Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2026-02-25 @ 3:35 AM
Study NCT ID:
NCT01763905
Status:
COMPLETED
Last Update Posted:
2020-07-20
First Post:
2013-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects -2
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D006937', 'term': 'Hypercholesterolemia'}], 'ancestors': [{'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C577155', 'term': 'evolocumab'}, {'id': 'D000069438', 'term': 'Ezetimibe'}], 'ancestors': [{'id': 'D001384', 'term': 'Azetidines'}, {'id': 'D001385', 'term': 'Azetines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'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 blinded investigational product until the end of the study (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': 'Ezetimibe (Q2W)', 'description': 'Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.', 'otherNumAtRisk': 51, 'otherNumAffected': 20, 'seriousNumAtRisk': 51, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Ezetimibe (QM)', 'description': 'Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.', 'otherNumAtRisk': 51, 'otherNumAffected': 29, 'seriousNumAtRisk': 51, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'Evolocumab Q2W', 'description': 'Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.', 'otherNumAtRisk': 103, 'otherNumAffected': 28, 'seriousNumAtRisk': 103, 'seriousNumAffected': 5}, {'id': 'EG003', 'title': 'Evolocumab QM', 'description': 'Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.', 'otherNumAtRisk': 102, 'otherNumAffected': 42, 'seriousNumAtRisk': 102, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 103, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 103, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 103, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 103, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 103, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 103, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 103, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 103, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 9}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 103, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 12}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 103, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 12}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}], 'seriousEvents': [{'term': 'Gastrointestinal motility disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Kidney infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Hepatic enzyme increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 103, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 103, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Bladder transitional cell carcinoma stage III', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 103, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Lipoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 103, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Neuroendocrine carcinoma metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 103, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Cartilage graft', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Osteotomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Spinal decompression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Change From Baseline in LDL-C at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '103', 'groupId': 'OG002'}, {'value': '102', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ezetimibe (Q2W)', 'description': 'Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.'}, {'id': 'OG001', 'title': 'Ezetimibe (QM)', 'description': 'Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe 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 placebo tablets 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 placebo tablets once a day for up to 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-18.08', 'spread': '2.52', 'groupId': 'OG000'}, {'value': '-15.05', 'spread': '2.13', 'groupId': 'OG001'}, {'value': '-56.14', 'spread': '1.91', 'groupId': 'OG002'}, {'value': '-52.60', 'spread': '1.58', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-38.06', 'ciLowerLimit': '-43.73', 'ciUpperLimit': '-32.99', 'pValueComment': 'Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.87', 'groupDescription': 'The null hypothesis was that there is no mean difference in the percent change from Baseline at Week 12 in LDL-C between evolocumab and ezetimibe, and the alternative hypothesis is that a mean difference does exist.', 'statisticalMethod': 'Repeated measures linear effects model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LS Mean Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-37.55', 'ciLowerLimit': '-42.16', 'ciUpperLimit': '-32.94', 'pValueComment': 'Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.33', 'groupDescription': 'The null hypothesis was that there is no mean difference in the percent change from baseline at Week 12 in LDL-C between evolocumab and ezetimibe, and the alternative hypothesis is that a mean difference does exist.', 'statisticalMethod': 'Repeated measures linear effects model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'The model includes treatment group, baseline LDL-C level and statin use, 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 (all randomized participants who received at least 1 dose of investigational product (subcutaneously or orally)) with available data (no imputation was performed).