Viewing Study NCT01276457

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Ignite Creation Date: 2025-12-24 @ 6:55 PM
Ignite Modification Date: 2025-12-30 @ 12:44 AM
Study NCT ID: NCT01276457
Status: COMPLETED
Last Update Posted: 2011-05-20
First Post: 2011-01-12
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Everolimus in Combination With Cyclosporine Microemulsion in de Novo Renal Transplant Recipients
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016572', 'term': 'Cyclosporine'}], 'ancestors': [{'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'}]}}, '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': '24 months', 'description': 'Population includes all the enrolled patients in the overall core and extension study.', 'eventGroups': [{'id': 'EG000', 'title': 'Upper Everolimus Blood Target + Very Low Dose Cyclosporine', 'description': 'Patients received everolimus orally twice daily at a dose that was adjusted to achieve a drug blood trough level in the range of 8-12 ng/mL. Patients also received a very low dose of cyclosporine (150-300 ng/mL) orally twice daily that was adjusted to maintain a drug blood level of 200 ng/mL 2 hours after the morning dose. Both drugs were taken in the morning and again 12 hours later. The drugs were taken consistently either before, during, or after meals. No grapefruit or grapefruit juice was allowed throughout the study.', 'otherNumAtRisk': 142, 'otherNumAffected': 142, 'seriousNumAtRisk': 142, 'seriousNumAffected': 85}, {'id': 'EG001', 'title': 'Standard Everolimus Blood Target + Low Dose Cyclosporine', 'description': 'Patients received everolimus orally twice daily at a dose that was adjusted to achieve a drug blood trough level in the range of 3-8 ng/mL. Patients also received a low dose of cyclosporine (350-500 ng/mL) orally twice daily that was adjusted to maintain a drug blood level of 400 ng/mL 2 hours after the morning dose. Both drugs were taken in the morning and again 12 hours later. The drugs were taken consistently either before, during, or after meals. No grapefruit or grapefruit juice was allowed throughout the study.', 'otherNumAtRisk': 143, 'otherNumAffected': 142, 'seriousNumAtRisk': 143, 'seriousNumAffected': 90}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 82}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 73}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 13}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 7}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 36}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 40}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Kidney transplant rejection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 10}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cytomegalovirus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 69}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 81}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Complications of transplanted kidney', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 31}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 12}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Transaminases increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 9}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 9}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dyslipidaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 66}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 55}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Fluid retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypercholesterolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 24}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 11}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 9}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hyperlipidaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 26}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypertriglyceridaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 17}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hyperuricaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 30}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 19}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 31}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Iron deficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 8}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 12}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Renal tubular necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 10}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ovarian cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 4}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 29}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lymphocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 19}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bone marrow toxicity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Haemolytic uraemic syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Atrioventricular block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cardiovascular disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Coronary artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hydrocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pulmonary arteriovenous fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Orbital oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abdominal compartment syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abdominal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Aphthous stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Enterovesical fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastrointestinal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Intestinal perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Malabsorption', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Subileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Umbilical hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Implant site effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 17}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Sudden death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 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'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Renal impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 6}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Renal tubular necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ureteral disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ureteric stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Urinary tract disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Urogenital fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vesicoureteric reflux', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Metrorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ovarian cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 2}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ovarian cyst torsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cholecystectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Inguinal hernia repair', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lymphocele marsupialisation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nephrectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nephrostomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Parathyroidectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Removal of ambulatory peritoneal catheter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Stent removal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ureteric repair', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Arteriovenous fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lymphocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 5}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lymphorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Venous thrombosis limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 142, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 143, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Biopsy-proven Acute Rejection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Upper Everolimus Blood Target + Very Low Dose Cyclosporine', 'description': 'Patients received everolimus orally twice daily at a dose that was adjusted to achieve a drug blood trough level in the range of 8-12 ng/mL. Patients also received a very low dose of cyclosporine (150-300 ng/mL) orally twice daily that was adjusted to maintain a drug blood level of 200 ng/mL 2 hours after the morning dose. Both drugs were taken in the morning and again 12 hours later. The drugs were taken consistently either before, during, or after meals. No grapefruit or grapefruit juice was allowed throughout the study.'}, {'id': 'OG001', 'title': 'Standard Everolimus Blood Target + Low Dose Cyclosporine', 'description': 'Patients received everolimus orally twice daily at a dose that was adjusted to achieve a drug blood trough level in the range of 3-8 ng/mL. Patients also received a low dose of cyclosporine (350-500 ng/mL) orally twice daily that was adjusted to maintain a drug blood level of 400 ng/mL 2 hours after the morning dose. Both drugs were taken in the morning and again 12 hours later. The drugs were taken consistently either before, during, or after meals. No grapefruit or grapefruit juice was allowed throughout the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to end of study (Month 24)', 'description': 'A graft core biopsy was performed on all suspected acute rejection episodes within 48 hours. Biopsies were read by the local pathologist according to the 1997 Banff criteria. A biopsy-proven acute rejection was be defined as a biopsy graded IA, IB, IIA, IIB, or III.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population: All randomized subjects for whom at least one valid post-baseline efficacy measurement was obtained and used for efficacy analyses.'}, {'type': 'PRIMARY', 'title': 'Renal Function Assessed by Creatinine Clearance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Upper Everolimus Blood Target + Very Low Dose Cyclosporine', 'description': 'Patients received everolimus orally twice daily at a dose that was adjusted to achieve a drug blood trough level in the range of 8-12 ng/mL. Patients also received a very low dose of cyclosporine (150-300 ng/mL) orally twice daily that was adjusted to maintain a drug blood level of 200 ng/mL 2 hours after the morning dose. Both drugs were taken in the morning and again 12 hours later. The drugs were taken consistently either before, during, or after meals. No grapefruit or grapefruit juice was allowed throughout the study.'