Ignite Creation Date:
2025-12-24 @ 10:51 PM
Ignite Modification Date:
2026-02-20 @ 6:39 PM
Study NCT ID:
NCT02662569
Status:
COMPLETED
Last Update Posted:
2019-01-11
First Post:
2016-01-20
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of Evolocumab in Combination With Statin Therapy in Adults With Diabetes and Hyperlipidemia or Mixed Dyslipidemia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D006949', 'term': 'Hyperlipidemias'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C577155', 'term': 'evolocumab'}, {'id': 'D000069059', 'term': 'Atorvastatin'}], 'ancestors': [{'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006538', 'term': 'Heptanoic Acids'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, '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': 'From the first dose of study drug to 30 days after last dose; up to 14 weeks.', 'description': 'Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo Q2W', 'description': 'Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and 20 mg atorvastatin orally once a day for up to 12 weeks.', 'otherNumAtRisk': 164, 'deathsNumAtRisk': 164, 'otherNumAffected': 28, 'seriousNumAtRisk': 164, 'deathsNumAffected': 0, 'seriousNumAffected': 6}, {'id': 'EG001', 'title': 'Placebo QM', 'description': 'Participants received placebo subcutaneous injection once a month (QM) and 20 mg atorvastatin orally once a day for up to 12 weeks.', 'otherNumAtRisk': 160, 'deathsNumAtRisk': 160, 'otherNumAffected': 22, 'seriousNumAtRisk': 160, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG002', 'title': 'Evolocumab Q2W', 'description': 'Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and 20 mg atorvastatin orally once a day for up to 12 weeks.', 'otherNumAtRisk': 325, 'deathsNumAtRisk': 325, 'otherNumAffected': 45, 'seriousNumAtRisk': 325, 'deathsNumAffected': 0, 'seriousNumAffected': 10}, {'id': 'EG003', 'title': 'Evolocumab QM', 'description': 'Participants received 420 mg evolocumab by subcutaneous injection once a month and 20 mg atorvastatin orally once a day for up to 12 weeks.', 'otherNumAtRisk': 332, 'deathsNumAtRisk': 332, 'otherNumAffected': 49, 'seriousNumAtRisk': 332, 'deathsNumAffected': 0, 'seriousNumAffected': 22}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 325, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 332, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 325, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 332, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 325, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 332, 'numAffected': 15}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 325, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 332, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 325, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 332, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 325, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 332, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 325, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 332, 'numAffected': 5}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}], 'seriousEvents': [{'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 325, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 332, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 325, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 332, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 325, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 332, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 325, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 332, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 325, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 332, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 325, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 332, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 325, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 332, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Gastric ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 325, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 332, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 325, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 332, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 325, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 332, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 325, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 332, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Herpes zoster cutaneous disseminated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 325, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 332, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Lung infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 325, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 332, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Periodontitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 325, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 332, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 325, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 332, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 325, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 332, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 325, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 332, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 325, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 332, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Humerus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 325, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 332, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Lower limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 325, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 332, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Diabetic ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 325, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 332, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Type 2 diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 325, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 332, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 325, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 332, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 325, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 332, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 325, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 332, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Rheumatoid arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 325, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 332, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Adenocarcinoma gastric', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 325, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 332, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Carotid artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 325, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 332, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Carpal tunnel syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 325, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 332, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 325, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 332, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Diabetic neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 325, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 332, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 325, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 332, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Lacunar stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 325, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 332, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Vascular encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 325, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 332, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Nephropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 325, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 332, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Benign prostatic hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 325, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 332, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Arteriosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 325, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 332, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 325, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 332, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 325, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 332, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Peripheral venous disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 164, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 325, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 332, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}, {'value': '325', 'groupId': 'OG002'}, {'value': '332', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Q2W', 'description': 'Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and 20 mg atorvastatin orally once a day for up to 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo QM', 'description': 'Participants received placebo subcutaneous injection once a month (QM) and 20 mg atorvastatin orally once a day for up to 12 weeks.'}, {'id': 'OG002', 'title': 'Evolocumab Q2W', 'description': 'Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and 20 mg atorvastatin orally once a day for up to 12 weeks.'}, {'id': 'OG003', 'title': 'Evolocumab QM', 'description': 'Participants received 420 mg evolocumab by subcutaneous injection once a month and 20 mg atorvastatin 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and geographic region, scheduled visit, and the interaction of treatment with scheduled visit'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LS Mean Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-70.04', 'ciLowerLimit': '-74.67', 'ciUpperLimit': '-65.41', 'pValueComment': 'Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.35', 'estimateComment': 'Treatment difference = Evolocumab QM - Placebo QM', 'statisticalMethod': 'Repeated measures linear effects model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and weeks 10 and 12', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'PRIMARY', 'title': 'Percent Change From Baseline in LDL-C at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}, {'value': '325', 'groupId': 'OG002'}, {'value': '332', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Q2W', 'description': 'Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and 20 mg atorvastatin orally once a day for up to 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo QM', 'description': 'Participants received placebo subcutaneous injection once a month (QM) and 20 mg atorvastatin orally once a day for up to 12 weeks.'}, {'id': 'OG002', 'title': 'Evolocumab Q2W', 'description': 'Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and 20 mg atorvastatin orally once a day for up to 12 weeks.'}, {'id': 'OG003', 'title': 'Evolocumab QM', 'description': 'Participants received 420 mg evolocumab by subcutaneous injection once a month and 20 mg atorvastatin orally once a day for up to 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.10', 'spread': '3.66', 'groupId': 'OG000'}, {'value': '2.63', 'spread': '3.41', 'groupId': 'OG001'}, {'value': '-64.66', 'spread': '3.20', 'groupId': 'OG002'}, {'value': '-62.30', 'spread': '3.02', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-71.77', 'ciLowerLimit': '-77.61', 'ciUpperLimit': '-65.93', 'pValueComment': 'Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.97', 'estimateComment': 'Treatment difference = Evolocumab Q2W - Placebo Q2W', 'statisticalMethod': 'Repeated measures linear 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'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and week 12', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in LDL-C at the Mean of Weeks 10 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}, {'value': '325', 'groupId': 'OG002'}, {'value': '332', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Q2W', 'description': 'Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and 20 mg atorvastatin orally once a day for up to 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo QM', 'description': 'Participants received placebo subcutaneous injection once a month (QM) and 20 mg atorvastatin orally once a day for up to 12 weeks.'}, {'id': 'OG002', 'title': 'Evolocumab Q2W', 'description': 'Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and 20 mg atorvastatin orally once a day for up to 12 weeks.'}, {'id': 'OG003', 'title': 'Evolocumab QM', 'description': 'Participants received 420 mg evolocumab by subcutaneous injection once a month and 20 mg atorvastatin orally once a day for up to 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.1', 'spread': '4.1', 'groupId': 'OG000'}, {'value': '-8.8', 'spread': '4.0', 'groupId': 'OG001'}, {'value': '-64.6', 'spread': '3.6', 'groupId': 'OG002'}, {'value': '-71.9', 'spread': '3.6', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-62.5', 'ciLowerLimit': '-68.2', 'ciUpperLimit': '-56.9', 'pValueComment': 'Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.9', 'estimateComment': 'Treatment difference = Evolocumab Q2W - Placebo Q2W', 'statisticalMethod': 'Repeated measures linear effects model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LS Mean Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-63.1', 'ciLowerLimit': '-68.4', 'ciUpperLimit': '-57.8', 'pValueComment': 'Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.7', 'estimateComment': 'Treatment difference = Evolocumab QM - Placebo QM', 'statisticalMethod': 'Repeated measures linear effects model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The model includes 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once a day for up to 12 weeks.'}, {'id': 'OG002', 'title': 'Evolocumab Q2W', 'description': 'Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and 20 mg atorvastatin orally once a day for up to 12 weeks.'