Ignite Creation Date:
2025-12-24 @ 9:16 PM
Ignite Modification Date:
2025-12-25 @ 7:04 PM
Study NCT ID:
NCT00251004
Status:
COMPLETED
Last Update Posted:
2011-05-10
First Post:
2005-11-07
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Efficacy and Safety Study of Everolimus Plus Reduced Cyclosporine Versus Mycophenolic Acid Plus Cyclosporine in Kidney Transplant Recipients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068338', 'term': 'Everolimus'}, {'id': 'D009173', 'term': 'Mycophenolic Acid'}, {'id': 'D016572', 'term': 'Cyclosporine'}, {'id': 'D000077552', 'term': 'Basiliximab'}, {'id': 'D000305', 'term': 'Adrenal Cortex Hormones'}], 'ancestors': [{'id': 'D020123', 'term': 'Sirolimus'}, {'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': 'D003524', 'term': 'Cyclosporins'}, {'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '862-778-8300', 'title': 'Study Director', 'organization': 'Novartis Pharmaceuticals'}, 'certainAgreement': {'otherDetails': "The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'At 24 month', 'description': 'Safety population', 'eventGroups': [{'id': 'EG000', 'title': 'Low-dose Everolimus Group', 'description': '1.5 mg everolimus (one 0.75-mg tablet bis in diem/twice a day (bid)) + basiliximab + reduced-dose Cyclosporine A (CsA) ± corticosteroids.\n\nThe CsA dose was adjusted to attain a trough (C0) value within the pre-specified target ranges: starting at the day 5 visit: 100-200 ng/mL, starting at the month 2 visit: 75-150 ng/mL, starting at the month 4 visit: 50-100 ng/mL and starting at the month 6 visit: 25-50 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy.', 'otherNumAtRisk': 274, 'otherNumAffected': 268, 'seriousNumAtRisk': 274, 'seriousNumAffected': 176}, {'id': 'EG001', 'title': 'High-dose Everolimus Group', 'description': '3.0 mg everolimus (two 0.75-mg tablets bid) + basiliximab + reduced-dose CsA ± corticosteroids.\n\nThe CsA dose was adjusted to attain a trough (C0) value within the pre-specified target ranges: starting at the day 5 visit: 100-200 ng/mL, starting at the month 2 visit: 75-150 ng/mL, starting at the month 4 visit: 50-100 ng/mL and starting at the month 6 visit: 25-50 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy.', 'otherNumAtRisk': 278, 'otherNumAffected': 272, 'seriousNumAtRisk': 278, 'seriousNumAffected': 193}, {'id': 'EG002', 'title': 'Control Group', 'description': '1.44 g Mycophenolic Acid (two 360-mg tablets bid) + basiliximab + standard-dose CsA ± corticosteroids.\n\nThe CsA dose was adjusted to attain a C0 value within the following range for the time of the study: starting at the day 5 visit: 200-300 ng/mL, starting at the month 2 visit and thereafter: 100-250 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy.', 'otherNumAtRisk': 273, 'otherNumAffected': 264, 'seriousNumAtRisk': 273, 'seriousNumAffected': 168}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 75}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 86}, {'groupId': 'EG002', 'numAtRisk': 273, 'numAffected': 67}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 273, 'numAffected': 30}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Polycythaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 273, 'numAffected': 12}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 273, 'numAffected': 9}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 273, 'numAffected': 23}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 273, 'numAffected': 43}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 273, 'numAffected': 35}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 107}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 125}, {'groupId': 'EG002', 'numAtRisk': 273, 'numAffected': 116}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 59}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 52}, {'groupId': 'EG002', 'numAtRisk': 273, 'numAffected': 65}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 273, 'numAffected': 38}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 273, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Mouth ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 273, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 85}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 81}, {'groupId': 'EG002', 'numAtRisk': 273, 'numAffected': 91}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 46}, {'groupId': 'EG002', 'numAtRisk': 273, 'numAffected': 65}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 273, 'numAffected': 15}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 273, 'numAffected': 31}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 273, 'numAffected': 19}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 134}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 126}, {'groupId': 'EG002', 'numAtRisk': 273, 'numAffected': 