported. Participants lost to follow-up or 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': 'Number of Participants With Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.'}, {'id': 'OG001', 'title': 'Alefacept', 'description': 'Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.'}], 'classes': [{'title': 'Any adverse event', 'categories': [{'measurements': [{'value': '102', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}]}, {'title': 'AE causally related to alefacept/placebo', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}]}, {'title': 'AE causally related to MMF', 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}]}, {'title': 'AE causally related to tacrolimus', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}]}, {'title': 'AE causally related to steroids', 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}]}, {'title': 'Serious adverse events', 'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}]}, {'title': 'SAE causally related to alefacept/placebo', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'SAE causally related to MMF', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'SAE causally related to tacrolimus', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'SAE causally related to steroids', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'AE leading to discontinuation of alefacept/placebo', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'AE leading to discontinuation of MMF', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'AE leading to discontinuation of tacrolimus', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'AE leading to discontinuation of steroids', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Deaths', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 Months', 'description': 'Causally related was defined as adverse events (AEs) assessed by the Investigator as possibly or probably related to study drug or records where the relationship was missing.\n\nA serious adverse event (SAE) was any untoward medical occurrence that, at any dose:\n\n* Resulted in death.\n* Was life-threatening.\n* Resulted in persistent or significant disability/incapacity.\n* Resulted in congenital anomaly or birth defect.\n* Required patient hospitalization or led to prolongation of hospitalization\n* Was considered a medically important event.\n\nAll rejections and any BK virus, Epstein Barr virus and/or cytomegalovirus infection had to be reported as an SAE', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set (all randomized participants who received at least one dose of study drug).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.'}, {'id': 'FG001', 'title': 'Alefacept', 'description': 'Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '110'}, {'groupId': 'FG001', 'numSubjects': '108'}]}, {'type': 'Received Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '107'}, {'groupId': 'FG001', 'numSubjects': '105'}]}, {'type': 'Completed 12 Weeks of Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '89'}, {'groupId': 'FG001', 'numSubjects': '83'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Completed Month 6 assessment', 'groupId': 'FG000', 'numSubjects': '92'}, {'comment': 'Completed Month 6 assessment', 'groupId': 'FG001', 'numSubjects': '88'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '20'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Miscellaneous Reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Randomized but Never Received Study Drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'Of 221 patients screened, 218 patients were enrolled into the study at 30 centers across 12 countries.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'BG000'}, {'value': '105', 'groupId': 'BG001'}, {'value': '212', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.'}, {'id': 'BG001', 'title': 'Alefacept', 'description': 'Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '46.5', 'spread': '11.3', 'groupId': 'BG000'}, {'value': '44.2', 'spread': '11.9', 'groupId': 'BG001'}, {'value': '45.4', 'spread': '11.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All randomized patients who took at least 1 dose of study drug (Safety Analysis Set).'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 218}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'dispFirstSubmitDate': '2010-09-29', 'completionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-05', 'studyFirstSubmitDate': '2008-02-06', 'dispFirstSubmitQcDate': '2010-09-29', 'resultsFirstSubmitDate': '2016-01-05', 'studyFirstSubmitQcDate': '2008-02-06', 'dispFirstPostDateStruct': {'date': '2010-10-01', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2016-02-04', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-01-05', 'studyFirstPostDateStruct': {'date': '2008-02-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-02-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Biopsy-confirmed Acute T-cell Mediated Rejection at Month 6 Assessed by Local Review', 'timeFrame': '6 months', 'description': 'Biopsies were graded by the clinical site pathologist.according to the Banff 97/05 updated histological classification:\n\n* Grade IA: significant interstitial infiltration (\\>25% parenchyma affected) and foci of moderate tubulitis;\n* Grade IB: significant interstitial infiltration (\\>25% parenchyma affected) and foci of severe tubulitis;\n* Grade IIA: mild to moderate intimal arteritis;\n* Grade IIB: severe intimal arteritis comprising \\>25% of the luminal area;\n* Grade III: "transmural" arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocyte inflammation.