}, {'id': 'OG003', 'title': 'Evolocumab QM', 'description': 'Participants received 420 mg evolocumab by subcutaneous injection once a month and 20 mg atorvastatin orally once a day for up to 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.3', 'spread': '4.2', 'groupId': 'OG000'}, {'value': '-7.3', 'spread': '4.1', 'groupId': 'OG001'}, {'value': '-63.9', 'spread': '3.7', 'groupId': 'OG002'}, {'value': '-66.1', 'spread': '3.7', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-63.6', 'ciLowerLimit': '-69.7', 'ciUpperLimit': '-57.6', 'pValueComment': 'Multiplicity adjusted p-value 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'ciPctValue': '95', 'paramValue': '-60.90', 'ciLowerLimit': '-65.51', 'ciUpperLimit': '-56.29', 'pValueComment': 'Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.35', 'estimateComment': 'Treatment difference = Evolocumab Q2W - Placebo Q2W', 'statisticalMethod': 'Repeated measures linear effects model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LS Mean Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-59.40', 'ciLowerLimit': '-63.52', 'ciUpperLimit': '-55.29', 'pValueComment': 'Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.09', 'estimateComment': 'Treatment difference = Evolocumab QM - Placebo QM', 'statisticalMethod': 'Repeated measures linear effects model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and weeks 10 and 12', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Non-HDL-C at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}, {'value': '325', 'groupId': 'OG002'}, {'value': '332', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Q2W', 'description': 'Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and 20 mg atorvastatin orally once a day for up to 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo QM', 'description': 'Participants received placebo subcutaneous injection once a month (QM) and 20 mg atorvastatin orally once a day for up to 12 weeks.'}, {'id': 'OG002', 'title': 'Evolocumab Q2W', 'description': 'Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and 20 mg atorvastatin orally once a day for up to 12 weeks.'}, {'id': 'OG003', 'title': 'Evolocumab QM', 'description': 'Participants received 420 mg evolocumab by subcutaneous injection once a month and 20 mg atorvastatin orally once a day for up to 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.87', 'spread': '3.20', 'groupId': 'OG000'}, {'value': '1.30', 'spread': '3.03', 'groupId': 'OG001'}, {'value': '-55.76', 'spread': '2.79', 'groupId': 'OG002'}, {'value': '-52.92', 'spread': '2.69', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-61.64', 'ciLowerLimit': '-66.82', 'ciUpperLimit': '-56.45', 'pValueComment': 'Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.64', 'estimateComment': 'Treatment difference = Evolocumab Q2W - Placebo Q2W', 'statisticalMethod': 'Repeated measures linear effects model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LS Mean Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-54.22', 'ciLowerLimit': '-58.70', 'ciUpperLimit': '-49.74', 'pValueComment': 'Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.28', 'estimateComment': 'Treatment difference = Evolocumab QM - Placebo QM', 'statisticalMethod': 'Repeated measures linear effects model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and week 12', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Apolipoprotein B100 at the Mean of Weeks 10 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}, {'value': '325', 'groupId': 'OG002'}, {'value': '332', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Q2W', 'description': 'Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and 20 mg atorvastatin orally once a day for up to 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo QM', 'description': 'Participants received placebo subcutaneous injection once a month (QM) and 20 mg atorvastatin orally once a day for up to 12 weeks.'}, {'id': 'OG002', 'title': 'Evolocumab Q2W', 'description': 'Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and 20 mg atorvastatin orally once a day for up to 12 weeks.'}, {'id': 'OG003', 'title': 'Evolocumab QM', 'description': 'Participants received 420 mg evolocumab by subcutaneous injection once a month and 20 mg atorvastatin orally once a day for up to 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.97', 'spread': '3.31', 'groupId': 'OG000'}, {'value': '-1.52', 'spread': '2.99', 'groupId': 'OG001'}, {'value': '-54.96', 'spread': '3.07', 'groupId': 'OG002'}, {'value': '-56.37', 'spread': '2.72', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-56.93', 'ciLowerLimit': '-60.93', 'ciUpperLimit': '-52.93', 'pValueComment': 'Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.03', 'estimateComment': 'Treatment difference = Evolocumab Q2W - Placebo Q2W', 'statisticalMethod': 'Repeated measures linear effects model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LS Mean Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-54.85', 'ciLowerLimit': '-58.52', 'ciUpperLimit': '-51.18', 'pValueComment': 'Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.87', 'estimateComment': 'Treatment difference = Evolocumab QM - Placebo QM', 'statisticalMethod': 'Repeated measures linear effects model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and weeks 10 and 12', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Apolipoprotein B100 at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}, {'value': '325', 'groupId': 'OG002'}, {'value': '332', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Q2W', 'description': 'Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and 20 mg atorvastatin orally once a day for up to 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo QM', 'description': 'Participants received placebo subcutaneous injection once a month (QM) and 20 mg atorvastatin orally once a day for up to 12 weeks.'}, {'id': 'OG002', 'title': 'Evolocumab Q2W', 'description': 'Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and 20 mg atorvastatin orally once a day for up to 12 weeks.'}, {'id': 'OG003', 'title': 'Evolocumab QM', 'description': 'Participants received 420 mg evolocumab by subcutaneous injection once a month and 20 mg atorvastatin orally once a day for up to 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.17', 'spread': '3.42', 'groupId': 'OG000'}, {'value': '-0.26', 'spread': '3.03', 'groupId': 'OG001'}, {'value': '-53.90', 'spread': '3.14', 'groupId': 'OG002'}, {'value': '-49.68', 'spread': '2.75', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-57.06', 'ciLowerLimit': '-61.59', 'ciUpperLimit': '-52.54', 'pValueComment': 'Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.30', 'estimateComment': 'Treatment difference = Evolocumab Q2W - Placebo Q2W', 'statisticalMethod': 'Repeated measures linear effects model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LS Mean Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-49.42', 'ciLowerLimit': '-53.31', 'ciUpperLimit': '-45.53', 'pValueComment': 'Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.98', 'estimateComment': 'Treatment difference = Evolocumab QM - Placebo QM', 'statisticalMethod': 'Repeated measures linear effects model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and week 12', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Total Cholesterol at the Mean of Weeks 10 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}, {'value': '325', 'groupId': 'OG002'}, {'value': '332', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Q2W', 'description': 'Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and 20 mg atorvastatin orally once a day for up to 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo QM', 'description': 'Participants received placebo subcutaneous injection once a month (QM) and 20 mg atorvastatin orally once a day for up to 12 weeks.'