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in LDL-C at the Mean of Weeks 10 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '103', 'groupId': 'OG002'}, {'value': '102', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ezetimibe (Q2W)', 'description': 'Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.'}, {'id': 'OG001', 'title': 'Ezetimibe (QM)', 'description': 'Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe 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 placebo tablets 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 placebo tablets once a day for up to 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-39.1', 'spread': '5.1', 'groupId': 'OG000'}, {'value': '-33.0', 'spread': '4.5', 'groupId': 'OG001'}, {'value': '-105.4', 'spread': '3.9', 'groupId': 'OG002'}, {'value': '-103.6', 'spread': '3.4', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-66.3', 'ciLowerLimit': '-77.9', 'ciUpperLimit': '-54.7', 'pValueComment': 'Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.9', 'statisticalMethod': 'Repeated measures linear effects model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LS Mean Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-70.6', 'ciLowerLimit': '-80.5', 'ciUpperLimit': '-60.7', 'pValueComment': 'Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.0', 'statisticalMethod': 'Repeated measures linear effects model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Weeks 10 and 12', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in LDL-C at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '103', 'groupId': 'OG002'}, {'value': '102', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ezetimibe (Q2W)', 'description': 'Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.'}, {'id': 'OG001', 'title': 'Ezetimibe (QM)', 'description': 'Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe 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 placebo tablets 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 placebo tablets once a day for up to 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-36.2', 'spread': '5.4', 'groupId': 'OG000'}, {'value': '-30.2', 'spread': '4.7', 'groupId': 'OG001'}, {'value': '-106.0', 'spread': '4.1', 'groupId': 'OG002'}, {'value': '-99.0', 'spread': '3.5', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-69.7', 'ciLowerLimit': '-82.0', 'ciUpperLimit': '-57.5', 'pValueComment': 'Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.2', 'statisticalMethod': 'Repeated measures linear effects model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LS Mean Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-68.8', 'ciLowerLimit': '-79.2', 'ciUpperLimit': '-58.4', 'pValueComment': 'Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.3', 'statisticalMethod': 'Repeated measures linear effects model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 12', 'unitOfMeasure': 'mg/dL', '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': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '103', 'groupId': 'OG002'}, {'value': '102', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ezetimibe (Q2W)', 'description': 'Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.'}, {'id': 'OG001', 'title': 'Ezetimibe (QM)', 'description': 'Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe 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 placebo tablets 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 placebo tablets once a day for up to 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '0.4', 'upperLimit': '10.5'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '7.3'}, {'value': '45.5', 'groupId': 'OG002', 'lowerLimit': '36.2', 'upperLimit': '55.2'}, {'value': '42.0', 'groupId': 'OG003', 'lowerLimit': '32.8', 'upperLimit': '51.8'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '43.5', 'ciLowerLimit': '30.9', 'ciUpperLimit': '53.4', 'pValueComment': 'Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Cochran-Mantel Haenszel test stratified by baseline LDL-C and statin use. For testing, non-achievement was imputed for participants with missing data.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '42.0', 'ciLowerLimit': '30.3', 'ciUpperLimit': '51.8', 'pValueComment': 'Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Cochran-Mantel Haenszel test stratified by baseline LDL-C and statin use. For testing, non-achievement was imputed for participants with missing data.'}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 10 and 12', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With LDL-C < 70 mg/dL (1.8 mmol/L) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '103', 'groupId': 'OG002'}, {'value': '102', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ezetimibe (Q2W)', 'description': 'Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.'