Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2026-03-09 @ 2:20 AM
Study NCT ID:
NCT01854918
Status:
COMPLETED
Last Update Posted:
2019-06-11
First Post:
2013-05-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Open-label Extension Study of Evolocumab (AMG 145) in Adults With Hyperlipidemia and Mixed Dyslipidemia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D006937', 'term': 'Hypercholesterolemia'}], 'ancestors': [{'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C577155', 'term': 'evolocumab'}, {'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, '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}}, 'adverseEventsModule': {'timeFrame': '48 weeks in the SOC-controlled period and up to 2 years in the All-IP period.', 'description': 'Adverse evens are reported for all randomized participants in the SOC-controlled period (year 1) and for all participants who entered the all-IP period (years 2-3).\n\nOther Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.', 'eventGroups': [{'id': 'EG000', 'title': 'Year 1: Standard of Care', 'description': 'Participants received standard of care (SOC) treatment for the first year of the study (SOC-controlled period).', 'otherNumAtRisk': 1227, 'deathsNumAtRisk': 1227, 'otherNumAffected': 334, 'seriousNumAtRisk': 1227, 'deathsNumAffected': 5, 'seriousNumAffected': 104}, {'id': 'EG001', 'title': 'Year 1: Evolocumab + Standard of Care', 'description': 'Participants received subcutaneous evolocumab plus standard of care during the first year of the study (SOC-controlled period). Evolocumab was administered at a dose of 140 mg every 2 weeks (Q2W) or 420 mg every month (QM) based on participant choice.', 'otherNumAtRisk': 2454, 'deathsNumAtRisk': 2454, 'otherNumAffected': 681, 'seriousNumAtRisk': 2454, 'deathsNumAffected': 5, 'seriousNumAffected': 195}, {'id': 'EG002', 'title': 'Years 2-3: SOC / Evolocumab + SOC', 'description': 'At week 48, participants began treatment with evolocumab at a dose of either 140 mg Q2W or 420 mg QM, based on participant choice, plus SOC, for approximately 2 years during the all-IP period.', 'otherNumAtRisk': 1197, 'deathsNumAtRisk': 1197, 'otherNumAffected': 498, 'seriousNumAtRisk': 1197, 'deathsNumAffected': 5, 'seriousNumAffected': 181}, {'id': 'EG003', 'title': 'Years 2-3: Evolocumab + SOC / Evolocumab + SOC', 'description': 'Participants continued to receive evolocumab plus SOC for approximately 2 years during the all-IP period. Evolocumab was administered at a dose of 140 mg Q2W or 420 mg QM based on participant choice.', 'otherNumAtRisk': 2391, 'deathsNumAtRisk': 2391, 'otherNumAffected': 928, 'seriousNumAtRisk': 2391, 'deathsNumAffected': 16, 'seriousNumAffected': 344}, {'id': 'EG004', 'title': 'Years 2-3: Total', 'description': 'All participants in the All-IP period who received evolocumab plus SOC for approximately 2 years. Evolocumab was administered at a dose of 140 mg Q2W or 420 mg QM based on participant choice.', 'otherNumAtRisk': 3588, 'deathsNumAtRisk': 3588, 'otherNumAffected': 1426, 'seriousNumAtRisk': 3588, 'deathsNumAffected': 21, 'seriousNumAffected': 525}], 'otherEvents': [{'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1227, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 2454, 'numAffected': 78}, {'groupId': 'EG002', 'numAtRisk': 1197, 'numAffected': 70}, {'groupId': 'EG003', 'numAtRisk': 2391, 'numAffected': 132}, {'groupId': 'EG004', 'numAtRisk': 3588, 'numAffected': 202}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1227, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 2454, 'numAffected': 66}, {'groupId': 'EG002', 'numAtRisk': 1197, 'numAffected': 60}, {'groupId': 'EG003', 'numAtRisk': 2391, 'numAffected': 115}, {'groupId': 'EG004', 'numAtRisk': 3588, 'numAffected': 175}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1227, 'numAffected': 108}, {'groupId': 'EG001', 'numAtRisk': 2454, 'numAffected': 201}, {'groupId': 'EG002', 'numAtRisk': 1197, 'numAffected': 151}, {'groupId': 'EG003', 'numAtRisk': 2391, 'numAffected': 253}, {'groupId': 'EG004', 'numAtRisk': 3588, 'numAffected': 404}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1227, 'numAffected': 55}, {'groupId': 'EG001', 'numAtRisk': 2454, 'numAffected': 104}, {'groupId': 'EG002', 'numAtRisk': 1197, 'numAffected': 99}, {'groupId': 'EG003', 'numAtRisk': 2391, 'numAffected': 178}, {'groupId': 'EG004', 'numAtRisk': 3588, 'numAffected': 277}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1227, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 2454, 'numAffected': 106}, {'groupId': 'EG002', 'numAtRisk': 1197, 'numAffected': 80}, {'groupId': 'EG003', 'numAtRisk': 2391, 'numAffected': 162}, {'groupId': 'EG004', 'numAtRisk': 3588, 'numAffected': 242}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1227, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 2454, 'numAffected': 83}, {'groupId': 'EG002', 'numAtRisk': 1197, 'numAffected': 78}, {'groupId': 'EG003', 'numAtRisk': 2391, 'numAffected': 147}, {'groupId': 'EG004', 'numAtRisk': 3588, 'numAffected': 225}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1227, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 2454, 'numAffected': 88}, {'groupId': 'EG002', 'numAtRisk': 1197, 'numAffected': 61}, {'groupId': 'EG003', 'numAtRisk': 2391, 'numAffected': 67}, {'groupId': 'EG004', 'numAtRisk': 3588, 'numAffected': 128}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1227, 'numAffected': 56}, {'groupId': 'EG001', 'numAtRisk': 2454, 'numAffected': 87}, {'groupId': 'EG002', 'numAtRisk': 1197, 'numAffected': 78}, {'groupId': 'EG003', 'numAtRisk': 2391, 'numAffected': 180}, {'groupId': 'EG004', 'numAtRisk': 3588, 'numAffected': 258}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1227, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2454, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1197, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2391, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3588, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Haemolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1227, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2454, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1197, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2391, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3588, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Haemorrhagic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1227, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2454, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1197, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2391, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3588, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1227, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2454, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1197, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2391, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3588, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1227, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2454, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1197, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2391, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3588, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Thrombocytopenic