}, {'id': 'OG002', 'title': 'Evolocumab Q2W', 'description': 'Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and 20 mg atorvastatin orally once a day for 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'dispersionValue': '1.64', 'estimateComment': 'Treatment difference = Evolocumab QM - Placebo QM', 'statisticalMethod': 'Repeated measures linear effects model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and weeks 10 and 12', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}, {'value': '325', 'groupId': 'OG002'}, {'value': '332', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Q2W', 'description': 'Participants 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'OG003'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-43.94', 'ciLowerLimit': '-47.90', 'ciUpperLimit': '-39.97', 'pValueComment': 'Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.02', 'estimateComment': 'Treatment difference = Evolocumab Q2W - Placebo Q2W', 'statisticalMethod': 'Repeated measures linear effects model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LS Mean Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-40.56', 'ciLowerLimit': '-44.08', 'ciUpperLimit': 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'groupIds': ['OG001', 'OG003'], 'paramType': 'LS Mean Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-56.73', 'ciLowerLimit': '-60.53', 'ciUpperLimit': '-52.93', 'pValueComment': 'Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.93', 'estimateComment': 'Treatment difference = Evolocumab QM - Placebo QM', 'statisticalMethod': 'Repeated measures linear effects model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and weeks 10 and 12', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Apolipoprotein B100/Apolipoprotein A1 Ratio at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}, {'value': '325', 'groupId': 'OG002'}, {'value': '332', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Q2W', 'description': 'Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and 20 mg atorvastatin orally once a day for up to 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo QM', 'description': 'Participants received placebo subcutaneous injection once a month (QM) and 20 mg atorvastatin orally once a day for up to 12 weeks.'}, {'id': 'OG002', 'title': 'Evolocumab Q2W', 'description': 'Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and 20 mg atorvastatin orally once a day for up to 12 weeks.'}, {'id': 'OG003', 'title': 'Evolocumab QM', 'description': 'Participants received 420 mg evolocumab by 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'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL (1.8 mmol/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}, {'value': '325', 'groupId': 'OG002'}, {'value': '332', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Q2W', 'description': 'Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and 20 mg atorvastatin orally once a day for up to 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo QM', 'description': 'Participants received placebo subcutaneous injection once a month (QM) and 20 mg atorvastatin orally once a day for up to 12 weeks.'}, {'id': 'OG002', 'title': 'Evolocumab Q2W', 'description': 'Participants received 140 mg evolocumab by subcutaneous injection once every 2 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Q2W', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel Haenszel test stratified by entry statin therapy and geographic region.'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '68.8', 'ciLowerLimit': '60.6', 'ciUpperLimit': '75.3', 'pValueComment': 'Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.', 'estimateComment': 'Treatment difference = Evolocumab QM - Placebo QM', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Cochran-Mantel Haenszel test stratified by entry statin therapy and geographic region.'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full 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'Participants received 420 mg evolocumab by subcutaneous injection once a month and 20 mg atorvastatin orally once a day for up to 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.89', 'spread': '17.49', 'groupId': 'OG000'}, {'value': '8.48', 'spread': '9.49', 'groupId': 'OG001'}, {'value': '-38.63', 'spread': '13.67', 'groupId': 'OG002'}, {'value': '-42.29', 'spread': '8.49', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-55.52', 'ciLowerLimit': '-92.64', 'ciUpperLimit': '-18.40', 'pValueComment': 'Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '18.85', 'estimateComment': 'Treatment difference = Evolocumab Q2W - Placebo Q2W', 'statisticalMethod': 'Repeated measures linear effects model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LS Mean Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-50.77', 'ciLowerLimit': '-63.82', 'ciUpperLimit': '-37.72', 'pValueComment': 'Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.63', 'estimateComment': 'Treatment difference = Evolocumab QM - Placebo QM', 'statisticalMethod': 'Repeated measures linear effects model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and weeks 10 and 12', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Lipoprotein(a) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}, {'value': '325', 'groupId': 'OG002'}, {'value': '332', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Q2W', 'description': 'Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and 20 mg atorvastatin orally once a day for up to 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo QM', 'description': 'Participants received placebo subcutaneous injection once a month (QM) and 20 mg atorvastatin orally once a day for up to 12 weeks.'}, {'id': 'OG002', 'title': 'Evolocumab Q2W', 'description': 'Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and 20 mg atorvastatin orally once a day for up to 12 weeks.'}, {'id': 'OG003', 'title': 'Evolocumab QM', 'description': 'Participants received 420 mg evolocumab by subcutaneous injection once a month and 20 mg atorvastatin orally once a day for up to 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '26.53', 'spread': '21.78', 'groupId': 'OG000'}, {'value': '7.47', 'spread': '10.40', 'groupId': 'OG001'}, {'value': '-35.93', 'spread': '16.47', 'groupId': 'OG002'}, {'value': '-37.85', 'spread': '9.02', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-62.46', 'ciLowerLimit': '-110.89', 'ciUpperLimit': '-14.03', 'pValueComment': 'Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '24.64', 'estimateComment': 'Treatment difference = Evolocumab Q2W - Placebo Q2W', 'statisticalMethod': 'Repeated measures linear effects model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LS Mean Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-45.32', 'ciLowerLimit': '-61.87', 'ciUpperLimit': '-28.77', 'pValueComment': 'Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.42', 'estimateComment': 'Treatment difference = Evolocumab QM - Placebo QM', 'statisticalMethod': 'Repeated measures linear effects model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and week 12', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}, {'value': '325', 'groupId': 'OG002'}, {'value': '332', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Q2W', 'description': 'Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and 20 mg atorvastatin orally once a day for up to 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo QM', 'description': 'Participants received placebo subcutaneous injection once a month (QM) and 20 mg atorvastatin orally once a day for up to 12 weeks.'}, {'id': 'OG002', 'title': 'Evolocumab Q2W', 'description': 'Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and 20 mg atorvastatin orally once a day for up to 12 weeks.'