116}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 51}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 55}, {'groupId': 'EG002', 'numAtRisk': 273, 'numAffected': 38}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 273, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 273, 'numAffected': 18}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 273, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 52}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 48}, {'groupId': 'EG002', 'numAtRisk': 273, 'numAffected': 60}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 62}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 59}, {'groupId': 'EG002', 'numAtRisk': 273, 'numAffected': 60}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Complications of transplant surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 273, 'numAffected': 12}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Complications of transplanted kidney', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 273, 'numAffected': 18}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Incision site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 48}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 56}, {'groupId': 'EG002', 'numAtRisk': 273, 'numAffected': 45}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Perinephric collection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 273, 'numAffected': 7}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Post procedural discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 273, 'numAffected': 13}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 35}, {'groupId': 'EG002', 'numAtRisk': 273, 'numAffected': 44}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Therapeutic agent toxicity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 273, 'numAffected': 16}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 38}, {'groupId': 'EG002', 'numAtRisk': 273, 'numAffected': 53}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Urine output decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 273, 'numAffected': 11}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 273, 'numAffected': 33}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 273, 'numAffected': 11}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 273, 'numAffected': 19}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dyslipidaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 38}, {'groupId': 'EG002', 'numAtRisk': 273, 'numAffected': 26}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Fluid overload', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 273, 'numAffected': 18}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypercholesterolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 51}, {'groupId': 'EG002', 'numAtRisk': 273, 'numAffected': 35}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 39}, {'groupId': 'EG002', 'numAtRisk': 273, 'numAffected': 38}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 51}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 57}, {'groupId': 'EG002', 'numAtRisk': 273, 'numAffected': 46}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hyperlipidaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 55}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 62}, {'groupId': 'EG002', 'numAtRisk': 273, 'numAffected': 44}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hyperphosphataemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 273, 'numAffected': 14}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypertriglyceridaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 273, 'numAffected': 13}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 273, 'numAffected': 22}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 273, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 47}, {'groupId': 'EG002', 'numAtRisk': 273, 'numAffected': 32}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 39}, {'groupId': 'EG002', 'numAtRisk': 273, 'numAffected': 43}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypophosphataemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 44}, {'groupId': 'EG002', 'numAtRisk': 273, 'numAffected': 36}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Metabolic acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 273, 'numAffected': 17}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 39}, {'groupId': 'EG002', 'numAtRisk': 273, 'numAffected': 32}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 273, 'numAffected': 31}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Muscle spasms', 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{'groupId': 'EG002', 'numAtRisk': 273, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Essential hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 273, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 273, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 273, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 273, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 273, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 273, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypovolaemic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 273, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Iliac artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 273, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lymphocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 273, 'numAffected': 8}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lymphorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 273, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 273, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 273, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Peripheral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 273, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Peripheral vascular disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 273, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Shock haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 273, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Steal syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 273, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Subclavian vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 273, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Thrombophlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 273, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 273, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Venous thrombosis limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 278, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 273, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Composite Efficacy Endpoints - 12 Month Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'OG000'}, {'value': '279', 'groupId': 'OG001'}, {'value': '277', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-dose Everolimus Group', 'description': '1.5 mg everolimus (one 0.75-mg tablet bis in diem/twice a day (bid)) + basiliximab + reduced-dose Cyclosporine A (CsA) ± corticosteroids.\n\nThe CsA dose was adjusted to attain a trough (C0) value within the pre-specified target ranges: starting at the day 5 visit: 100-200 ng/mL, starting at the month 2 visit: 75-150 ng/mL, starting at the month 4 visit: 50-100 ng/mL and starting at the month 6 visit: 25-50 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy.'}, {'id': 'OG001', 'title': 'High-dose Everolimus Group', 'description': '3.0 mg everolimus (two 0.75-mg tablets bid) + basiliximab + reduced-dose CsA ± corticosteroids.\n\nThe CsA dose was adjusted to attain a trough (C0) value within the pre-specified target ranges: starting at the day 5 visit: 100-200 ng/mL, starting at the month 2 visit: 75-150 ng/mL, starting at the month 4 visit: 50-100 ng/mL and starting at the month 6 visit: 25-50 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy.'}, {'id': 'OG002', 'title': 'Control Group', 'description': '1.44 g Mycophenolic Acid (MPA) (two 360-mg tablets bid) + basiliximab + standard-dose CsA ± corticosteroids.\n\nThe CsA dose was adjusted to attain a C0 value within the following range for the time of the study: starting at the day 5 visit: 200-300 ng/mL, starting at the month 2 visit and thereafter: 100-250 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy.'}], 'classes': [{'title': 'Composite Endpoint (n)', 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}]}]}, {'title': '--Death', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': '--Graft Loss', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}, {'title': '--Treated BPAR', 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}]}, {'title': '--Lost to follow up', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'The primary efficacy endpoint was the 12 month analysis of primary efficacy failure defined as a composite endpoint including treated biopsy proven acute rejection (BPAR), graft loss, death or loss to follow-up. A treated BPAR episode was defined as a biopsy graded IA, IB, IIA, IIB, or III that was treated with anti-rejection therapy. Graft loss was defined as the allograft was presumed to be lost on the day the patient started dialysis and was not able to subsequently be removed from dialysis as well as re-transplant.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat (ITT) population'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With the Composite Incidence of Graft Loss, Death or Loss to Follow up at 12 Months Post-transplantation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'OG000'}, {'value': '279', 'groupId': 'OG001'}, {'value': '277', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-dose Everolimus Group', 'description': '1.5 mg everolimus (one 0.75-mg tablet bis in diem/twice a day (bid)) + basiliximab + reduced-dose Cyclosporine A (CsA) ± corticosteroids.