}, {'id': 'OG001', 'title': 'Ezetimibe (QM)', 'description': 'Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe 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 placebo tablets 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 placebo tablets once a day for up to 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '0.4', 'upperLimit': '10.7'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '7.9'}, {'value': '50.0', 'groupId': 'OG002', 'lowerLimit': '40.3', 'upperLimit': '59.7'}, {'value': '37.5', 'groupId': 'OG003', 'lowerLimit': '28.5', 'upperLimit': '47.5'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '48.0', 'ciLowerLimit': '35.0', 'ciUpperLimit': '57.8', 'pValueComment': 'Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Cochran-Mantel Haenszel test stratified by baseline LDL-C and statin use. For testing, non-achievement was imputed for participants with missing data.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '37.5', 'ciLowerLimit': '25.5', 'ciUpperLimit': '47.5', 'pValueComment': 'Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Cochran-Mantel Haenszel test stratified by baseline LDL-C and statin use. For testing, non-achievement was imputed for participants with missing data.'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Non-HDL-C at the Mean of Weeks 10 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '103', 'groupId': 'OG002'}, {'value': '102', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ezetimibe (Q2W)', 'description': 'Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.'}, {'id': 'OG001', 'title': 'Ezetimibe (QM)', 'description': 'Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe 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 placebo tablets 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 placebo tablets once a day for up to 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-17.18', 'spread': '2.15', 'groupId': 'OG000'}, {'value': '-14.54', 'spread': '1.86', 'groupId': 'OG001'}, {'value': '-48.72', 'spread': '1.64', 'groupId': 'OG002'}, {'value': '-49.13', 'spread': '1.40', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-31.53', 'ciLowerLimit': '-36.34', 'ciUpperLimit': '-26.73', 'pValueComment': 'Multiplicity adjusted p-value is significant if less than the familywise error 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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': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '103', 'groupId': 'OG002'}, {'value': '102', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ezetimibe (Q2W)', 'description': 'Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.'}, {'id': 'OG001', 'title': 'Ezetimibe (QM)', 'description': 'Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe 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 placebo tablets 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 placebo tablets once a day for up to 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-16.53', 'spread': '2.30', 'groupId': 'OG000'}, {'value': '-13.16', 'spread': '1.93', 'groupId': 'OG001'}, {'value': '-48.62', 'spread': '1.74', 'groupId': 'OG002'}, {'value': '-46.15', 'spread': '1.43', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-32.09', 'ciLowerLimit': '-37.28', 'ciUpperLimit': '-26.90', 'pValueComment': 'Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.', 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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 B at the Mean of Weeks 10 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '103', 'groupId': 'OG002'}, {'value': '102', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ezetimibe (Q2W)', 'description': 'Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.'}, {'id': 'OG001', 'title': 'Ezetimibe (QM)', 'description': 'Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe 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 placebo tablets 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 placebo tablets once a day for up to 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-13.67', 'spread': '2.15', 'groupId': 'OG000'}, {'value': '-11.02', 'spread': '2.21', 'groupId': 'OG001'}, {'value': '-45.88', 'spread': '1.68', 'groupId': 'OG002'}, {'value': '-46.01', 'spread': '1.65', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-32.20', 'ciLowerLimit': '-36.92', 'ciUpperLimit': '-27.49', 'pValueComment': 'Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.', 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10 mg ezetimibe 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 placebo tablets 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 placebo tablets once a day for up to 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-14.13', 'spread': '2.30', 'groupId': 'OG000'}, {'value': '-9.92', 'spread': '2.34', 'groupId': 'OG001'}, {'value': '-40.42', 'spread': '1.75', 'groupId': 'OG002'}, {'value': '-38.57', 'spread': '1.73', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-26.28', 'ciLowerLimit': '-31.42', 'ciUpperLimit': '-21.15', 'pValueComment': 'Multiplicity 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subcutaneous injection once a month and 10 mg ezetimibe 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 placebo tablets 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 placebo tablets once a day for up to 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-13.00', 'spread': '2.27', 'groupId': 'OG000'}, {'value': '-11.94', 'spread': '2.56', 'groupId': 'OG001'}, {'value': '-47.86', 'spread': '1.77', 'groupId': 'OG002'}, {'value': '-48.31', 'spread': '1.92', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-34.86', 