Viewing Study NCT03071692

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Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug

Ignite Creation Date: 2025-12-24 @ 3:36 PM

Ignite Modification Date: 2026-04-18 @ 3:24 AM

Study NCT ID: NCT03071692

Status: TERMINATED

Last Update Posted: 2025-09-25

First Post: 2017-02-23

Is NOT Gene Therapy: True

Has Adverse Events: True

Brief Title: Pemafibrate to Reduce Cardiovascular OutcoMes by Reducing Triglycerides IN patiENts With diabeTes (PROMINENT)

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-07-29', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D050171', 'term': 'Dyslipidemias'}], 'ancestors': [{'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000603947', 'term': 'K-877 compound'}, {'id': 'C540740', 'term': '(R)-2-(3-((benzoxazol-2-yl-d4 (3-(4-methoxyphenoxy-d7)propyl)amino)methyl)phenoxy) butanoic acid'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'CTGResults@KowaUS.com', 'phone': '1 (919) 433-1600', 'title': 'Director, Clinical Operations', 'organization': 'Kowa Research Institute, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From Baseline to a Median of 3.3 Years', 'description': 'Treatment emergent adverse events (TEAE) were any adverse event that occurred or worsened after the first dose of study treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Pemafibrate', 'description': 'Participants receiving K-877 tablets administered twice daily.', 'otherNumAtRisk': 5264, 'deathsNumAtRisk': 5264, 'otherNumAffected': 2817, 'seriousNumAtRisk': 5264, 'deathsNumAffected': 308, 'seriousNumAffected': 1715}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Participants receiving Placebo matching tablet twice daily.', 'otherNumAtRisk': 5274, 'deathsNumAtRisk': 5274, 'otherNumAffected': 2883, 'seriousNumAtRisk': 5274, 'deathsNumAffected': 310, 'seriousNumAffected': 1663}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 308}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 343}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 417}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 461}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 361}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 377}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 358}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 354}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Coronavirus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 221}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 265}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 251}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 290}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 738}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 677}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 417}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 454}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 311}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 355}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 227}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 265}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Diabetic nephropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 358}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 343}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 683}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 664}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 10}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Blood loss anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Autoimmune haemolytic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Hypochromic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Anaemia of chronic disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Hypercoagulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Immune thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Microcytic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Normocytic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Pernicious anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 97}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 95}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 97}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 93}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 84}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 68}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 69}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 59}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 53}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 73}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 66}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 59}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 56}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 58}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 55}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Coronary artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 33}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Cardiac failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 16}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 22}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 18}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Cardiac failure chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 15}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 9}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Arteriosclerosis coronary artery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 11}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Coronary artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 12}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Acute left ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 8}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 7}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Atrioventricular block complete', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Aortic valve stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Left ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Atrioventricular block second degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Sinus node dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Pericarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Ventricular fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Atrioventricular block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Left ventricular dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Atrial tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Bundle branch block left', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Ischaemic cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Ventricular extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Aortic valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Atrial thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Cardiac ventricular thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Coronary artery insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Mitral valve stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Myocarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Right ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Sinus arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Sinus bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 0}], 'organSystem': 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[{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Squamous cell carcinoma of skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 