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Ignite Creation Date: 2025-12-24 @ 10:20 PM

Ignite Modification Date: 2026-04-04 @ 6:22 AM

Study NCT ID: NCT03080935

Status: TERMINATED

Last Update Posted: 2024-05-29

First Post: 2017-03-10

Is NOT Gene Therapy: True

Has Adverse Events: True

Brief Title: Fourier Open-label Extension Study in Subjects With Clinically Evident Cardiovascular Disease in Selected European Countries

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': '2022-12-14', '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': 'C577155', 'term': 'evolocumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'medinfo@amgen.com', 'phone': '866-572-6436', 'title': 'Study Director', 'organization': 'Amgen Inc.'}, 'certainAgreement': {'otherDetails': "The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'This study was terminated to coincide with the completion of study 20130295 (NCT02867813). The study was not terminated due to any safety findings.'}}, 'adverseEventsModule': {'timeFrame': 'Up to 5 years', 'description': 'All-cause mortality is reported for all participants enrolled/randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo in Parent Study', 'description': 'Participants with Placebo in Parent Study', 'otherNumAtRisk': 745, 'deathsNumAtRisk': 745, 'otherNumAffected': 451, 'seriousNumAtRisk': 745, 'deathsNumAffected': 35, 'seriousNumAffected': 323}, {'id': 'EG001', 'title': 'Evolocumab in Parent Study', 'description': 'Participants with Evolocumab in Parent Study', 'otherNumAtRisk': 854, 'deathsNumAtRisk': 855, 'otherNumAffected': 528, 'seriousNumAtRisk': 854, 'deathsNumAffected': 51, 'seriousNumAffected': 410}], 'otherEvents': [{'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 49}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 32}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 29}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 43}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 53}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 75}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 111}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 41}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 60}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 57}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 61}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 75}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 50}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 70}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 55}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 47}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 50}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 43}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 40}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 132}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 150}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Autoimmune haemolytic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Coagulopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Haemorrhagic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Microcytic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Necrotic lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Normochromic normocytic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 7}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 15}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 24}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 13}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Aortic valve calcification', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Aortic valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Aortic valve stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Arteriosclerosis coronary artery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 22}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Atrioventricular block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Atrioventricular block complete', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Atrioventricular block second degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Bundle branch block left', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 27}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Cardiac failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Cardiac failure chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Cardiac valve disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Cardiogenic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Cardiorenal syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Chronic coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Congestive cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 10}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Coronary artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Coronary artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 11}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Coronary artery thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Coronary ostial stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': "Dressler's syndrome", 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Ischaemic cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Left ventricular dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Left ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Left ventricular hypertrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Low cardiac output syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Mitral valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Mitral valve stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 9}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Sinoatrial block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Sinus bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Sinus node dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Tricuspid valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Ventricular extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Ventricular fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 4}], 'organSystem': 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'numAtRisk': 854, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Rotator cuff syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Spinal osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Spinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Spondylolisthesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Synovitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Tendon disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Tendon pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Adenocarcinoma of colon', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Adenocarcinoma pancreas', 'stats': [{'groupId': 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'numAtRisk': 745, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Benign neoplasm of thyroid gland', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Bladder cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Bladder cancer recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Bladder cancer stage III', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Bladder transitional cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Bladder transitional cell carcinoma recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Bladder transitional cell carcinoma stage I', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Brain cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Brain neoplasm malignant', 'stats': 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2}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Colon cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Colon cancer stage I', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Colon cancer stage III', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 0}, {'groupId': 'EG001', 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0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Lentigo maligna stage I', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Lung adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Lung adenocarcinoma stage I', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Lung cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Lung carcinoma cell type unspecified stage IV', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Lung neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Lung neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Lung squamous cell carcinoma metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Lymphangiosis carcinomatosa', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Malignant melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Malignant neoplasm of unknown primary site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Malignant palate neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Meningioma benign', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Metastases to bone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Metastases to central nervous system', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Metastases to lung', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Metastases to lymph nodes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Metastatic gastric cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Metastatic squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Nasal neoplasm benign', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Neuroendocrine tumour of the lung', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Non-small cell lung cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Non-small cell lung cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Non-small cell lung cancer stage IV', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Oropharyngeal squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Ovarian adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': "Pancoast's tumour", 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Pancreatic carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Pancreatic carcinoma metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 4}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Pituitary tumour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Plasma cell myeloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Pleural mesothelioma malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Pleural neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 0}], 'organSystem': 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unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Rectal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Rectal neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Renal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Renal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': "Richter's syndrome", 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Skin angiosarcoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Small intestine carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Small intestine carcinoma stage IV', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Squamous cell carcinoma of skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Transitional cell cancer of the renal pelvis and ureter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Transitional cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Amputation stump pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 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{'term': 'Implantable defibrillator insertion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Knee arthroplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Mitral valve repair', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Skin neoplasm excision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Aortic aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Aortic stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Arterial stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Arteriosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Extremity necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Femoral artery aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Iliac artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Iliac artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Intermittent claudication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Ischaemic limb pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Lymphocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 12}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Peripheral artery aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Peripheral artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Peripheral artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Peripheral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Peripheral vascular disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 5}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Peripheral vein stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Subclavian vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Vascular pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Venous thrombosis limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 854, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Who Experienced an Adverse Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '745', 'groupId': 'OG000'}, {'value': '854', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Once Every 2 Weeks (Q2W) or Once Every Month (QM) in Parent Study', 'description': "Participants in the parent study who received placebo subcutaneous injections either Q2W or QM, and received evolocumab 140 mg Q2W or 420 mg QM in the open label extension, according to the participant's preference."}, {'id': 'OG001', 'title': 'Evolocumab Once Every 2 Weeks (Q2W) or Once Every Month (QM) in Parent Study', 'description': 'Participants in the parent study who received evolocumab either Q2W or QM, and received evolocumab 140 mg Q2W or 420 mg QM in the open label extension according to the participants preference.'}], 'classes': [{'categories': [{'measurements': [{'value': '686', 'groupId': 'OG000'}, {'value': '810', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 5 years', 'description': 'All adverse event summaries for the primary analysis of the primary endpoint (OLE study period only) included all treatment-emergent events reported on the Event electronic case report form (eCRF), including CEC positively reviewed events and disease-related events.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'OLE Safety Analysis Set which included all participants who received at least 1 dose of open-label evolocumab in the OLE study.'}, {'type': 'SECONDARY', 'title': 'Percent Change of Low-density Lipoprotein Cholesterol (LDL-C) From Baseline at Each Scheduled Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '745', 'groupId': 'OG000'}, {'value': '854', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Once Every 2 Weeks (Q2W) or Once Every Month (QM) in Parent Study', 'description': "Participants in the parent study who received placebo subcutaneous injections either Q2W or QM, and received evolocumab 140 mg Q2W or 420 mg QM in the open label extension, according to the participant's preference."}, {'id': 'OG001', 'title': 'Evolocumab Once Every 2 Weeks (Q2W) or Once Every Month (QM) in Parent Study', 'description': 'Participants in the parent study who received evolocumab either Q2W or QM, and received evolocumab 140 mg Q2W or 420 mg QM in the open label extension according to the participants preference.'}], 'classes': [{'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '724', 'groupId': 'OG000'}, {'value': '822', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-66.32', 'spread': '26.88', 'groupId': 'OG000'}, {'value': '-67.24', 'spread': '25.23', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '726', 'groupId': 'OG000'}, {'value': '837', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-66.48', 'spread': '27.52', 'groupId': 'OG000'}, {'value': '-66.47', 'spread': '28.11', 'groupId': 'OG001'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '714', 'groupId': 'OG000'}, {'value': '823', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-62.61', 'spread': '26.60', 'groupId': 'OG000'}, {'value': '-63.45', 'spread': '26.03', 'groupId': 'OG001'}]}]}, {'title': 'Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '708', 'groupId': 'OG000'}, {'value': '819', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-65.58', 'spread': '28.13', 'groupId': 'OG000'}, {'value': '-65.33', 'spread': '28.42', 'groupId': 'OG001'}]}]}, {'title': 'Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '705', 'groupId': 'OG000'}, {'value': '811', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-64.58', 'spread': '27.01', 'groupId': 'OG000'}, {'value': '-63.43', 'spread': '28.80', 'groupId': 'OG001'}]}]}, {'title': 'Week 120', 'denoms': [{'units': 'Participants', 'counts': [{'value': '695', 'groupId': 'OG000'}, {'value': '797', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-64.26', 'spread': '28.31', 'groupId': 'OG000'}, {'value': '-63.10', 'spread': '29.56', 'groupId': 'OG001'}]}]}, {'title': 'Week 144', 'denoms': [{'units': 'Participants', 'counts': [{'value': '489', 'groupId': 'OG000'}, {'value': '590', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-66.79', 'spread': '29.22', 'groupId': 'OG000'}, {'value': '-65.13', 'spread': '31.96', 'groupId': 'OG001'}]}]}, {'title': 'Week 168', 'denoms': [{'units': 'Participants', 'counts': [{'value': '661', 'groupId': 'OG000'}, {'value': '750', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-65.28', 'spread': '27.55', 'groupId': 'OG000'}, {'value': '-63.55', 'spread': '29.60', 'groupId': 'OG001'}]}]}, {'title': 'Week 192', 'denoms': [{'units': 'Participants', 'counts': [{'value': '633', 'groupId': 'OG000'}, {'value': '722', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-65.02', 'spread': '27.93', 'groupId': 'OG000'}, {'value': '-62.46', 