Viewing Study NCT00622869

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Ignite Creation Date: 2025-12-24 @ 10:51 PM
Ignite Modification Date: 2026-02-22 @ 7:03 PM
Study NCT ID: NCT00622869
Status: COMPLETED
Last Update Posted: 2013-05-27
First Post: 2008-02-13
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Efficacy and Safety of Concentration-controlled Everolimus to Eliminate or to Reduce Tacrolimus Compared to Tacrolimus in de Novo Liver Transplant Recipients
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Switzerland']}, 'interventionBrowseModule': {'meshes': [{'id': 'D016559', 'term': 'Tacrolimus'}, {'id': 'D000068338', 'term': 'Everolimus'}, {'id': 'D000305', 'term': 'Adrenal Cortex Hormones'}], 'ancestors': [{'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D020123', 'term': 'Sirolimus'}, {'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 (ie, data from all sites) in the clinical trial.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events (AE) were followed until resolution or judged permanent. Serious AEs occurring after transplantation, until 30 days after study medication (SM) discontinuation, or > 4 weeks after study discontinuation if related to SM were reported.', 'description': 'Safety population: All patients who received at least 1 dose of randomized study medication.\n\nAdverse events up to Month 24 were reported.', 'eventGroups': [{'id': 'EG000', 'title': 'Everolimus + Reduced Tacrolimus', 'description': 'Low dose tacrolimus (tacrolimus reduced) + everolimus + corticosteroids', 'otherNumAtRisk': 245, 'otherNumAffected': 218, 'seriousNumAtRisk': 245, 'seriousNumAffected': 138}, {'id': 'EG001', 'title': 'Tacrolimus Elimination', 'description': 'Low dose tacrolimus (until Month 4, then tacrolimus eliminated) + everolimus + corticosteroids', 'otherNumAtRisk': 229, 'otherNumAffected': 194, 'seriousNumAtRisk': 229, 'seriousNumAffected': 152}, {'id': 'EG002', 'title': 'Tacrolimus Control Arm', 'description': 'Control dose tacrolimus + corticosteroids', 'otherNumAtRisk': 242, 'otherNumAffected': 205, 'seriousNumAtRisk': 242, 'seriousNumAffected': 131}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 20}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 12}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 29}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 28}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 20}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numAffected': 56}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 55}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 58}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 33}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 21}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 28}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 43}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 31}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 39}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 23}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Cholestasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 7}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hepatitis C', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 21}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 26}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Incisional hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 15}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 18}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hepatic enzyme increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 14}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Liver function test abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 23}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Transaminases increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 9}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 16}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 12}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hypercholesterolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 9}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 24}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hyperlipidaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hypertriglyceridaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 9}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 17}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 23}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 29}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 23}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 15}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 16}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numAffected': 51}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 40}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 53}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 36}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 14}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 24}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 22}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Renal impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 16}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 20}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 13}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 11}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pruritus generalised', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 17}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numAffected': 51}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 35}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 42}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Anaemia megaloblastic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Coagulopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Thrombotic thrombocytopenic purpura', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Arteriosclerosis coronary artery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 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'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Respiratory acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Sinus disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Actinic keratosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Cholestatic pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Decubitus ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Erythema nodosum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Scar', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Stevens-Johnson syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Colostomy closure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Aortic aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 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'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hypovolaemic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Lymphocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 229, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Incidence Rate of Composite Efficacy Failure From Randomization to Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '245', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}, {'value': '243', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Everolimus + Reduced Tacrolimus', 'description': 'Low dose tacrolimus (tacrolimus reduced) + everolimus + corticosteroids.'}, {'id': 'OG001', 'title': 'Tacrolimus Elimination', 'description': 'Low-dose tacrolimus (until Month 4, then tacrolimus eliminated) + everolimus + corticosteroids.'}, {'id': 'OG002', 'title': 'Tacrolimus Control Arm', 'description': 'Control dose tacrolimus + corticosteroids.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000'}, {'value': '24.2', 'groupId': 'OG001'}, {'value': '9.7', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Randomization to Month 12', 'description': 'Composite efficacy failure was defined as treated biopsy proven acute rejection (tBPAR), graft loss, or death. A BPAR was defined as an acute rejection confirmed by biopsy with a Rejection Activity Index (RAI) score ≥ 3. tBPAR was defined as a BPAR which was treated with anti-rejection therapy. The RAI is used to score liver biopsies with acute rejection and is composed of 3 categories (portal inflammation, bile duct inflammation damage, venous endothelial inflammation) each scored on a scale of 0 (absent) to 3 (severe) by a trained pathologist. The total RAI score = the sum of the scores of the 3 categories and ranges from 0 to 9, with a higher score indicating greater rejection. The graft was presumed to be lost on the day the patient was newly listed for a liver graft, they received a graft re-transplant, or they died.\n\nThe incidence rates of composite efficacy failure were estimated with a Kaplan-Meier product-limit formula.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population: All randomized patients.'}, {'type': 'SECONDARY', 'title': 'Incidence Rate of Composite Efficacy Failure From Randomization to Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '245', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}, {'value': '243', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Everolimus + Reduced Tacrolimus', 'description': 'Low dose tacrolimus (tacrolimus reduced) + everolimus + corticosteroids.'}, {'id': 'OG001', 'title': 'Tacrolimus Elimination', 'description': 'Low-dose tacrolimus (until Month 4, then tacrolimus eliminated) + everolimus + corticosteroids.'}, {'id': 'OG002', 'title': 'Tacrolimus Control Arm', 'description': 'Control dose tacrolimus + corticosteroids.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.3', 'groupId': 'OG000'}, {'value': '26.0', 'groupId': 'OG001'}, {'value': '12.5', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Randomization to Month 24', 'description': 'Composite efficacy failure was defined as treated biopsy proven acute rejection (tBPAR), graft loss, or death.\n\nThe incidence rates of composite efficacy failure were estimated with a Kaplan-Meier product-limit formula.', 'unitOfMeasure': 'Percentage', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population: All randomized patients.'