purpura', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1227, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2454, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1197, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2391, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3588, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1227, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2454, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1197, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2391, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3588, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1227, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 2454, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 1197, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 2391, 'numAffected': 12}, {'groupId': 'EG004', 'numAtRisk': 3588, 'numAffected': 15}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1227, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2454, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 1197, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 2391, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 3588, 'numAffected': 18}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1227, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 2454, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 1197, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 2391, 'numAffected': 11}, {'groupId': 'EG004', 'numAtRisk': 3588, 'numAffected': 15}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Aortic valve disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1227, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2454, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1197, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2391, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3588, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Aortic valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1227, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2454, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1197, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2391, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3588, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Aortic valve sclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1227, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2454, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1197, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2391, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3588, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Aortic valve stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1227, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2454, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1197, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2391, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3588, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1227, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2454, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1197, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2391, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3588, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Arteriosclerosis coronary artery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1227, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2454, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1197, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2391, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3588, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1227, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 2454, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1197, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 2391, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 3588, 'numAffected': 14}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1227, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2454, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1197, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2391, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 3588, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Atrioventricular block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1227, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2454, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1197, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2391, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3588, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1227, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2454, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1197, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2391, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3588, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1227, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2454, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1197, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2391, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 3588, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1227, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2454, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1197, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2391, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 3588, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Cardiac failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1227, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2454, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1197, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2391, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3588, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1227, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2454, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1197, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 