'spread': '26.39', 'groupId': 'OG001'}]}]}, {'title': 'Week 216', 'denoms': [{'units': 'Participants', 'counts': [{'value': '653', 'groupId': 'OG000'}, {'value': '741', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-64.92', 'spread': '27.93', 'groupId': 'OG000'}, {'value': '-62.46', 'spread': '28.32', 'groupId': 'OG001'}]}]}, {'title': 'Week 260', 'denoms': [{'units': 'Participants', 'counts': [{'value': '373', 'groupId': 'OG000'}, {'value': '426', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-66.45', 'spread': '29.84', 'groupId': 'OG000'}, {'value': '-64.72', 'spread': '29.50', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12, Week 24, Week 48, Week 72, Week 96, Week 120, Week 144, Week 168, Week 192, Week 216, Week 260', 'unitOfMeasure': 'Percent Change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'OLE Safety Analysis Set which included all participants who received at least 1 dose of open-label evolocumab in the OLE study.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Achieved an LDL-C Level < 40 mg/dL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '745', 'groupId': 'OG000'}, {'value': '854', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Once Every 2 Weeks (Q2W) or Once Every Month (QM) in Parent Study', 'description': "Participants in the parent study who received placebo subcutaneous injections either Q2W or QM, and received evolocumab 140 mg Q2W or 420 mg QM in the open label extension, according to the participant's preference."}, {'id': 'OG001', 'title': 'Evolocumab Once Every 2 Weeks (Q2W) or Once Every Month (QM) in Parent Study', 'description': 'Participants in the parent study who received evolocumab either Q2W or QM, and received evolocumab 140 mg Q2W or 420 mg QM in the open label extension according to the participants preference.'}], 'classes': [{'title': 'Baseline in parent study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '745', 'groupId': 'OG000'}, {'value': '854', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.5'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.4'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '724', 'groupId': 'OG000'}, {'value': '822', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '72.8', 'groupId': 'OG000', 'lowerLimit': '69.4', 'upperLimit': '75.9'}, {'value': '72.5', 'groupId': 'OG001', 'lowerLimit': '69.4', 'upperLimit': '75.4'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '726', 'groupId': 'OG000'}, {'value': '837', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '72.9', 'groupId': 'OG000', 'lowerLimit': '69.5', 'upperLimit': '76.0'}, {'value': '73.4', 'groupId': 'OG001', 'lowerLimit': '70.3', 'upperLimit': '76.2'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '714', 'groupId': 'OG000'}, {'value': '823', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '66.5', 'groupId': 'OG000', 'lowerLimit': '63.0', 'upperLimit': '69.9'}, {'value': '68.0', 'groupId': 'OG001', 'lowerLimit': '64.8', 'upperLimit': '71.1'}]}]}, {'title': 'Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '708', 'groupId': 'OG000'}, {'value': '819', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '73.2', 'groupId': 'OG000', 'lowerLimit': '69.8', 'upperLimit': '76.3'}, {'value': '72.3', 'groupId': 'OG001', 'lowerLimit': '69.1', 'upperLimit': '75.2'}]}]}, {'title': 'Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '705', 'groupId': 'OG000'}, {'value': '811', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '71.1', 'groupId': 'OG000', 'lowerLimit': '67.6', 'upperLimit': '74.3'}, {'value': '69.2', 'groupId': 'OG001', 'lowerLimit': '65.9', 'upperLimit': '72.3'}]}]}, {'title': 'Week 120', 'denoms': [{'units': 'Participants', 'counts': [{'value': '695', 'groupId': 'OG000'}, {'value': '797', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '70.9', 'groupId': 'OG000', 'lowerLimit': '67.5', 'upperLimit': '74.2'}, {'value': '68.6', 'groupId': 'OG001', 'lowerLimit': '65.3', 'upperLimit': '71.8'}]}]}, {'title': 'Week 144', 'denoms': [{'units': 'Participants', 'counts': [{'value': '489', 'groupId': 'OG000'}, {'value': '590', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '75.3', 'groupId': 'OG000', 'lowerLimit': '71.2', 'upperLimit': '78.9'}, {'value': '72.2', 'groupId': 'OG001', 'lowerLimit': '68.5', 'upperLimit': '75.7'}]}]}, {'title': 'Week 168', 'denoms': [{'units': 'Participants', 'counts': [{'value': '661', 'groupId': 'OG000'}, {'value': '750', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '72.3', 'groupId': 'OG000', 'lowerLimit': '68.8', 'upperLimit': '75.6'}, {'value': '69.3', 'groupId': 'OG001', 'lowerLimit': '65.9', 'upperLimit': '72.5'}]}]}, {'title': 'Week 192', 'denoms': [{'units': 'Participants', 'counts': [{'value': '633', 'groupId': 'OG000'}, {'value': '722', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '71.6', 'groupId': 'OG000', 'lowerLimit': '67.9', 'upperLimit': '74.9'}, {'value': '66.3', 'groupId': 'OG001', 'lowerLimit': '62.8', 'upperLimit': '69.7'}]}]}, {'title': 'Week 216', 'denoms': [{'units': 'Participants', 'counts': [{'value': '653', 'groupId': 'OG000'}, {'value': '741', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '72.1', 'groupId': 'OG000', 'lowerLimit': '68.6', 'upperLimit': '75.4'}, {'value': '67.3', 'groupId': 'OG001', 'lowerLimit': '63.9', 'upperLimit': '70.6'}]}]}, {'title': 'Week 260', 'denoms': [{'units': 'Participants', 'counts': [{'value': '373', 'groupId': 'OG000'}, {'value': '426', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '76.1', 'groupId': 'OG000', 'lowerLimit': '71.6', 'upperLimit': '80.2'}, {'value': '68.8', 'groupId': 'OG001', 'lowerLimit': '64.2', 'upperLimit': '73.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 12, Week 24, Week 48, Week 72, Week 96, Week 120, Week 144, Week 168, Week 192, Week 216, Week 260', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'OLE Safety Analysis Set which included all participants who received at least 1 dose of open-label evolocumab in the OLE study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo Once Every 2 Weeks (Q2W) or Once Every Month (QM) in Parent Study', 'description': "Participants in the parent study who received placebo subcutaneous injections either Q2W or QM, and received evolocumab 140 mg Q2W or 420 mg QM in the open label extension, according to the participant's preference."