4}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Bladder neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Bladder transitional cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Laryngeal squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': "Non-Hodgkin's lymphoma", 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Oesophageal adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Renal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'B-cell lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Colon adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Diffuse large B-cell lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Gastric cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Invasive breast carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Invasive lobular breast carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Lung adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Lung cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Plasma cell myeloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Hepatic cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Hepatocellular carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Intraductal papillary mucinous neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Lung neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Malignant melanoma in situ', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Metastases to bone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Metastases to lung', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Prostate cancer stage IV', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Rectal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Renal neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Uterine cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Adenocarcinoma gastric', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Adenocarcinoma pancreas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Benign breast neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Brain neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Cholangiocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Chronic lymphocytic leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Clear cell renal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Colon cancer metastatic', 'stats': [{'groupId': 'EG000', 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5264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Lung neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Meningioma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Metastases to central nervous system', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Metastases to lymph nodes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Metastases to peritoneum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Metastatic renal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Metastatic squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Myelodysplastic syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Oesophageal squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Pancreatic carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Papillary cystadenoma lymphomatosum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Papillary renal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Papillary thyroid cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Prostate cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Rectal adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Rectal cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Transitional cell carcinoma recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Ureteral neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Acute myeloid leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Adenocarcinoma of appendix', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Adenoma benign', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Benign small intestinal neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Bladder cancer stage 0, with cancer in situ', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Bladder papilloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Bladder transitional cell carcinoma stage II', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Bone cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': "Bowen's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Brain cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Breast cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Breast neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Cervix carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Chondrosarcoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Chondrosarcoma metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Choroid melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Colon cancer stage III', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Colorectal adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Colorectal cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Dysplastic naevus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Endometrial adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Endometrial cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Endometrial cancer stage II', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Epithelioid sarcoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Essential thrombocythaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Follicular thyroid cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Gallbladder adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Gallbladder neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Gastrointestinal carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Gastrointestinal stromal tumour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Gastrointestinal tract adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': "Hodgkin's disease mixed cellularity stage III", 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Hypergammaglobulinaemia benign monoclonal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Hypopharyngeal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Intestinal adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Intraductal papillary-mucinous carcinoma of pancreas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Laryngeal neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Lip neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Lung adenocarcinoma stage IV', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Malignant ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Malignant mediastinal neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Malignant melanoma stage III', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Malignant palate neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Malignant peritoneal neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Malignant pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Melanoma recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Metastases to kidney', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Metastases to pleura', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Metastases to spine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Metastatic neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Monoclonal gammopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Myelofibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Myeloproliferative neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Neuroendocrine