Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
Study NCT ID:
NCT01551212
Status:
COMPLETED
Last Update Posted:
2019-05-10
First Post:
2012-03-08
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Efficacy of Everolimus in Combination With Tacrolimus in Liver Transplant Recipients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068338', 'term': 'Everolimus'}, {'id': 'D016559', 'term': 'Tacrolimus'}, {'id': 'D000305', 'term': 'Adrenal Cortex Hormones'}], 'ancestors': [{'id': 'D020123', 'term': 'Sirolimus'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Novartis.email@novartis.com', '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 (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 12 months', 'eventGroups': [{'id': 'EG000', 'title': 'Everolimus/Tacrolimus', 'description': 'Tacrolimus minimization arm. Everolimus (C0-h: 3-8 ng/mL) + tacrolimus (C0-h: \\< 5 ng/mL)', 'otherNumAtRisk': 169, 'deathsNumAtRisk': 169, 'otherNumAffected': 164, 'seriousNumAtRisk': 169, 'deathsNumAffected': 3, 'seriousNumAffected': 111}, {'id': 'EG001', 'title': 'Tacrolimus', 'description': 'Tacrolimus (C0-h: 6-10 ng/ml)', 'otherNumAtRisk': 164, 'deathsNumAtRisk': 164, 'otherNumAffected': 153, 'seriousNumAtRisk': 164, 'deathsNumAffected': 4, 'seriousNumAffected': 101}], 'otherEvents': [{'term': 'ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 20}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'LEUKOPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 12}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'THROMBOCYTOPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'ABDOMINAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'ABDOMINAL PAIN UPPER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'APHTHOUS ULCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'ASCITES', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'CONSTIPATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 39}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'VOMITING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'IMPAIRED HEALING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'OEDEMA PERIPHERAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 15}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'PYREXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'CHOLANGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'HEPATIC CYST', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 3}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'HEPATIC STEATOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 8}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'CYTOMEGALOVIRUS INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 28}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'URINARY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 24}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'VIRAL UPPER RESPIRATORY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 29}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'INCISIONAL HERNIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 10}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'PROCEDURAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 9}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'BLOOD CREATININE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 21}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'BODY TEMPERATURE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 9}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'C-REACTIVE PROTEIN INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 9}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'GAMMA-GLUTAMYLTRANSFERASE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 12}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'HEPATIC ENZYME INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 13}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'TRANSAMINASES INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'DIABETES MELLITUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'HYPERCHOLESTEROLAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 9}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'HYPERKALAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 17}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'HYPERLIPIDAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'HYPERTRIGLYCERIDAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'HYPERURICAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'HYPOKALAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'IRON DEFICIENCY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'VITAMIN D DEFICIENCY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 10}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'ARTHRALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'BACK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 12}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'MUSCLE SPASMS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 9}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'PAIN IN EXTREMITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 48}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 22}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'TREMOR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 23}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'DEPRESSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 10}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'INSOMNIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 9}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'PROTEINURIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 12}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'RENAL FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 15}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'RENAL IMPAIRMENT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 15}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'COUGH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'DYSPNOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'PLEURAL EFFUSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 12}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'ALOPECIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'PRURITUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 