\n\nThe CsA dose was adjusted to attain a trough (C0) value within the pre-specified target ranges: starting at the day 5 visit: 100-200 ng/mL, starting at the month 2 visit: 75-150 ng/mL, starting at the month 4 visit: 50-100 ng/mL and starting at the month 6 visit: 25-50 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy.'}, {'id': 'OG001', 'title': 'High-dose Everolimus Group', 'description': '3.0 mg everolimus (two 0.75-mg tablets bid) + basiliximab + reduced-dose CsA ± corticosteroids.\n\nThe CsA dose was adjusted to attain a trough (C0) value within the pre-specified target ranges: starting at the day 5 visit: 100-200 ng/mL, starting at the month 2 visit: 75-150 ng/mL, starting at the month 4 visit: 50-100 ng/mL and starting at the month 6 visit: 25-50 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy.'}, {'id': 'OG002', 'title': 'Control Group', 'description': '1.44 g Mycophenolic Acid (MPA) (two 360-mg tablets bid) + basiliximab + standard-dose CsA ± corticosteroids.\n\nThe CsA dose was adjusted to attain a C0 value within the following range for the time of the study: starting at the day 5 visit: 200-300 ng/mL, starting at the month 2 visit and thereafter: 100-250 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.6', 'groupId': 'OG000'}, {'value': '9.7', 'groupId': 'OG001'}, {'value': '9.4', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.2', 'ciLowerLimit': '-2.9', 'ciUpperLimit': '7.3', 'pValueComment': 'To control for multiple comparisons, the two-sided significance level was set at 0.025.', 'groupDescription': 'Everolimus is non-inferior to mycophenolic acid (MPA) if the upper limit of the 95% confidence interval for the difference in combined graft loss, death or loss to follow-up rates is \\<10%.', 'statisticalMethod': 'Z-test', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The non-inferiority margin was set at 10%.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-4.6', 'ciUpperLimit': '5.2', 'pValueComment': 'To control for multiple comparisons, the two-sided significance level was set at 0.025.', 'groupDescription': 'Everolimus is non-inferior to MPA if the upper limit of the 95% confidence interval for the difference in combined graft loss, death or loss to follow-up rates is \\<10%.', 'statisticalMethod': 'Z-test', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The non-inferiority margin was set at 10%.'}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Graft loss was defined as graft loss (the allograft was presumed to be lost on the day the patient started dialysis and was not able to subsequently be removed from dialysis) and re-transplant.\n\nA loss to follow-up patient in the composite endpoint of graft loss, death or loss to follow-up (the main secondary efficacy endpoint) was a patient who did not experience graft loss or death from day 1 and whose last day of contact was prior to study day 316.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat (ITT) population.'}, {'type': 'PRIMARY', 'title': 'Non-inferiority Analysis on Percentage of Participants With Composite Efficacy Endpoints', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'OG000'}, {'value': '279', 'groupId': 'OG001'}, {'value': '277', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-dose Everolimus Group', 'description': '1.5 mg everolimus (one 0.75-mg tablet bis in diem/twice a day (bid)) + basiliximab + reduced-dose Cyclosporine A (CsA) ± corticosteroids.\n\nThe CsA dose was adjusted to attain a trough (C0) value within the pre-specified target ranges: starting at the day 5 visit: 100-200 ng/mL, starting at the month 2 visit: 75-150 ng/mL, starting at the month 4 visit: 50-100 ng/mL and starting at the month 6 visit: 25-50 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy.'}, {'id': 'OG001', 'title': 'High-dose Everolimus Group', 'description': '3.0 mg everolimus (two 0.75-mg tablets bid) + basiliximab + reduced-dose CsA ± corticosteroids.\n\nThe CsA dose was adjusted to attain a trough (C0) value within the pre-specified target ranges: starting at the day 5 visit: 100-200 ng/mL, starting at the month 2 visit: 75-150 ng/mL, starting at the month 4 visit: 50-100 ng/mL and starting at the month 6 visit: 25-50 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy.'}, {'id': 'OG002', 'title': 'Control Group', 'description': '1.44 g Mycophenolic Acid (MPA) (two 360-mg tablets bid) + basiliximab + standard-dose CsA ± corticosteroids.