}, {'id': 'OG003', 'title': 'Evolocumab QM', 'description': 'Participants received 420 mg evolocumab by subcutaneous injection once a month and 20 mg atorvastatin orally once a day for up to 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.54', 'spread': '5.27', 'groupId': 'OG000'}, {'value': '8.48', 'spread': '4.48', 'groupId': 'OG001'}, {'value': '-6.48', 'spread': '4.70', 'groupId': 'OG002'}, {'value': '-7.15', 'spread': '4.02', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.0002', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-18.02', 'ciLowerLimit': '-25.89', 'ciUpperLimit': '-10.14', 'pValueComment': 'Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.01', 'estimateComment': 'Treatment difference = Evolocumab Q2W - Placebo Q2W', 'statisticalMethod': 'Repeated measures linear effects model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LS Mean Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-15.63', 'ciLowerLimit': '-21.69', 'ciUpperLimit': '-9.58', 'pValueComment': 'Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.08', 'estimateComment': 'Treatment difference = Evolocumab QM - Placebo QM', 'statisticalMethod': 'Repeated measures linear effects model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and weeks 10 and 12', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Triglycerides at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}, {'value': '325', 'groupId': 'OG002'}, {'value': '332', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Q2W', 'description': 'Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and 20 mg atorvastatin orally once a day for up to 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo QM', 'description': 'Participants received placebo subcutaneous injection once a month (QM) and 20 mg atorvastatin orally once a day for up to 12 weeks.'}, {'id': 'OG002', 'title': 'Evolocumab Q2W', 'description': 'Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and 20 mg atorvastatin orally once a day for up to 12 weeks.'}, {'id': 'OG003', 'title': 'Evolocumab QM', 'description': 'Participants received 420 mg evolocumab by subcutaneous injection once a month and 20 mg atorvastatin orally once a day for up to 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.50', 'spread': '5.36', 'groupId': 'OG000'}, {'value': '8.07', 'spread': '4.57', 'groupId': 'OG001'}, {'value': '-5.91', 'spread': '4.75', 'groupId': 'OG002'}, {'value': '-4.24', 'spread': '4.09', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.0002', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-16.41', 'ciLowerLimit': '-24.63', 'ciUpperLimit': '-8.19', 'pValueComment': 'Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '14.18', 'estimateComment': 'Treatment difference = Evolocumab Q2W - Placebo Q2W', 'statisticalMethod': 'Repeated measures linear effects model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LS Mean Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-12.31', 'ciLowerLimit': '-18.76', 'ciUpperLimit': '-5.86', 'pValueComment': 'Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.28', 'estimateComment': 'Treatment difference = Evolocumab QM - Placebo QM', 'statisticalMethod': 'Repeated measures linear effects model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and week 12', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}, {'value': '325', 'groupId': 'OG002'}, {'value': '332', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Q2W', 'description': 'Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and 20 mg atorvastatin orally once a day for up to 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo QM', 'description': 'Participants received placebo subcutaneous injection once a month (QM) and 20 mg atorvastatin orally once a day for up to 12 weeks.'}, {'id': 'OG002', 'title': 'Evolocumab Q2W', 'description': 'Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and 20 mg atorvastatin orally once a day for up to 12 weeks.'}, {'id': 'OG003', 'title': 'Evolocumab QM', 'description': 'Participants received 420 mg evolocumab by subcutaneous injection once a month and 20 mg atorvastatin orally once a day for up to 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.25', 'spread': '2.19', 'groupId': 'OG000'}, {'value': '5.88', 'spread': '2.11', 'groupId': 'OG001'}, {'value': '7.59', 'spread': '1.99', 'groupId': 'OG002'}, {'value': '13.75', 'spread': '1.90', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.0003', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.34', 'ciLowerLimit': '3.36', 'ciUpperLimit': '9.33', 'pValueComment': 'Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.52', 'estimateComment': 'Treatment difference = Evolocumab Q2W - Placebo Q2W', 'statisticalMethod': 'Repeated measures linear effects model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LS Mean Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.87', 'ciLowerLimit': '5.10', 'ciUpperLimit': '10.65', 'pValueComment': 'Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.41', 'estimateComment': 'Treatment difference = Evolocumab QM - Placebo QM', 'statisticalMethod': 'Repeated measures linear effects model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and weeks 10 and 12', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in HDL-C at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}, {'value': '325', 'groupId': 'OG002'}, {'value': '332', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Q2W', 'description': 'Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and 20 mg atorvastatin orally once a day for up to 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo QM', 'description': 'Participants received placebo subcutaneous injection once a month (QM) and 20 mg atorvastatin orally once a day for up to 12 weeks.'}, {'id': 'OG002', 'title': 'Evolocumab Q2W', 'description': 'Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and 20 mg atorvastatin orally once a day for up to 12 weeks.'}, {'id': 'OG003', 'title': 'Evolocumab QM', 'description': 'Participants received 420 mg evolocumab by subcutaneous injection once a month and 20 mg atorvastatin orally once a day for up to 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.57', 'spread': '2.29', 'groupId': 'OG000'}, {'value': '6.04', 'spread': '2.18', 'groupId': 'OG001'}, {'value': '8.45', 'spread': '2.04', 'groupId': 'OG002'}, {'value': '14.18', 'spread': '1.95', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.0003', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.88', 'ciLowerLimit': '2.49', 'ciUpperLimit': '9.27', 'pValueComment': 'Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.72', 'estimateComment': 'Treatment difference = Evolocumab Q2W - Placebo Q2W', 'statisticalMethod': 'Repeated measures linear effects model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LS Mean Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.14', 'ciLowerLimit': '5.03', 'ciUpperLimit': '11.25', 'pValueComment': 'Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.58', 'estimateComment': 'Treatment difference = Evolocumab QM - Placebo QM', 'statisticalMethod': 'Repeated measures linear effects model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and week 12', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in VLDL-C at the Mean of Weeks 10 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}, {'value': '325', 'groupId': 'OG002'}, {'value': '332', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Q2W', 'description': 'Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and 20 mg atorvastatin orally once a day for up to 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo QM', 'description': 'Participants received placebo subcutaneous injection once a month (QM) and 20 mg atorvastatin orally once a day for up to 12 weeks.'}, {'id': 'OG002', 'title': 'Evolocumab Q2W', 'description': 'Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and 20 mg atorvastatin orally once a day for up to 12 weeks.'