Ignite Creation Date:
2025-12-24 @ 10:00 PM
Ignite Modification Date:
2026-01-02 @ 3:28 AM
Study NCT ID:
NCT01858532
Status:
TERMINATED
Last Update Posted:
2019-04-24
First Post:
2013-05-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study Of Diabetic Nephropathy With Atrasentan
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Argentina', 'Australia', 'Austria', 'Belgium', 'Brazil', 'Bulgaria', 'Canada', 'Chile', 'China', 'Czechia', 'Denmark', 'Finland', 'France', 'Germany', 'Greece', 'Hong Kong', 'Ireland', 'Israel', 'Italy', 'Japan', 'Malaysia', 'Mexico', 'Netherlands', 'New Zealand', 'Peru', 'Poland', 'Portugal', 'Puerto Rico', 'Romania', 'Russia', 'Singapore', 'Slovakia', 'South Africa', 'South Korea', 'Spain', 'Sweden', 'Switzerland', 'Taiwan', 'Turkey (Türkiye)', 'Ukraine', 'United Kingdom', 'United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D003928', 'term': 'Diabetic Nephropathies'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D007674', 'term': 'Kidney Diseases'}], 'ancestors': [{'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077868', 'term': 'Atrasentan'}], 'ancestors': [{'id': 'D052117', 'term': 'Benzodioxoles'}, {'id': 'D004149', 'term': 'Dioxoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011759', 'term': 'Pyrrolidines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'abbvieclinicaltrials@abbvie.com', 'phone': '800-633-9110', 'title': 'Global Medical Services', 'organization': 'AbbVie'}, 'certainAgreement': {'otherDetails': 'AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were reported from the time of study drug administration until 45 days after the last dose of study drug (up to 24 weeks for the All Atrasentan Set in the Enrichment Period; up to 54 months for the ITT sets in the Double-Blind Period)', 'description': 'TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 45 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.', 'eventGroups': [{'id': 'EG000', 'title': 'Enrichment Atrasentan', 'description': 'Participants who received at least one dose of atrasentan, including both Enrichment and Double-Blind Treatment Periods', 'otherNumAtRisk': 5107, 'deathsNumAtRisk': 5107, 'otherNumAffected': 1781, 'seriousNumAtRisk': 5107, 'deathsNumAffected': 25, 'seriousNumAffected': 292}, {'id': 'EG001', 'title': 'Double-Blind Atrasentan', 'description': 'All participants who received at least one dose of atrasentan during the Double-Blind Treatment Period', 'otherNumAtRisk': 1829, 'deathsNumAtRisk': 1829, 'otherNumAffected': 1043, 'seriousNumAtRisk': 1829, 'deathsNumAffected': 84, 'seriousNumAffected': 685}, {'id': 'EG002', 'title': 'Double-Blind Placebo', 'description': 'All participants who received at least one dose of placebo during the Double-Blind Treatment Period', 'otherNumAtRisk': 1830, 'deathsNumAtRisk': 1830, 'otherNumAffected': 1038, 'seriousNumAtRisk': 1830, 'deathsNumAffected': 79, 'seriousNumAffected': 626}], 'otherEvents': [{'term': 'ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5107, 'numEvents': 183, 'numAffected': 180}, {'groupId': 'EG001', 'numAtRisk': 1829, 'numEvents': 241, 'numAffected': 216}, {'groupId': 'EG002', 'numAtRisk': 1830, 'numEvents': 138, 'numAffected': 127}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5107, 'numEvents': 108, 'numAffected': 103}, {'groupId': 'EG001', 'numAtRisk': 1829, 'numEvents': 116, 'numAffected': 99}, {'groupId': 'EG002', 'numAtRisk': 1830, 'numEvents': 110, 'numAffected': 103}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'OEDEMA PERIPHERAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5107, 'numEvents': 1273, 'numAffected': 1148}, {'groupId': 'EG001', 'numAtRisk': 1829, 'numEvents': 765, 'numAffected': 534}, {'groupId': 'EG002', 'numAtRisk': 1830, 'numEvents': 666, 'numAffected': 483}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'NASOPHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5107, 'numEvents': 152, 'numAffected': 145}, {'groupId': 'EG001', 'numAtRisk': 1829, 'numEvents': 274, 'numAffected': 180}, {'groupId': 'EG002', 'numAtRisk': 1830, 'numEvents': 278, 'numAffected': 169}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'UPPER RESPIRATORY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5107, 'numEvents': 114, 'numAffected': 110}, {'groupId': 'EG001', 'numAtRisk': 1829, 'numEvents': 131, 'numAffected': 106}, {'groupId': 'EG002', 'numAtRisk': 1830, 'numEvents': 140, 'numAffected': 114}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'URINARY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5107, 'numEvents': 51, 'numAffected': 50}, {'groupId': 'EG001', 'numAtRisk': 1829, 'numEvents': 126, 'numAffected': 93}, {'groupId': 'EG002', 'numAtRisk': 1830, 'numEvents': 135, 'numAffected': 93}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'HYPERKALAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5107, 'numEvents': 77, 'numAffected': 77}, {'groupId': 'EG001', 'numAtRisk': 1829, 'numEvents': 159, 'numAffected': 132}, {'groupId': 'EG002', 'numAtRisk': 1830, 'numEvents': 165, 'numAffected': 143}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'HYPERURICAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5107, 'numEvents': 85, 'numAffected': 84}, {'groupId': 'EG001', 'numAtRisk': 1829, 'numEvents': 105, 'numAffected': 101}, {'groupId': 'EG002', 'numAtRisk': 1830, 'numEvents': 106, 'numAffected': 105}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'HYPOGLYCAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5107, 'numEvents': 189, 'numAffected': 126}, {'groupId': 'EG001', 'numAtRisk': 1829, 'numEvents': 193, 'numAffected': 114}, {'groupId': 'EG002', 'numAtRisk': 1830, 'numEvents': 212, 'numAffected': 120}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'BACK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5107, 'numEvents': 62, 'numAffected': 61}, {'groupId': 'EG001', 'numAtRisk': 1829, 'numEvents': 93, 'numAffected': 88}, {'groupId': 'EG002', 'numAtRisk': 1830, 'numEvents': 133, 'numAffected': 125}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'HYPERTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5107, 'numEvents': 79, 'numAffected': 78}, {'groupId': 'EG001', 'numAtRisk': 1829, 'numEvents': 179, 'numAffected': 158}, {'groupId': 'EG002', 'numAtRisk': 1830, 'numEvents': 257, 'numAffected': 218}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}], 'seriousEvents': [{'term': 'ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5107, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 1829, 'numEvents': 28, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 1830, 'numEvents': 15, 'numAffected': 11}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'ANAEMIA OF CHRONIC DISEASE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1829, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1830, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'AUTOIMMUNE HAEMOLYTIC ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1829, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1830, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'COAGULOPATHY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1829, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1830, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'DISSEMINATED