\n\nThe CsA dose was adjusted to attain a C0 value within the following range for the time of the study: starting at the day 5 visit: 200-300 ng/mL, starting at the month 2 visit and thereafter: 100-250 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '27.1', 'groupId': 'OG000'}, {'value': '21.5', 'groupId': 'OG001'}, {'value': '25.3', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.014', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.8', 'ciLowerLimit': '-5.5', 'ciUpperLimit': '9.1', 'pValueComment': 'To control for multiple comparisons, the two-sided significance level was set at 0.025.', 'groupDescription': 'Everolimus is non-inferior to mycophenolic acid (MPA) if the upper limit of the 95% confidence interval for the difference in percentage of participants composite efficacy failure is \\<10%.', 'statisticalMethod': 'Z - test', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The non-inferiority margin was set at 10%.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.8', 'ciLowerLimit': '-10.8', 'ciUpperLimit': '3.3', 'pValueComment': 'To control for multiple comparisons, the two-sided significance level was set at 0.025.', 'groupDescription': 'Everolimus is non-inferior to MPA if the upper limit of the 95% confidence interval for the difference in composite efficacy failure rates is \\<10%.', 'statisticalMethod': 'Z-test', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The non-inferiority margin was set at 10%.'}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'The primary efficacy endpoint was the 12 month analysis of primary efficacy failure defined as a composite endpoint including treated biopsy proven acute rejection (BPAR), graft loss, death or loss to follow-up. In the definition of composite efficacy failure, loss to follow-up includes patients who did not experience treated BPAR, graft loss or death on or after day 1 and whose last day of contact was prior to day 316, the start day of the 12 month visit window.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat population'}, {'type': 'SECONDARY', 'title': 'Non-inferiority Analysis of Renal Function, Calculated by Glomerular Filtration Rate (cGFR) Using Modification of Diet in Renal Disease (MDRD) Formula', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'OG000'}, {'value': '279', 'groupId': 'OG001'}, {'value': '277', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Low-dose Everolimus Group', 'description': '1.5 mg everolimus (one 0.75-mg tablet bis in diem/twice a day (bid)) + basiliximab + reduced-dose Cyclosporine A (CsA) ± corticosteroids.\n\nThe CsA dose was adjusted to attain a trough (C0) value within the pre-specified target ranges: starting at the day 5 visit: 100-200 ng/mL, starting at the month 2 visit: 75-150 ng/mL, starting at the month 4 visit: 50-100 ng/mL and starting at the month 6 visit: 25-50 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy.'}, {'id': 'OG001', 'title': 'High-dose Everolimus Group', 'description': '3.0 mg everolimus (two 0.75-mg tablets bid) + basiliximab + reduced-dose CsA ± corticosteroids.\n\nThe CsA dose was adjusted to attain a trough (C0) value within the pre-specified target ranges: starting at the day 5 visit: 100-200 ng/mL, starting at the month 2 visit: 75-150 ng/mL, starting at the month 4 visit: 50-100 ng/mL and starting at the month 6 visit: 25-50 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy.'}, {'id': 'OG002', 'title': 'Control Group', 'description': '1.44 g Mycophenolic Acid (MPA) (two 360-mg tablets bid) + basiliximab + standard-dose CsA ± corticosteroids.\n\nThe CsA dose was adjusted to attain a C0 value within the following range for the time of the study: starting at the day 5 visit: 200-300 ng/mL, starting at the month 2 visit and thereafter: 100-250 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '54.66', 'groupId': 'OG000', 'lowerLimit': '-1.6'}, {'value': '51.41', 'groupId': 'OG001', 'lowerLimit': '-4.9'}, {'value': '52.24', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.42', 'ciLowerLimit': '-1.6', 'ciUpperLimit': '6.5', 'pValueComment': 'To control for multiple comparisons, the two-sided significance level was set at 0.025.', 'groupDescription': 'The null hypothesis: the mean GFR of the everolimus arm is lower (worse) than that of the MPA arm by 8 mL/min/1.73m\\^2 or more.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The non-inferiority margin was set at -8 mL/min/1.73m\\^2.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.83', 'ciLowerLimit': '-4.9', 'ciUpperLimit': '3.3', 'pValueComment': 'To control for multiple comparisons, the two-sided significance level was set at 0.025.', 'groupDescription': 'The null hypothesis: the mean GFR of the everolimus arm is lower (worse) than that of the MPA arm by 8 mL/min/1.73m\\^2 or more.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'The non-inferiority margin was set at -8 mL/min/1.73m\\^2.'