}, {'id': 'OG003', 'title': 'Evolocumab QM', 'description': 'Participants received 420 mg evolocumab by subcutaneous injection once a month and 20 mg atorvastatin orally once a day for up to 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.63', 'spread': '4.70', 'groupId': 'OG000'}, {'value': '7.92', 'spread': '4.43', 'groupId': 'OG001'}, {'value': '-17.55', 'spread': '4.19', 'groupId': 'OG002'}, {'value': '-16.09', 'spread': '3.99', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-27.18', 'ciLowerLimit': '-34.20', 'ciUpperLimit': '-20.17', 'pValueComment': 'Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.57', 'estimateComment': 'Treatment difference = Evolocumab Q2W - Placebo Q2W', 'statisticalMethod': 'Repeated measures linear effects model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LS Mean Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-24.01', 'ciLowerLimit': '-29.88', 'ciUpperLimit': '-18.14', 'pValueComment': 'Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.99', 'estimateComment': 'Treatment difference = Evolocumab QM - Placebo QM', 'statisticalMethod': 'Repeated measures linear effects model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The model includes treatment group, entry statin therapy and geographic region, scheduled visit, and the interaction of treatment with scheduled visit'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and weeks 10 and 12', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo Q2W', 'description': 'Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and 20 mg atorvastatin orally once a day for up to 12 weeks.'}, {'id': 'FG001', 'title': 'Placebo QM', 'description': 'Participants received placebo subcutaneous injection once a month (QM) and 20 mg atorvastatin orally once a day for up to 12 weeks.'}, {'id': 'FG002', 'title': 'Evolocumab Q2W', 'description': 'Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and 20 mg atorvastatin orally once a day for up to 12 weeks.'}, {'id': 'FG003', 'title': 'Evolocumab QM', 'description': 'Participants received 420 mg evolocumab by subcutaneous injection once a month and 20 mg atorvastatin orally once a day for up to 12 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '166'}, {'groupId': 'FG001', 'numSubjects': '161'}, {'groupId': 'FG002', 'numSubjects': '327'}, {'groupId': 'FG003', 'numSubjects': '332'}]}, {'type': 'Received Study Drug', 'comment': 'Study drug defined as subcutaneous evolocumab or placebo to evolocumab', 'achievements': [{'groupId': 'FG000', 'numSubjects': '164'}, {'groupId': 'FG001', 'numSubjects': '160'}, {'groupId': 'FG002', 'numSubjects': '325'}, {'groupId': 'FG003', 'numSubjects': '332'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '159'}, {'groupId': 'FG001', 'numSubjects': '160'}, {'groupId': 'FG002', 'numSubjects': '321'}, {'groupId': 'FG003', 'numSubjects': '328'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were enrolled at 102 study centers and randomized at 98 centers in Argentina, Brazil, Canada, China, Colombia, France, Republic of Korea, Russian Federation, Turkey, and the United States from 14 April 2016 to 28 July 2017.', 'preAssignmentDetails': 'Participants who met eligibility criteria and completed at least 4 weeks of lipid stabilization on atorvastatin 20 mg daily were randomized in a 1:1:2:2 ratio to receive placebo every 2 weeks (Q2W), placebo once a month (QM), evolocumab Q2W, or evolocumab QM. Randomization was stratified by entry statin therapy and geographic region.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'BG000'}, {'value': '161', 'groupId': 'BG001'}, {'value': '327', 'groupId': 'BG002'}, {'value': '332', 'groupId': 'BG003'}, {'value': '986', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo Q2W', 'description': 'Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and 20 mg atorvastatin orally once a day for up to 12 weeks.'}, {'id': 'BG001', 'title': 'Placebo QM', 'description': 'Participants received placebo subcutaneous injection once a month (QM) and 20 mg atorvastatin orally once a day for up to 12 weeks.'}, {'id': 'BG002', 'title': 'Evolocumab Q2W', 'description': 'Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and 20 mg atorvastatin orally once a day for up to 12 weeks.'}, {'id': 'BG003', 'title': 'Evolocumab 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[{'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'BG000'}, {'value': '161', 'groupId': 'BG001'}, {'value': '327', 'groupId': 'BG002'}, {'value': '332', 'groupId': 'BG003'}, {'value': '986', 'groupId': 'BG004'}]}], 'categories': [{'title': '18 - 64 years', 'measurements': [{'value': '105', 'groupId': 'BG000'}, {'value': '101', 'groupId': 'BG001'}, {'value': '206', 'groupId': 'BG002'}, {'value': '208', 'groupId': 'BG003'}, {'value': '620', 'groupId': 'BG004'}]}, {'title': '65 - 80 years', 'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '121', 'groupId': 'BG002'}, {'value': '124', 'groupId': 'BG003'}, {'value': '366', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'BG000'}, {'value': '161', 'groupId': 'BG001'}, {'value': '327', 'groupId': 'BG002'}, {'value': '332', 'groupId': 'BG003'}, {'value': '986', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '102', 'groupId': 'BG000'}, {'value': '94', 'groupId': 'BG001'}, {'value': '178', 'groupId': 'BG002'}, {'value': '190', 'groupId': 'BG003'}, {'value': '564', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '149', 'groupId': 'BG002'}, {'value': '142', 'groupId': 'BG003'}, {'value': '422', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'BG000'}, {'value': '161', 'groupId': 'BG001'}, {'value': '327', 'groupId': 'BG002'}, {'value': '332', 'groupId': 'BG003'}, {'value': '986', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}, {'value': '67', 'groupId': 'BG003'}, {'value': '195', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '137', 'groupId': 'BG000'}, {'value': '127', 'groupId': 'BG001'}, {'value': '262', 'groupId': 'BG002'}, {'value': '265', 'groupId': 'BG003'}, {'value': '791', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'BG000'}, {'value': '161', 'groupId': 'BG001'}, {'value': '327', 'groupId': 'BG002'}, {'value': '332', 'groupId': 'BG003'}, {'value': '986', 'groupId': 'BG004'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '82', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '164', 'groupId': 'BG002'}, {'value': '166', 'groupId': 'BG003'}, {'value': '492', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}, {'value': '42', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '72', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '140', 'groupId': 'BG002'}, {'value': '140', 'groupId': 'BG003'}, {'value': '420', 'groupId': 'BG004'}]}, {'title': 'Multiple', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '30', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Stratification Factor: Statin Therapy at Study Entry', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'BG000'}, {'value': '161', 'groupId': 'BG001'}, {'value': '327', 'groupId': 'BG002'}, {'value': '332', 'groupId': 'BG003'}, {'value': '986', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Intensive statin usage', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}, {'value': '94', 'groupId': 'BG004'}]}, {'title': 'Non-intensive statin usage', 'measurements': [{'value': '83', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '167', 'groupId': 'BG002'}, {'value': '166', 'groupId': 'BG003'}, {'value': '496', 'groupId': 'BG004'}]}, {'title': 'No statin', 'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '129', 'groupId': 'BG002'}, {'value': '134', 'groupId': 'BG003'}, {'value': '396', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Intensive: at least one of the following recorded for the last 4 weeks prior to screening: atorvastatin ≥ 40 mg once daily (QD); rosuvastatin ≥ 20 mg QD; simvastatin ≥ 80 mg QD; any statin (atorvastatin, fluvastatin, lovastatin, pitavastatin, pravastatin, rosuvastatin, and simvastatin) QD plus ezetimibe.