'ciLowerLimit': '-39.84', 'ciUpperLimit': 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measures linear effects model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'The model includes treatment group, baseline LDL-C level and statin use, 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 Very Low-Density Lipoprotein Cholesterol at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '103', 'groupId': 'OG002'}, {'value': '102', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ezetimibe (Q2W)', 'description': 'Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 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'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.67', 'ciLowerLimit': '-9.96', 'ciUpperLimit': '8.61', 'pValueComment': 'Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.70', 'statisticalMethod': 'Repeated measures linear effects model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.'}, {'pValue': '0.33', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LS Mean Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.08', 'ciLowerLimit': '-11.24', 'ciUpperLimit': '11.39', 'pValueComment': 'Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.72', 'statisticalMethod': 'Repeated measures linear effects model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'The model includes treatment group, baseline LDL-C level and statin use, 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': 'PRIMARY', 'title': 'Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '103', 'groupId': 'OG002'}, {'value': '102', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Ezetimibe (Q2W)', 'description': 'Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.'}, {'id': 'OG001', 'title': 'Ezetimibe (QM)', 'description': 'Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe 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 placebo tablets 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 placebo tablets once a day for up to 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-19.21', 'spread': '2.40', 'groupId': 'OG000'}, {'value': '-16.62', 'spread': '2.03', 'groupId': 'OG001'}, {'value': '-56.11', 'spread': '1.83', 'groupId': 'OG002'}, {'value': '-55.31', 'spread': '1.53', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-36.90', 'ciLowerLimit': '-42.26', 'ciUpperLimit': '-31.55', 'pValueComment': 'Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.71', 'groupDescription': 'The null hypothesis was that there is no mean difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and ezetimibe, and the alternative hypothesis is that a mean difference does exist.', 'statisticalMethod': 'Repeated measures linear effects model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'The model includes treatment group, baseline LDL-C level and statin use, scheduled visit, and the interaction of treatment with scheduled visit.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LS Mean Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-38.69', 'ciLowerLimit': '-43.06', 'ciUpperLimit': '-34.22', 'pValueComment': 'Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.21', 'groupDescription': 'The null hypothesis was that there is no mean difference in the percent change from Baseline in the average value of LDL-C at Weeks 10 and 12 between evolocumab and ezetimibe, and the alternative hypothesis is that a mean difference does exist.', 'statisticalMethod': 'Repeated measures linear effects model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'The model includes treatment group, baseline LDL-C level and statin use, 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 with available data (no imputation was performed).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ezetimibe (Q2W)', 'description': 'Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.'}, {'id': 'FG001', 'title': 'Ezetimibe (QM)', 'description': 'Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe 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 placebo tablets 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 placebo tablets once a day for up to 12 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': 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'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Men and women ≥ 18 to ≤ 80 years of age who have tried at least 2 statins and were unable to tolerate any dose or increase in statin dose due to muscle-related side effects were eligible for this study.\n\nThe first participant was enrolled on 24 January 2013 and the last participant enrolled on 29 August 2013.', 'preAssignmentDetails': 'Participants received subcutaneous placebo corresponding to the once monthly dose volume during a 6-week screening period. Those who completed the screening period and met final eligibility criteria were randomized 1:1:2:2 into 4 treatment groups. Randomization was stratified by low-density lipoprotein cholesterol (LDL-C) level and statin use.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}, {'value': '102', 'groupId': 'BG003'}, {'value': '307', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Ezetimibe (Q2W)', 'description': 'Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.'}, {'id': 'BG001', 'title': 'Ezetimibe (QM)', 'description': 'Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe 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 placebo tablets once a day for up to 12 weeks.'