2391, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 3588, 'numAffected': 9}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1227, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2454, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1197, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2391, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3588, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1227, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 2454, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 1197, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 2391, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 3588, 'numAffected': 9}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Coronary artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1227, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2454, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1197, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2391, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3588, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Coronary artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1227, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2454, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1197, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2391, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 3588, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Left ventricular failure', 'stats': [{'groupId': 'EG000', 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[{'groupId': 'EG000', 'numAtRisk': 1227, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2454, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1197, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2391, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3588, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1227, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2454, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1197, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2391, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3588, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1227, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2454, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1197, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2391, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 3588, 'numAffected': 5}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1227, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2454, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1197, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2391, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3588, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Hypertensive emergency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1227, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2454, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1197, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2391, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3588, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1227, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2454, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1197, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2391, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3588, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Labile blood pressure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1227, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2454, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1197, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2391, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3588, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Malignant hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1227, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2454, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1197, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2391, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3588, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Microangiopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1227, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2454, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1197, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2391, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3588, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1227, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2454, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1197, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 2391, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3588, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Pelvic venous thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1227, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2454, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1197, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2391, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3588, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1227, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2454, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 1197, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2391, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3588, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Peripheral artery aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1227, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2454, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1197, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2391, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3588, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Peripheral artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1227, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2454, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1197, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2391, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3588, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Peripheral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1227, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2454, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1197, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2391, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3588, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Peripheral