INTRAVASCULAR COAGULATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1829, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1830, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'HAEMORRHAGIC ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5107, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1829, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1830, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'IRON DEFICIENCY ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5107, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1829, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 1830, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'LEUKOCYTOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5107, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1829, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1830, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'MICROCYTIC ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1829, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1830, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'NEPHROGENIC ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1829, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1830, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'NEUTROPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1829, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1830, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'PANCYTOPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1829, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1830, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'THROMBOCYTOPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1829, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1830, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'ACUTE CORONARY SYNDROME', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5107, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1829, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 1830, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'ACUTE LEFT VENTRICULAR FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5107, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1829, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1830, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'ACUTE MYOCARDIAL INFARCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5107, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 1829, 'numEvents': 40, 'numAffected': 34}, {'groupId': 'EG002', 'numAtRisk': 1830, 'numEvents': 29, 'numAffected': 28}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'ADAMS-STOKES SYNDROME', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1829, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1830, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'ANGINA PECTORIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5107, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 1829, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 1830, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'ANGINA UNSTABLE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5107, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 1829, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 1830, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'AORTIC VALVE STENOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1829, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1830, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'ARRHYTHMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1829, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1830, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'ARRHYTHMIA SUPRAVENTRICULAR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1829, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1830, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'ARTERIOSCLEROSIS CORONARY ARTERY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1829, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1830, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'ATRIAL FIBRILLATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5107, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1829, 'numEvents': 17, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 1830, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'ATRIAL FLUTTER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5107, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1829, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 1830, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'ATRIAL TACHYCARDIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1829, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1830, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'ATRIOVENTRICULAR BLOCK', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1829, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1830, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'ATRIOVENTRICULAR BLOCK COMPLETE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5107, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1829, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 1830, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'ATRIOVENTRICULAR BLOCK FIRST DEGREE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1829, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1830, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'ATRIOVENTRICULAR BLOCK SECOND DEGREE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5107, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1829, 'numEvents': 1, 'numAffected': 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'DIABETIC FOOT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5107, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1829, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 1830, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'ECZEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1829, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1830, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'INGROWING NAIL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1829, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1830, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'PRURITUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1829, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1830, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'SKIN DISCOLOURATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1829, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1830, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'SKIN ULCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5107, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 1829, 'numEvents': 10, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 1830, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'OVERWORK', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1829, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1830, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'ANEURYSM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1829, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1830, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'AORTIC