10}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'HYPERTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 24}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}], 'seriousEvents': [{'term': 'ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'BONE MARROW TOXICITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'EVANS SYNDROME', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'HYPOCHROMIC ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'IRON DEFICIENCY ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'LYMPHOCYTOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'PANCYTOPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'THROMBOCYTOPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'ACUTE MYOCARDIAL INFARCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'ATRIAL FIBRILLATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'CARDIOGENIC SHOCK', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'CORONARY ARTERY DISEASE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'MITRAL VALVE INCOMPETENCE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'PERICARDIAL EFFUSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'SUPRAVENTRICULAR TACHYCARDIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'TACHYCARDIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'VENTRICULAR EXTRASYSTOLES', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'VENTRICULAR TACHYCARDIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}], 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complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'COMPLICATIONS OF TRANSPLANTED LIVER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'CONCUSSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'FALL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 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'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'LUMBAR VERTEBRAL FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'OVERDOSE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'PELVIC FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'POST PROCEDURAL BILE LEAK', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'SPINAL COMPRESSION FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'SPINAL FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'SUBARACHNOID HAEMORRHAGE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'THORACIC VERTEBRAL FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'TRANSPLANT FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'ULNA FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'VASCULAR PSEUDOANEURYSM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'WEANING FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'WOUND DEHISCENCE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'ALANINE AMINOTRANSFERASE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'ASPARTATE AMINOTRANSFERASE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'BLOOD ALKALINE PHOSPHATASE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'BLOOD BILIRUBIN INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'BLOOD CREATINE PHOSPHOKINASE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'BLOOD CREATININE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'BLOOD POTASSIUM INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'C-REACTIVE PROTEIN INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'CHEST X-RAY ABNORMAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'GAMMA-GLUTAMYLTRANSFERASE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'GLUTAMATE DEHYDROGENASE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'HAEMOGLOBIN DECREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'HEPATIC ARTERY FLOW DECREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'HEPATIC ENZYME INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'LIVER FUNCTION TEST INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'TRANSAMINASES INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'TROPONIN INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'WHITE BLOOD CELL COUNT INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'ACIDOSIS HYPERCHLORAEMIC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'DEHYDRATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'DIABETIC COMPLICATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'FLUID RETENTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'GOUT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'HYPERGLYCAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'HYPERINSULINAEMIC HYPOGLYCAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'HYPERKALAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'HYPONATRAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'BACK PAIN', 'stats': 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164, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'ACUTE MYELOID LEUKAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'CHRONIC MYELOID LEUKAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'HEPATOCELLULAR CARCINOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'LYMPHOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'PROSTATE CANCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'SQUAMOUS CELL CARCINOMA OF SKIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}], 'organSystem': 'Neoplasms 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STROKE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'NERVOUS SYSTEM DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'PARAPARESIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'POLYNEUROPATHY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'POSTERIOR REVERSIBLE ENCEPHALOPATHY SYNDROME', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'PRESYNCOPE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'SEIZURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'SYNCOPE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'TRANSIENT ISCHAEMIC ATTACK', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'TREMOR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'ABORTION SPONTANEOUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'DEVICE OCCLUSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'DISORIENTATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'ACUTE