vascular disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1227, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2454, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1197, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2391, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3588, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Subclavian artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1227, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2454, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1197, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2391, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3588, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Thrombophlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1227, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2454, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1197, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2391, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3588, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Varicose vein', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1227, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2454, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1197, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2391, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 3588, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Venous thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1227, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2454, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1197, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2391, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3588, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Venous thrombosis limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1227, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2454, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1197, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2391, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3588, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1227', 'groupId': 'OG000'}, {'value': '2454', 'groupId': 'OG001'}, {'value': '1152', 'groupId': 'OG002'}, {'value': '2291', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Year 1: Standard of Care', 'description': 'Participants received standard of care (SOC) treatment for the first year of the study (SOC-controlled period).'}, {'id': 'OG001', 'title': 'Year 1: Evolocumab + Standard of Care', 'description': 'Participants received subcutaneous evolocumab plus standard of care during the first year of the study (SOC-controlled period). Evolocumab was administered at a dose of 140 mg every 2 weeks (Q2W) or 420 mg every month (QM) based on participant choice.'}, {'id': 'OG002', 'title': 'Years 2-3: SOC / Evolocumab + SOC', 'description': 'At week 48, participants began treatment with evolocumab at a dose of either 140 mg Q2W or 420 mg QM, based on participant choice, plus SOC, for approximately 2 years during the all-IP period.'}, {'id': 'OG003', 'title': 'Years 2-3: Evolocumab + SOC / Evolocumab + SOC', 'description': 'Participants continued to receive evolocumab plus SOC for approximately 2 years during the all-IP period. Evolocumab was administered at a dose of 140 mg Q2W or 420 mg QM based on participant choice.'}], 'classes': [{'title': 'All adverse events', 'categories': [{'measurements': [{'value': '796', 'groupId': 'OG000'}, {'value': '1655', 'groupId': 'OG001'}, {'value': '929', 'groupId': 'OG002'}, {'value': '1789', 'groupId': 'OG003'}]}]}, {'title': 'Adverse events ≥ grade 2', 'categories': [{'measurements': [{'value': '519', 'groupId': 'OG000'}, {'value': '1070', 'groupId': 'OG001'}, {'value': '700', 'groupId': 'OG002'}, {'value': '1339', 'groupId': 'OG003'}]}]}, {'title': 'Adverse events ≥ grade 3', 'categories': [{'measurements': [{'value': '124', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}, {'value': '214', 'groupId': 'OG002'}, {'value': '379', 'groupId': 'OG003'}]}]}, {'title': 'Adverse events ≥ grade 4', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}]}]}, {'title': 'Serious adverse events', 'categories': [{'measurements': [{'value': '104', 'groupId': 'OG000'}, {'value': '195', 'groupId': 'OG001'}, {'value': '178', 'groupId': 'OG002'}, {'value': '332', 'groupId': 'OG003'}]}]}, {'title': 'AEs leading to discontinuation of evolocumab', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}]}]}, {'title': 'Fatal adverse events', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}]}, {'title': 'Device related adverse events', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '48 weeks in the SOC-controlled period and up to 2 years in the All-IP period', 'description': 'Adverse event (AE) severity assessments were made using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) grading, version 4.0, where grade 1 = mild AE, grade 2 = moderate AE, Grade 3 = severe AE, grade 4 = life-threatening AE and Grade 5 = death due to AE.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants (year 1) and randomized participants on study and who received at least 1 dose of evolocumab in the all-IP period (years 2-3).'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in LDL-C at Weeks 48 and 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1152', 'groupId': 'OG000'}, {'value': '2291', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care', 'description': 'Participants received standard of care (SOC) treatment for the first year of the study (SOC-controlled period). At week 48, participants began treatment with evolocumab at a dose of either 140 mg every 2 weeks (Q2W) or 420 mg every month (QM), based on participant choice, for approximately 2 years during the all-investigational product \\[all-IP\\] period.'}, {'id': 'OG001', 'title': 'Evolocumab + Standard of Care', 'description': 'Participants received subcutaneous evolocumab plus standard of care during the first year of the study (SOC-controlled period) and for approximately 2 years during the all-IP period. Evolocumab was administered at a dose of 140 mg every 2 weeks (Q2W) or 420 mg every month (QM) based on participant choice.'