tumour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Neuroendocrine tumour of the lung', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Non-small cell lung cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Oropharyngeal squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Pancreatic carcinoma metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Papilloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Paranasal sinus neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Parathyroid tumour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 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'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Pituitary tumour benign', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Pleomorphic adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Pleural neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 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'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Prostatic adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Rectal cancer stage I', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Rectal cancer stage II', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 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(24.0)'}, {'term': 'Aortic stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 9}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 6}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 10}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Peripheral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 8}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Peripheral artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 6}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 5}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Peripheral artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 5}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Peripheral artery thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 7}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Aortic aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Hypertensive emergency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Iliac artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Extremity necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 5}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Intermittent claudication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Peripheral artery aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Peripheral vascular disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Circulatory collapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Hypertensive urgency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Arteriosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Diabetic vascular disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Dry gangrene', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Hypovolaemic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Venous thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Arterial thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Distributive shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Embolism arterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Pelvic venous thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Shock haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Varicose vein', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Aortic aneurysm rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Aortic arteriosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Aortic dissection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Aortic occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Aortic thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Arterial insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Arterial stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Femoral artery aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Haemorrhagic infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Iliac artery dissection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Iliac artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Ischaemic limb pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Leriche syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Neurogenic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Phlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Subclavian artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Thromboangiitis obliterans', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Thrombophlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Varicose ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Vasculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}, {'term': 'Venous stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5274, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With First Occurrence of 4-component Composite Primary Endpoint (Nonfatal MI, Nonfatal Ischemic Stroke, Coronary Revascularization, or CV Death)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5240', 'groupId': 'OG000'}, {'value': '5257', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pemafibrate', 'description': 'Participants receiving K-877 tablets administered twice daily.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants receiving Placebo matching tablet twice daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '590', 'groupId': 'OG000'}, {'value': '570', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.03', 'ciLowerLimit': '0.92', 'ciUpperLimit': '1.16', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline to a Median of 3.3 Years', 'description': 'Number of participants experiencing their first occurrence of any component of the 4-component composite primary endpoint, which includes nonfatal myocardial infarction (MI), nonfatal ischemic stroke, coronary revascularization, or cardiovascular (CV) death. Each participant is counted only once, regardless of any subsequent events.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat population (ITT)'}, {'type': 'SECONDARY', 'title': 'Number of Participants With First Occurrence of the 4-component Composite Secondary Endpoint (Nonfatal MI, Nonfatal Ischemic Stroke, Hospitalization for Unstable Angina Requiring Unplanned Coronary Revascularization, or CV Death)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5240', 'groupId': 'OG000'}, {'value': '5257', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pemafibrate', 'description': 'Participants receiving K-877 tablets administered twice daily.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants receiving Placebo matching tablet twice daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '447', 'groupId': 'OG000'}, {'value': '427', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.05', 'ciLowerLimit': '0.92', 'ciUpperLimit': '1.20', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline to a Median of 3.3 Years', 'description': 'The 4-component composite secondary endpoints events are nonfatal myocardial infarction, nonfatal ischemic stroke, hospitalization for unstable angina requiring unplanned coronary revascularization, or cardiovascular death', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With First Occurrence of the 3-component Composite Endpoint (Nonfatal Myocardial Infarction, Nonfatal Ischemic Stroke, or Cardiovascular Death)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5240', 'groupId': 'OG000'}, {'value': '5257', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pemafibrate', 'description': 'Participants receiving K-877 tablets administered twice daily.