}, {'id': 'BG003', 'title': 'Evolocumab 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'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}]}]}, {'title': 'Not Hispanic or Latino', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}, {'value': '101', 'groupId': 'BG003'}, {'value': '300', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Stratification Factor: Low-density Lipoprotein Cholesterol (LDL-C) Level', 'classes': [{'title': '< 180 mg/dL', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}, {'value': '156', 'groupId': 'BG004'}]}]}, {'title': '≥ 180 mg/dL', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 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{'value': '192.0', 'spread': '57.0', 'groupId': 'BG002'}, {'value': '192.2', 'spread': '61.2', 'groupId': 'BG003'}, {'value': '193.1', 'spread': '58.5', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Non-High-Density Lipoprotein Cholesterol (non-HDL-C) Concentration', 'classes': [{'categories': [{'measurements': [{'value': '231.4', 'spread': '66.0', 'groupId': 'BG000'}, {'value': '232.9', 'spread': '57.0', 'groupId': 'BG001'}, {'value': '227.9', 'spread': '56.6', 'groupId': 'BG002'}, {'value': '222.1', 'spread': '63.2', 'groupId': 'BG003'}, {'value': '227.4', 'spread': '60.4', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Apolipoprotein B Concentration', 'classes': [{'categories': [{'measurements': [{'value': '140.0', 'spread': '37.0', 'groupId': 'BG000'}, {'value': '140.0', 'spread': '31.1', 'groupId': 'BG001'}, {'value': '140.2', 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'spread': '0.318', 'groupId': 'BG002'}, {'value': '0.901', 'spread': '0.283', 'groupId': 'BG003'}, {'value': '0.952', 'spread': '0.298', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'ratio', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Lipoprotein(a) Concentration', 'classes': [{'categories': [{'measurements': [{'value': '106.3', 'spread': '101.0', 'groupId': 'BG000'}, {'value': '76.6', 'spread': '96.7', 'groupId': 'BG001'}, {'value': '66.2', 'spread': '72.5', 'groupId': 'BG002'}, {'value': '70.9', 'spread': '99.9', 'groupId': 'BG003'}, {'value': '76.2', 'spread': '91.9', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'nmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Triglyceride Concentration', 'classes': [{'categories': [{'measurements': [{'value': '183.4', 'spread': '79.8', 'groupId': 'BG000'}, {'value': '187.0', 'spread': '81.5', 'groupId': 'BG001'}, {'value': '179.8', 'spread': '80.0', 'groupId': 'BG002'}, {'value': '149.3', 'spread': '63.1', 'groupId': 'BG003'}, {'value': '171.5', 'spread': '76.3', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Very Low-density Lipoprotein Cholesterol (VLDL-C) Concentration', 'classes': [{'categories': [{'measurements': [{'value': '36.7', 'spread': '16.0', 'groupId': 'BG000'}, {'value': '37.1', 'spread': '15.8', 'groupId': 'BG001'}, {'value': '35.2', 'spread': '14.5', 'groupId': 'BG002'}, {'value': '29.9', 'spread': '12.6', 'groupId': 'BG003'}, {'value': '34.0', 'spread': '14.6', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'High-Density Lipoprotein Cholesterol (HDL-C)', 'classes': [{'categories': [{'measurements': [{'value': '52.4', 'spread': '18.3', 'groupId': 'BG000'}, {'value': '48.0', 'spread': '11.0', 'groupId': 'BG001'}, {'value': '51.1', 'spread': '16.4', 'groupId': 'BG002'}, {'value': '54.0', 'spread': '16.0', 'groupId': 'BG003'}, {'value': '51.8', 'spread': '15.9', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}]}}, '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': 307}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'dispFirstSubmitDate': '2014-05-02', 'completionDateStruct': {'date': '2013-11-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-01', 'studyFirstSubmitDate': '2013-01-07', 'dispFirstSubmitQcDate': '2014-05-02', 'resultsFirstSubmitDate': '2015-09-02', 'studyFirstSubmitQcDate': '2013-01-08', 'dispFirstPostDateStruct': {'date': '2014-05-20', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2020-07-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-11-18', 'studyFirstPostDateStruct': {'date': '2013-01-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-12-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change From Baseline in LDL-C at Week 12', 'timeFrame': 'Baseline and Week 12'}, {'measure': 'Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12', 'timeFrame': 'Baseline and Weeks 10 and 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': '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 < 70 mg/dL (1.8 mmol/L) at Week 12', 'timeFrame': '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 B at the Mean of Weeks 10 and 12', 'timeFrame': 'Baseline and Weeks 10 and 12'}, {'measure': 'Percent Change From Baseline in Apolipoprotein B at Week 12', 'timeFrame': 'Baseline and Week 12'}, {'measure': 'Percent Change From Baseline in the Total Cholesterol/High Density Lipoprotein Cholesterol Ratio at the Mean of Weeks 10 and 12', 'timeFrame': 'Baseline and Weeks 10 and 12'}, {'measure': 'Percent Change From Baseline in the Total Cholesterol/High Density Lipoprotein Cholesterol Ratio at Week 12', 'timeFrame': 'Baseline and Week 12'}, {'measure': 'Percent Change From Baseline in