}, {'id': 'OG001', 'title': 'Standard Everolimus Blood Target + Low Dose Cyclosporine', 'description': 'Patients received everolimus orally twice daily at a dose that was adjusted to achieve a drug blood trough level in the range of 3-8 ng/mL. Patients also received a low dose of cyclosporine (350-500 ng/mL) orally twice daily that was adjusted to maintain a drug blood level of 400 ng/mL 2 hours after the morning dose. Both drugs were taken in the morning and again 12 hours later. The drugs were taken consistently either before, during, or after meals. No grapefruit or grapefruit juice was allowed throughout the study.'}], 'classes': [{'title': 'Month 12 (n=111, 111)', 'categories': [{'measurements': [{'value': '61.26', 'spread': '22.06', 'groupId': 'OG000'}, {'value': '62.50', 'spread': '20.70', 'groupId': 'OG001'}]}]}, {'title': 'Month 18 (n=108, 108)', 'categories': [{'measurements': [{'value': '60.90', 'spread': '22.85', 'groupId': 'OG000'}, {'value': '62.80', 'spread': '21.18', 'groupId': 'OG001'}]}]}, {'title': 'Month 24 (n=106, 110)', 'categories': [{'measurements': [{'value': '61.92', 'spread': '25.37', 'groupId': 'OG000'}, {'value': '63.76', 'spread': '21.71', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 12, Month 18, and Month 24', 'description': 'Renal function was assessed by measuring serum creatinine and by computing creatinine clearance using the formula of Cockcroft-Gault.', 'unitOfMeasure': 'mL/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population: All randomized subjects for whom at least one valid post-baseline efficacy measurement was obtained and used for efficacy analyses.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Died, Number of Participants Who Lost Their Graft, and Number of Participants Who Died or Lost Their Graft', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Upper Everolimus Blood Target + Very Low Dose Cyclosporine', 'description': 'Patients received everolimus orally twice daily at a dose that was adjusted to achieve a drug blood trough level in the range of 8-12 ng/mL. Patients also received a very low dose of cyclosporine (150-300 ng/mL) orally twice daily that was adjusted to maintain a drug blood level of 200 ng/mL 2 hours after the morning dose. Both drugs were taken in the morning and again 12 hours later. The drugs were taken consistently either before, during, or after meals. No grapefruit or grapefruit juice was allowed throughout the study.'}, {'id': 'OG001', 'title': 'Standard Everolimus Blood Target + Low Dose Cyclosporine', 'description': 'Patients received everolimus orally twice daily at a dose that was adjusted to achieve a drug blood trough level in the range of 3-8 ng/mL. Patients also received a low dose of cyclosporine (350-500 ng/mL) orally twice daily that was adjusted to maintain a drug blood level of 400 ng/mL 2 hours after the morning dose. Both drugs were taken in the morning and again 12 hours later. The drugs were taken consistently either before, during, or after meals. No grapefruit or grapefruit juice was allowed throughout the study.'}], 'classes': [{'title': 'Died', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Lost graft', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Died or lost graft', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to end of study (Month 24)', 'description': 'A participant lost his graft if he/she started dialysis and was not able to subsequently be removed from dialysis or underwent graft nephrectomy.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population: All randomized subjects who took at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE) or Deaths', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Upper Everolimus Blood Target + Very Low Dose Cyclosporine', 'description': 'Patients received everolimus orally twice daily at a dose that was adjusted to achieve a drug blood trough level in the range of 8-12 ng/mL. Patients also received a very low dose of cyclosporine (150-300 ng/mL) orally twice daily that was adjusted to maintain a drug blood level of 200 ng/mL 2 hours after the morning dose. Both drugs were taken in the morning and again 12 hours later. The drugs were taken consistently either before, during, or after meals. No grapefruit or grapefruit juice was allowed throughout the study.'}, {'id': 'OG001', 'title': 'Standard Everolimus Blood Target + Low Dose Cyclosporine', 'description': 'Patients received everolimus orally twice daily at a dose that was adjusted to achieve a drug blood trough level in the range of 3-8 ng/mL. Patients also received a low dose of cyclosporine (350-500 ng/mL) orally twice daily that was adjusted to maintain a drug blood level of 400 ng/mL 2 hours after the morning dose. Both drugs were taken in the morning and again 12 hours later. The drugs were taken consistently either before, during, or after meals. No grapefruit or grapefruit juice was allowed throughout the study.'}], 'classes': [{'title': 'AEs', 'categories': [{'measurements': [{'value': '142', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}]}, {'title': 'Infection', 'categories': [{'measurements': [{'value': '95', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}]}, {'title': 'Clinically significant AEs', 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}]}, {'title': 'Died', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to end of study (Month 24)', 'description': 'Safety was assessed using reports of adverse events of all participants in this study. Serious adverse events are those events that resulted in death, were life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect.', 'unitOfMeasure': 'Partcipants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population: All randomized subjects who took at least one dose of study drug.