}], 'classes': [{'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1115', 'groupId': 'OG000'}, {'value': '2241', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.43', 'spread': '38.93', 'groupId': 'OG000'}, {'value': '-51.59', 'spread': '28.88', 'groupId': 'OG001'}]}]}, {'title': 'Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1087', 'groupId': 'OG000'}, {'value': '2166', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-49.96', 'spread': '33.29', 'groupId': 'OG000'}, {'value': '-50.31', 'spread': '30.34', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline of the parent study and weeks 48 amd 104', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who were randomized in 20120138 and on-study and with known dosing information in the All-IP period, and with non-missing data at each time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in LDL-C at Weeks 48 and 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1152', 'groupId': 'OG000'}, {'value': '2291', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care', 'description': 'Participants received standard of care (SOC) treatment for the first year of the study (SOC-controlled period). At week 48, participants began treatment with evolocumab at a dose of either 140 mg every 2 weeks (Q2W) or 420 mg every month (QM), based on participant choice, for approximately 2 years during the all-investigational product \\[all-IP\\] period.'}, {'id': 'OG001', 'title': 'Evolocumab + Standard of Care', 'description': 'Participants received subcutaneous evolocumab plus standard of care during the first year of the study (SOC-controlled period) and for approximately 2 years during the all-IP period. Evolocumab was administered at a dose of 140 mg every 2 weeks (Q2W) or 420 mg every month (QM) based on participant choice.'}], 'classes': [{'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1115', 'groupId': 'OG000'}, {'value': '2241', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '43.9', 'groupId': 'OG000'}, {'value': '-68.8', 'spread': '46.6', 'groupId': 'OG001'}]}]}, {'title': 'Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1087', 'groupId': 'OG000'}, {'value': '2166', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-66.4', 'spread': '50.1', 'groupId': 'OG000'}, {'value': '-67.2', 'spread': '46.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline of the parent study and weeks 48 amd 104', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who were randomized in 20120138 and on-study and with known dosing information in the All-IP period, and with non-missing data at each time point.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Standard of Care', 'description': 'Participants received standard of care (SOC) treatment for the first year of the study (SOC-controlled period). At week 48, participants began treatment with evolocumab at a dose of either 140 mg every 2 weeks (Q2W) or 420 mg every month (QM), based on participant choice, for approximately 2 years during the all-investigational product \\[all-IP\\] period.'}, {'id': 'FG001', 'title': 'Evolocumab + Standard of Care', 'description': 'Participants received subcutaneous evolocumab plus standard of care during the first year of the study (SOC-controlled period) and for approximately 2 years during the all-IP period. Evolocumab was administered at a dose of 140 mg every 2 weeks (Q2W) or 420 mg every month (QM) based on participant choice.'}], 'periods': [{'title': 'SOC-controlled Period (Year 1)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1227'}, {'groupId': 'FG001', 'numSubjects': '2454'}]}, {'type': 'Received Evolocumab', 'achievements': [{'comment': '5 participants received evolocumab in error', 'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2452'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1197'}, {'groupId': 'FG001', 'numSubjects': '2391'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '63'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '49'}]}, {'type': 'Decision by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}, {'title': 'All-IP Period (Years 2 and 3)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1197'}, {'groupId': 'FG001', 'numSubjects': '2391'}]}, {'type': 'Received Evolocumab', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1152'}, {'groupId': 'FG001', 'numSubjects': '2291'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1079'}, {'groupId': 'FG001', 'numSubjects': '2196'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '118'}, {'groupId': 'FG001', 'numSubjects': '195'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '78'}, {'groupId': 'FG001', 'numSubjects': '117'}]}, {'type': 'Decision by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '51'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '16'}]}]}], 'recruitmentDetails': 'Participants were enrolled at 365 study centers in 24 countries in Europe, North America, and Asia Pacific from 23 April 2013 to 31 August 2015.', 'preAssignmentDetails': 'Participants were randomized in a 2:1 ratio to receive evolocumab plus standard of care (SOC) or SOC alone for the first year. In years 2 and 3 all participants received evolocumab. Randomization was stratified by the parent study and parent study dose frequency (every 2 weeks \\[Q2W\\] or once monthly \\[QM\\]).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1227', 'groupId': 'BG000'}, {'value': '2454', 'groupId': 'BG001'}, {'value': '3681', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Standard of Care', 'description': 'Participants received standard of care (SOC) treatment for the first year of the study (SOC-controlled period). At week 48, participants began treatment with evolocumab at a dose of either 140 mg every 2 weeks (Q2W) or 420 mg every month (QM), based on participant choice, for approximately 2 years during the all-investigational product \\[all-IP\\] period.'}, {'id': 'BG001', 'title': 'Evolocumab + Standard of Care', 'description': 'Participants received subcutaneous evolocumab plus standard of care during the first year of the study (SOC-controlled period) and for approximately 2 years during the all-IP period. 