ANEURYSM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1829, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1830, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'AORTIC ANEURYSM RUPTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1829, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1830, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'AORTIC STENOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5107, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1829, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1830, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'ARTERIAL DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1829, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1830, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'ARTERIAL STENOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1829, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1830, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'ARTERIOSCLEROSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1829, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1830, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'ARTERITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5107, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1829, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1830, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'BLOOD PRESSURE INADEQUATELY CONTROLLED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5107, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1829, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1830, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'DEEP VEIN THROMBOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1829, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 1830, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'DIABETIC VASCULAR DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5107, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1829, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1830, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'DRY GANGRENE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1829, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1830, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'EXTREMITY NECROSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1829, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 1830, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'HAEMATOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1829, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1830, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'HYPERTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1829, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 1830, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'HYPERTENSIVE CRISIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5107, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1829, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1830, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'HYPERTENSIVE EMERGENCY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1829, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1830, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'HYPOTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5107, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 1829, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 1830, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'HYPOVOLAEMIC SHOCK', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1829, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1830, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'MALIGNANT HYPERTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1829, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1830, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'ORTHOSTATIC HYPOTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5107, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1829, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1830, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'PERIPHERAL ARTERIAL OCCLUSIVE DISEASE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5107, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1829, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1830, 'numEvents': 10, 'numAffected': 7}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'PERIPHERAL ARTERY OCCLUSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1829, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1830, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'PERIPHERAL ARTERY STENOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5107, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1829, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1830, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'PERIPHERAL ARTERY THROMBOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1829, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1830, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'PERIPHERAL ISCHAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5107, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1829, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1830, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'PERIPHERAL VASCULAR DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1829, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 1830, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'PERIPHERAL VENOUS DISEASE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5107, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1829, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1830, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'SHOCK HAEMORRHAGIC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5107, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1829, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1830, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'SUBCLAVIAN ARTERY OCCLUSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1829, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1830, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'THROMBOPHLEBITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5107, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1829, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1830, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'VASCULAR OCCLUSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1829, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1830, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time to the First Occurrence of a Component of the Composite Renal Endpoint in the Intent-to-Treat (ITT) Responder Set (as Randomized)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1325', 'groupId': 'OG000'}, {'value': '1323', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intent-to-Treat (ITT) Responder Atrasentan', 'description': 'Participants who achieved at least 30% reduction in their albumin to creatinine ratio (UACR) in the Enrichment Period and were randomized to receive atrasentan in the Double-Blind Treatment Period'}, {'id': 'OG001', 'title': 'Intent-to-Treat (ITT) Responder Placebo', 'description': 'Participants who achieved at least 30% reduction in their albumin to creatinine ratio (UACR) in the Enrichment Period and were randomized to receive placebo in the Double-Blind Treatment Period'}], 'classes': [{'categories': [{'measurements': [{'value': '79', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '=0.029', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'The endpoint was analyzed using the stratified log-rank test for treatment comparison.', 'statisticalMethod': 'Stratified log-rank test', 'nonInferiorityType': 'OTHER'}, {'pValue': '=0.005', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.654', 'ciLowerLimit': '0.488', 'ciUpperLimit': '0.878', 'groupDescription': 'A Cox Proportional Hazards regression model with pre-specified covariates adjusted was used to estimate the hazard ratio of atrasentan to placebo and its 95% confidence interval.