}, {'id': 'FG001', 'title': 'Evolocumab Once Every 2 Weeks (Q2W) or Once Every Month (QM) in Parent Study', 'description': 'Participants in the parent study who received evolocumab either Q2W or QM, and received evolocumab 140 mg Q2W or 420 mg QM in the open label extension according to the participants preference.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '745'}, {'groupId': 'FG001', 'numSubjects': '855'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '695'}, {'groupId': 'FG001', 'numSubjects': '786'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '69'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '50'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '15'}]}]}], 'recruitmentDetails': 'This was an open-label extension of study 20110118 (NCT01764633). Eligible participants were enrolled after the completion of the 20110118 study. 1600 participants were enrolled at 86 centers in Belgium, Germany, Denmark, France, Italy, Portugal, and Sweden from 13 March 2017 to 04 March 2022.', 'preAssignmentDetails': '1600 participants were enrolled and 1599 of those participants received study drug.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '745', 'groupId': 'BG000'}, {'value': '854', 'groupId': 'BG001'}, {'value': '1599', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo Once Every 2 Weeks (Q2W) or Once Every Month (QM) in Parent Study', 'description': "Participants in the parent study who received placebo subcutaneous injections either Q2W or QM, and received evolocumab 140 mg Q2W or 420 mg QM in the open label extension, according to the participant's preference."}, {'id': 'BG001', 'title': 'Evolocumab Once Every 2 Weeks (Q2W) or Once Every Month (QM) in Parent Study', 'description': 'Participants in the parent study who received evolocumab either Q2W or QM, and received evolocumab 140 mg Q2W or 420 mg QM in the open label extension according to the participants preference.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.7', 'spread': '9.1', 'groupId': 'BG000'}, {'value': '62.6', 'spread': '8.9', 'groupId': 'BG001'}, {'value': '62.6', 'spread': '9.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '138', 'groupId': 'BG000'}, {'value': '151', 'groupId': 'BG001'}, {'value': '289', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '607', 'groupId': 'BG000'}, {'value': '703', 'groupId': 'BG001'}, {'value': '1310', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '728', 'groupId': 'BG000'}, {'value': '830', 'groupId': 'BG001'}, {'value': '1558', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '706', 'groupId': 'BG000'}, {'value': '797', 'groupId': 'BG001'}, {'value': '1503', 'groupId': 'BG002'}]}, {'title': 'Multiple', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The Overall Number of Baseline Participants is made up of all of the participants that received study drug.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-02-19', 'size': 5275631, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-11-17T09:07', 'hasProtocol': True}, {'date': '2022-03-24', 'size': 2856837, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-11-17T09:07', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Open label'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1600}}, 'statusModule': {'whyStopped': 'Amgen business decision to close study early', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-03-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2022-03-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-10', 'studyFirstSubmitDate': '2017-03-10', 'resultsFirstSubmitDate': '2022-11-17', 'studyFirstSubmitQcDate': '2017-03-10', 'lastUpdatePostDateStruct': {'date': '2024-05-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-12-19', 'studyFirstPostDateStruct': {'date': '2017-03-15', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-01-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Who Experienced an Adverse Event', 'timeFrame': 'Up to 5 years', 'description': 'All adverse event summaries for the primary analysis of the primary endpoint (OLE study period only) included all treatment-emergent events reported on the Event electronic case report form (eCRF), including CEC positively reviewed events and disease-related events.'}], 'secondaryOutcomes': [{'measure': 'Percent Change of Low-density Lipoprotein Cholesterol (LDL-C) From Baseline at Each Scheduled Visit', 'timeFrame': 'Baseline, Week 12, Week 24, Week 48, Week 72, Week 96, Week 120, Week 144, Week 168, Week 192, Week 216, Week 260'}, {'measure': 'Percentage of Participants Who Achieved an LDL-C Level < 40 mg/dL', 'timeFrame': 'Baseline, Week 12, Week 24, Week 48, Week 72, Week 96, Week 120, Week 144, Week 168, Week 192, Week 216, Week 260'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dyslipidemia']}, 'referencesModule': {'references': [{'pmid': '36031810', 'type': 'BACKGROUND', 'citation': "O'Donoghue ML, Giugliano RP, Wiviott SD, Atar D, Keech A, Kuder JF, Im K, Murphy SA, Flores-Arredondo JH, Lopez JAG, Elliott-Davey M, Wang B, Monsalvo ML, Abbasi S, Sabatine MS. Long-Term Evolocumab in Patients With Established Atherosclerotic Cardiovascular Disease. Circulation. 2022 Oct 11;146(15):1109-1119. doi: 10.1161/CIRCULATIONAHA.122.061620. Epub 2022 Aug 29."}, {'pmid': '38325990', 'type': 'BACKGROUND', 'citation': "McClintick DJ, O'Donoghue ML, De Ferrari GM, Ferreira J, Ran X, Im K, Lopez JAG, Elliott-Davey M, Wang B, Monsalvo ML, Atar D, Keech A, Giugliano RP, Sabatine MS. Long-Term Efficacy of Evolocumab in Patients With or Without Multivessel Coronary Disease. J Am Coll Cardiol. 2024 Feb 13;83(6):652-664. doi: 10.1016/j.jacc.2023.11.029."