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'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '560', 'groupId': 'BG000'}, {'value': '1176', 'groupId': 'BG001'}, {'value': '1736', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '667', 'groupId': 'BG000'}, {'value': '1278', 'groupId': 'BG001'}, {'value': '1945', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '109', 'groupId': 'BG001'}, {'value': '167', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '1169', 'groupId': 'BG000'}, {'value': '2345', 'groupId': 'BG001'}, {'value': '3514', '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': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '152', 'groupId': 'BG000'}, {'value': '288', 'groupId': 'BG001'}, {'value': '440', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '1003', 'groupId': 'BG000'}, {'value': '2041', 'groupId': 'BG001'}, {'value': '3044', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}, {'title': 'Mixed Race', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region', 'classes': [{'categories': [{'title': 'North America', 'measurements': [{'value': '514', 'groupId': 'BG000'}, {'value': '1001', 'groupId': 'BG001'}, {'value': '1515', 'groupId': 'BG002'}]}, {'title': 'Europe', 'measurements': [{'value': '504', 'groupId': 'BG000'}, {'value': '1018', 'groupId': 'BG001'}, {'value': '1522', 'groupId': 'BG002'}]}, {'title': 'Asia Pacific', 'measurements': [{'value': '209', 'groupId': 'BG000'}, {'value': '435', 'groupId': 'BG001'}, {'value': '644', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Parent Study Baseline Low-density Lipoprotein Cholesterol (LDL-C) Concentration', 'classes': [{'categories': [{'measurements': [{'value': '125.8', 'spread': '49.3', 'groupId': 'BG000'}, {'value': '127.4', 'spread': '51.7', 'groupId': 'BG001'}, {'value': '126.9', 'spread': '50.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'All randomized participants'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-04-03', 'size': 2849346, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-05-20T13:54', 'hasProtocol': True}, {'date': '2013-11-18', 'size': 469664, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-05-20T13:54', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3681}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2018-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-20', 'studyFirstSubmitDate': '2013-05-01', 'resultsFirstSubmitDate': '2019-05-20', 'studyFirstSubmitQcDate': '2013-05-15', 'lastUpdatePostDateStruct': {'date': '2019-06-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-05-20', 'studyFirstPostDateStruct': {'date': '2013-05-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Adverse Events', 'timeFrame': '48 weeks in the SOC-controlled period and up to 2 years in the All-IP period', 'description': 'Adverse event (AE) severity assessments were made using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) grading, version 4.0, where grade 1 = mild AE, grade 2 = moderate AE, Grade 3 = severe AE, grade 4 = life-threatening AE and Grade 5 = death due to AE.'}], 'secondaryOutcomes': [{'measure': 'Percent Change From Baseline in LDL-C at Weeks 48 and 104', 'timeFrame': 'Baseline of the parent study and weeks 48 amd 104'}, {'measure': 'Change From Baseline in LDL-C at Weeks 48 and 104', 'timeFrame': 'Baseline of the parent study and weeks 48 amd 104'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['High cholesterol', 'Raised cholesterol', 'Cholesterol', 'Elevated Cholesterol'], 'conditions': ['Hyperlipidemia and Mixed Dyslipidemia']}, 'referencesModule': {'references': [{'pmid': '29353350', 'type': 'BACKGROUND', 'citation': 'Kasichayanula S, Grover A, Emery MG, Gibbs MA, Somaratne R, Wasserman SM, Gibbs JP. Clinical Pharmacokinetics and Pharmacodynamics of Evolocumab, a PCSK9 Inhibitor. Clin Pharmacokinet. 2018 Jul;57(7):769-779. doi: 10.1007/s40262-017-0620-7.'}, {'pmid': '28844508', 'type': 'RESULT', 'citation': 'Sattar N, Toth PP, Blom DJ, Koren MJ, Soran H, Uhart M, Elliott M, Cyrille M, Somaratne R, Preiss D. Effect of the Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitor Evolocumab on Glycemia, Body Weight, and New-Onset Diabetes Mellitus. Am J Cardiol. 2017 Nov 1;120(9):1521-1527. doi: 10.1016/j.amjcard.2017.07.047. Epub 2017 Jul 31.'}, {'pmid': '29066265', 'type': 'RESULT', 'citation': 'Hovingh GK, Raal FJ, Dent R, Stefanutti C, Descamps O, Masana L, Lira A, Bridges I, Coll B, Sullivan D. Long-term safety, tolerability, and efficacy of evolocumab in patients with heterozygous familial hypercholesterolemia. J Clin Lipidol. 2017 Nov-Dec;11(6):1448-1457. doi: 10.1016/j.jacl.2017.09.003. Epub 2017 Sep 22.'}, {'pmid': '33078867', 'type': 'DERIVED', 'citation': 'Schmidt AF, Carter JL, Pearce LS, Wilkins JT, Overington JP, Hingorani AD, Casas JP. PCSK9 monoclonal antibodies for the primary and secondary prevention of cardiovascular disease. Cochrane Database Syst Rev. 2020 Oct 20;10(10):CD011748. doi: 10.1002/14651858.CD011748.pub3.'}, {'pmid': '25773607', 'type': 'DERIVED', 'citation': 'Sabatine MS, Giugliano RP, Wiviott SD, Raal FJ, Blom DJ, Robinson J, Ballantyne CM, Somaratne R, Legg J, Wasserman SM, Scott R, Koren MJ, Stein EA; Open-Label Study of Long-Term Evaluation against LDL Cholesterol (OSLER) Investigators. Efficacy and safety of evolocumab in reducing lipids and cardiovascular events. N Engl J Med. 2015 Apr 16;372(16):1500-9. doi: 10.1056/NEJMoa1500858. Epub 2015 Mar 15.'}], 'seeAlsoLinks': [{'url': 'http://www.amgentrials.com', 'label': 'AmgenTrials clinical trials website'}]}, 'descriptionModule': {'briefSummary': 'This study will contribute to the evaluation of long-term safety, tolerability and efficacy of evolocumab (AMG 145) in adults with hyperlipidemia and adults with mixed dyslipidemia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Complete a qualifying evolocumab (AMG 145) parent study (ie, Study 20110114 \\[NCT01763827\\], 20110115 \\[NCT01763866\\], 20110116 \\[NCT01763905\\], 20110117 \\[NCT01763918\\], 20110109 \\[NCT01516879\\], 20120122 \\[NCT01953328\\], 20120332 \\[NCT01984424\\], 20120348 \\[NCT01849497\\], or 20120356 \\[NCT01879319\\]).\n\nExclusion Criteria:\n\n* Experienced a treatment-related serious adverse event that led to study drug discontinuation in the parent study\n* Have an unstable medical condition, in the judgment of the investigator\n* Known sensitivity to any of the products to be administered during dosing\n* Currently enrolled in another investigational device or drug study (excluding evolocumab (AMG 145) parent study), or less than 30 days since ending another investigational device or drug study(s),or receiving other investigational agent(s)'}, 'identificationModule': {'nctId': 'NCT01854918', 'acronym': 'OSLER-2', 'briefTitle': 'Open-label Extension Study of Evolocumab (AMG 145) in Adults With Hyperlipidemia and Mixed Dyslipidemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amgen'}, 'officialTitle': 'A Multicenter, Controlled, Open-label Extension (OLE) Study to Assess the Long-term Safety and Efficacy of AMG 145', 'orgStudyIdInfo': {'id': '20120138'}, 'secondaryIdInfos': [{'id': '2012-004357-83', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of Care', 'description': 'Participants received standard of care (SOC) treatment for the first year of the study (SOC-controlled period). 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