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants receiving Placebo matching tablet twice daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '396', 'groupId': 'OG000'}, {'value': '386', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.03', 'ciLowerLimit': '0.89', 'ciUpperLimit': '1.18', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline to a Median of 3.3 Years', 'description': 'Number of Participants with First Occurrence of Composite Cardiovascular Events (nonfatal myocardial infarction, nonfatal ischemic stroke, or cardiovascular death)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With First Occurrence of Any Component of the Primary Endpoint or Hospitalization for Heart Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5240', 'groupId': 'OG000'}, {'value': '5257', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pemafibrate', 'description': 'Participants receiving K-877 tablets administered twice daily.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants receiving Placebo matching tablet twice daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '670', 'groupId': 'OG000'}, {'value': '645', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.04', 'ciLowerLimit': '0.93', 'ciUpperLimit': '1.16', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline to a Median of 3.3 Years', 'description': 'Event is the first occurrence of any component of the composite endpoint of nonfatal myocardial infarction, nonfatal ischemic stroke, coronary revascularization, cardiovascular death, or hospitalization for heart failure', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Occurrence of Any Component of the Primary Endpoint or All-Cause Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5240', 'groupId': 'OG000'}, {'value': '5257', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pemafibrate', 'description': 'Participants receiving K-877 tablets administered twice daily.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants receiving Placebo matching tablet twice daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '830', 'groupId': 'OG000'}, {'value': '806', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.03', 'ciLowerLimit': '0.93', 'ciUpperLimit': '1.13', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline to a Median of 3.3 Years', 'description': 'Event is the first occurrence of any component of the composite endpoint of nonfatal myocardial infarction, nonfatal ischemic stroke, coronary revascularization, cardiovascular death, or all-cause mortality.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Total Number of Events of the 4-component Composite Primary Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5240', 'groupId': 'OG000'}, {'value': '5257', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pemafibrate', 'description': 'Participants receiving K-877 tablets administered twice daily.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants receiving Placebo matching tablet twice daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '895', 'groupId': 'OG000'}, {'value': '892', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Event Rate Ration', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.99', 'ciLowerLimit': '0.87', 'ciUpperLimit': '1.13', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline to a Median of 3.3 Years', 'description': 'Total number of events for the 4-component composite primary endpoint, counting all occurrences, including multiple events in the same participant. The endpoint events include nonfatal myocardial infarction (MI), nonfatal ischemic stroke, coronary revascularization, and cardiovascular (CV) death.', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With First Occurrence of Any New or Worsening Peripheral Artery Disease (PAD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5240', 'groupId': 'OG000'}, {'value': '5257', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pemafibrate', 'description': 'Participants receiving K-877 tablets administered twice daily.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants receiving Placebo matching tablet twice daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '138', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.87', 'ciLowerLimit': '0.69', 'ciUpperLimit': '1.09', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline to a Median of 3.3 Years', 'description': 'Any new or worsening Peripheral artery disease (PAD), defined as incidence of lower extremity revascularization, intermittent claudication, rest pain, lower extremity ischemic ulceration, or major amputation with either ankle-brachial index ≤ 0.9 or other diagnostic testing (eg, toe-brachial index, angiogram, or other imaging study)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With First Occurrence of Nonfatal Myocardial Infarction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5240', 'groupId': 'OG000'}, {'value': '5257', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pemafibrate', 'description': 'Participants receiving K-877 tablets administered twice daily.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants receiving Placebo matching tablet twice daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '210', 'groupId': 'OG000'}, {'value': '182', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.16', 'ciLowerLimit': '0.95', 'ciUpperLimit': '1.41', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline to a Median of 3.3 Years', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With First Occurrence of Nonfatal Ischemic Stroke', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5240', 'groupId': 'OG000'}, {'value': '5257', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pemafibrate', 'description': 'Participants receiving K-877 tablets administered twice daily.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants receiving Placebo matching tablet twice daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '96', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.90', 'ciLowerLimit': '0.69', 'ciUpperLimit': '1.19', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline to a Median of 3.3 Years', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With First Occurrence of Coronary Revascularization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5240', 'groupId': 'OG000'}, {'value': '5257', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pemafibrate', 'description': 'Participants receiving K-877 tablets administered twice daily.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants receiving Placebo matching tablet twice daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '340', 'groupId': 'OG000'}, {'value': '347', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.98', 'ciLowerLimit': '0.84', 'ciUpperLimit': '1.14', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline to a Median of 3.3 Years', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With First Occurrence of Cardiovascular Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5240', 'groupId': 'OG000'}, {'value': '5257', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pemafibrate', 'description': 'Participants receiving K-877 tablets administered twice daily.