\n\nA biopsy confirmed acute rejection was an event of suspected acute rejection confirmed by a graft biopsy result of Banff grade ≥ 1.\n\nThe Kaplan-Meier estimate of biopsy-confirmed acute T-cell mediated rejection within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow up visit.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Biopsy Confirmed Antibody-Mediated Acute Rejection at Month 6', 'timeFrame': '6 months', 'description': "Biopsies were graded by the clinical site pathologist.according to the Banff 97/05 updated histological classification:\n\nAcute antibody-mediated rejection - documented anti-donor antibody ('suspicious for' if antibody not demonstrated):\n\n* Grade I: acute tubular necrosis-like - complement split product positive (C4d+), minimal inflammation;\n* Grade II: capillary-margination and/or thromboses, C4d+\n* Grade III: arterial - v3, C4d+.\n\nA biopsy confirmed acute rejection was an event of suspected acute rejection confirmed by a graft biopsy result of Banff grade ≥ 1.\n\nThe Kaplan-Meier estimate of biopsy-confirmed antibody-mediated acute rejection within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow up visit."}, {'measure': 'Percentage of Participants With Biopsy Confirmed Acute Rejection (T-Cell Mediated or Antibody Mediated) at Month 6', 'timeFrame': '6 months', 'description': 'Biopsies were graded by the clinical site pathologist.according to the Banff 97/05 updated histological classification. A biopsy confirmed acute rejection was an event of suspected acute rejection confirmed by a graft biopsy result of Banff grade ≥ 1.\n\nThe Kaplan-Meier estimate of biopsy-confirmed acute T-cell mediated or antibody-mediated rejection within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow up visit.'}, {'measure': 'Percentage of Participants With Biopsy Confirmed Acute Mixed T-Cell Mediated and Antibody-Mediated Rejection at Month 6', 'timeFrame': '6 months', 'description': 'Biopsies were graded by the clinical site pathologist.according to the Banff 97/05 updated histological classification. A biopsy confirmed acute rejection was an event of suspected acute rejection confirmed by a graft biopsy result of Banff grade ≥ 1.\n\nThe Kaplan-Meier estimate of biopsy-confirmed acute mixed T-cell mediated and antibody-mediated rejections within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow up visit.'}, {'measure': 'Percentage of Participants With Acute Rejection Diagnosed by Signs and Symptoms at Month 6', 'timeFrame': '6 months', 'description': 'Acute rejection diagnosed by signs and symptoms, including biopsy-confirmed or suspected (not confirmed by biopsy - i.e. no biopsy was performed or biopsy did not confirm an acute T-cell mediated rejection). The Kaplan-Meier estimate of acute rejection diagnosed by signs and symptoms within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow up visit.'}, {'measure': 'Percentage of Participants With Clinically Treated Acute Rejection at Month 6', 'timeFrame': '6 months', 'description': 'Patients who received immunosuppressive medications for the treatment of suspected or biopsy-confirmed acute rejections were considered to have a clinically-treated acute rejection. The Kaplan-Meier estimate of clinically treated acute rejection within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow-up visit.'}, {'measure': 'Percentage of Participants With Steroid-resistant Acute Rejection at Month 6', 'timeFrame': '6 months', 'description': 'A steroid-resistant acute rejection is defined as a rejection episode which did not resolve following treatment with corticosteroids. In the case that a rejection episode was not treated with corticosteroids first but only with antibodies, it was included in this category.\n\nThe Kaplan-Meier estimate of steroid-resistant acute rejection within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow up visit.'}, {'measure': 'Percentage of Participants With Biopsy-Confirmed Acute T-cell Mediated Rejection as Assessed by Central Review at Month 6', 'timeFrame': '6 months', 'description': 'Biopsies were graded by the central reviewer according to the Banff 97/05 updated histological classification. A biopsy confirmed acute rejection was an event of suspected acute rejection confirmed by a graft biopsy result of Banff grade ≥ 1.\n\nThe Kaplan-Meier estimate of biopsy-confirmed acute T-cell mediated rejection within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow up visit.'}, {'measure': 'Patient Survival', 'timeFrame': '6 months', 'description': 'Patient survival is any participant known to be alive at Month 6. The Kaplan-Meier estimate of patient survival within the first 6 months following transplantation is reported. Participants lost to follow-up were censored at the time of last assessment.'}, {'measure': 'Graft Survival', 'timeFrame': '6 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. Graft loss is defined as re-transplantation, nephrectomy, death or as dialysis ongoing at end of study or at discontinuation of the participant unless superseded by follow-up information.\n\nThe Kaplan-Meier estimate of graft survival within the first 6 months following transplantation is reported. Participants lost to follow-up were censored at the time of last assessment.'