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From randomization to individual end of observation, up to 53 months', 'description': 'Time to the first occurrence of a component of the composite renal endpoint was defined as doubling of serum creatinine (confirmed by a 30-day serum creatinine measurement) or the onset of end stage renal disease (estimated glomerular filtration rate \\[eGFR\\] less than 15 ml/min/1.73 m\\^2 confirmed by a 90-day eGFR measurement, receiving chronic dialysis, renal transplantation, or renal death). Only events adjudicated by the Events Adjudication Committee (EAC) were considered in defining this endpoint. Data are presented as number of participants with a primary renal composite event (first event per participant).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Responders (participants who achieved at least 30% reduction in their albumin to creatinine ratio \\[UACR\\] in the Enrichment Period \\[EP\\])'}, {'type': 'SECONDARY', 'title': 'Time to a 50% Estimated Glomerular Filtration Rate Reduction in the Intent-to-Treat (ITT) Responder Set (as Randomized)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1325', 'groupId': 'OG000'}, {'value': '1323', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intent-to-Treat (ITT) Responder Atrasentan', 'description': 'Participants who achieved at least 30% reduction in their albumin to creatinine ratio (UACR) in the Enrichment Period and were randomized to receive atrasentan in the Double-Blind Treatment Period'}, {'id': 'OG001', 'title': 'Intent-to-Treat (ITT) Responder Placebo', 'description': 'Participants who achieved at least 30% reduction in their albumin to creatinine ratio (UACR) in the Enrichment Period and were randomized to receive placebo in the Double-Blind Treatment Period'}], 'classes': [{'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '=0.289', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'The endpoint was analyzed using the stratified log-rank test for treatment comparison.', 'statisticalMethod': 'Stratified log-rank test', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.112', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.779', 'ciLowerLimit': '0.573', 'ciUpperLimit': '1.060', 'groupDescription': 'A Cox Proportional Hazards regression model with pre-specified covariates adjusted was used to estimate the hazard ratio of atrasentan to placebo and its 95% confidence interval.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From randomization to individual end of observation, up to 53 months', 'description': "The event of interest for this outcome was a 50% reduction in a participant's estimated glomerular filtration rate (eGFR) value as compared to baseline, confirmed by a repeated value at least 20 days apart. The event time was defined as the first time that a 50% reduction in eGFR was observed. Data are presented as number of participants with a 50% reduction in eGFR (first event per participant).", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Responders (participants who achieved at least 30% reduction in their albumin to creatinine ratio \\[UACR\\] in the Enrichment Period \\[EP\\])'}, {'type': 'SECONDARY', 'title': 'Time to Cardio-renal Composite Endpoint in the Intent-to-Treat (ITT) Responder Set (as Randomized)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1325', 'groupId': 'OG000'}, {'value': '1323', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intent-to-Treat (ITT) Responder Atrasentan', 'description': 'Participants who achieved at least 30% reduction in their albumin to creatinine ratio (UACR) in the Enrichment Period and were randomized to receive atrasentan in the Double-Blind Treatment Period'}, {'id': 'OG001', 'title': 'Intent-to-Treat (ITT) Responder Placebo', 'description': 'Participants who achieved at least 30% reduction in their albumin to creatinine ratio (UACR) in the Enrichment Period and were randomized to receive placebo in the Double-Blind Treatment Period'}], 'classes': [{'categories': [{'measurements': [{'value': '147', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.089', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'The endpoint was analyzed using the stratified log-rank test for treatment comparison.', 'statisticalMethod': 'Stratified log-rank test', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.049', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.801', 'ciLowerLimit': '0.642', 'ciUpperLimit': '0.999', 'groupDescription': 'A Cox Proportional Hazards regression model with pre-specified covariates adjusted was used to estimate the hazard ratio of atrasentan to placebo and its 95% confidence interval.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From randomization to individual end of observation, up to 53 months', 'description': 'The composite event of interest for this outcome consisted of doubling of serum creatinine, end-stage renal disease (ESRD), cardiovascular (CV) death (including CV death and presumed CV death), nonfatal myocardial infarction (MI; heart attack) and nonfatal stroke. Presumed sudden cardiac death was included as a subcategory of presumed CV death. Only events adjudicated by the Events Adjudication Committee (EAC) were considered in defining this endpoint. Data are presented as number of participants with a cardio-renal composite event (first event per participant).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Responders (participants who achieved at least 30% reduction in their albumin to creatinine ratio \\[UACR\\] in the Enrichment Period \\[EP\\])'}, {'type': 'SECONDARY', 'title': 'Time to First Occurrence of a Component of Composite Renal Endpoint for All Randomized Participants (Pooled)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1834', 'groupId': 'OG000'}, {'value': '1834', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intent-to-Treat (ITT) Atrasentan', 'description': 'All randomized participants who entered the Double-Blind Treatment Period and were randomized to receive atrasentan'}, {'id': 'OG001', 'title': 'Intent-to-Treat Placebo', 'description': 'All randomized participants who entered the Double-Blind Treatment Period and were randomized to receive placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '152', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.72', 'ciLowerLimit': '0.58', 'ciUpperLimit': '0.89', 'groupDescription': 'A Cox Proportional Hazards regression model with pre-specified covariates adjusted was used to estimate the hazard ratio of atrasentan to placebo and its 95% confidence interval.