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants receiving Placebo matching tablet twice daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '145', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.04', 'ciLowerLimit': '0.83', 'ciUpperLimit': '1.32', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline to a Median of 3.3 Years', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With First Occurrence of the 4-component Composite Endpoint by PPAR-α Gene Variant Subgroup (TT, CT, CC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2800', 'groupId': 'OG000'}, {'value': '2841', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pemafibrate', 'description': 'Participants receiving K-877 tablets administered twice daily.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants receiving Placebo matching tablet twice daily.'}], 'classes': [{'title': 'TT variant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1011', 'groupId': 'OG000'}, {'value': '973', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '114', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}]}, {'title': 'CT variant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1312', 'groupId': 'OG000'}, {'value': '1372', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '177', 'groupId': 'OG000'}, {'value': '156', 'groupId': 'OG001'}]}]}, {'title': 'CC variant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '477', 'groupId': 'OG000'}, {'value': '496', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.97', 'ciLowerLimit': '0.75', 'ciUpperLimit': '1.26', 'groupDescription': 'TT Variant', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.19', 'ciLowerLimit': '0.96', 'ciUpperLimit': '1.47', 'groupDescription': 'CT Variant', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.98', 'ciLowerLimit': '0.69', 'ciUpperLimit': '1.39', 'groupDescription': 'CC Variant', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline to a Median of 3.3 Years', 'description': 'Number of participants experiencing their first occurrence of any component of the 4-component composite primary endpoint (nonfatal myocardial infarction, nonfatal ischemic stroke, coronary revascularization, or cardiovascular death), reported as a subgroup analysis by PPAR-α gene variants (TT, CT, CC).', 'unitOfMeasure': 'Count of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis includes participants from the intent-to-treat population who consented to genetic testing for the PPAR-α gene. Participants who did not provide consent for genetic testing are excluded from the numbers reported for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Month 4 for Total Cholesterol (TC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4859', 'groupId': 'OG000'}, {'value': '4899', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pemafibrate', 'description': 'Participants receiving K-877 tablets administered twice daily.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants receiving Placebo matching tablet twice daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.235', 'spread': '23.7683', 'groupId': 'OG000'}, {'value': '4.562', 'spread': '23.9991', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.13496', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Month 4', 'unitOfMeasure': 'Percent Change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '* ITT population\n* The number of participants analyzed for the outcome measure may differ from the overall number of participants in each group. This discrepancy can be attributed to several factors, including:\n\n * Missing data: Some participants may have incomplete data due to factors such as missed visits, early withdrawal, refusal or inability to draw blood, or loss to follow-up.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Month 4 for Fasting Triglycerides', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4814', 'groupId': 'OG000'}, {'value': '4848', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pemafibrate', 'description': 'Participants receiving K-877 tablets administered twice daily.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants receiving Placebo matching tablet twice daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '-23.860', 'spread': '49.2289', 'groupId': 'OG000'}, {'value': '2.593', 'spread': '60.6399', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 4 Months', 'unitOfMeasure': 'Percent Change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '* ITT Population\n* The number of participants analyzed for the outcome measure may differ from the overall number of participants in each group. This discrepancy can be attributed to several factors, including:\n\n * Missing data: Some participants may have incomplete data due to factors such as missed visits, early withdrawal, refusal or inability to draw blood, or loss to follow-up.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Month 4 for HDL - Cholesterol (HDL-C)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4858', 'groupId': 'OG000'}, {'value': '4896', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pemafibrate', 'description': 'Participants receiving K-877 tablets administered twice daily.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants receiving Placebo matching tablet twice daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.856', 'spread': '24.7407', 'groupId': 'OG000'}, {'value': '6.004', 'spread': '21.7838', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Month 4', 'unitOfMeasure': 'Percent Change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '* ITT population\n* The number of participants analyzed for the outcome measure may differ from the overall number of participants in each group. This discrepancy can be attributed to several factors, including:\n\n * Missing data: Some participants may have incomplete data due to factors such as missed visits, early withdrawal, refusal or inability to draw blood, or loss to follow-up.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Month 4 for Calculated Non-HDL Cholesterol (Non-HDL-C)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4858', 'groupId': 'OG000'}, {'value': '4896', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pemafibrate', 'description': 'Participants receiving K-877 tablets administered twice daily.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants receiving Placebo matching tablet twice daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.219', 'spread': '31.9262', 'groupId': 'OG000'}, {'value': '5.502', 'spread': '31.9739', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.96689', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Month 4', 'unitOfMeasure': 'Percent Change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '* ITT population\n* The number of participants analyzed for the outcome measure may differ from the overall number of participants in each group. This discrepancy can be attributed to several factors, including:\n\n * Missing data: Some participants may have incomplete data due to factors such as missed visits, early withdrawal, refusal or inability to draw blood, or loss to follow-up.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Month 4 for Calculated VLDL Cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3841', 'groupId': 'OG000'}, {'value': '3614', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pemafibrate', 'description': 'Participants receiving K-877 tablets administered twice daily.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants receiving Placebo matching tablet twice daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '-22.788', 'spread': '32.5741', 'groupId': 'OG000'}, {'value': '-1.601', 'spread': '36.4352', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Month 4', 'unitOfMeasure': 'Percent Change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '* ITT population\n* The number of participants analyzed for the outcome measure may differ from the overall number of participants in each group. This discrepancy can be attributed to several factors, including:\n\n * Missing data: Some participants may have incomplete data due to factors such as missed visits, early withdrawal, refusal or inability to draw blood, or loss to follow-up.