KIDNEY INJURY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 8}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'ALBUMINURIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'CYSTITIS HAEMORRHAGIC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'IGA NEPHROPATHY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'OLIGURIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'PRERENAL FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'PROTEINURIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'RENAL FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'RENAL IMPAIRMENT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'ACUTE RESPIRATORY DISTRESS SYNDROME', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'ASTHMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'DYSPNOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'HAEMOPTYSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'PLEURAL EFFUSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'PLEURISY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'PNEUMONIA ASPIRATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'PNEUMOTHORAX', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'PULMONARY EMBOLISM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'RESPIRATORY FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'ANGIOEDEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'DIABETIC FOOT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'PRURITUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'ANGIODYSPLASIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'ARTERY DISSECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'DIABETIC VASCULAR DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'HAEMATOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'HYPERTENSIVE CRISIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'INFERIOR VENA CAVA STENOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'INTERNAL HAEMORRHAGE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'LYMPHATIC FISTULA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'PERIPHERAL ARTERIAL OCCLUSIVE DISEASE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'POOR PERIPHERAL CIRCULATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'THROMBOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'VENA CAVA THROMBOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 169, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 164, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Estimated Glomerular Filtration Rate (GFR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}, {'value': '164', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Everolimus/Tacrolimus', 'description': 'Tacrolimus minimization arm. Everolimus (C0-h: 3-8 ng/mL) + tacrolimus (C0-h: \\< 5 ng/mL)'}, {'id': 'OG001', 'title': 'Tacrolimus', 'description': 'Tacrolimus (C0-h: 6-10 ng/ml)'}], 'classes': [{'categories': [{'measurements': [{'value': '73.46', 'spread': '25.57', 'groupId': 'OG000'}, {'value': '71.95', 'spread': '27.17', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.097', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.09', 'ciLowerLimit': '-0.74', 'ciUpperLimit': '8.91', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'factors: treatment, center, HCV-Class (positive, negative) and lab MELD (≤ 30 vs \\> 30) covariate: baseline value'}], 'paramType': 'MEAN', 'timeFrame': 'month 12', 'description': 'The estmated GFR was calculated using MDRD-4 formula (Modification of Diet in Renal Disease Study Group).', 'unitOfMeasure': 'mL/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS (Full Analysis Set - All Randomized AND Treated Patients) with LOCF (last observation carried forward)'}, {'type': 'SECONDARY', 'title': 'Estimated GFR - PP Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Everolimus/Tacrolimus', 'description': 'Tacrolimus minimization arm. Everolimus (C0-h: 3-8 ng/mL) + tacrolimus (C0-h: \\< 5 ng/mL)'}, {'id': 'OG001', 'title': 'Tacrolimus', 'description': 'Tacrolimus (C0-h: 6-10 ng/ml)'}], 'classes': [{'categories': [{'measurements': [{'value': '74.83', 'spread': '25.19', 'groupId': 'OG000'}, {'value': '70.65', 'spread': '24.91', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0085', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.99', 'ciLowerLimit': '2.06', 'ciUpperLimit': '13.92', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'factors: treatment, center, HCV-Class (positive, negative) and lab MELD (≤ 30 vs \\> 30) covariate: baseline value'}], 'paramType': 'MEAN', 'timeFrame': 'month 12', 'description': 'This was a sensitivity analysis for the primary outcome measure based on the per-protocol set of patients.', 'unitOfMeasure': 'mL/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Set (PP)'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Treated Biopsy Proven Acute Rejection (BPAR), Graft Loss or Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}, {'value': '164', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Everolimus/Tacrolimus', 'description': 'Tacrolimus minimization arm. Everolimus (C0-h: 3-8 ng/mL) + tacrolimus (C0-h: \\< 5 ng/mL)'}, {'id': 'OG001', 'title': 'Tacrolimus', 'description': 'Tacrolimus (C0-h: 6-10 ng/ml)'}], 'classes': [{'categories': [{'measurements': [{'value': '9.5', 'groupId': 'OG000'}, {'value': '7.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.699', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Percentage of Participants with Treated Biopsy Proven Acute Rejection (BPAR), Graft Loss or Death at Month 12', 'unitOfMeasure': 'Percent of Patients', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Number of Participants With HCV', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}, {'value': '164', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Everolimus/Tacrolimus', 'description': 'Tacrolimus minimization arm. Everolimus (C0-h: 3-8 ng/mL) + tacrolimus (C0-h: \\< 5 ng/mL)'}, {'id': 'OG001', 'title': 'Tacrolimus', 'description': 'Tacrolimus (C0-h: 6-10 ng/ml)'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'Number of Participants with HCV (hepatitis C virus) assessed as treatment emergent adverse events of special interest', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Set'}, {'type': 'SECONDARY', 'title': 'Incidence of