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From randomization to individual end of observation, up to 53 months', 'description': 'Time to the first occurrence of a component of the composite renal endpoint was defined as doubling of serum creatinine (confirmed by a 30-day serum creatinine measurement) or the onset of end stage renal disease (estimated glomerular filtration rate \\[eGFR\\] less than 15 ml/min/1.73 m\\^2 confirmed by a 90-day eGFR measurement, receiving chronic dialysis, renal transplantation, or renal death). Data for all randomized participants were pooled by treatment and analyzed. Data are presented as number of participants with a renal composite event (first event per participant).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population: participants who were randomized to receive either atrasentan or placebo during the Double-Blind Treatment Period'}, {'type': 'SECONDARY', 'title': 'Time to the Cardiovascular Composite Endpoint in the Intent-to-Treat (ITT) Responder Set (as Randomized)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1325', 'groupId': 'OG000'}, {'value': '1323', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intent-to-Treat (ITT) Responder Atrasentan', 'description': 'Participants who achieved at least 30% reduction in their albumin to creatinine ratio (UACR) in the Enrichment Period and were randomized to receive atrasentan in the Double-Blind Treatment Period'}, {'id': 'OG001', 'title': 'Intent-to-Treat (ITT) Responder Placebo', 'description': 'Intent-to-Treat (ITT) Responder Placebo: Participants who achieved at least 30% reduction in their albumin to creatinine ratio (UACR) in the Enrichment Period and were randomized to receive placebo in the Double-Blind Treatment Period'}], 'classes': [{'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.446', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'The endpoint was analyzed using the stratified log-rank test for treatment comparison.', 'statisticalMethod': 'Stratified log-rank test', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.447', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.884', 'ciLowerLimit': '0.643', 'ciUpperLimit': '1.215', 'groupDescription': 'A Cox Proportional Hazards regression model with pre-specified covariates adjusted was used to estimate the hazard ratio of atrasentan to placebo and its 95% confidence interval.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From randomization to individual end of observation, up to 53 months', 'description': 'The composite event of interest for this outcome was cardiovascular (CV) death (CV death, presumed CV death), nonfatal myocardial infarction (MI; heart attack), and nonfatal stroke. Presumed sudden cardiac death was included as a sub-category of presumed CV death. Only events adjudicated by the Events Adjudication Committee (EAC) were used. Data are presented as number of participants with a cardiovascular composite event (first event per participant).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Responders (participants who achieved at least 30% reduction in their albumin to creatinine ratio \\[UACR\\] in the Enrichment Period \\[EP\\])'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intent-to-Treat (ITT) Responder Atrasentan', 'description': 'Participants who achieved at least 30% reduction in their albumin to creatinine ratio (UACR) in the Enrichment Period and were randomized to receive atrasentan in the Double-Blind Treatment Period'}, {'id': 'FG001', 'title': 'Intent-to-Treat (ITT) Responder Placebo', 'description': 'Participants who achieved at least 30% reduction in their albumin to creatinine ratio (UACR) in the Enrichment Period and were randomized to receive placebo in the Double-Blind Treatment Period'}, {'id': 'FG002', 'title': 'Intent-to-Treat (ITT) Non-responder Atrasentan', 'description': 'Participants who achieved \\< 30% reduction in their urinary albumin to creatinine ratio (UACR) in the Enrichment Period and were randomized to receive atrasentan in the Double-Blind Treatment Period'}, {'id': 'FG003', 'title': 'Intent-to-Treat (ITT) Non-responder Placebo', 'description': 'Participants who achieved \\< 30% reduction in their urinary albumin to creatinine ratio (UACR) in the Enrichment Period and were randomized to receive placebo in the Double-Blind Treatment Period'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1325'}, {'groupId': 'FG001', 'numSubjects': '1323'}, {'groupId': 'FG002', 'numSubjects': '509'}, {'groupId': 'FG003', 'numSubjects': '511'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1144'}, {'groupId': 'FG001', 'numSubjects': '1131'}, {'groupId': 'FG002', 'numSubjects': '411'}, {'groupId': 'FG003', 'numSubjects': '418'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '181'}, {'groupId': 'FG001', 'numSubjects': '192'}, {'groupId': 'FG002', 'numSubjects': '98'}, {'groupId': 'FG003', 'numSubjects': '93'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '58'}, {'groupId': 'FG001', 'numSubjects': '50'}, {'groupId': 'FG002', 'numSubjects': '23'}, {'groupId': 'FG003', 'numSubjects': '28'}]}, {'type': 'Withdrew consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '71'}, {'groupId': 'FG001', 'numSubjects': '93'}, {'groupId': 'FG002', 'numSubjects': '46'}, {'groupId': 'FG003', 'numSubjects': '27'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '26'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '14'}]}, {'type': 'Deterioration of medical status', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '7'}]}, {'type': 'Investigator request', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '6'}]}, {'type': 'Other, not specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '13'}, {'groupId': 'FG003', 'numSubjects': '11'}]}]}], 'preAssignmentDetails': '5107 participants dosed in Enrichment Period (EP); 1441 prematurely discontinued Tx or did not proceed to Double-Blind Treatment Period per criteria. 3666 participants completed EP and proceeded to Double-Blind Treatment Period, along with 2 additional participants who discontinued study drug in EP but were randomized in error.