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Month 4 for Apolipoprotein A1 (ApoA1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4807', 'groupId': 'OG000'}, {'value': '4847', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pemafibrate', 'description': 'Participants receiving K-877 tablets administered twice daily.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants receiving Placebo matching tablet twice daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.878', 'spread': '19.3749', 'groupId': 'OG000'}, {'value': '3.956', 'spread': '18.5293', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.09178', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Month 4', 'unitOfMeasure': 'Percent Change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '* ITT population\n* The number of participants analyzed for the outcome measure may differ from the overall number of participants in each group. This discrepancy can be attributed to several factors, including:\n\n * Missing data: Some participants may have incomplete data due to factors such as missed visits, early withdrawal, refusal or inability to draw blood, or loss to follow-up.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Month 4 for Apolipoprotein CIII (ApoC3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4783', 'groupId': 'OG000'}, {'value': '4808', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pemafibrate', 'description': 'Participants receiving K-877 tablets administered twice daily.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants receiving Placebo matching tablet twice daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '-23.397', 'spread': '31.5756', 'groupId': 'OG000'}, {'value': '4.861', 'spread': '56.0921', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Month 4', 'unitOfMeasure': 'Percent Change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '* ITT population\n* The number of participants analyzed for the outcome measure may differ from the overall number of participants in each group. This discrepancy can be attributed to several factors, including:\n\n * Missing data: Some participants may have incomplete data due to factors such as missed visits, early withdrawal, refusal or inability to draw blood, or loss to follow-up.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Month 4 for Apolipoprotein E (ApoE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4801', 'groupId': 'OG000'}, {'value': '4842', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pemafibrate', 'description': 'Participants receiving K-877 tablets administered twice daily.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants receiving Placebo matching tablet twice daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.5201', 'spread': '30.89475', 'groupId': 'OG000'}, {'value': '-0.5209', 'spread': '31.79989', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Month 4', 'unitOfMeasure': 'Percent Change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '* ITT population\n* The number of participants analyzed for the outcome measure may differ from the overall number of participants in each group. This discrepancy can be attributed to several factors, including:\n\n * Missing data: Some participants may have incomplete data due to factors such as missed visits, early withdrawal, refusal or inability to draw blood, or loss to follow-up.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Month 6 for Non-fasting Remnant Cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4614', 'groupId': 'OG000'}, {'value': '4643', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pemafibrate', 'description': 'Participants receiving K-877 tablets administered twice daily.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants receiving Placebo matching tablet twice daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '-21.27', 'spread': '46.506', 'groupId': 'OG000'}, {'value': '10.60', 'spread': '54.029', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Month 6', 'unitOfMeasure': 'Percent Change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '* ITT population\n* The number of participants analyzed for the outcome measure may differ from the overall number of participants in each group. This discrepancy can be attributed to several factors, including:\n\n * Missing data: Some participants may have incomplete data due to factors such as missed visits, early withdrawal, refusal or inability to draw blood, or loss to follow-up.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pemafibrate', 'description': 'Participants receiving K-877 tablets administered twice daily.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Participants receiving Placebo matching tablet twice daily.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5269'}, {'groupId': 'FG001', 'numSubjects': '5275'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4647'}, {'groupId': 'FG001', 'numSubjects': '4674'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '622'}, {'groupId': 'FG001', 'numSubjects': '601'}]}]}], 'preAssignmentDetails': 'Prior to treatment, participants attended a Prescreening Visit, a Screening/Enrollment Visit and a Placebo Run-In Period. Eligible subjects who were compliant with study treatment during the Placebo Run-In Period returned for the Randomization Visit, at which time they were randomly allocated to receive either pemafibrate or a matching placebo tablet.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5240', 'groupId': 'BG000'}, {'value': '5257', 'groupId': 'BG001'}, {'value': '10497', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Pemafibrate', 'description': 'Participants receiving K-877 tablets administered twice daily.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Participants receiving Placebo matching tablet twice daily.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.28', 'spread': '8.524', 'groupId': 'BG000'}, {'value': '63.56', 'spread': '8.411', 'groupId': 'BG001'}, {'value': '63.42', 'spread': '8.468', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1443', 'groupId': 'BG000'}, {'value': '1448', 'groupId': 'BG001'}, {'value': '2891', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '3797', 'groupId': 'BG000'}, {'value': '3809', 'groupId': 'BG001'}, {'value': '7606', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1014', 'groupId': 'BG000'}, {'value': '1007', 'groupId': 'BG001'}, {'value': '2021', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '4187', 'groupId': 'BG000'}, {'value': '4213', 'groupId': 'BG001'}, {'value': '8400', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'White', 'measurements': [{'value': '4484', 'groupId': 'BG000'}, {'value': '4549', 'groupId': 'BG001'}, {'value': '9033', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '134', 'groupId': 'BG000'}, {'value': '136', 'groupId': 'BG001'}, {'value': '270', 'groupId': 'BG002'}]}, {'title': 'American Indian or Alaska Native', 'measurements': [{'value': '73', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '149', 'groupId': 'BG002'}]}, {'title': 'Asian Indian', 'measurements': [{'value': '97', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '177', 'groupId': 'BG002'}]}, {'title': 'Bangladeshi', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Chinese', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Filipino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Japanese', 