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Upper Everolimus Blood Target + Very Low Dose Cyclosporine', 'description': 'Patients received everolimus orally twice daily at a dose that was adjusted to achieve a drug blood trough level in the range of 8-12 ng/mL. Patients also received a very low dose of cyclosporine (150-300 ng/mL) orally twice daily that was adjusted to maintain a drug blood level of 200 ng/mL 2 hours after the morning dose. Both drugs were taken in the morning and again 12 hours later. The drugs were taken consistently either before, during, or after meals. No grapefruit or grapefruit juice was allowed throughout the study.'}, {'id': 'FG001', 'title': 'Standard Everolimus Blood Target + Low Dose Cyclosporine', 'description': 'Patients received everolimus orally twice daily at a dose that was adjusted to achieve a drug blood trough level in the range of 3-8 ng/mL. Patients also received a low dose of cyclosporine (350-500 ng/mL) orally twice daily that was adjusted to maintain a drug blood level of 400 ng/mL 2 hours after the morning dose. Both drugs were taken in the morning and again 12 hours later. The drugs were taken consistently either before, during, or after meals. No grapefruit or grapefruit juice was allowed throughout the study.'}], 'periods': [{'title': 'Core Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '142'}, {'groupId': 'FG001', 'numSubjects': '143'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '129'}, {'groupId': 'FG001', 'numSubjects': '123'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '20'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Administrative problems', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '12'}]}]}, {'title': 'Extension Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '111'}, {'groupId': 'FG001', 'numSubjects': '112'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '105'}, {'groupId': 'FG001', 'numSubjects': '110'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'This study was an 18-month extension to the 6-month core study NCT01276457. All patients who were receiving treatment at the end of the core study and signed the informed consent of the extension study were included. Patients received the same treatment in the extension study that they received in the core study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'BG000'}, {'value': '112', 'groupId': 'BG001'}, {'value': '223', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Upper Everolimus Blood Target + Very Low Dose Cyclosporine', 'description': 'Patients received everolimus orally twice daily at a dose that was adjusted to achieve a drug blood trough level in the range of 8-12 ng/mL. Patients also received a very low dose of cyclosporine (150-300 ng/mL) orally twice daily that was adjusted to maintain a drug blood level of 200 ng/mL 2 hours after the morning dose. Both drugs were taken in the morning and again 12 hours later. The drugs were taken consistently either before, during, or after meals. No grapefruit or grapefruit juice was allowed throughout the study.'}, {'id': 'BG001', 'title': 'Standard Everolimus Blood Target + Low Dose Cyclosporine', 'description': 'Patients received everolimus orally twice daily at a dose that was adjusted to achieve a drug blood trough level in the range of 3-8 ng/mL. Patients also received a low dose of cyclosporine (350-500 ng/mL) orally twice daily that was adjusted to maintain a drug blood level of 400 ng/mL 2 hours after the morning dose. Both drugs were taken in the morning and again 12 hours later. The drugs were taken consistently either before, during, or after meals. No grapefruit or grapefruit juice was allowed throughout the study.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45.3', 'spread': '12.2', 'groupId': 'BG000'}, {'value': '45.7', 'spread': '10.2', 'groupId': 'BG001'}, {'value': '45.5', 'spread': '11.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '146', 'groupId': 'BG002'}]}]}], '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': 223}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-05', 'completionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-05-17', 'studyFirstSubmitDate': '2011-01-12', 'resultsFirstSubmitDate': '2011-01-25', 'studyFirstSubmitQcDate': '2011-01-12', 'lastUpdatePostDateStruct': {'date': '2011-05-20', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-03-22', 'studyFirstPostDateStruct': {'date': '2011-01-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-04-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Biopsy-proven Acute Rejection', 'timeFrame': 'Baseline to end of study (Month 24)', 'description': 'A graft core biopsy was performed on all suspected acute rejection episodes within 48 hours. Biopsies were read by the local pathologist according to the 1997 Banff criteria. A biopsy-proven acute rejection was be defined as a biopsy graded IA, IB, IIA, IIB, or III.'}, {'measure': 'Renal Function Assessed by Creatinine Clearance', 'timeFrame': 'Month 12, Month 18, and Month 24', 'description': 'Renal function was assessed by measuring serum creatinine and by computing creatinine clearance using the formula of Cockcroft-Gault.