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1325', 'groupId': 'BG000'}, {'value': '1323', 'groupId': 'BG001'}, {'value': '509', 'groupId': 'BG002'}, {'value': '511', 'groupId': 'BG003'}, {'value': '3668', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Intent-to-Treat (ITT) Responder Atrasentan', 'description': 'Participants who achieved at least 30% reduction in their albumin to creatinine ratio (UACR) in the Enrichment Period and were randomized to receive atrasentan in the Double-Blind Treatment Period'}, {'id': 'BG001', 'title': 'Intent-to-Treat (ITT) Responder Placebo', 'description': 'Participants who achieved at least 30% reduction in their albumin to creatinine ratio (UACR) in the Enrichment Period and were randomized to receive placebo in the Double-Blind Treatment Period'}, {'id': 'BG002', 'title': 'Intent-to-Treat (ITT) Non-responder Atrasentan', 'description': 'Participants who achieved \\< 30% reduction in their urinary albumin to creatinine ratio (UACR) in the Enrichment Period and were randomized to receive atrasentan in the Double-Blind Treatment Period'}, {'id': 'BG003', 'title': 'Intent-to-Treat (ITT) Non-responder Placebo', 'description': 'Participants who achieved \\< 30% reduction in their urinary albumin to creatinine ratio (UACR) in the Enrichment Period and were randomized to receive placebo in the Double-Blind Treatment Period'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.9', 'spread': '8.64', 'groupId': 'BG000'}, {'value': '64.7', 'spread': '8.66', 'groupId': 'BG001'}, {'value': '63.8', 'spread': '9.12', 'groupId': 'BG002'}, {'value': '63.6', 'spread': '8.93', 'groupId': 'BG003'}, {'value': '64.5', 'spread': '8.77', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '331', 'groupId': 'BG000'}, {'value': '352', 'groupId': 'BG001'}, {'value': '127', 'groupId': 'BG002'}, {'value': '136', 'groupId': 'BG003'}, {'value': '946', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '994', 'groupId': 'BG000'}, {'value': '971', 'groupId': 'BG001'}, {'value': '382', 'groupId': 'BG002'}, {'value': '375', 'groupId': 'BG003'}, {'value': '2722', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '76', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '446', 'groupId': 'BG000'}, {'value': '455', 'groupId': 'BG001'}, {'value': '143', 'groupId': 'BG002'}, {'value': '154', 'groupId': 'BG003'}, {'value': '1198', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '28', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '73', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '39', 'groupId': 'BG003'}, {'value': '224', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '753', 'groupId': 'BG000'}, {'value': '744', 'groupId': 'BG001'}, {'value': '313', 'groupId': 'BG002'}, {'value': '300', 'groupId': 'BG003'}, {'value': '2110', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '32', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Intent-to-Treat (ITT) Responders (participants who achieved at least 30% reduction in their albumin to creatinine ratio \\[UACR\\] in the Enrichment Period \\[EP\\]) and ITT Non-responders (Participants who achieved \\< 30% reduction in their UACR in the EP)'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-05-19', 'size': 2004321, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-03-29T16:06', 'hasProtocol': True}, {'date': '2018-03-20', 'size': 795974, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-03-29T16:06', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5107}}, 'statusModule': {'whyStopped': 'Strategic considerations', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-05-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2018-03-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-29', 'studyFirstSubmitDate': '2013-05-17', 'resultsFirstSubmitDate': '2019-03-29', 'studyFirstSubmitQcDate': '2013-05-17', 'lastUpdatePostDateStruct': {'date': '2019-04-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-03-29', 'studyFirstPostDateStruct': {'date': '2013-05-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to the First Occurrence of a Component of the Composite Renal Endpoint in the Intent-to-Treat (ITT) Responder Set (as Randomized)', 'timeFrame': 'From randomization to individual end of observation, up to 53 months', 'description': 'Time to the first occurrence of a component of the composite renal endpoint was defined as doubling of serum creatinine (confirmed by a 30-day serum creatinine measurement) or the onset of end stage renal disease (estimated glomerular filtration rate \\[eGFR\\] less than 15 ml/min/1.73 m\\^2 confirmed by a 90-day eGFR measurement, receiving chronic dialysis, renal transplantation, or renal death). Only events adjudicated by the Events Adjudication Committee (EAC) were considered in defining this endpoint. Data are presented as number of participants with a primary renal composite event (first event per participant).'}], 'secondaryOutcomes': [{'measure': 'Time to a 50% Estimated Glomerular Filtration Rate Reduction in the Intent-to-Treat (ITT) Responder Set (as Randomized)', 'timeFrame': 'From randomization to individual end of observation, up to 53 months', 'description': "The event of interest for this outcome was a 50% reduction in a participant's estimated glomerular filtration rate (eGFR) value as compared to baseline, confirmed by a repeated value at least 20 days apart. The event time was defined as the first time that a 50% reduction in eGFR was observed. Data are presented as number of participants with a 50% reduction in eGFR (first event per participant)."}, {'measure': 'Time to Cardio-renal Composite Endpoint in the Intent-to-Treat (ITT) Responder Set (as Randomized)', 'timeFrame': 'From randomization to individual end of observation, up to 53 months', 'description': 'The composite event of interest for this outcome consisted of doubling of serum creatinine, end-stage renal disease (ESRD), cardiovascular (CV) death (including CV death and presumed CV death), nonfatal myocardial infarction (MI; heart attack) and nonfatal stroke. Presumed sudden cardiac death was included as a subcategory of presumed CV death. Only events adjudicated by the Events Adjudication Committee (EAC) were considered in defining this endpoint. Data are presented as number of participants with a cardio-renal composite event (first event per participant).'}, {'measure': 'Time to First Occurrence of a Component of Composite Renal Endpoint for All Randomized Participants (Pooled)', 'timeFrame': 'From randomization to individual end of observation, up to 53 months', 'description': 'Time to the first occurrence of a component of the composite renal endpoint was defined as doubling of serum creatinine (confirmed by a 30-day serum creatinine measurement) or the onset of end stage renal disease (estimated glomerular filtration rate \\[eGFR\\] less than 15 ml/min/1.73 m\\^2 confirmed by a 90-day eGFR measurement, receiving chronic dialysis, renal transplantation, or renal death). Data for all randomized participants were pooled by treatment and analyzed. Data are presented as number of participants with a renal composite event (first event per participant).'}, {'measure': 'Time to the Cardiovascular Composite Endpoint in the Intent-to-Treat (ITT) Responder Set (as Randomized)', 'timeFrame': 'From randomization to individual end of observation, up to 53 months', 'description': 'The composite event of interest for this outcome was cardiovascular (CV) death (CV death, presumed CV death), nonfatal myocardial infarction (MI; heart attack), and nonfatal stroke. Presumed sudden cardiac death was included as a sub-category of presumed CV death. Only events adjudicated by the Events Adjudication Committee (EAC) were used. Data are presented as number of participants with a cardiovascular composite event (first event per participant).