'measurements': [{'value': '162', 'groupId': 'BG000'}, {'value': '146', 'groupId': 'BG001'}, {'value': '308', 'groupId': 'BG002'}]}, {'title': 'Korean', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Pakistani', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'Vietnamese', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 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'208', 'groupId': 'BG000'}, {'value': '201', 'groupId': 'BG001'}, {'value': '409', 'groupId': 'BG002'}]}, {'title': 'Declined', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Cardiovascular Diseases and Risk Factors at Baseline', 'classes': [{'title': 'Statin Status', 'categories': [{'title': 'No', 'measurements': [{'value': '220', 'groupId': 'BG000'}, {'value': '219', 'groupId': 'BG001'}, {'value': '439', 'groupId': 'BG002'}]}, {'title': 'Yes', 'measurements': [{'value': '5020', 'groupId': 'BG000'}, {'value': '5038', 'groupId': 'BG001'}, {'value': '10058', 'groupId': 'BG002'}]}]}, {'title': 'Established CV Disease', 'categories': [{'title': 'No', 'measurements': [{'value': '1695', 'groupId': 'BG000'}, {'value': '1713', 'groupId': 'BG001'}, {'value': '3408', 'groupId': 'BG002'}]}, {'title': 'Yes', 'measurements': [{'value': '3545', 'groupId': 'BG000'}, {'value': '3544', 'groupId': 'BG001'}, {'value': '7089', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'To qualify for this study, subjects had to have type 2 diabetes (T2D) and a high risk for future cardiovascular (CV) events.', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The Intent to treat (ITT) population included all randomized subjects who received at least 1 dose of study treatment without GCP deviations.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-11-16', 'size': 2026141, 'label': 'Study Protocol: Initial', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-07-10T16:12', 'hasProtocol': True}, {'date': '2017-03-27', 'size': 1862701, 'label': 'Study Protocol: Amdt. 1', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-07-10T16:14', 'hasProtocol': True}, {'date': '2020-03-18', 'size': 2568996, 'label': 'Study Protocol: Amdt. 2', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-07-10T16:15', 'hasProtocol': True}, {'date': '2022-10-24', 'size': 21320697, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_003.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-07-10T16:05', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10544}}, 'statusModule': {'whyStopped': 'The study was stopped for futility based on efficacy results at the interim analysis; no unexpected safety findings were observed.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-03-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'dispFirstSubmitDate': '2023-07-11', 'completionDateStruct': {'date': '2022-07-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-05', 'studyFirstSubmitDate': '2017-02-23', 'resultsFirstSubmitDate': '2025-07-10', 'studyFirstSubmitQcDate': '2017-03-01', 'dispFirstPostDateStruct': {'date': '2025-09-25', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2025-09-25', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-09-05', 'studyFirstPostDateStruct': {'date': '2017-03-07', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-09-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-07-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With First Occurrence of 4-component Composite Primary Endpoint (Nonfatal MI, Nonfatal Ischemic Stroke, Coronary Revascularization, or CV Death)', 'timeFrame': 'From Baseline to a Median of 3.3 Years', 'description': 'Number of participants experiencing their first occurrence of any component of the 4-component composite primary endpoint, which includes nonfatal myocardial infarction (MI), nonfatal ischemic stroke, coronary revascularization, or cardiovascular (CV) death. Each participant is counted only once, regardless of any subsequent events.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With First Occurrence of the 4-component Composite Secondary Endpoint (Nonfatal MI, Nonfatal Ischemic Stroke, Hospitalization for Unstable Angina Requiring Unplanned Coronary Revascularization, or CV Death)', 'timeFrame': 'From Baseline to a Median of 3.3 Years', 'description': 'The 4-component composite secondary endpoints events are nonfatal myocardial infarction, nonfatal ischemic stroke, hospitalization for unstable angina requiring unplanned coronary revascularization, or cardiovascular death'}, {'measure': 'Number of Participants With First Occurrence of the 3-component Composite Endpoint (Nonfatal Myocardial Infarction, Nonfatal Ischemic Stroke, or Cardiovascular Death)', 'timeFrame': 'From Baseline to a Median of 3.3 Years', 'description': 'Number of Participants with First Occurrence of Composite Cardiovascular Events (nonfatal myocardial infarction, nonfatal ischemic stroke, or cardiovascular death)'}, {'measure': 'Number of Participants With First Occurrence of Any Component of the Primary Endpoint or Hospitalization for Heart Failure', 'timeFrame': 'From Baseline to a Median of 3.3 Years', 'description': 'Event is the first occurrence of any component of the composite endpoint of nonfatal myocardial infarction, nonfatal ischemic stroke, coronary revascularization, cardiovascular death, or hospitalization for heart failure'}, {'measure': 'Number of Participants With Occurrence of Any Component of the Primary Endpoint or All-Cause Mortality', 'timeFrame': 'From Baseline to a Median of 3.3 Years', 'description': 'Event is the first occurrence of any component of the composite endpoint of nonfatal myocardial infarction, nonfatal ischemic stroke, coronary revascularization, cardiovascular death, or all-cause mortality.'}, {'measure': 'Total Number of Events of the 4-component Composite Primary Endpoint', 'timeFrame': 'From Baseline to a Median of 3.3 Years', 'description': 'Total number of events for the 4-component composite primary endpoint, counting all occurrences, including multiple events in the same participant. The endpoint events include nonfatal myocardial infarction (MI), nonfatal ischemic stroke, coronary revascularization, and cardiovascular (CV) death.'}, {'measure': 'Number of Participants With First Occurrence of Any New or Worsening Peripheral Artery Disease (PAD)', 'timeFrame': 'From Baseline to a Median of 3.3 Years', 'description': 'Any new or worsening Peripheral artery disease (PAD), defined as incidence of lower extremity revascularization, intermittent claudication, rest pain, lower extremity ischemic ulceration, or major amputation with either ankle-brachial index ≤ 0.9 or other diagnostic testing (eg, toe-brachial index, angiogram, or other imaging study)'}, {'measure': 'Number of Participants With First Occurrence of Nonfatal Myocardial Infarction', 'timeFrame': 'From Baseline to a Median of 3.3 Years'}, {'measure': 'Number of Participants With First Occurrence of Nonfatal Ischemic Stroke', 'timeFrame': 'From Baseline to a Median of 3.3 Years'}, {'measure': 'Number of Participants With First Occurrence of Coronary Revascularization', 'timeFrame': 'From Baseline to a Median of 3.3 Years'}, {'measure': 'Number of Participants With First Occurrence of Cardiovascular Death', 'timeFrame': 'From Baseline to a Median of 3.3 Years'}, {'measure': 'Number of Participants With First Occurrence of the 4-component Composite Endpoint by PPAR-α Gene Variant Subgroup (TT, CT, CC)', 'timeFrame': 'From Baseline to a Median of 3.3 Years', 'description': 'Number of participants experiencing their first occurrence of any component of the 4-component composite primary endpoint (nonfatal myocardial infarction, nonfatal ischemic stroke, coronary revascularization, or cardiovascular death), reported as a subgroup analysis by PPAR-α gene variants (TT, CT, CC).'