\n\nNon-intensive: Participant was taking any dose of a statin at least weekly for the last 4 weeks prior to screening and is not included in the intensive statin usage.\n\nNo statin: Participant was not included in the intensive statin usage or non-intensive statin usage.', 'unitOfMeasure': 'Participants'}, {'title': 'Stratification Factor: Geographic Region', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'BG000'}, {'value': '161', 'groupId': 'BG001'}, {'value': '327', 'groupId': 'BG002'}, {'value': '332', 'groupId': 'BG003'}, {'value': '986', 'groupId': 'BG004'}]}], 'categories': [{'title': 'China', 'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '150', 'groupId': 'BG002'}, {'value': '152', 'groupId': 'BG003'}, {'value': '453', 'groupId': 'BG004'}]}, {'title': 'South Korea', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '38', 'groupId': 'BG004'}]}, {'title': 'Other countries', 'measurements': [{'value': '84', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '163', 'groupId': 'BG002'}, {'value': '167', 'groupId': 'BG003'}, {'value': '495', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Low-density Lipoprotein Cholesterol (LDL-C) Concentration', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'BG000'}, {'value': '160', 'groupId': 'BG001'}, {'value': '325', 'groupId': 'BG002'}, {'value': '332', 'groupId': 'BG003'}, {'value': '981', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '92.2', 'spread': '32.0', 'groupId': 'BG000'}, {'value': '91.0', 'spread': '30.7', 'groupId': 'BG001'}, {'value': '92.4', 'spread': '33.8', 'groupId': 'BG002'}, {'value': '93.5', 'spread': '33.6', 'groupId': 'BG003'}, {'value': '92.5', 'spread': '32.9', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Full analysis set, defined as all randomized participants who received at least 1 dose of study drug (subcutaneous evolocumab or placebo to evolocumab).'}, {'title': 'Non-high-density Lipoprotein Cholesterol (non-HDL-C) Concentration', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'BG000'}, {'value': '160', 'groupId': 'BG001'}, {'value': '325', 'groupId': 'BG002'}, {'value': '332', 'groupId': 'BG003'}, {'value': '981', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '119.2', 'spread': '38.2', 'groupId': 'BG000'}, {'value': '119.4', 'spread': '36.0', 'groupId': 'BG001'}, {'value': '121.3', 'spread': '38.1', 'groupId': 'BG002'}, {'value': '121.2', 'spread': '37.0', 'groupId': 'BG003'}, {'value': '120.6', 'spread': '37.4', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Full analysis set'}, {'title': 'Apolipoprotein B100 Concentration', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'BG000'}, {'value': '158', 'groupId': 'BG001'}, {'value': '325', 'groupId': 'BG002'}, {'value': '332', 'groupId': 'BG003'}, {'value': '977', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '82.1', 'spread': '23.1', 'groupId': 'BG000'}, {'value': '83.4', 'spread': '22.3', 'groupId': 'BG001'}, {'value': '84.8', 'spread': '23.0', 'groupId': 'BG002'}, {'value': '84.4', 'spread': '21.8', 'groupId': 'BG003'}, {'value': '84.0', 'spread': '22.5', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'Apolipoprotein B100 is the primary apolipoprotein of low-density lipoprotein cholesterol particles, and plays a role in moving cholesterol around the body.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Full analysis set with available data'}, {'title': 'Total Cholesterol', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'BG000'}, {'value': '160', 'groupId': 'BG001'}, {'value': '325', 'groupId': 'BG002'}, {'value': '332', 'groupId': 'BG003'}, {'value': '981', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '166.5', 'spread': '38.6', 'groupId': 'BG000'}, {'value': '169.3', 'spread': '37.5', 'groupId': 'BG001'}, {'value': '167.8', 'spread': '38.9', 'groupId': 'BG002'}, {'value': '168.9', 'spread': '38.9', 'groupId': 'BG003'}, {'value': '168.2', 'spread': '38.6', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Full analysis set'}, {'title': 'Total Cholesterol/High-density Lipoprotein Cholesterol(HDL-C) Ratio', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'BG000'}, {'value': '160', 'groupId': 'BG001'}, {'value': '325', 'groupId': 'BG002'}, {'value': '332', 'groupId': 'BG003'}, {'value': '981', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '3.717', 'spread': '1.337', 'groupId': 'BG000'}, {'value': '3.598', 'spread': '1.071', 'groupId': 'BG001'}, {'value': '3.804', 'spread': '1.273', 'groupId': 'BG002'}, {'value': '3.725', 'spread': '1.201', 'groupId': 'BG003'}, {'value': '3.729', 'spread': '1.229', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'ratio', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Full analysis set'}, {'title': 'Apolipoprotein B100/Apolipoprotein A1 Ratio', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'BG000'}, {'value': '158', 'groupId': 'BG001'}, {'value': '325', 'groupId': 'BG002'}, {'value': '332', 'groupId': 'BG003'}, {'value': '977', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '0.573', 'spread': '0.192', 'groupId': 'BG000'}, {'value': '0.563', 'spread': '0.161', 'groupId': 'BG001'}, {'value': '0.601', 'spread': '0.200', 'groupId': 'BG002'}, {'value': '0.586', 'spread': '0.185', 'groupId': 'BG003'}, {'value': '0.585', 'spread': '0.188', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'ratio', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Full analysis set with available data'}, {'title': 'Lipoprotein (a)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'BG000'}, {'value': '160', 'groupId': 'BG001'}, {'value': '325', 'groupId': 'BG002'}, {'value': '332', 'groupId': 'BG003'}, {'value': '981', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '67.0', 'spread': '90.9', 'groupId': 'BG000'}, {'value': '71.8', 'spread': '96.5', 'groupId': 'BG001'}, {'value': '65.6', 'spread': '92.5', 'groupId': 'BG002'}, {'value': '73.2', 'spread': '95.9', 'groupId': 'BG003'}, {'value': '69.4', 'spread': '94.0', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'nmol/L', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Full analysis set'}, {'title': 'Triglycerides Concentration', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'BG000'}, {'value': '160', 'groupId': 'BG001'}, {'value': '325', 'groupId': 'BG002'}, {'value': '332', 'groupId': 'BG003'}, {'value': '981', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '137.3', 'spread': '77.3', 'groupId': 'BG000'}, {'value': '150.6', 'spread': '154.6', 'groupId': 'BG001'}, {'value': '145.9', 'spread': '67.5', 'groupId': 'BG002'}, {'value': '139.7', 'spread': '64.9', 'groupId': 'BG003'}, {'value': '143.1', 'spread': '88.4', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Full analysis set'}, {'title': 'High-density Lipoprotein Cholesterol (HDL-C) Concentration', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'BG000'}, {'value': '160', 'groupId': 'BG001'}, {'value': '325', 'groupId': 'BG002'}, {'value': '332', 'groupId': 'BG003'}, {'value': '981', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '47.3', 'spread': '11.9', 'groupId': 'BG000'}, {'value': '49.9', 'spread': '15.2', 'groupId': 'BG001'}, {'value': '46.5', 'spread': '11.5', 'groupId': 'BG002'}, {'value': '47.6', 'spread': '12.3', 'groupId': 'BG003'}, {'value': '47.6', 'spread': '12.6', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Full analysis set'}, {'title': 'Very Low-density Lipoprotein Cholesterol (VLDL-C) Concentration', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'BG000'}, {'value': '160', 'groupId': 'BG001'}, {'value': '325', 'groupId': 