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diabetes', 'Nephropathy'], 'conditions': ['Diabetic Nephropathy']}, 'referencesModule': {'references': [{'pmid': '40526444', 'type': 'DERIVED', 'citation': 'Jongs N, Gasparyan SB, Frison L, Schloemer P, Brinker M, Little DJ, Heerspink HJL. Use of eGFR Slope Thresholds as End Point Components in a Kidney Disease Progression Hierarchical Composite End Point. J Am Soc Nephrol. 2025 Jun 17. doi: 10.1681/ASN.0000000766. Online ahead of print. No abstract available.'}, {'pmid': '39661119', 'type': 'DERIVED', 'citation': 'Smeijer JD, de Vries ST, Kohan DE, Hou FF, Heerspink HJL. Sex differences in response to the endothelin receptor antagonist atrasentan in individuals with type 2 diabetes and chronic kidney disease: a post hoc analysis of the SONAR trial. Diabetologia. 2025 Mar;68(3):516-525. doi: 10.1007/s00125-024-06326-x. Epub 2024 Dec 11.'}, {'pmid': '37872654', 'type': 'DERIVED', 'citation': 'Heerspink HJL, Jongs N, Schloemer P, Little DJ, Brinker M, Tasto C, Karpefors M, Wheeler DC, Bakris G, Perkovic V, Nkulikiyinka R, Rossert J, Gasparyan SB. Development and Validation of a New Hierarchical Composite End Point for Clinical Trials of Kidney Disease Progression. J Am Soc Nephrol. 2023 Dec 1;34(12):2025-2038. doi: 10.1681/ASN.0000000000000243. Epub 2023 Oct 24.'}, {'pmid': '37716952', 'type': 'DERIVED', 'citation': 'Smeijer JD, Kohan DE, Rossing P, Correa-Rotter R, Liew A, Tang SCW, de Zeeuw D, Gansevoort RT, Ju W, Lambers Heerspink HJ. Insulin resistance, kidney outcomes and effects of the endothelin receptor antagonist atrasentan in patients with type 2 diabetes and chronic kidney disease. Cardiovasc Diabetol. 2023 Sep 16;22(1):251. doi: 10.1186/s12933-023-01964-8.'}, {'pmid': '37657768', 'type': 'DERIVED', 'citation': 'Chan KW, Smeijer JD, Schechter M, Jongs N, Vart P, Kohan DE, Gansevoort RT, Liew A, Tang SCW, Wanner C, de Zeeuw D, Heerspink HJL. Post hoc analysis of the SONAR trial indicates that the endothelin receptor antagonist atrasentan is associated with less pain in patients with type 2 diabetes and chronic kidney disease. Kidney Int. 2023 Dec;104(6):1219-1226. doi: 10.1016/j.kint.2023.08.014. Epub 2023 Aug 31.'}, {'pmid': '35772861', 'type': 'DERIVED', 'citation': 'Smeijer JD, Koomen J, Kohan DE, McMurray JJV, Bakris GL, Correa-Rotter R, Hou FF, Januzzi JL, Kitzman DW, Kolansky DM, Makino H, Perkovic V, Tobe S, Parving HH, de Zeeuw D, Heerspink HJL. Increase in BNP in Response to Endothelin-Receptor Antagonist Atrasentan Is Associated With Incident Heart Failure. JACC Heart Fail. 2022 Jul;10(7):498-507. doi: 10.1016/j.jchf.2022.03.004. Epub 2022 May 4.'}, {'pmid': '34853062', 'type': 'DERIVED', 'citation': 'Waijer SW, Gansevoort RT, Bakris GL, Correa-Rotter R, Hou FF, Kohan DE, Kitzman DW, Makino H, McMurray JJV, Perkovic V, Tobe S, Parving HH, de Zeeuw D, Heerspink HJL. The Effect of Atrasentan on Kidney and Heart Failure Outcomes by Baseline Albuminuria and Kidney Function: A Post Hoc Analysis of the SONAR Randomized Trial. Clin J Am Soc Nephrol. 2021 Dec;16(12):1824-1832. doi: 10.2215/CJN.07340521. Epub 2021 Dec 1.'}, {'pmid': '33338269', 'type': 'DERIVED', 'citation': 'Koomen JV, Stevens J, Bakris G, Correa-Rotter R, Hou FF, Kitzman DW, Kohan DE, Makino H, McMurray JJV, Parving HH, Perkovic V, Tobe SW, de Zeeuw D, Heerspink HJL. Individual Atrasentan Exposure is Associated With Long-term Kidney and Heart Failure Outcomes in Patients With Type 2 Diabetes and Chronic Kidney Disease. Clin Pharmacol Ther. 2021 Jun;109(6):1631-1638. doi: 10.1002/cpt.2143. Epub 2021 Jan 5.'}, {'pmid': '30995972', 'type': 'DERIVED', 'citation': 'Heerspink HJL, Parving HH, Andress DL, Bakris G, Correa-Rotter R, Hou FF, Kitzman DW, Kohan D, Makino H, McMurray JJV, Melnick JZ, Miller MG, Pergola PE, Perkovic V, Tobe S, Yi T, Wigderson M, de Zeeuw D; SONAR Committees and Investigators. Atrasentan and renal events in patients with type 2 diabetes and chronic kidney disease (SONAR): a double-blind, randomised, placebo-controlled trial. Lancet. 2019 May 11;393(10184):1937-1947. doi: 10.1016/S0140-6736(19)30772-X. Epub 2019 Apr 14.'}]}, 'descriptionModule': {'briefSummary': 'The study objective was to evaluate the effect of atrasentan compared with placebo on time to doubling of serum creatinine (DBSC) or the onset of end-stage renal disease (ESRD) in participants with type 2 diabetes and nephropathy who were treated with the maximum tolerated labeled daily dose (MTLDD) of a renin-angiotensin system (RAS) inhibitor. In addition, the study assessed the effects of atrasentan compared with placebo on cardiovascular (CV) morbidity and mortality, urine albumin excretion, changes in estimated glomerular filtration rate (eGFR), as well as the impact on quality of life in participants with type 2 diabetes and nephropathy.', 'detailedDescription': 'This was a Phase 3, prospective, randomized, double-blind, enriched-population, placebo controlled, multicenter study in adult participants with type 2 diabetes and nephropathy. Participants who met the inclusion criteria for initial study entry and none of the exclusion criteria were eligible to proceed to the Run-In Period to optimize RAS inhibitor and diuretic doses. Following the Run-In Period, eligible participants entered the 6-week Enrichment Period in which all received atrasentan to determine their urinary albumin to creatinine ratio (UACR) response and to assess tolerability of atrasentan. Responders and nonresponders were then randomly assigned to receive atrasentan or placebo in the Double-Blind Treatment Period. The study was performed in 5 to 6 periods in the following sequence: Pre-Screening Period (optional); Screening Period (Visits S1 and S2); Run-In Period (up to 12 weeks; Visits R1 to R6); Enrichment Period (6 weeks; Visits E1 to E5); Double-Blind Treatment Period (randomization to final treatment visit); and Follow-Up Period (Final Treatment to F1 visit \\[45 days post treatment\\] and other post-treatment visits). The study was prematurely discontinued because of a lower than expected event rate for the renal composite endpoint, which was adjudicated by a blinded independent events adjudication committee (EAC).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participant, or legal representative, had voluntarily signed and dated an Informed Consent Form, approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC), after the nature of the study had been explained and the participant had the opportunity to ask questions. The informed consent must have been signed before any study-specific procedures were performed.\n* Participant had type 2 diabetes (including participants with latent autoimmune diabetes or insulin-treated participants without a history of diabetic ketoacidosis who also had a negative anti-glutamic acid decarboxylase test AND an elevated post-prandial serum C-peptide level) and had been treated with at least one anti-hyperglycemic medication and an angiotensin-converting enzyme inhibitor (ACEi) or Angiotensin II receptor blocker (ARB; RAS inhibitor) for at least 4 weeks prior to the Screening S2 visit.