HCV Related Fibrosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}, {'value': '164', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Everolimus/Tacrolimus', 'description': 'Tacrolimus minimization arm. Everolimus (C0-h: 3-8 ng/mL) + tacrolimus (C0-h: \\< 5 ng/mL)'}, {'id': 'OG001', 'title': 'Tacrolimus', 'description': 'Tacrolimus (C0-h: 6-10 ng/ml)'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'Incidence of hepatitis C virus (HCV) related fibrosis assessed as treatment emergent adverse events of special interest', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Set'}, {'type': 'SECONDARY', 'title': 'Incidence of de Novo HCC Malignancies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}, {'value': '164', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Everolimus/Tacrolimus', 'description': 'Tacrolimus minimization arm. Everolimus (C0-h: 3-8 ng/mL) + tacrolimus (C0-h: \\< 5 ng/mL)'}, {'id': 'OG001', 'title': 'Tacrolimus', 'description': 'Tacrolimus (C0-h: 6-10 ng/ml)'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'Incidence of de novo Hepatocellular Carcinoma (HCC) malignancies assessed as treatment emergent adverse events of special interest', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Set'}, {'type': 'SECONDARY', 'title': 'Incidence and Severity of CMV Viral Infections.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}, {'value': '164', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Everolimus/Tacrolimus', 'description': 'Tacrolimus minimization arm. Everolimus (C0-h: 3-8 ng/mL) + tacrolimus (C0-h: \\< 5 ng/mL)'}, {'id': 'OG001', 'title': 'Tacrolimus', 'description': 'Tacrolimus (C0-h: 6-10 ng/ml)'}], 'classes': [{'categories': [{'title': 'No CMV viral infection', 'measurements': [{'value': '136', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}, {'title': 'Asymptomatic', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'title': 'Mild', 'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}, {'title': 'Moderate', 'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}, {'title': 'Severe', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'Incidence and severity of cytomegalovirus (CMV) viral infections assessed as treatment emergent adverse events of special interest.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Set'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Everolimus/Tacrolimus', 'description': 'Tacrolimus minimization arm. Everolimus (C0-h: 3-8 ng/mL) + tacrolimus (C0-h: \\< 5 ng/mL)'}, {'id': 'FG001', 'title': 'Tacrolimus', 'description': 'Tacrolimus (C0-h: 6-10 ng/ml)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Randomized', 'achievements': [{'groupId': 'FG000', 'numSubjects': '171'}, {'groupId': 'FG001', 'numSubjects': '168'}]}, {'type': 'Full Anylsis Set (FAS)', 'comment': 'Randomized and received at least 1 dose of study drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '169'}, {'groupId': 'FG001', 'numSubjects': '164'}]}, {'type': 'Safety Set', 'comment': 'Received at least 1 dose of study drug and had a post-baseline safety assessment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '169'}, {'groupId': 'FG001', 'numSubjects': '164'}]}, {'type': 'Per Protocol Set (PP)', 'comment': 'In FAS without a major protocol deviation', 'achievements': [{'groupId': 'FG000', 'numSubjects': '110'}, {'groupId': 'FG001', 'numSubjects': '101'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '166'}, {'groupId': 'FG001', 'numSubjects': '148'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '20'}]}], 'dropWithdraws': [{'type': 'Graft loss/Retransplantation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Administrative problems', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Never Received Study Treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}], 'recruitmentDetails': 'In total, 642 patients were screened for study eligibility at 15 study centers in Germany. 339 patients were randomized out of which 333 received study treatment and were included in the analyses.', 'preAssignmentDetails': "Patients were screened for eligibility prior to liver transplantation (LTx). The study treatment started after a run-in period that ended on the day of randomization, scheduled at Day 7-21 post-LTx. Patients may have been initiated on an optional induction therapy, MMF, TAC at investigators' discretion."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'BG000'}, {'value': '164', 'groupId': 'BG001'}, {'value': '333', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Everolimus/Tacrolimus', 'description': 'Tacrolimus minimization arm. Everolimus (C0-h: 3-8 ng/mL) + tacrolimus (C0-h: \\< 5 ng/mL)'}, {'id': 'BG001', 'title': 'Tacrolimus', 'description': 'Tacrolimus (C0-h: 6-10 ng/ml)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.68', 'spread': '9.38', 'groupId': 'BG000'}, {'value': '53.46', 'spread': '9.64', 'groupId': 'BG001'}, {'value': '53.57', 'spread': '9.49', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Full Analysis Set (FAS)'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '133', 'groupId': 'BG000'}, {'value': '121', 'groupId': 'BG001'}, {'value': '254', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '168', 'groupId': 'BG000'}, {'value': '157', 'groupId': 'BG001'}, {'value': '325', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Full Analysis Set (FAS)'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-08-19', 'size': 844135, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-08-02T08:42', 'hasProtocol': True}, {'date': '2017-11-06', 'size': 819408, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-08-02T10:01', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 339}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2017-08-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-09', 'studyFirstSubmitDate': '2012-03-08', 'resultsFirstSubmitDate': '2018-08-02', 'studyFirstSubmitQcDate': '2012-03-09', 'lastUpdatePostDateStruct': {'date': '2019-05-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-05-09', 'studyFirstPostDateStruct': {'date': '2012-03-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-05-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-08-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Estimated Glomerular Filtration Rate (GFR)', 'timeFrame': 'month 12', 'description': 'The estmated GFR was calculated using MDRD-4 formula (Modification of Diet in Renal Disease Study Group).'