Apolipoprotein B/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 B/Apolipoprotein A1 Ratio at Week 12', 'timeFrame': 'Baseline and 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 High-Density Lipoprotein Cholesterol (HDL-C) at the Mean of Weeks 10 and 12', 'timeFrame': 'Baseline and Weeks 10 and 12'}, {'measure': 'Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) at Week 12', 'timeFrame': 'Baseline and Week 12'}, {'measure': 'Percent Change From Baseline in Very Low-Density Lipoprotein Cholesterol at the Mean of Weeks 10 and 12', 'timeFrame': 'Baseline and Weeks 10 and 12'}, {'measure': 'Percent Change From Baseline in Very Low-Density Lipoprotein Cholesterol at Week 12', 'timeFrame': 'Baseline and Week 12'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['High Cholesterol, Treatment for high cholesterol, Lowering cholesterol, Lowering high cholesterol, Hypercholesterolemia'], 'conditions': ['Hyperlipidemia']}, 'referencesModule': {'references': [{'pmid': '28249876', 'type': 'BACKGROUND', 'citation': 'Toth PP, Descamps O, Genest J, Sattar N, Preiss D, Dent R, Djedjos C, Wu Y, Geller M, Uhart M, Somaratne R, Wasserman SM; PROFICIO Investigators. Pooled Safety Analysis of Evolocumab in Over 6000 Patients From Double-Blind and Open-Label Extension Studies. Circulation. 2017 May 9;135(19):1819-1831. doi: 10.1161/CIRCULATIONAHA.116.025233. Epub 2017 Mar 1.'}, {'pmid': '29736889', 'type': 'BACKGROUND', 'citation': 'Kuchimanchi M, Grover A, Emery MG, Somaratne R, Wasserman SM, Gibbs JP, Doshi S. Population pharmacokinetics and exposure-response modeling and simulation for evolocumab in healthy volunteers and patients with hypercholesterolemia. J Pharmacokinet Pharmacodyn. 2018 Jun;45(3):505-522. doi: 10.1007/s10928-018-9592-y. Epub 2018 May 7.'}, {'pmid': '30073585', 'type': 'BACKGROUND', 'citation': 'Cho L, Dent R, Stroes ESG, Stein EA, Sullivan D, Ruzza A, Flower A, Somaratne R, Rosenson RS. Persistent Safety and Efficacy of Evolocumab in Patients with Statin Intolerance: a Subset Analysis of the OSLER Open-Label Extension Studies. Cardiovasc Drugs Ther. 2018 Aug;32(4):365-372. doi: 10.1007/s10557-018-6817-7.'}, {'pmid': '29353350', 'type': 'BACKGROUND', 'citation': 'Kasichayanula S, Grover A, Emery MG, Gibbs MA, Somaratne R, Wasserman SM, Gibbs JP. Clinical Pharmacokinetics and Pharmacodynamics of Evolocumab, a PCSK9 Inhibitor. Clin Pharmacokinet. 2018 Jul;57(7):769-779. doi: 10.1007/s40262-017-0620-7.'}, {'pmid': '29768954', 'type': 'BACKGROUND', 'citation': 'Wasserman SM, Sabatine MS, Koren MJ, Giugliano RP, Legg JC, Emery MG, Doshi S, Liu T, Somaratne R, Gibbs JP. Comparison of LDL-C Reduction Using Different Evolocumab Doses and Intervals: Biological Insights and Treatment Implications. J Cardiovasc Pharmacol Ther. 2018 Sep;23(5):423-432. doi: 10.1177/1074248418774043. Epub 2018 May 16.'}, {'pmid': '24477778', 'type': 'BACKGROUND', 'citation': 'Cho L, Rocco M, Colquhoun D, Sullivan D, Rosenson RS, Dent R, Xue A, Scott R, Wasserman SM, Stroes E. Design and rationale of the GAUSS-2 study trial: a double-blind, ezetimibe-controlled phase 3 study of the efficacy and tolerability of evolocumab (AMG 145) in subjects with hypercholesterolemia who are intolerant of statin therapy. Clin Cardiol. 2014 Mar;37(3):131-9. doi: 10.1002/clc.22248. Epub 2014 Jan 29.'}, {'pmid': '24694531', 'type': 'BACKGROUND', 'citation': 'Stroes E, Colquhoun D, Sullivan D, Civeira F, Rosenson RS, Watts GF, Bruckert E, Cho L, Dent R, Knusel B, Xue A, Scott R, Wasserman SM, Rocco M; GAUSS-2 Investigators. Anti-PCSK9 antibody effectively lowers cholesterol in patients with statin intolerance: the GAUSS-2 randomized, placebo-controlled phase 3 clinical trial of evolocumab. J Am Coll Cardiol. 2014 Jun 17;63(23):2541-2548. doi: 10.1016/j.jacc.2014.03.019. Epub 2014 Mar 30.'}, {'pmid': '30755061', 'type': 'BACKGROUND', 'citation': 'Shapiro MD, Minnier J, Tavori H, Kassahun H, Flower A, Somaratne R, Fazio S. Relationship Between Low-Density Lipoprotein Cholesterol and Lipoprotein(a) Lowering in Response to PCSK9 Inhibition With Evolocumab. J Am Heart Assoc. 2019 Feb 19;8(4):e010932. doi: 10.1161/JAHA.118.010932.'}, {'pmid': '30120772', 'type': 'BACKGROUND', 'citation': 'Stroes E, Robinson JG, Raal FJ, Dufour R, Sullivan D, Kassahun H, Ma Y, Wasserman SM, Koren MJ. Consistent LDL-C response with evolocumab among patient subgroups in PROFICIO: A pooled analysis of 3146 patients from phase 3 studies. Clin Cardiol. 2018 Oct;41(10):1328-1335. doi: 10.1002/clc.23049. Epub 2018 Oct 21.'}, {'pmid': '32114889', 'type': 'BACKGROUND', 'citation': 'Toth PP, Jones SR, Monsalvo ML, Elliott-Davey M, Lopez JAG, Banach M. Effect of Evolocumab on Non-High-Density Lipoprotein Cholesterol, Apolipoprotein B, and Lipoprotein(a): A Pooled Analysis of Phase 2 and Phase 3 Studies. J Am Heart Assoc. 2020 Mar 3;9(5):e014129. doi: 10.1161/JAHA.119.014129. Epub 2020 Mar 2.'}, {'pmid': '32564340', 'type': 'BACKGROUND', 'citation': 'Koren MJ, Jones PH, Robinson JG, Sullivan D, Cho L, Hucko T, Lopez JAG, Fleishman AN, Somaratne R, Stroes E. A Comparison of Ezetimibe and Evolocumab for Atherogenic Lipid Reduction in Four Patient Populations: A Pooled Efficacy and Safety Analysis of Three Phase 3 Studies. Cardiol Ther. 2020 Dec;9(2):447-465. doi: 10.1007/s40119-020-00181-8. 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