\n* For entry into the Run-In Period the participant must have satisfied the following criteria based on the Screening laboratory values:\n\n * Estimated glomerular filtration rate (eGFR) 25 to 75 mL/min/1.73 m\\^2 \\[until the eGFR cap on participants (approximately 300) with a baseline of \\> 60 mL/min/1.73 m\\^2 was reached\\] and a urine albumin creatinine ratio (UACR) greater than or equal to 300 and less than 5,000 mg/g (greater than or equal to 34 mg/mmol and less than 565 mg/mmol);\n * Serum albumin greater than or equal to 2.5 g/dL (25 g/L);\n * Brain natriuretic peptide (BNP) less than or equal to 200 pg/mL (200 ng/L);\n * Systolic blood pressure (SBP) greater than or equal to 110 and less than or equal to 180 mmHg;\n * Serum potassium greater than or equal to 3.5 mEq/L (3.5 mmol/L) and less than or equal to 6.0 mEq/L (6.0 mmol/L);\n * Participants on a maximum tolerated labeled daily dose (MTLDD) of a RAS inhibitor for greater than or equal to 4 weeks and on a diuretic at the time of screening and who satisfied the above criteria may have proceeded to the last visit in the Run-In Period (R6);\n * Participants already on a MTLDD of a RAS inhibitor for greater than or equal to 4 weeks and not on a diuretic (unless medically contraindicated) at the time of Screening were to start with a diuretic and participate in Run-In for at least 2 weeks.\n* For entry into the Enrichment Period the participant must have satisfied the following criteria based on the last visit of the Run-In Period:\n\n * RAS inhibitor at the MTLDD for the previous 4 weeks with no adjustments of the dose;\n * Participants that were on a MTLDD RAS inhibitor and not on a diuretic (unless medically contraindicated) at the time of Screening must have been in Run-In for at least 2 weeks.\n* For entry into the Double-Blind Treatment Period, participants must have satisfied the following criteria based on the last visit of the Enrichment Period:\n\n * RAS inhibitor at the MTLDD for the previous 6 weeks during the Enrichment Period with no adjustments of the dose;\n * Diuretic at any dose unless medically contraindicated or clinically intolerable in the investigator's judgement (i.e., hypotension or hypokalemia);\n * Participants must not have had a weight change greater than or equal to 3 kg from the beginning of Enrichment to the end of the Enrichment Period and absolute serum BNP greater than or equal to 300 pg/mL (300 ng/L) at the last Enrichment visit;\n * Participants must not have had an increase in serum creatinine greater than 0.5 mg/dL and greater than 20% increase from the beginning of Enrichment to the end of the Enrichment Period.\n\nExclusion Criteria:\n\nA participant was not eligible for entry into the Run-in Period if he/she met any of the following criteria:\n\n* Participant had a history of severe peripheral edema or facial edema requiring diuretics unrelated to trauma or a history of myxedema in the prior 4 weeks to the initial Screening S1 visit.\n* Participant had a history of pulmonary hypertension, pulmonary fibrosis or any lung diseases requiring oxygen therapy (e.g., chronic obstructive pulmonary disease, emphysema).\n* Participant had a documented diagnosis of heart failure, previous hospitalization for heart failure or current or constellation of symptoms (dyspnea on exertion, pedal edema, orthopnea, paroxysmal nocturnal dyspnea) felt to be compatible with heart failure, that was not explained by other causes, and for which there was a change in medication or other management directed at heart failure.\n* Participant had known non-diabetic kidney disease (other than kidney stones).\n* Participant had elevated liver enzymes (serum alanine aminotransaminase \\[ALT\\] and/or serum aspartate aminotransaminase \\[AST\\]) \\> 3 × the upper limit of normal (ULN).\n* Participant had hemoglobin \\< 9 g/dL (90 g/L).\n* Participant had a sensitivity to loop diuretics.\n* Participant had a history of an allergic reaction or significant sensitivity to atrasentan (or its excipients) or similar compounds.\n* Participant had a history of chronic gastrointestinal disease, which, in the Investigator's opinion, may have caused significant GI malabsorption.\n* Participant had a history of secondary hypertension (i.e., hemodynamically significant renal artery stenosis, primary aldosteronism or pheochromocytoma).\n* Participant had significant comorbidities (e.g., advanced malignancy, advanced liver disease) with a life expectancy of less than 1 year.\n* Participant had clinically significant cerebrovascular disease (CVD) or coronary artery disease (CAD) within 3 months prior to the Screening S1 visit, defined as one of the following:\n\n * Hospitalization for MI or unstable angina; or\n * New onset angina with positive functional study or coronary angiogram revealing stenosis; or\n * Coronary revascularization procedure; or\n * Transient Ischemic Attack or Stroke.\n* Participant had received any investigational drug including atrasentan within 3 months prior to the Screening S1 visit.\n* Participant received dialysis treatments or was expected to receive dialysis or renal transplant within 6 months of screening.\n* Participant was currently receiving rosiglitazone, moxonidine, aldosterone blockers, aliskiren or a combination of ACEi and ARB.\n* Participant was a premenopausal woman defined as (for study purposes) any female subject with a menses in the past 2 years. For women who were \\< 50 years old, serum FSH must have been greater than 35 IU/L. Women who were surgically sterile or had a history of hysterectomy may not have necessarily be postmenopausal, and must also have had an FSH \\> 35 IU/L.\n* Participant was at high risk for QT/QTc prolongation such as a family history of Long QT Syndrome, defined as QTc prolongation exceeding 450 ms in men, or 460 ms in women.\n* Participant had type 1 diabetes.\n* Participant was considered to be clinically unstable regarding general, metabolic or cardiovascular health as determined by the Investigator."}, 'identificationModule': {'nctId': 'NCT01858532', 'acronym': 'SONAR', 'briefTitle': 'Study Of Diabetic Nephropathy With Atrasentan', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'A Randomized, Multicountry, Multicenter, Double-Blind, Parallel, Placebo-Controlled Study of the Effects of Atrasentan on Renal Outcomes in Subjects With Type 2 Diabetes and Nephropathy. SONAR: Study Of Diabetic Nephropathy With Atrasentan', 'orgStudyIdInfo': {'id': 'M11-352'}, 'secondaryIdInfos': [{'id': '2012-005848-21', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Atrasentan', 'description': '0.75 mg atrasentan once daily by mouth for up to 52 months', 'interventionNames': ['Drug: Atrasentan']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo once daily by mouth for up to 52 months', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Atrasentan', 'type': 'DRUG', 'otherNames': ['ABT-627'], 'description': 'Film-coated tablet', 'armGroupLabels': ['Atrasentan']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Film-coated tablet', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'AbbVie Inc.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}