}, {'measure': 'Percent Change From Baseline to Month 4 for Total Cholesterol (TC)', 'timeFrame': 'Baseline to Month 4'}, {'measure': 'Percent Change From Baseline to Month 4 for Fasting Triglycerides', 'timeFrame': 'Baseline to 4 Months'}, {'measure': 'Percent Change From Baseline to Month 4 for HDL - Cholesterol (HDL-C)', 'timeFrame': 'Baseline to Month 4'}, {'measure': 'Percent Change From Baseline to Month 4 for Calculated Non-HDL Cholesterol (Non-HDL-C)', 'timeFrame': 'Baseline to Month 4'}, {'measure': 'Percent Change From Baseline to Month 4 for Calculated VLDL Cholesterol', 'timeFrame': 'Baseline to Month 4'}, {'measure': 'Percent Change From Baseline to Month 4 for Apolipoprotein A1 (ApoA1)', 'timeFrame': 'Baseline to Month 4'}, {'measure': 'Percent Change From Baseline to Month 4 for Apolipoprotein CIII (ApoC3)', 'timeFrame': 'Baseline to Month 4'}, {'measure': 'Percent Change From Baseline to Month 4 for Apolipoprotein E (ApoE)', 'timeFrame': 'Baseline to Month 4'}, {'measure': 'Percent Change From Baseline to Month 6 for Non-fasting Remnant Cholesterol', 'timeFrame': 'Baseline to Month 6'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type2 Diabetes', 'Dyslipidemia']}, 'referencesModule': {'references': [{'pmid': '36342113', 'type': 'DERIVED', 'citation': 'Das Pradhan A, Glynn RJ, Fruchart JC, MacFadyen JG, Zaharris ES, Everett BM, Campbell SE, Oshima R, Amarenco P, Blom DJ, Brinton EA, Eckel RH, Elam MB, Felicio JS, Ginsberg HN, Goudev A, Ishibashi S, Joseph J, Kodama T, Koenig W, Leiter LA, Lorenzatti AJ, Mankovsky B, Marx N, Nordestgaard BG, Pall D, Ray KK, Santos RD, Soran H, Susekov A, Tendera M, Yokote K, Paynter NP, Buring JE, Libby P, Ridker PM; PROMINENT Investigators. Triglyceride Lowering with Pemafibrate to Reduce Cardiovascular Risk. N Engl J Med. 2022 Nov 24;387(21):1923-1934. doi: 10.1056/NEJMoa2210645. Epub 2022 Nov 5.'}, {'pmid': '30342298', 'type': 'DERIVED', 'citation': 'Pradhan AD, Paynter NP, Everett BM, Glynn RJ, Amarenco P, Elam M, Ginsberg H, Hiatt WR, Ishibashi S, Koenig W, Nordestgaard BG, Fruchart JC, Libby P, Ridker PM. Rationale and design of the Pemafibrate to Reduce Cardiovascular Outcomes by Reducing Triglycerides in Patients with Diabetes (PROMINENT) study. Am Heart J. 2018 Dec;206:80-93. doi: 10.1016/j.ahj.2018.09.011. Epub 2018 Sep 29.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of the study is to determine whether pemafibrate administered twice daily will delay the time to first occurrence of any component of the clinical composite endpoint of:\n\n* nonfatal Myocardial Infarction (MI)\n* nonfatal ischemic stroke\n* coronary revascularization; or\n* Cardio Vascular (CV) death.', 'detailedDescription': 'A multi-regional clinical trial with participating sites in the following countries. India is being conducted under a previous protocol version due to regulatory requirements.\n\n* Argentina\n* Brazil\n* Bulgaria\n* Canada\n* Colombia\n* Czech Republic\n* Denmark\n* France\n* Germany\n* Hungary\n* India\n* Israel\n* Japan\n* Mexico\n* Netherlands\n* Poland\n* Romania\n* Russian Federation\n* Slovakia\n* South Africa\n* Spain\n* Ukraine\n* United Kingdom\n* United States'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Fasting TG ≥ 200 mg/dL (2.26 mmol/L) and \\< 500 mg/dL (5.65 mmol/L) at Visit 1 (Screening/Enrollment Visit) or Visit 1.1 (Retest)\n2. HDL-C ≤ 40 mg/dL (1.03 mmol/L) at Visit 1 (Screening/Enrollment Visit) or Visit 1.1 (Retest)\n3. Type 2 diabetes of longer than 12 weeks duration documented in medical records, for example: local laboratory evidence through medical record review of elevated HbA1c (≥ 6.5% \\[48 mmol/mol\\]), elevated plasma glucose (fasting ≥ 126 mg/dL \\[7.0 mmol/L\\], 2-hour ≥ 200 mg/dL \\[11.1 mmol/L\\] during oral glucose tolerance testing, or random value ≥ 200 mg/dL with classic symptoms, or currently taking medication for treatment of diabetes; AND either\n\n 1. Age ≥ 50 years if male or ≥ 55 years if female (primary prevention cohort); OR\n 2. Age ≥ 18 years and established systemic atherosclerosis (secondary prevention cohort), defined as any 1 of the following:\n\n * i. Prior MI or ischemic (non-hemorrhagic) stroke\n * ii. Coronary angiographic lesion of ≥ 60% stenosis in a major epicardial vessel or ≥ 50% left main stenosis\n * iii. Asymptomatic carotid disease with ≥ 70% carotid artery stenosis\n * iv. Symptomatic carotid disease with ≥ 50% carotid artery stenosis\n * v. Symptomatic lower extremity PAD (ie, intermittent claudication, rest pain, lower extremity ischemic ulceration, or major amputation with either ankle-brachial index ≤ 0.9 or other diagnostic testing \\[eg, toe-brachial index, angiogram, or other imaging study\\])\n * vi. Prior arterial revascularization procedure (including coronary, carotid, or peripheral angioplasty/stenting, bypass, or atherectomy/endarterectomy)\n\nExclusion Criteria:\n\n1. Current or planned use of fibrates or agents with PPAR-α agonist activity (eg, saroglitazar) within 6 weeks (42 days) of Visit 1 (Screening/Enrollment Visit). Note: PPAR-γ agonists (eg, glizatones such as pioglitazone and rosiglitazone) are allowed\n2. Known sensitivity to PPAR-α agonists or tablet excipients\n3. Initiation of, or change in, current TG-lowering therapy within 12 weeks of Visit 1 (if applicable). Note: TG-lowering therapy is defined as niacin \\> 100 mg/day or dietary supplements or prescription omega-3 fatty acids \\> 1 g/day\n4. Type 1 diabetes mellitus'}, 'identificationModule': {'nctId': 'NCT03071692', 'acronym': 'PROMINENT', 'briefTitle': 'Pemafibrate to Reduce Cardiovascular OutcoMes by Reducing Triglycerides IN patiENts With diabeTes (PROMINENT)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kowa Research Institute, Inc.'}, 'officialTitle': 'Pemafibrate to Reduce Cardiovascular OutcoMes by Reducing Triglycerides IN patiENts With diabeTes (PROMINENT)', 'orgStudyIdInfo': {'id': 'K-877-302'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Group', 'description': 'K-877 (pemafibrate) tablet twice daily.', 'interventionNames': ['Drug: K-877']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control Group', 'description': 'Matching K-877 placebo tablet twice daily.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'K-877', 'type': 'DRUG', 'otherNames': ['pemafibrate'], 'description': '0.2mg tablet', 'armGroupLabels': ['Treatment Group']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'K-877 matching placebo tablet', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35211', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Synexus Clinical Research US, Inc.', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'VA Medical Center - Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35235', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Alabama Clinical Therapeutics, LLC', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '36542', 'city': 'Gulf Shores', 'state': 'Alabama', 'country': 'United States', 'facility': 'Fundamental Research, LLC', 'geoPoint': {'lat': 30.24604, 'lon': -87.70082}}, {'zip': '36608', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'Mobile Heart Specialists, PC', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '35674', 'city': 'Tuscumbia', 'state': 'Alabama', 'country': 'United States', 'facility': 'Terence T. 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