}, {'type': 'SECONDARY', 'title': 'Incidence Rate of Treated Biopsy Proven Acute Rejection (tBPAR) at Months 12 and 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '245', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}, {'value': '243', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Everolimus + Reduced Tacrolimus', 'description': 'Low dose tacrolimus (tacrolimus reduced) + everolimus + corticosteroids.'}, {'id': 'OG001', 'title': 'Tacrolimus Elimination', 'description': 'Low-dose tacrolimus (until Month 4, then tacrolimus eliminated) + everolimus + corticosteroids.'}, {'id': 'OG002', 'title': 'Tacrolimus Control Arm', 'description': 'Control dose tacrolimus + corticosteroids.'}], 'classes': [{'title': 'Month 12', 'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000'}, {'value': '18.8', 'groupId': 'OG001'}, {'value': '7.2', 'groupId': 'OG002'}]}]}, {'title': 'Month 24', 'categories': [{'measurements': [{'value': '4.8', 'groupId': 'OG000'}, {'value': '19.9', 'groupId': 'OG001'}, {'value': '7.7', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Randomization to Month 24', 'description': 'tBPAR was defined as an acute rejection confirmed by biopsy with a Rejection Activity Index (RAI) score ≥ 3, which was treated with anti-rejection therapy. Liver biopsies were collected for all cases of suspected acute rejection preferably within 24 hours, at the latest within 48 hours, whenever clinically possible. The RAI is used to score liver biopsies with acute rejection and is composed of 3 categories (portal inflammation, bile duct inflammation damage, venous endothelial inflammation) each scored on a scale of 0 (absent) to 3 (severe) by a trained pathologist. The total RAI score = the sum of the scores of the 3 categories and ranges from 0 to 9, with a higher score indicating greater rejection. The graft was presumed to be lost on the day the patient was newly listed for a liver graft, they received a graft re-transplant, or they died.\n\nThe incidence rates of tBPAR were estimated with a Kaplan-Meier product-limit formula.', 'unitOfMeasure': 'Percentage', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population: All randomized patients.'}, {'type': 'SECONDARY', 'title': 'Change in Renal Function From Randomization to Months 12 and 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '245', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}, {'value': '243', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Everolimus + Reduced Tacrolimus', 'description': 'Low dose tacrolimus (tacrolimus reduced) + everolimus + corticosteroids.'}, {'id': 'OG001', 'title': 'Tacrolimus Elimination', 'description': 'Low-dose tacrolimus (until Month 4, then tacrolimus eliminated) + everolimus + corticosteroids.'}, {'id': 'OG002', 'title': 'Tacrolimus Control Arm', 'description': 'Control dose tacrolimus + corticosteroids.'}], 'classes': [{'title': 'Month 12 (N=244, 231, 243)', 'categories': [{'measurements': [{'value': '-2.23', 'spread': '1.54', 'groupId': 'OG000'}, {'value': '-1.51', 'spread': '1.58', 'groupId': 'OG001'}, {'value': '-10.73', 'spread': '1.54', 'groupId': 'OG002'}]}]}, {'title': 'Month 24 (N=245, 231, 243)', 'categories': [{'measurements': [{'value': '-7.94', 'spread': '1.53', 'groupId': 'OG000'}, {'value': '-4.19', 'spread': '1.58', 'groupId': 'OG001'}, {'value': '-14.60', 'spread': '1.54', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Randomization to Month 24', 'description': 'Change in renal function was assessed by the estimated Glomerular Filtration Rate (eGFR) using the abbreviated (4 variables) Modification of Diet in Renal Disease (MDRD-4) formula which was developed by the MDRD Study Group and has been validated in patients with chronic kidney disease. The MDRD-4 formula used for the eGFR calculation is: eGFR (mL/min/1.73m\\^2) = 186.3\\*(C\\^-1.154)\\*(A\\^-0.203)\\*G\\*R, where C is the serum concentration of creatinine (mg/dL), A is age (years), G=0.742 when gender is female, otherwise G=1, R=1.21 when race is black, otherwise R=1.\n\nThe changes in renal function were analyzed via analysis of covariance (ANCOVA) with treatment, pre-transplant hepatitis C virus status and randomization eGFR as covariates. Based on these ANCOVA analyses, the least-squares mean and standard errors of change were reported.', 'unitOfMeasure': 'mL/min/1.73m^2', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population: All randomized patients.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Everolimus + Reduced Tacrolimus', 'description': 'Low dose tacrolimus (tacrolimus reduced) + everolimus + corticosteroids.'}, {'id': 'FG001', 'title': 'Tacrolimus Elimination', 'description': 'Low-dose tacrolimus (until Month 4, then tacrolimus eliminated) + everolimus + corticosteroids.'}, {'id': 'FG002', 'title': 'Tacrolimus Control Arm', 'description': 'Control dose tacrolimus + corticosteroids.