}], 'paramType': 'NUMBER', 'timeFrame': 'at 12 months', 'description': 'Modification of Diet in Renal Disease (MDRD) formula is:\n\nGFR \\[mL/min/1.73m\\^2\\] = 186.3\\*(C\\^-1.154)\\*(A\\^-0.203)\\*G\\*R where\n\n* C is the serum concentration of creatinine \\[mg/dL\\],\n* A is patient age at sample collection date \\[years\\],\n* G=0.742 when gender is female, otherwise G=1,\n* R=1.21 when race is black, otherwise R=1', 'unitOfMeasure': 'mL/min/1.73m^2', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat (ITT) population.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Low-dose Everolimus Group', 'description': '1.5 mg everolimus (one 0.75-mg tablet bis in diem/twice a day (bid)) + basiliximab + reduced-dose Cyclosporine A (CsA) ± corticosteroids.\n\nThe CsA dose was adjusted to attain a trough (C0) value within the pre-specified target ranges: starting at the day 5 visit: 100-200 ng/mL, starting at the month 2 visit: 75-150 ng/mL, starting at the month 4 visit: 50-100 ng/mL and starting at the month 6 visit: 25-50 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy.'}, {'id': 'FG001', 'title': 'High-dose Everolimus Group', 'description': '3.0 mg everolimus (two 0.75-mg tablets bid) + basiliximab + reduced-dose CsA ± corticosteroids.\n\nThe CsA dose was adjusted to attain a trough (C0) value within the pre-specified target ranges: starting at the day 5 visit: 100-200 ng/mL, starting at the month 2 visit: 75-150 ng/mL, starting at the month 4 visit: 50-100 ng/mL and starting at the month 6 visit: 25-50 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy.'}, {'id': 'FG002', 'title': 'Control Group', 'description': '1.44 g Mycophenolic Acid (MPA) (two 360-mg tablets bid) + basiliximab + standard-dose CsA ± corticosteroids.\n\nThe CsA dose was adjusted to attain a C0 value within the following range for the time of the study: starting at the day 5 visit: 200-300 ng/mL, starting at the month 2 visit and thereafter: 100-250 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '277'}, {'groupId': 'FG001', 'numSubjects': '279'}, {'groupId': 'FG002', 'numSubjects': '277'}]}, {'type': '12 Month Analysis', 'achievements': [{'comment': 'Under 12 month analysis under group 1, 179 Completed study medication.', 'groupId': 'FG000', 'numSubjects': '241'}, {'comment': 'Under 12 month analysis under group 2, 175 Completed study medication.', 'groupId': 'FG001', 'numSubjects': '249'}, {'comment': 'Under 12 month analysis under group 3, 200 Completed study medication.', 'groupId': 'FG002', 'numSubjects': '253'}]}, {'type': '24 Month Analysis', 'achievements': [{'comment': 'Under 24 month analysis under group 1, 167 Completed study medication.', 'groupId': 'FG000', 'numSubjects': '232'}, {'comment': 'Under 24 month analysis under group 2, 161 Completed study medication.', 'groupId': 'FG001', 'numSubjects': '238'}, {'comment': 'Under 24 month analysis under group 3, 185 Completed study medication.', 'groupId': 'FG002', 'numSubjects': '246'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '232'}, {'groupId': 'FG001', 'numSubjects': '238'}, {'groupId': 'FG002', 'numSubjects': '246'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}, {'groupId': 'FG001', 'numSubjects': '41'}, {'groupId': 'FG002', 'numSubjects': '31'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '14'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Graft Loss', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '8'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'BG000'}, {'value': '279', 'groupId': 'BG001'}, {'value': '277', 'groupId': 'BG002'}, {'value': '833', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Low-dose Everolimus Group', 'description': '1.5 mg everolimus (one 0.75-mg tablet bis in diem/twice a day (bid)) + basiliximab + reduced-dose Cyclosporine A (CsA) ± corticosteroids.\n\nThe CsA dose was adjusted to attain a trough (C0) value within the pre-specified target ranges: starting at the day 5 visit: 100-200 ng/mL, starting at the month 2 visit: 75-150 ng/mL, starting at the month 4 visit: 50-100 ng/mL and starting at the month 6 visit: 25-50 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy.'}, {'id': 'BG001', 'title': 'High-dose Everolimus Group', 'description': '3.0 mg everolimus (two 0.75-mg tablets bid) + basiliximab + reduced-dose CsA ± corticosteroids.\n\nThe CsA dose was adjusted to attain a trough (C0) value within the pre-specified target ranges: starting at the day 5 visit: 100-200 ng/mL, starting at the month 2 visit: 75-150 ng/mL, starting at the month 4 visit: 50-100 ng/mL and starting at the month 6 visit: 25-50 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy.'}, {'id': 'BG002', 'title': 'Control Group', 'description': '1.44 g Mycophenolic Acid (MPA) (two 360-mg tablets bid) + basiliximab + standard-dose CsA ± corticosteroids.