}, {'pmid': '28477848', 'type': 'DERIVED', 'citation': 'Katsiki N, Athyros VG, Mikhailidis DP, Mantzoros C. Proprotein convertase subtilisin-kexin type 9 (PCSK9) inhibitors: Shaping the future after the further cardiovascular outcomes research with PCSK9 inhibition in subjects with elevated risk (FOURIER) trial. Metabolism. 2017 Sep;74:43-46. doi: 10.1016/j.metabol.2017.04.007. Epub 2017 Apr 20. No abstract available.'}], 'seeAlsoLinks': [{'url': 'http://www.amgentrials.com', 'label': 'AmgenTrials clinical trials website'}]}, 'descriptionModule': {'briefSummary': 'This is a multicenter, open-label extension (OLE) study designed to assess the extended long-term safety of evolocumab in subjects who have completed the FOURIER trial (Study 20110118). Approximately 1600 subjects will be enrolled in this study. This study will continue for 260 weeks (approximately 5 years).', 'detailedDescription': 'This is a multicenter, open-label extension (OLE) study designed to assess the extended long-term safety of evolocumab in subjects who have completed the FOURIER trial (Study 20110118). FOURIER is a randomized placebo-controlled study of evolocumab, in patients with clinically evident atherosclerotic CVD on stable effective statin therapy. Subjects at sites participating in FOURIER OLE (Study 20160250) who are eligible and have signed the FOURIER OLE informed consent will be enrolled after completion of FOURIER.\n\nThe FOURIER OLE study requires laboratory assessments at day 1, week 12, and thereafter approximately every 6 months from day 1; the corresponding blood samples will be processed using a central laboratory.\n\nUpon enrollment in FOURIER OLE study, subjects will receive evolocumab 140 mg every 2 weeks (Q2W) or 420 mg monthly (QM) according to their preference. Frequency and corresponding dose of administration can be changed at any scheduled time point where evolocumab is supplied to the subject, provided the appropriate supply is available. It is recommended that subjects continue the same background lipid-lowering therapy (LLT), including statin, as taken during FOURIER.\n\nThis study will continue for 260 weeks (approximately 5 years). Subjects ending administration of evolocumab should continue study assessments until the end of study. All subjects will be followed and complete procedures/assessments from enrollment through the date of study termination unless the subject has withdrawn consent, irrespective of whether the subject is continuing to receive treatment.\n\nAll deaths and cardiovascular events of interest will be reviewed by an independent external Clinical Events Committee (CEC), using standardized definitions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject has provided informed consent prior to initiation of any study-specific activities/procedures.\n* Subject had completed FOURIER (Study 20110118) while still receiving assigned Investigational Product.\n\nExclusion Criteria:\n\n* Permanent discontinuation of Investigational Product during FOURIER for any reason including an adverse event or serious adverse event.\n* Currently receiving treatment in another investigational device or drug study, or less than 4 weeks since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded.\n* Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the subject and investigator's knowledge.\n* History or evidence of any other clinically significant disorder, condition or disease that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.\n* Subject has known sensitivity to any of the active substances or excipients (eg, sodium acetate) to be administered during dosing.\n* Females who are pregnant or breastfeeding or planning to become pregnant or breastfeed during treatment with evolocumab and for an additional 15 weeks after treatment with evolocumab discontinues.\n* Female subjects of childbearing potential unwilling to use an acceptable method of effective contraception during treatment and for an additional 15 weeks after the last dose of protocol-required therapies."}, 'identificationModule': {'nctId': 'NCT03080935', 'briefTitle': 'Fourier Open-label Extension Study in Subjects With Clinically Evident Cardiovascular Disease in Selected European Countries', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amgen'}, 'officialTitle': 'A Multicenter, Open-label, Single-arm, Extension Study to Assess Long-term Safety of Evolocumab Therapy in Subjects With Clinically Evident Cardiovascular Disease in Selected European Countries', 'orgStudyIdInfo': {'id': '20160250'}, 'secondaryIdInfos': [{'id': '2016-004066-26', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Evolocumab', 'description': 'Single arm study administering Evolocumab.', 'interventionNames': ['Drug: Evolocumab']}], 'interventions': [{'name': 'Evolocumab', 'type': 'DRUG', 'otherNames': ['AMG 145'], 'description': "Subjects will receive Evolocumab 140 mg every 2 weeks (Q2W) or 420 mg monthly (QM), according to the subject's preference.", 'armGroupLabels': ['Evolocumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9300', 'city': 'Aalst', 'country': 'Belgium', 'facility': 'Algemeen Stedelijk Ziekenhuis Aalst', 'geoPoint': {'lat': 50.93604, 'lon': 4.0355}}, {'zip': '9300', 'city': 'Aalst', 'country': 'Belgium', 'facility': 'Onze Lieve Vrouw Ziekenhuis Aalst', 'geoPoint': {'lat': 50.93604, 'lon': 4.0355}}, {'zip': '2020', 'city': 'Antwerp', 'country': 'Belgium', 'facility': 'Ziekenhuis Netwerk Antwerpen Middelheim', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}, {'zip': '2060', 'city': 'Antwerp', 'country': 'Belgium', 'facility': 'Ziekenhuis Netwerk Antwerpen Stuivenberg', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}, {'zip': '2820', 'city': 'Bonheiden', 'country': 'Belgium', 'facility': 'Imelda Ziekenhuis vzw', 'geoPoint': {'lat': 51.02261, 'lon': 4.54714}}, {'zip': '1020', 'city': 'Brussels', 'country': 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been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.', 'ipdSharing': 'YES', 'description': 'De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.', 'accessCriteria': 'Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amgen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}