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '245'}, {'groupId': 'FG001', 'numSubjects': '231'}, {'groupId': 'FG002', 'numSubjects': '243'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '202'}, {'groupId': 'FG001', 'numSubjects': '174'}, {'groupId': 'FG002', 'numSubjects': '204'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '57'}, {'groupId': 'FG002', 'numSubjects': '39'}]}], 'dropWithdraws': [{'type': 'Subject Withdrew Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '11'}]}, {'type': 'Administrative Problems', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '13'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '10'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Graft Loss', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Missing', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '245', 'groupId': 'BG000'}, {'value': '231', 'groupId': 'BG001'}, {'value': '243', 'groupId': 'BG002'}, {'value': '719', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Everolimus + Reduced Tacrolimus', 'description': 'Low dose tacrolimus (tacrolimus reduced) + everolimus + corticosteroids.'}, {'id': 'BG001', 'title': 'Tacrolimus Elimination', 'description': 'Low-dose tacrolimus (until Month 4, then tacrolimus eliminated) + everolimus + corticosteroids.'}, {'id': 'BG002', 'title': 'Tacrolimus Control Arm', 'description': 'Control dose tacrolimus + corticosteroids.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.6', 'spread': '9.2', 'groupId': 'BG000'}, {'value': '53.2', 'spread': '10.8', 'groupId': 'BG001'}, {'value': '54.5', 'spread': '8.7', 'groupId': 'BG002'}, {'value': '53.8', 'spread': '9.6', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}, {'value': '196', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '180', 'groupId': 'BG000'}, {'value': '164', 'groupId': 'BG001'}, {'value': '179', 'groupId': 'BG002'}, {'value': '523', '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': 719}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-17', 'studyFirstSubmitDate': '2008-02-13', 'resultsFirstSubmitDate': '2013-04-02', 'studyFirstSubmitQcDate': '2008-02-22', 'lastUpdatePostDateStruct': {'date': '2013-05-27', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-04-02', 'studyFirstPostDateStruct': {'date': '2008-02-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-05-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence Rate of Composite Efficacy Failure From Randomization to Month 12', 'timeFrame': 'Randomization to Month 12', 'description': 'Composite efficacy failure was defined as treated biopsy proven acute rejection (tBPAR), graft loss, or death. A BPAR was defined as an acute rejection confirmed by biopsy with a Rejection Activity Index (RAI) score ≥ 3. tBPAR was defined as a BPAR which was treated with anti-rejection therapy. The RAI is used to score liver biopsies with acute rejection and is composed of 3 categories (portal inflammation, bile duct inflammation damage, venous endothelial inflammation) each scored on a scale of 0 (absent) to 3 (severe) by a trained pathologist. The total RAI score = the sum of the scores of the 3 categories and ranges from 0 to 9, with a higher score indicating greater rejection. The graft was presumed to be lost on the day the patient was newly listed for a liver graft, they received a graft re-transplant, or they died.\n\nThe incidence rates of composite efficacy failure were estimated with a Kaplan-Meier product-limit formula.'}], 'secondaryOutcomes': [{'measure': 'Incidence Rate of Composite Efficacy Failure From Randomization to Month 24', 'timeFrame': 'Randomization to Month 24', 'description': 'Composite efficacy failure was defined as treated biopsy proven acute rejection (tBPAR), graft loss, or death.\n\nThe incidence rates of composite efficacy failure were estimated with a Kaplan-Meier product-limit formula.'}, {'measure': 'Incidence Rate of Treated Biopsy Proven Acute Rejection (tBPAR) at Months 12 and 24', 'timeFrame': 'Randomization to Month 24', 'description': 'tBPAR was defined as an acute rejection confirmed by biopsy with a Rejection Activity Index (RAI) score ≥ 3, which was treated with anti-rejection therapy. Liver biopsies were collected for all cases of suspected acute rejection preferably within 24 hours, at the latest within 48 hours, whenever clinically possible. The RAI is used to score liver biopsies with acute rejection and is composed of 3 categories (portal inflammation, bile duct inflammation damage, venous endothelial inflammation) each scored on a scale of 0 (absent) to 3 (severe) by a trained pathologist. The total RAI score = the sum of the scores of the 3 categories and ranges from 0 to 9, with a higher score indicating greater rejection. The graft was presumed to be lost on the day the patient was newly listed for a liver graft, they received a graft re-transplant, or they died.\n\nThe incidence rates of tBPAR were estimated with a Kaplan-Meier product-limit formula.'}, {'measure': 'Change in Renal Function From Randomization to Months 12 and 24', 'timeFrame': 'Randomization to Month 24', 'description': 'Change in renal function was assessed by the estimated Glomerular Filtration Rate (eGFR) using the abbreviated (4 variables) Modification of Diet in Renal Disease (MDRD-4) formula which was developed by the MDRD Study Group and has been validated in patients with chronic kidney disease. The MDRD-4 formula used for the eGFR calculation is: eGFR (mL/min/1.73m\\^2) = 186.3\\*(C\\^-1.154)\\*(A\\^-0.203)\\*G\\*R, where C is the serum concentration of creatinine (mg/dL), A is age (years), G=0.742 when gender is female, otherwise G=1, R=1.21 when race is black, otherwise R=1.