}, {'measure': 'Maximum Histological Grade of All Biopsies After Local Review', 'timeFrame': '6 months', 'description': 'The grade of acute rejection was classified according to Banff 97/05 updated version. If a patient had more than 1 rejection episode, the episode with the most severe grade was used.\n\nAcute T-cell mediated rejection:\n\n* Grade IA: significant interstitial infiltration (\\>25% parenchyma affected) and foci of moderate tubulitis;\n* Grade IB: significant interstitial infiltration (\\>25% parenchyma affected) and foci of severe tubulitis;\n* Grade IIA: mild to moderate intimal arteritis;\n* Grade IIB: severe intimal arteritis comprising \\>25% of the luminal area;\n* Grade III: "transmural" arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocyte inflammation.\n\nAcute antibody-mediated rejection:\n\n* Grade I: acute tubular necrosis-like - complement split product positive (C4d+), minimal inflammation;\n* Grade II: capillary-margination and/or thromboses, C4d+\n* Grade III: arterial - v3, C4d+.'}, {'measure': 'Percentage of Participants With Anti-Lymphocyte Antibody Therapy for Treatment of Rejection at Month 6', 'timeFrame': '6 months', 'description': 'The Kaplan-Meier estimate of anti-lymphocyte antibody therapy for acute rejection (clinically-treated or biopsy-confirmed) within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow-up visit.'}, {'measure': 'Change From Month 1 in Serum Creatinine', 'timeFrame': 'Month 1, 3, and 6'}, {'measure': 'Change From Month 1 in Glomerular Filtration Rate (GFR)', 'timeFrame': 'Month 1, 3, and 6', 'description': 'The GFR was calculated using the Modification of Diet in Renal Disease (MDRD) formula.'}, {'measure': 'Change From Month 1 in Creatinine Clearance', 'timeFrame': 'Month 1, 3, and 6', 'description': 'The creatinine clearance was calculated according to the Cockcroft-Gault formula.'}, {'measure': 'GFR Measured by Iothalamate Clearance at Month 6', 'timeFrame': 'Month 6', 'description': 'GFR measured using the iothalamate clearance method and determined by a central laboratory.'}, {'measure': 'Percentage of Participants With Efficacy Failure at Month 6', 'timeFrame': '6 months', 'description': 'Efficacy failure is defined as death, graft loss, biopsy-confirmed acute T-cell mediated rejection assessed by local reading or lost to follow-up.\n\nThe Kaplan-Meier estimate of efficacy failure within the first 6 months following transplantation is reported.'}, {'measure': 'Percentage of Participants With Delayed Graft Function', 'timeFrame': '1 week', 'description': 'Delayed graft function was defined as the requirement for dialysis within the first week post-transplant.'}, {'measure': 'Percentage of Participants With Treatment Failure at Month 6', 'timeFrame': '6 months', 'description': 'Treatment failure is defined as efficacy failure (death, graft loss, biopsy-confirmed acute T-cell mediated rejection assessed by local reading, lost to follow-up) or early discontinuation of alefacept/placebo at any time (during the 12-week administration period) for any reason. The Kaplan-Meier estimate of treatment failure within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow-up visit.'}, {'measure': 'Number of Participants With Adverse Events', 'timeFrame': '6 Months', 'description': 'Causally related was defined as adverse events (AEs) assessed by the Investigator as possibly or probably related to study drug or records where the relationship was missing.\n\nA serious adverse event (SAE) was any untoward medical occurrence that, at any dose:\n\n* Resulted in death.\n* Was life-threatening.\n* Resulted in persistent or significant disability/incapacity.\n* Resulted in congenital anomaly or birth defect.\n* Required patient hospitalization or led to prolongation of hospitalization\n* Was considered a medically important event.\n\nAll rejections and any BK virus, Epstein Barr virus and/or cytomegalovirus infection had to be reported as an SAE'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['kidney transplant', 'alefacept'], 'conditions': ['De Novo Kidney Transplantation']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether alefacept is effective and well tolerated when used with a combination of tacrolimus, mycophenolate mofetil and steroids versus a combination therapy of placebo, tacrolimus and steroids in the prevention of kidney transplant rejection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject with end stage kidney disease who is a suitable candidate for primary kidney transplantation or retransplantation\n* Male or female subject at least 18 years of age and younger than 65 years\n* Subject receiving a kidney transplant from a non-human leucocyte antigen (HLA) identical living donor or deceased HLA identical/non-HLA identical donor between 5 and 59 years of age with compatible ABO blood type (Blood group system A, B, AB and 0)\n\nExclusion Criteria:\n\n* Subject has a panel reactivity antibody grade \\> 20% in the previous 6 months and/or had had a previous graft survival shorter than 1 year due to immunological reasons\n* Subject received a kidney transplant from a non-heart beating donor\n* Subject has received a kidney transplant from a 50 - 59 year old donor with two of the following three factors: history of hypertension, cerebrovascular accident as cause of death, final pre-procurement serum creatinine \\> 1.5 mg/dL (united network for organ sharing \\[UNOS\\] expanded