'BG002'}, {'value': '332', 'groupId': 'BG003'}, {'value': '981', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '27.3', 'spread': '14.9', 'groupId': 'BG000'}, {'value': '28.4', 'spread': '16.2', 'groupId': 'BG001'}, {'value': '28.7', 'spread': '12.6', 'groupId': 'BG002'}, {'value': '27.8', 'spread': '12.7', 'groupId': 'BG003'}, {'value': '28.1', 'spread': '13.7', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Full analysis set'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-11-11', 'size': 3419622, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-11-30T12:12', 'hasProtocol': True}, {'date': '2017-07-14', 'size': 568084, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-11-30T12:12', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 986}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2017-12-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-10', 'studyFirstSubmitDate': '2016-01-20', 'resultsFirstSubmitDate': '2018-11-30', 'studyFirstSubmitQcDate': '2016-01-20', 'lastUpdatePostDateStruct': {'date': '2019-01-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-01-10', 'studyFirstPostDateStruct': {'date': '2016-01-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-01-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12', 'timeFrame': 'Baseline and weeks 10 and 12'}, {'measure': 'Percent Change From Baseline in LDL-C at Week 12', 'timeFrame': 'Baseline and week 12'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in LDL-C at the Mean of Weeks 10 and 12', 'timeFrame': 'Baseline and weeks 10 and 12'}, {'measure': 'Change From Baseline in LDL-C at Week 12', 'timeFrame': 'Baseline and week 12'}, {'measure': 'Percent Change From Baseline in Non-HDL-C at the Mean of Weeks 10 and 12', 'timeFrame': 'Baseline and weeks 10 and 12'}, {'measure': 'Percent Change From Baseline in Non-HDL-C at Week 12', 'timeFrame': 'Baseline and week 12'}, {'measure': 'Percent Change From Baseline in Apolipoprotein B100 at the Mean of Weeks 10 and 12', 'timeFrame': 'Baseline and weeks 10 and 12'}, {'measure': 'Percent Change From Baseline in Apolipoprotein B100 at Week 12', 'timeFrame': 'Baseline and week 12'}, {'measure': 'Percent Change From Baseline in Total Cholesterol at the Mean of Weeks 10 and 12', 'timeFrame': 'Baseline and weeks 10 and 12'}, {'measure': 'Percent Change From Baseline in Total Cholesterol at Week 12', 'timeFrame': 'Baseline and week 12'}, {'measure': 'Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at the Mean of Weeks 10 and 12', 'timeFrame': 'Baseline and weeks 10 and 12'}, {'measure': 'Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at Week 12', 'timeFrame': 'Baseline and week 12'}, {'measure': 'Percent Change From Baseline in Apolipoprotein B100/Apolipoprotein A1 Ratio at the Mean of Weeks 10 and 12', 'timeFrame': 'Baseline and weeks 10 and 12'}, {'measure': 'Percent Change From Baseline in Apolipoprotein B100/Apolipoprotein A1 Ratio at Week 12', 'timeFrame': 'Baseline and week 12'}, {'measure': 'Percentage of Participants With Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL (1.8 mmol/L)', 'timeFrame': 'Weeks 10 and 12'}, {'measure': 'Percentage of Participants With LDL-C Less Than 70 mg/dL (1.8 mmol/L) at Week 12', 'timeFrame': 'Week 12'}, {'measure': 'Percent Change From Baseline in Lipoprotein(a) at the Mean of Weeks 10 and 12', 'timeFrame': 'Baseline and weeks 10 and 12'}, {'measure': 'Percent Change From Baseline in Lipoprotein(a) at Week 12', 'timeFrame': 'Baseline and week 12'}, {'measure': 'Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12', 'timeFrame': 'Baseline and weeks 10 and 12'}, {'measure': 'Percent Change From Baseline in Triglycerides at Week 12', 'timeFrame': 'Baseline and week 12'}, {'measure': 'Percent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12', 'timeFrame': 'Baseline and weeks 10 and 12'}, {'measure': 'Percent Change From Baseline in HDL-C at Week 12', 'timeFrame': 'Baseline and week 12'}, {'measure': 'Percent Change From Baseline in VLDL-C at the Mean of Weeks 10 and 12', 'timeFrame': 'Baseline and weeks 10 and 12'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Diabetes, Hyperlipidemia, Mixed Dyslipidemia']}, 'referencesModule': {'references': [{'pmid': '32318641', 'type': 'DERIVED', 'citation': 'Blom DJ, Chen J, Yuan Z, Borges JLC, Monsalvo ML, Wang N, Hamer AW, Ge J. Effects of evolocumab therapy and low LDL-C levels on vitamin E and steroid hormones in Chinese and global patients with type 2 diabetes. Endocrinol Diabetes Metab. 2020 Mar 6;3(2):e00123. doi: 10.1002/edm2.123. eCollection 2020 Apr.'}, {'pmid': '30851062', 'type': 'DERIVED', 'citation': 'Chen Y, Yuan Z, Lu J, Eliaschewitz FG, Lorenzatti AJ, Monsalvo ML, Wang N, Hamer AW, Ge J. Randomized study of evolocumab in patients with type 2 diabetes and dyslipidaemia on background statin: Pre-specified analysis of the Chinese population from the BERSON clinical trial. Diabetes Obes Metab. 2019 Jun;21(6):1464-1473. doi: 10.1111/dom.13700. Epub 2019 Apr 14.'}], 'seeAlsoLinks': [{'url': 'http://www.amgentrials.com', 'label': 'AmgenTrials clinical trials website'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study was to evaluate the effect of 12 weeks of subcutaneous evolocumab (AMG 145) in combination with statin therapy (atorvastatin) on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in diabetic adults with hyperlipidemia or mixed dyslipidemia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and females with type 2 diabetes (receiving pharmacologic treatment for at least 6 months or longer) with stable diabetes therapy\n* Lipid-lowering therapy must be unchanged for at least 4 weeks or more\n* Subjects receiving statin therapy at screening must have a fasting LDL-C of greater than or equal to 100 mg/dL\n* Subjects not receiving statin therapy at screening must have a fasting LDL-C of greater than or equal to 130 mg/dL\n\nExclusion criteria:\n\n* New York Heart Association (NYHA) class III or IV heart failure\n* Uncontrolled cardiac arrhythmia\n* Uncontrolled hypertension\n* Type 1 diabetes or poorly controlled type 2 diabetes\n* Uncontrolled hypothyroidism or hyperthyroidism.'}, 'identificationModule': {'nctId': 'NCT02662569', 'acronym': 'BERSON', 'briefTitle': 'Safety and Efficacy of Evolocumab in Combination With Statin Therapy in Adults With Diabetes and Hyperlipidemia or Mixed Dyslipidemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amgen'}, 'officialTitle': 'A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Safety and Efficacy of Evolocumab (AMG 145) in Combination With Statin Therapy in Diabetic Subjects With Hyperlipidemia or Mixed Dyslipidemia (BERSON)', 'orgStudyIdInfo': {'id': '20120119'}, 'secondaryIdInfos': [{'id': '2013-000723-14', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Atorvastatin (Q2W)', 'description': 'Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and 20 mg atorvastatin orally once a day for up to 12 weeks.', 'interventionNames': ['Drug: Atorvastatin', 'Other: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Atorvastatin (QM)', 'description': 'Participants received placebo subcutaneous injection once a month (QM) and 20 mg atorvastatin orally once a day for up to 12 weeks.', 'interventionNames': ['Drug: Atorvastatin', 'Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Evolocumab Q2W + Atorvastatin', 'description': 'Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and 20 mg atorvastatin orally once a day for up to 12 weeks.', 'interventionNames': ['Biological: Evolocumab', 'Drug: Atorvastatin']}, {'type': 'EXPERIMENTAL', 'label': 'Evolocumab QM + Atorvastatin', 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