\n\nThe changes in renal function were analyzed via analysis of covariance (ANCOVA) with treatment, pre-transplant hepatitis C virus status and randomization eGFR as covariates. Based on these ANCOVA analyses, the least-squares mean and standard errors of change were reported.'}]}, 'conditionsModule': {'keywords': ['Liver transplantation', 'everolimus', 'calcineurin inhibitors', 'tacrolimus', 'renal function', 'MDRD formula', 'progression of fibrosis'], 'conditions': ['Liver Transplantation']}, 'referencesModule': {'references': [{'pmid': '28817434', 'type': 'DERIVED', 'citation': 'Charlton M, Rinella M, Patel D, McCague K, Heimbach J, Watt K. Everolimus Is Associated With Less Weight Gain Than Tacrolimus 2 Years After Liver Transplantation: Results of a Randomized Multicenter Study. Transplantation. 2017 Dec;101(12):2873-2882. doi: 10.1097/TP.0000000000001913.'}, {'pmid': '26151607', 'type': 'DERIVED', 'citation': 'Fischer L, Saliba F, Kaiser GM, De Carlis L, Metselaar HJ, De Simone P, Duvoux C, Nevens F, Fung JJ, Dong G, Rauer B, Junge G; H2304 Study Group. Three-year Outcomes in De Novo Liver Transplant Patients Receiving Everolimus With Reduced Tacrolimus: Follow-Up Results From a Randomized, Multicenter Study. Transplantation. 2015 Jul;99(7):1455-62. doi: 10.1097/TP.0000000000000555.'}, {'pmid': '23714399', 'type': 'DERIVED', 'citation': 'Saliba F, De Simone P, Nevens F, De Carlis L, Metselaar HJ, Beckebaum S, Jonas S, Sudan D, Fischer L, Duvoux C, Chavin KD, Koneru B, Huang MA, Chapman WC, Foltys D, Dong G, Lopez PM, Fung J, Junge G; H2304 Study Group. Renal function at two years in liver transplant patients receiving everolimus: results of a randomized, multicenter study. Am J Transplant. 2013 Jul;13(7):1734-45. doi: 10.1111/ajt.12280. Epub 2013 May 28.'}]}, 'descriptionModule': {'briefSummary': 'This trial was designed to address important issues that impact recipients of liver allografts as well as clinicians, ie, renal function, reduction or discontinuation of tacrolimus early post-transplantation, and progression rate of fibrosis in hepatitis C virus (HCV) positive patients.', 'detailedDescription': 'This 24-month study consisted of a screening period, a baseline period (3 to 7 days post-transplantation) followed by a run-in period that ended on the day of randomization at 30 days (± 5 days) post-transplantation. Patients were screened for eligibility prior to liver transplantation. Patients who had undergone successful liver transplantation were initiated on a tacrolimus-based regimen that included corticosteroids and entered the baseline period (between 3 and 7 days post-transplantation). At 30 (± 5) days post-transplantation, patients who met additional randomization inclusion/exclusion criteria were randomized into the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ability and willingness to provide written informed consent and adhere to study regimen.\n* Recipients who are 18-70 years of age of a primary liver transplant from a deceased donor.\n* Recipients who have been initiated on an immunosuppressive regimen that contains corticosteroids and tacrolimus, 3-7 days post-transplantation.\n* Confirmed recipient hepatitis C virus (HCV) status at Screening (either by antibody or by PCR (polymerase chain reaction).\n* Allograft is functioning at an acceptable level by the time of randomization as defined by protocol specific laboratory values.\n* Abbreviated Modification of Diet in Renal Disease estimated glomerular filtration rate (MDRD eGFR) ≥ 30 mL/min/1.73m2. Results obtained within 5 days prior to randomization are acceptable, however, no sooner than Day 25 post-transplantation.\n* Verification of at least 1 tacrolimus trough level of ≥ 8 ng/mL in the week prior to randomization. Investigators should make adjustments in tacrolimus dosing to continue to target trough levels above 8 ng/mL prior to randomization.\n\nExclusion Criteria\n\n* Patients who are recipients of multiple solid organ or islet cell tissue transplants, or have previously received an organ or tissue transplant. Patients who have a combined liver-kidney transplant.\n* Recipients of a liver from a living donor, or of a split liver.\n* History of malignancy of any organ system within the past 5 years whether or not there is evidence of local recurrence or metastases, other than non-metastatic basal or squamous cell carcinoma of the skin, or HCC (hepatocellular carcinoma) (see next criteria).\n* Hepatocellular carcinoma that does not fulfill Milan criteria (1 nodule ≤ 5 cm, 2-3 nodules all \\< 3 cm) at the time of transplantation as per explant histology of the recipient liver.\n* Any use of antibody induction therapy.\n* Patients with a known hypersensitivity to the drugs used on study or their class, or to any of the excipients.\n* Patients who are recipients of ABO incompatible transplant grafts.