\n\nThe CsA dose was adjusted to attain a C0 value within the following range for the time of the study: starting at the day 5 visit: 200-300 ng/mL, starting at the month 2 visit and thereafter: 100-250 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45.7', 'spread': '12.72', 'groupId': 'BG000'}, {'value': '45.3', 'spread': '13.36', 'groupId': 'BG001'}, {'value': '47.2', 'spread': '12.74', 'groupId': 'BG002'}, {'value': '46.1', 'spread': '12.95', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '100', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}, {'value': '276', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '177', 'groupId': 'BG000'}, {'value': '191', 'groupId': 'BG001'}, {'value': '189', 'groupId': 'BG002'}, {'value': '557', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 833}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-04', 'completionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-04-07', 'studyFirstSubmitDate': '2005-11-07', 'resultsFirstSubmitDate': '2010-12-17', 'studyFirstSubmitQcDate': '2005-11-07', 'lastUpdatePostDateStruct': {'date': '2011-05-10', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-04-07', 'studyFirstPostDateStruct': {'date': '2005-11-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-05-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Composite Efficacy Endpoints - 12 Month Analysis', 'timeFrame': '12 months', 'description': 'The primary efficacy endpoint was the 12 month analysis of primary efficacy failure defined as a composite endpoint including treated biopsy proven acute rejection (BPAR), graft loss, death or loss to follow-up. A treated BPAR episode was defined as a biopsy graded IA, IB, IIA, IIB, or III that was treated with anti-rejection therapy. Graft loss was defined as the allograft was presumed to be lost on the day the patient started dialysis and was not able to subsequently be removed from dialysis as well as re-transplant.'}, {'measure': 'Non-inferiority Analysis on Percentage of Participants With Composite Efficacy Endpoints', 'timeFrame': '12 months', 'description': 'The primary efficacy endpoint was the 12 month analysis of primary efficacy failure defined as a composite endpoint including treated biopsy proven acute rejection (BPAR), graft loss, death or loss to follow-up. In the definition of composite efficacy failure, loss to follow-up includes patients who did not experience treated BPAR, graft loss or death on or after day 1 and whose last day of contact was prior to day 316, the start day of the 12 month visit window.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With the Composite Incidence of Graft Loss, Death or Loss to Follow up at 12 Months Post-transplantation', 'timeFrame': '12 months', 'description': 'Graft loss was defined as graft loss (the allograft was presumed to be lost on the day the patient started dialysis and was not able to subsequently be removed from dialysis) and re-transplant.\n\nA loss to follow-up patient in the composite endpoint of graft loss, death or loss to follow-up (the main secondary efficacy endpoint) was a patient who did not experience graft loss or death from day 1 and whose last day of contact was prior to study day 316.'}, {'measure': 'Non-inferiority Analysis of Renal Function, Calculated by Glomerular Filtration Rate (cGFR) Using Modification of Diet in Renal Disease (MDRD) Formula', 'timeFrame': 'at 12 months', 'description': 'Modification of Diet in Renal Disease (MDRD) formula is:\n\nGFR \\[mL/min/1.73m\\^2\\] = 186.3\\*(C\\^-1.154)\\*(A\\^-0.203)\\*G\\*R where\n\n* C is the serum concentration of creatinine \\[mg/dL\\],\n* A is patient age at sample collection date \\[years\\],\n* G=0.742 when gender is female, otherwise G=1,\n* R=1.21 when race is black, otherwise R=1'}]}, 'conditionsModule': {'keywords': ['Renal transplantation, kidney, and organ transplant', 'Renal transplant rejection'], 'conditions': ['Kidney Transplantation', 'Graft Rejection']}, 'referencesModule': {'references': [{'pmid': '39382091', 'type': 'DERIVED', 'citation': 'Wajih Z, Karpe KM, Walters GD. Interventions for BK virus infection in kidney transplant recipients. Cochrane Database Syst Rev. 2024 Oct 9;10(10):CD013344. doi: 10.1002/14651858.CD013344.pub2.'}, {'pmid': '23422495', 'type': 'DERIVED', 'citation': 'Cibrik D, Silva HT Jr, Vathsala A, Lackova E, Cornu-Artis C, Walker RG, Wang Z, Zibari GB, Shihab F, Kim YS. Randomized trial of everolimus-facilitated calcineurin inhibitor minimization over 24 months in renal transplantation. Transplantation. 2013 Apr 15;95(7):933-42. doi: 10.1097/TP.0b013e3182848e03.'}, {'pmid': '23230975', 'type': 'DERIVED', 'citation': 'Shihab FS, Cibrik D, Chan L, Kim YS, Carmellini M, Walker R, Zibari G, Pattison J, Cornu-Artis C, Wang Z, Tedesco-Silva H Jr. Association of clinical events with everolimus exposure in kidney transplant patients receiving reduced cyclosporine. Clin Transplant. 2013 Mar-Apr;27(2):217-26. doi: 10.1111/ctr.12045. Epub 2012 Dec 12.