}], 'secondaryOutcomes': [{'measure': 'Estimated GFR - PP Set', 'timeFrame': 'month 12', 'description': 'This was a sensitivity analysis for the primary outcome measure based on the per-protocol set of patients.'}, {'measure': 'Percentage of Participants With Treated Biopsy Proven Acute Rejection (BPAR), Graft Loss or Death', 'timeFrame': '12 months', 'description': 'Percentage of Participants with Treated Biopsy Proven Acute Rejection (BPAR), Graft Loss or Death at Month 12'}, {'measure': 'Number of Participants With HCV', 'timeFrame': '12 months', 'description': 'Number of Participants with HCV (hepatitis C virus) assessed as treatment emergent adverse events of special interest'}, {'measure': 'Incidence of HCV Related Fibrosis', 'timeFrame': '12 months', 'description': 'Incidence of hepatitis C virus (HCV) related fibrosis assessed as treatment emergent adverse events of special interest'}, {'measure': 'Incidence of de Novo HCC Malignancies', 'timeFrame': '12 months', 'description': 'Incidence of de novo Hepatocellular Carcinoma (HCC) malignancies assessed as treatment emergent adverse events of special interest'}, {'measure': 'Incidence and Severity of CMV Viral Infections.', 'timeFrame': '12 months', 'description': 'Incidence and severity of cytomegalovirus (CMV) viral infections assessed as treatment emergent adverse events of special interest.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Liver transplantation', 'Everolimus', 'Tacrolimus', 'Renal function'], 'conditions': ['Liver Transplantation']}, 'referencesModule': {'references': [{'pmid': '34525259', 'type': 'DERIVED', 'citation': 'Nashan B, Schemmer P, Braun F, Schlitt HJ, Pascher A, Klein CG, Neumann UP, Kroeger I, Wimmer P; Hephaistos Study Group. Early Everolimus-Facilitated Reduced Tacrolimus in Liver Transplantation: Results From the Randomized HEPHAISTOS Trial. Liver Transpl. 2022 Jun;28(6):998-1010. doi: 10.1002/lt.26298. Epub 2021 Oct 12.'}, {'pmid': '25873064', 'type': 'DERIVED', 'citation': 'Nashan B, Schemmer P, Braun F, Dworak M, Wimmer P, Schlitt H. Evaluating the efficacy, safety and evolution of renal function with early initiation of everolimus-facilitated tacrolimus reduction in de novo liver transplant recipients: Study protocol for a randomized controlled trial. Trials. 2015 Mar 26;16:118. doi: 10.1186/s13063-015-0626-0.'}]}, 'descriptionModule': {'briefSummary': 'This trial evaluated the efficacy and safety of Everolimus in combination with tacrolimus versus a standard immunosuppressive regimen concerning kidney function in liver transplant recipients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\nMale or female recipients of a full-size liver allograft, aged 18 to 65 years.\n\nExclusion criteria:\n\nPatients with thrombocytopenia (platelets \\<50,000/mm³), with an absolute neutrophil count of \\<1,000/mm³ or leucopenia (leucocytes \\<2000/mm³), with anemia with Hb \\< 6g/dl at time of randomization\n\nPatients with uncontrolled hypercholesterolemia (\\>350mg/dL; \\>9mmol/L) or hypertriglyceridemia (\\>750 mg/dL; \\>8.5 mmol/L) at time of randomization\n\nHistory 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'}, 'identificationModule': {'nctId': 'NCT01551212', 'acronym': 'HEPHAISTOS', 'briefTitle': 'Efficacy of Everolimus in Combination With Tacrolimus in Liver Transplant Recipients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A 12-month, Multi-center, Open-label, Randomized, Controlled Study to Evaluate Efficacy/Safety and Evolution of Renal Function of Everolimus in Co-exposure With Tacrolimus in de Novo Liver Transplant Recipients', 'orgStudyIdInfo': {'id': 'CRAD001HDE13'}, 'secondaryIdInfos': [{'id': '2011-003118-17', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'EVR/TAC', 'description': 'Tacrolimus minimization arm. Everolimus (C0-h: 3-8 ng/mL) + tacrolimus (C0-h: \\< 5 ng/mL)', 'interventionNames': ['Drug: Everolimus', 'Drug: Tacrolimus', 'Drug: Corticosteroids']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TAC', 'description': 'Tacrolimus (C0-h: 6-10 ng/ml)', 'interventionNames': ['Drug: Tacrolimus', 'Drug: Corticosteroids']}], 'interventions': [{'name': 'Everolimus', 'type': 'DRUG', 'otherNames': ['RAD001 / Certican'], 'description': 'tablet containing 0.25mg, 0.5mg, 0.75mg or 1.0mg', 'armGroupLabels': ['EVR/TAC']}, {'name': 'Tacrolimus', 'type': 'DRUG', 'otherNames': ['Tacrolimus Hexal'], 'description': 'capsule containing 0.5, 1.0, or 5.0mg', 'armGroupLabels': ['EVR/TAC', 'TAC']}, {'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 may have been used for the duration of the study according to the investigator's discretion, but may not have been eliminated sooner than 6 months post-transplantation.", 'armGroupLabels': ['EVR/TAC', 'TAC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52074', 'city': 'Aachen', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 50.77664, 'lon': 6.08342}}, {'zip': '13353', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '53105', 'city': 'Bonn', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}, {'zip': '91052', 'city': 'Erlangen', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 49.59099, 'lon': 11.00783}}, {'zip': '45147', 'city': 'Essen', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '60590', 'city': 'Frankfurt', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'zip': '20246', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '30625', 'city': 'Hanover', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': '69120', 'city': 'Heidelberg', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'zip': '24105', 'city': 'Kiel', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 54.32133, 'lon': 10.13489}}, {'zip': '04103', 'city': 'Leipzig', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': '55131', 'city': 'Mainz', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'zip': '81377', 'city': 'München', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': '93053', 'city': 'Regensburg', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 49.01513, 'lon': 12.10161}}, {'zip': '72076', 'city': 'Tübingen', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}