\n* Recipients of organs from donors who test positive for Hepatitis B surface antigen or HIV are excluded.\n* Patients who have any surgical or medical condition, which in the opinion of the investigator, might significantly alter the absorption, distribution, metabolism and excretion of study drug.\n* Women of child-bearing potential (WOCBP).\n* Patients with any history of coagulopathy or medical condition requiring long-term anticoagulation which would preclude liver biopsy after transplantation. (Low dose aspirin treatment or interruption of chronic anticoagulant is allowed).\n\nOther protocol-defined inclusion/exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT00622869', 'acronym': 'RAD', 'briefTitle': 'Efficacy and Safety of Concentration-controlled Everolimus to Eliminate or to Reduce Tacrolimus Compared to Tacrolimus in de Novo Liver Transplant Recipients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A 24 Month, Multicenter, Open-label, Randomized, Controlled Study to Evaluate the Efficacy and Safety of Concentration-controlled Everolimus to Eliminate or to Reduce Tacrolimus Compared to Tacrolimus in de Novo Liver Transplant Recipients', 'orgStudyIdInfo': {'id': 'CRAD001H2304'}, 'secondaryIdInfos': [{'id': '2007-001821-85', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Everolimus + reduced tacrolimus', 'description': 'Low dose tacrolimus (tacrolimus reduced) + everolimus + corticosteroids.', 'interventionNames': ['Drug: Tacrolimus (reduced tacrolimus)', 'Drug: Everolimus (reduced tacrolimus)', 'Drug: Corticosteroids']}, {'type': 'EXPERIMENTAL', 'label': 'Tacrolimus elimination', 'description': 'Low-dose tacrolimus (until Month 4, then tacrolimus eliminated) + everolimus + corticosteroids.', 'interventionNames': ['Drug: Tacrolimus (tacrolimus elimination)', 'Drug: Everolimus (tacrolimus elimination)', 'Drug: Corticosteroids']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Tacrolimus control', 'description': 'Control dose tacrolimus + corticosteroids.', 'interventionNames': ['Drug: Tacrolimus (tacrolimus control)', 'Drug: Corticosteroids']}], 'interventions': [{'name': 'Tacrolimus (reduced tacrolimus)', 'type': 'DRUG', 'otherNames': ['FK-506', 'fujimycin', 'Prograf', 'Advagraf', 'Protopic'], 'description': 'After everolimus whole blood trough levels were confirmed to be in the target range of 3-8 ng/mL, tacrolimus tapering began, achieving a target tacrolimus whole blood trough level of 3-5 ng/mL by 3 weeks after randomization, a level which was maintained for the duration of the study.', 'armGroupLabels': ['Everolimus + reduced tacrolimus']}, {'name': 'Tacrolimus (tacrolimus elimination)', 'type': 'DRUG', 'otherNames': ['FK-506', 'fujimycin', 'Prograf', 'Advagraf', 'Protopic'], 'description': 'After everolimus whole blood trough levels were confirmed to be in the target range of 3-8 ng/mL, tacrolimus tapering began, achieving a target tacrolimus whole blood trough level of 3-5 ng/mL by 3 weeks after randomization. Tacrolimus elimination was started beginning at Month 4. Tacrolimus was tapered after everolimus whole blood trough levels were within the target range of 6-10 ng/mL. Tacrolimus was completely eliminated by the end of Month 4.', 'armGroupLabels': ['Tacrolimus elimination']}, {'name': 'Tacrolimus (tacrolimus control)', 'type': 'DRUG', 'otherNames': ['FK-506', 'fujimycin', 'Prograf', 'Advagraf', 'Protopic'], 'description': 'Tacrolimus trough levels were targeted to be maintained at 8-12 ng/mL until Month 4. At Month 4, tacrolimus whole blood trough levels were decreased to a target trough level of 6-10 ng/mL for the remainder of the study.', 'armGroupLabels': ['Tacrolimus control']}, {'name': 'Everolimus (reduced tacrolimus)', 'type': 'DRUG', 'otherNames': ['RAD-001', 'Zortress', 'Certican', 'Afinitor'], 'description': 'Everolimus was started within 24 hours of randomization at a dose of 1.0 mg twice a day (bid, 2 mg daily dose). The dose was adjusted to maintain everolimus trough blood levels between 3-8 ng/mL for the duration of the study.', 'armGroupLabels': ['Everolimus + reduced tacrolimus']}, {'name': 'Everolimus (tacrolimus elimination)', 'type': 'DRUG', 'otherNames': ['RAD-001', 'Zortress', 'Certican', 'Afinitor'], 'description': 'Everolimus was started within 24 hours of randomization at a dose of 1.0 mg twice a day (bid, 2 mg daily dose). The dose was adjusted to maintain everolimus trough blood levels between 3-8 ng/mL until Month 4; beginning with Month 4, the dose was adjusted to maintain everolimus trough blood levels between 6-10 ng/mL.', 'armGroupLabels': ['Tacrolimus elimination']}, {'name': 'Corticosteroids', 'type': 'DRUG', 'description': 'For patients in all groups, corticosteroids were initiated at or prior to the time of transplantation according to local practice. Corticosteroids could be used for the duration of the study but could not be eliminated before Month 6.', 'armGroupLabels': ['Everolimus + reduced tacrolimus', 'Tacrolimus control', 'Tacrolimus elimination']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, 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