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to compare the safety and efficacy of three immunosuppressive treatment regimens following a kidney transplant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female patients of any race between 18 to 70 years old (inclusive)\n* Patients who gave written informed consent to participate in the study\n\nExclusion Criteria:\n\n* Recipients of multi-organ transplantation\n* Recipients of a primary cadaveric or primary non-human leucocyte antigen (HLA) identical living donor kidney transplantation.\n* Graft cold ischemia time greater than 40 hours.\n\nOther protocol-defined inclusion/exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT00251004', 'briefTitle': 'Efficacy and Safety Study of Everolimus Plus Reduced Cyclosporine Versus Mycophenolic Acid Plus Cyclosporine in Kidney Transplant Recipients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'Efficacy and Safety Study Comparing Concentration-controlled Everolimus in Two Doses (1.5 and 3.0 mg/Day Starting Doses) With Reduced Cyclosporine Versus 1.44 g Mycophenolic Acid (as Sodium Salt) With Standard Dose Cyclosporine in de Novo Renal Transplant Recipients', 'orgStudyIdInfo': {'id': 'CRAD001A2309'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low-dose Everolimus Group', 'description': '1.5 mg everolimus (one 0.75-mg tablet bis in diem/twice a day (bid)) + basiliximab + reduced-dose Cyclosporine A (CsA) ± corticosteroids.\n\nThe CsA dose was adjusted to attain a trough (C0) value within the pre-specified target ranges: starting at the day 5 visit: 100-200 ng/mL, starting at the month 2 visit: 75-150 ng/mL, starting at the month 4 visit: 50-100 ng/mL and starting at the month 6 visit: 25-50 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy.', 'interventionNames': ['Drug: Everolimus', 'Drug: Cyclosporine A (CsA)', 'Drug: Basiliximab', 'Drug: Corticosteroids']}, {'type': 'EXPERIMENTAL', 'label': 'High-dose Everolimus Group', 'description': '3.0 mg everolimus (two 0.75-mg tablets bid) + basiliximab + reduced-dose CsA ± corticosteroids.\n\nThe CsA dose was adjusted to attain a trough (C0) value within the pre-specified target ranges: starting at the day 5 visit: 100-200 ng/mL, starting at the month 2 visit: 75-150 ng/mL, starting at the month 4 visit: 50-100 ng/mL and starting at the month 6 visit: 25-50 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy.', 'interventionNames': ['Drug: Everolimus', 'Drug: Cyclosporine A (CsA)', 'Drug: Basiliximab', 'Drug: Corticosteroids']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': '1.44 g Mycophenolic Acid (two 360-mg tablets bid) + basiliximab + standard-dose CsA ± corticosteroids.\n\nThe CsA dose was adjusted to attain a C0 value within the following range for the time of the study: starting at the day 5 visit: 200-300 ng/mL, starting at the month 2 visit and thereafter: 100-250 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy.', 'interventionNames': ['Drug: Mycophenolic Acid (MPA)', 'Drug: Cyclosporine A (CsA)', 'Drug: Basiliximab', 'Drug: Corticosteroids']}], 'interventions': [{'name': 'Everolimus', 'type': 'DRUG', 'otherNames': ['Certican, Zotress'], 'description': 'oral, bis in diem/twice a day (bid)', 'armGroupLabels': ['High-dose Everolimus Group', 'Low-dose Everolimus Group']}, {'name': 'Mycophenolic Acid (MPA)', 'type': 'DRUG', 'otherNames': ['Myfortic'], 'description': '2 oral capsules of mycophenolic acid 360mg administered bid', 'armGroupLabels': ['Control Group']}, {'name': 'Cyclosporine A (CsA)', 'type': 'DRUG', 'otherNames': ['Neoral'], 'description': 'CsA dose adjustments were based on CsA trough levels (C0).', 'armGroupLabels': ['Control Group', 'High-dose Everolimus Group', 'Low-dose Everolimus Group']}, {'name': 'Basiliximab', 'type': 'DRUG', 'otherNames': ['Simulect'], 'description': 'All patients received two 20 mg doses of basiliximab administered intravenously. The first dose was to be given within 2 hours prior to transplant surgery and the second dose was to be administered on day 4, or each dose could have been administered according to local practice.', 'armGroupLabels': ['Control Group', 'High-dose Everolimus Group', 'Low-dose Everolimus Group']}, {'name': 'Corticosteroids', 'type': 'DRUG', 'description': 'Oral corticosteroids were administered according to local practice during the trial. At the same center, all patients were to follow the same steroid administration protocol.', 'armGroupLabels': ['Control Group', 'High-dose Everolimus Group', 'Low-dose Everolimus Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07936', 'city': 'East Hanover', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Novartis', 'geoPoint': {'lat': 40.8201, 'lon': -74.36487}}], 'overallOfficials': [{'name': 'Novartis', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Novartis', 'oldOrganization': 'Novartis'}}}}