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Who Died, Number of Participants Who Lost Their Graft, and Number of Participants Who Died or Lost Their Graft', 'timeFrame': 'Baseline to end of study (Month 24)', 'description': 'A participant lost his graft if he/she started dialysis and was not able to subsequently be removed from dialysis or underwent graft nephrectomy.'}, {'measure': 'Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE) or Deaths', 'timeFrame': 'Baseline to end of study (Month 24)', 'description': 'Safety was assessed using reports of adverse events of all participants in this study. Serious adverse events are those events that resulted in death, were life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect.'}]}, 'conditionsModule': {'keywords': ['immunosuppression', 'kidney transplantation', 'everolimus', 'safety'], 'conditions': ['Transplantation Infection']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to allow the continuation of everolimus treatment in patients who have completed the core study (NCT00170885) and to collect long-term safety, tolerability, and efficacy data in a group of patients treated with the upper everolimus target levels plus very low dose cyclosporin in comparison with the standard everolimus target levels plus low dose cyclosporin in patients with renal transplantation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with functioning graft who had completed the 6-month treatment period of core study\n* Patients who were receiving treatment with either everolimus and cyclosporin at the end of the core study\n* Patients who signed the informed consent of the present study extension\n\nExclusion Criteria:\n\n\\- Women who were pregnant, lactating or who wished to became pregnant.\n\nOther protocol-defined inclusion/exclusion criteria applied to the study.'}, 'identificationModule': {'nctId': 'NCT01276457', 'acronym': 'EVEREST', 'briefTitle': 'Everolimus in Combination With Cyclosporine Microemulsion in de Novo Renal Transplant Recipients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'An 18 Month Extension to the Multicenter, Randomized, Open-label Trial (NCT00170885) to Evaluate the Safety, Tolerability, and Efficacy of Two Regimens of Everolimus Plus Cyclosporine Microemulsion, Given According to Different Blood Target Levels, in de Novo Renal Transplant Recipients', 'orgStudyIdInfo': {'id': 'CRAD001AIT02E1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Upper everolimus blood target + very low dose cyclosporine', 'description': 'Patients received everolimus orally twice daily at a dose that was adjusted to achieve a drug blood trough level in the range of 8-12 ng/mL. Patients also received a very low dose of cyclosporine (150-300 ng/mL) orally twice daily that was adjusted to maintain a drug blood level of 200 ng/mL 2 hours after the morning dose. Both drugs were taken in the morning and again 12 hours later. The drugs were taken consistently either before, during, or after meals. No grapefruit or grapefruit juice was allowed throughout the study.', 'interventionNames': ['Drug: Everolimus 0.25 and 0.75 mg tablets', 'Drug: Cyclosporine very low dose (150-300 ng/mL) microemulsion']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard everolimus blood target + low dose cyclosporine', 'description': 'Patients received everolimus orally twice daily at a dose that was adjusted to achieve a drug blood trough level in the range of 3-8 ng/mL. Patients also received a low dose of cyclosporine (350-500 ng/mL) orally twice daily that was adjusted to maintain a drug blood level of 400 ng/mL 2 hours after the morning dose. Both drugs were taken in the morning and again 12 hours later. The drugs were taken consistently either before, during, or after meals. No grapefruit or grapefruit juice was allowed throughout the study.', 'interventionNames': ['Drug: Everolimus 0.25 and 0.75 mg tablets', 'Drug: Cyclosporine low dose (350-500 ng/mL) microemulsion']}], 'interventions': [{'name': 'Everolimus 0.25 and 0.75 mg tablets', 'type': 'DRUG', 'description': 'The dose of everolimus for each patient was adjusted to achieve the target everolimus blood level range. Everolimus blood trough level was measured 5 days after any dose adjustment to verify that the blood level was within the desired target level range.', 'armGroupLabels': ['Standard everolimus blood target + low dose cyclosporine', 'Upper everolimus blood target + very low dose cyclosporine']}, {'name': 'Cyclosporine very low dose (150-300 ng/mL) microemulsion', 'type': 'DRUG', 'otherNames': ['Neoral'], 'description': 'The dose of cyclosporine for each patient was adjusted to achieve the target cyclosporine blood level. Cyclosporine dose adjustments were based on drug blood level determined from whole blood samples taken 2 hours (± 10 min) after the morning dose.', 'armGroupLabels': ['Upper everolimus blood target + very low dose cyclosporine']}, {'name': 'Cyclosporine low dose (350-500 ng/mL) microemulsion', 'type': 'DRUG', 'otherNames': ['Neoral'], 'description': 'The dose of cyclosporine for each patient was adjusted to achieve the target cyclosporine blood level. Cyclosporine dose adjustments were based on drug blood level determined from whole blood samples taken 2 hours (± 10 min) after the morning dose.', 'armGroupLabels': ['Standard everolimus blood target + low dose cyclosporine']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'External Affairs', 'oldOrganization': 'Novartis Pharmaceuticals'}}}}