criteria donor)\n* Cold ischemia time of the donor kidney is ≥ 30 hours'}, 'identificationModule': {'nctId': 'NCT00617604', 'briefTitle': 'A Study to Assess the Efficacy and Safety of Alefacept in Kidney Transplant Recipients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': 'Efficacy and Safety of Alefacept in Combination With Tacrolimus, Mycophenolate Mofetil and Steroids in de Novo Kidney Transplantation - a Multicenter, Randomized, Double-Blind, Placebo Controlled, Parallel Group Study', 'orgStudyIdInfo': {'id': '0485-CL-E201'}, 'secondaryIdInfos': [{'id': '2007-002092-14', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.', 'interventionNames': ['Drug: placebo', 'Drug: Tacrolimus', 'Drug: Mycophenolate Mofetil', 'Drug: Steroids']}, {'type': 'EXPERIMENTAL', 'label': 'Alefacept', 'description': 'Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.', 'interventionNames': ['Drug: Alefacept', 'Drug: Tacrolimus', 'Drug: Mycophenolate Mofetil', 'Drug: Steroids']}], 'interventions': [{'name': 'Alefacept', 'type': 'DRUG', 'otherNames': ['Amevive'], 'description': 'IV and subcutaneous injection', 'armGroupLabels': ['Alefacept']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'IV and subcutaneous injection', 'armGroupLabels': ['Placebo']}, {'name': 'Tacrolimus', 'type': 'DRUG', 'description': 'The initial daily dose was 0.2 mg/kg orally given in 2 doses commencing 24 hours after completion of surgery.', 'armGroupLabels': ['Alefacept', 'Placebo']}, {'name': 'Mycophenolate Mofetil', 'type': 'DRUG', 'description': 'Mycophenolic mofetil was administered as 750 mg twice per day orally', 'armGroupLabels': ['Alefacept', 'Placebo']}, {'name': 'Steroids', 'type': 'DRUG', 'description': 'Methylprednisolone or equivalent:\n\nDay 0: 500 - 1000 mg IV bolus Day 1: 125 - 250 mg IV bolus\n\nPrednisone or equivalent:\n\nDays 2 - 14: 20 - 30 mg orally Days 15 - 28: 10 - 20 mg orally Days 29 - 60: 10 - 15 mg orally Days 61 onwards: 5 - 10 mg orally', 'armGroupLabels': ['Alefacept', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'country': 'Austria', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '1070', 'city': 'Brussels', 'country': 'Belgium', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '1200', 'city': 'Brussels', 'country': 'Belgium', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '4000', 'city': 'Liège', 'country': 'Belgium', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'zip': '140 21', 'city': 'Prague', 'country': 'Czechia', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '94010', 'city': 'Créteil', 'country': 'France', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'zip': '94275', 'city': 'Le Kremlin-Bicêtre', 'country': 'France', 'geoPoint': {'lat': 48.81471, 'lon': 2.36073}}, {'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '44093', 'city': 'Nantes', 'country': 'France', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '6002', 'city': 'Nice', 'country': 'France', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '75475', 'city': 'Paris', 'country': 'France', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '31054', 'city': 'Toulouse', 'country': 'France', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '44892', 'city': 'Bochum', 'country': 'Germany', 'geoPoint': {'lat': 51.48165, 'lon': 7.21648}}, {'zip': '93053', 'city': 'Regensburg', 'country': 'Germany', 'geoPoint': {'lat': 49.01513, 'lon': 12.10161}}, {'zip': '1082', 'city': 'Budapest', 'country': 'Hungary', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '40138', 'city': 'Bologna', 'country': 'Italy', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'zip': '35128', 'city': 'Padua', 'country': 'Italy', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}, {'zip': '00168', 'city': 'Rome', 'country': 'Italy', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'zip': '53100', 'city': 'Siena', 'country': 'Italy', 'geoPoint': {'lat': 43.31822, 'lon': 11.33064}}, {'zip': '6229', 'city': 'Maastricht', 'country': 'Netherlands', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}, {'zip': '85-094', 'city': 'Bydgoszcz', 'country': 'Poland', 'geoPoint': {'lat': 53.1235, 'lon': 18.00762}}, {'zip': '60-479', 'city': 'Poznan', 'country': 'Poland', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'zip': '70-111', 'city': 'Szczecin', 'country': 'Poland', 'geoPoint': {'lat': 53.42894, 'lon': 14.55302}}, {'zip': '8036', 'city': 'Barcelona', 'country': 'Spain', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '8907', 'city': 'Llobregat', 'country': 'Spain'}, {'zip': '28041', 'city': 'Madrid', 'country': 'Spain', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '29010', 'city': 'Málaga', 'country': 'Spain', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'zip': '39008', 'city': 'Santander', 'country': 'Spain', 'geoPoint': {'lat': 43.46589, 'lon': -3.80493}}, {'zip': '41345', 'city': 'Gothenburg', 'country': 'Sweden', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}, {'zip': '75185', 'city': 'Uppsala', 'country': 'Sweden', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}, {'zip': 'M13 9WL', 'city': 'Manchester', 'country': 'United Kingdom', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}], 'overallOfficials': [{'name': 'Central Contact', 'role': 'STUDY_CHAIR', 'affiliation': 'Astellas Pharma Europe B.V.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Astellas Pharma Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}